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M Turbo User Manual

The M-Turbo Ultrasound System User Guide provides comprehensive instructions on preparing, using, and maintaining the ultrasound system, including details on system setup, imaging modes, measurements, and safety protocols. It is designed for users familiar with ultrasound techniques and includes information on intended uses for various imaging applications. The guide also emphasizes the importance of proper training and provides contact information for technical support.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
8 views208 pages

M Turbo User Manual

The M-Turbo Ultrasound System User Guide provides comprehensive instructions on preparing, using, and maintaining the ultrasound system, including details on system setup, imaging modes, measurements, and safety protocols. It is designed for users familiar with ultrasound techniques and includes information on intended uses for various imaging applications. The guide also emphasizes the importance of proper training and provides contact information for technical support.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 208

M-Turbo TM

Ultrasound System

User Guide
M-Turbo TM

Ultrasound System

User Guide
SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021
USA
T: 1‐888‐482‐9449 or 1‐425‐951‐1200
F: 1‐425‐951‐1201
SonoSite Ltd
Alexander House
40A Wilbury Way
Hitchin
Herts SG4 0AP
UK
T: +44‐1462‐444800
F: +44‐1462‐444801

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

M-Turbo, SiteLink, SonoCalc, SonoHD, SonoMB, and SonoSite are registered trademarks or trademarks of SonoSite, Inc.

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital
communications of medical information.

Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.

Protected by U.S. patents: 5722412, 5817024, 5893363, 6135961, 6364839, 6371918, 6383139, 6416475, 6471651, 6569101, 6648826,
6962566, 7169108, D456509, D538432. Patents pending.

P07662‐01 11/2007
Copyright 2007 by SonoSite, Inc.
All rights reserved.

ii
Contents

Introduction

Conventions, symbols, and terms ......................................................................... vii


Customer comments .................................................................................................. vii

Chapter 1: Getting Started

About the system .......................................................................................................... 1


About the system software ........................................................................................ 2
Transducers, accessories, and peripherals ............................................................ 2
Intended uses ................................................................................................................. 2
Preparing the system ................................................................................................... 5
Installing or removing the battery ................................................................. 5
Using AC power and charging the battery ................................................. 6
Turning the system on or off ............................................................................ 6
Connecting transducers .................................................................................... 7
Inserting and removing USB storage devices ............................................ 7
System controls .............................................................................................................. 9
Screen layout ................................................................................................................12
General interaction .....................................................................................................13
Touchpad and cursor ........................................................................................13
On-screen options .............................................................................................13
Annotation and text ..........................................................................................14
Preparing transducers ...............................................................................................16

Chapter 2: System Setup

A & B Key, Footswitch setup ....................................................................................17


Administration setup .................................................................................................18
Security settings .................................................................................................18
User setup .............................................................................................................19
Exporting or importing user accounts .......................................................20
Exporting and clearing the Event log .........................................................20
Logging in as user ..............................................................................................21
Choosing a secure password .........................................................................21
Annotations setup ......................................................................................................22
Audio, Battery setup ...................................................................................................23
Cardiac Calculations setup ......................................................................................23
Connectivity setup ......................................................................................................24
Date and Time setup ..................................................................................................25
Display Information setup ........................................................................................25
IMT Calculations setup ..............................................................................................25
Network Status setup .................................................................................................26
OB Calculations setup ................................................................................................26

iii
OB Custom Measurements setup .......................................................................... 27
OB Custom Tables setup ........................................................................................... 28
Presets setup ................................................................................................................. 29
System Information setup ........................................................................................ 30
USB Devices setup ...................................................................................................... 30
Restoring default settings ........................................................................................ 31

Chapter 3: Imaging

Imaging modes ............................................................................................................ 33


Adjusting depth and gain ............................................................................... 33
Freezing, viewing frames, and zooming .................................................... 33
Changing the exam type ................................................................................. 34
2D imaging ........................................................................................................... 34
M Mode imaging ................................................................................................ 36
CPD and color Doppler imaging ................................................................... 37
PW and CW Doppler imaging ........................................................................ 39
Imaging modes and exams available by transducer ............................. 42
Annotations ................................................................................................................... 43
Patient information form .......................................................................................... 45
Saving images and clips ............................................................................................ 48
Patient list ...................................................................................................................... 50
ECG Monitoring ............................................................................................................ 52

Chapter 4: Measurements and Calculations

Measurements .............................................................................................................. 55
Working with calipers ....................................................................................... 55
2D measurements .............................................................................................. 56
M Mode measurements ................................................................................... 58
Doppler measurements ................................................................................... 59
General calculations ................................................................................................... 61
Calculations menu ............................................................................................. 61
Performing and saving measurements in calculations ........................ 62
Viewing, repeating, and deleting saved measurements
in calculations ...................................................................................................... 62
Percent reduction calculations ...................................................................... 63
Volume calculations .......................................................................................... 65
Volume flow calculations ................................................................................ 66
Specialized calculations ............................................................................................ 68
Cardiac calculations .......................................................................................... 68
Gynecology (Gyn) calculations ...................................................................... 79
IMT calculations .................................................................................................. 80
OB calculations ................................................................................................... 83
Small Parts calculations ................................................................................... 89
Vascular calculations ......................................................................................... 90
Patient report ................................................................................................................ 92
Vascular and cardiac reports .......................................................................... 92

iv
OB reports .............................................................................................................92
Sending reports and viewing EMED worksheets ....................................94

Chapter 5: Troubleshooting and Maintenance

Troubleshooting ..........................................................................................................95
Software licensing .......................................................................................................96
Maintenance .................................................................................................................97
Cleaning and disinfecting the ultrasound system .................................98
Cleaning and disinfecting transducers .......................................................99
Cleaning and disinfecting transducer cables ........................................ 101
Cleaning and disinfecting the battery .................................................... 102
Cleaning the footswitch ................................................................................ 102
Cleaning and disinfecting ECG cables ..................................................... 102

Chapter 6: Safety

Ergonomic safety ...................................................................................................... 111


Position the system ........................................................................................ 112
Position yourself .............................................................................................. 112
Take breaks, exercise, and vary activities ................................................ 113
Electrical safety classification ............................................................................... 113
Electrical safety .......................................................................................................... 113
Equipment safety ..................................................................................................... 116
Battery safety ............................................................................................................. 116
Biological safety ........................................................................................................ 117
Electromagnetic compatibility ............................................................................ 118
Manufacturer’s declaration .......................................................................... 119
ALARA principle ........................................................................................................ 122
Applying ALARA .............................................................................................. 123
Direct controls .................................................................................................. 123
Indirect controls ............................................................................................... 124
Receiver controls ............................................................................................. 124
Acoustic artifacts ...................................................................................................... 124
Guidelines for reducing MI and TI ...................................................................... 124
Output display ........................................................................................................... 126
Mechanical and thermal indices output display accuracy ............... 127
Factors that contribute to display uncertainty ..................................... 127
Related guidance documents ..................................................................... 127
Transducer surface temperature rise ................................................................ 128
Acoustic output measurement ............................................................................ 129
In Situ, derated, and water value intensities .......................................... 129
Tissue models and equipment survey ..................................................... 130
Acoustic output tables ........................................................................................... 131
Terms used in the acoustic output tables .............................................. 148
Acoustic measurement precision and uncertainty ............................. 149
Labeling symbols ...................................................................................................... 150

v
Chapter 7: References

Measurement accuracy ...........................................................................................155


Sources of measurement errors ...........................................................................157
Measurement publications and terminology .................................................157
Cardiac references ............................................................................................157
Obstetrical references .....................................................................................164
Gestational age tables ....................................................................................165
Growth analysis tables ...................................................................................167
Ratio calculations .............................................................................................169
General references ...........................................................................................169

Chapter 8: Specifications

Dimensions ..................................................................................................................173
Supported transducers ...........................................................................................173
Imaging modes ..........................................................................................................173
Images and clips storage ........................................................................................174
Accessories ..................................................................................................................174
Peripherals ...................................................................................................................174
Temperature and humidity limits ........................................................................175
Operating limits ................................................................................................175
Shipping and storage limits .........................................................................175
Electrical .......................................................................................................................175
Battery ...........................................................................................................................175
Electromechanical safety standards ...................................................................176
EMC standards classification .................................................................................176
Airborne equipment standards ............................................................................176
DICOM standard ........................................................................................................176
HIPAA standard ..........................................................................................................177

Glossary

Terms .............................................................................................................................179
Abbreviations .............................................................................................................181

Index ...........................................................................................................................191

vi
Introduction

Introduction
This M‐Turbo Ultrasound System User Guide provides information on preparing and using the
M‐Turbo™ ultrasound system and on cleaning and disinfecting the system and transducers. It
also provides references for calculations, system specifications, and safety and acoustic output
information.
The user guide is for a reader familiar with ultrasound techniques. It does not provide training
in sonography or clinical practices. Before using the system, you must have ultrasound
training.
See the applicable SonoSite accessory user guide for information on using accessories and
peripherals. See the manufacturer’s instructions for specific information about peripherals.

Conventions, symbols, and terms


The user guide follows these conventions:
• A WARNING describes precautions necessary to prevent injury or loss of life.
• A Caution describes precautions necessary to protect the products.
• Numbered steps must be performed in a specific order.
• Bulleted lists present information in list format but do not imply a sequence.
Symbols and terms used on the system and transducer are explained in Chapter 2, Chapter 5,
Chapter 6, and Glossary.

Customer comments
Questions and comments are encouraged. SonoSite is interested in your feedback regarding the
system and the user guide. Please call SonoSite at 888‐482‐9449 in the US. Outside the US, call
the nearest SonoSite representative. You can also e‐mail SonoSite at [email protected].

Introduction vii
For technical support, please contact SonoSite as follows:

SonoSite Technical Support

Phone (US or Canada): 877-657-8118

Phone (Outside US 425-951-1330


and Canada): Or call your local representative.

Fax: 425-951-6700

E-mail: [email protected]

Web site: www.sonosite.com. Click Support & Service.

Europe Service Center: +44-(0)1462-444-800


e-mail: [email protected]

viii
Chapter 1: Getting Started

About the system


The M‐Turbo ultrasound system is a portable, software‐controlled device using all‐digital
architecture. The system has multiple configurations and feature sets used to acquire and
display high‐resolution, real‐time ultrasound images. Features available on your system

Getting Started
depend on system configuration, transducer, and exam type.

4
1

Figure 1 System Front Features:


(1) Control panel, (2) Handle, (3) Display, (4) USB ports for storage, updates, importing, and exporting

2 3 4

Figure 2 System Back Connectors:


(1) DC input connector, (2) I/O connector, (3) Battery, and (4) ECG connector

Chapter 1: Getting Started 1


To use the ultrasound system
1 Turn the system on. (For power switch location, see “System controls” on page 9.)
2 Attach a transducer.
3 Press the PATIENT key, and complete the patient information form.
4 Press an imaging mode key:
• 2D
• M MODE
• COLOR
• DOPPLER

About the system software


The ultrasound system contains software that controls its operation. A license key is required
to activate the software. See “Software licensing” on page 96.
On occasion, a software upgrade may be required. SonoSite provides a USB device containing
the software. One USB device can be used to upgrade multiple systems.

Transducers, accessories, and peripherals


The ultrasound system may include transducers, accessories and peripherals. Peripherals
include medical grade (conforming to EN60601‐1 requirements) and non‐medical grade
(commercial) products. Manufacturer’s instructions accompany each peripheral.
See Chapter 8, “Specifications,” for a complete list of compatible transducers, accessories, and
peripherals.

Intended uses
The intended uses for each exam type are as follows. For the intended transducer for each exam
type, see “Imaging modes and exams available by transducer” on page 42.
Abdominal Imaging Applications This system transmits ultrasound energy into the abdomen
of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue
Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The
liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal
vessels, and surrounding anatomical structures can be assessed for the presence or absence of
pathology transabdominally.
Cardiac Imaging Applications This system transmits ultrasound energy into the thorax of
patients using 2D, M Mode, color Doppler (Color), Tissue Harmonic Imaging (THI), pulsed
wave (PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW)

2
Doppler to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding
anatomical structures, overall cardiac performance, and heart size can be assessed for the
presence or absence of pathology.
The patient’s electrocardiogram (ECG) may be obtained and is used for timing of diastolic and
systolic function.

WARNING: The ECG is not used to diagnose cardiac arrhythmias and is not designed for long
term cardiac rhythm monitoring.

Getting Started
Gynecology and Infertility Imaging Applications This system transmits ultrasound energy in
the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler
(Color), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound
images. The uterus, ovaries, adnexa, and surrounding anatomical structures can be assessed for
the presence or absence of pathology transabdominally or transvaginally.
Interventional Imaging Applications This system transmits ultrasound energy into the various
parts of the body using 2D, color Doppler (Color), color power Doppler (CPD), Tissue
Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that
provide guidance during interventional procedures. This system can be used to provide
ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral
nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical
procedures, and provide assistance during abdominal, breast, and neurological surgery.
Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of
pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD),
Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images.
The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and
surrounding anatomical structures can be assessed for the presence or absence of pathology
transabdominally or transvaginally. CPD and color Doppler (Color) imaging is intended for
high‐risk pregnant women. High‐risk pregnancy indications include, but are not limited to,
multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension,
diabetes, and lupus.

WARNING: To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical
Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been
validated to be proven effective for these two uses.
CPD or Color images can be used as an adjunctive method, not as a screening tool,
for the detection of structural anomalies of the fetal heart and as an adjunctive
method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation
(IUGR).

Pediatric Imaging Applications This system transmits ultrasound energy into the pediatric
patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), pulsed wave
(PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW) Doppler to

Chapter 1: Getting Started 3


obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips,
neonatal head, and surrounding anatomical structures can be assessed for the presence or
absence of pathology.
Prostate Imaging Applications This system transmits ultrasound energy into the prostate of an
adult male using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed
wave (PW) Doppler to obtain ultrasound images. The prostate gland can be assessed for the
presence or absence of pathology.
Superficial Imaging Applications This system transmits ultrasound energy into various parts
of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed
wave (PW) Doppler to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes,
hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical
structures can be assessed for the presence or absence of pathology. This system can be used to
provide ultrasound guidance for biopsy and drainage procedures, vascular line placement,
peripheral nerve blocks, and spinal nerve blocks and taps.
Vascular Imaging Applications This system transmits ultrasound energy into the various parts
of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed
wave (PW) Doppler to obtain ultrasound images. The carotid arteries, deep veins, and arteries
in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and
various small vessels feeding organs can be assessed for the presence or absence of pathology.

4
Preparing the system
Installing or removing the battery
WARNING: To avoid injury to the operator and to prevent damage to the ultrasound system,
inspect the battery for leaks prior to installing.
To avoid data loss and to conduct a safe system shutdown, always keep a battery in
the system.

Getting Started
Locking levers

Figure 3 Install the Battery

To install the battery


1 Disconnect the power supply from the ultrasound system.
2 Remove the system from the mini‐dock (if present) and turn it upside down.
3 Place the battery into the battery compartment, at a slight angle. See Figure 3.
4 Slide the battery forward until it locks into place.
5 Push down on the two locking levers to secure the battery.

To remove the battery


1 Disconnect the power supply from the ultrasound system.
2 Remove the system from the mini‐dock (if present) and turn it upside down.
3 Pull up the two locking levers.
4 Slide the battery back.
5 Lift the battery from the compartment.

Chapter 1: Getting Started 5


Using AC power and charging the battery
The battery charges when the system is connected to the AC power supply. A fully discharged
battery recharges in less than five hours.
The system can run on AC power and charge the battery if AC power is connected to the system
directly, to a mini‐dock, or to a docking system.
The system can run on battery power for up to two hours, depending on the imaging mode and
the display brightness.

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

Caution: Verify that the hospital supply voltage corresponds to the power supply voltage
range. See “Electrical” on page 175.

To operate the system using AC power


1 Connect the DC power cable from the power supply to the connector on the system. See
Figure 2 on page 1.
2 Connect the AC power cord to the power supply and to a hospital‐grade electrical outlet.

Turning the system on or off


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

To turn the system on or off


™ Press the power switch. (See “System controls” on page 9.)

To wake up the system


To conserve battery life while the system is on, the system goes into sleep mode if the lid is
closed or if the system is untouched for a preset time. To adjust the time for sleep delay, see
“Audio, Battery setup” on page 23.
™ Press a key, touch the touchpad, or open the lid.

6
Connecting transducers
WARNING: To avoid injury to the patient, do not place the connector on the patient. Operate
the ultrasound system in a docking system or on a flat hard surface to allow air flow
past the connector.

Caution: To avoid damaging the transducer connector, do not allow foreign material in the
connector.

Getting Started
Figure 4 Connect the Transducer

To connect a transducer
1 Remove the system from the mini‐dock (if present), and turn it upside down.
2 Pull the transducer latch up, and rotate it clockwise.
3 Align the transducer connector with the connector on the bottom of the system.
4 Insert the transducer connector into the system connector.
5 Turn the latch counterclockwise.
6 Press the latch down, securing the transducer connector to the system.

To remove a transducer
1 Pull the transducer latch up, and rotate it clockwise.
2 Pull the transducer connector away from the system.

Inserting and removing USB storage devices


Images and clips are saved to internal storage and are organized in a sortable patient list. You
can archive the images and clips from the ultrasound system to a PC using a USB storage device
or Ethernet connection. Although the images and clips cannot be viewed from a USB storage
device on the ultrasound system, you can remove the device and view them on your PC.

Chapter 1: Getting Started 7


There are two USB ports on the system, and one on the mini‐dock. For additional USB ports,
you can connect a USB hub into any USB port.

WARNING: To avoid damaging the USB storage device and losing patient data from it, observe
the following:
• Do not remove the USB storage device or turn off the ultrasound system while the
system is exporting.
• Do not bump or otherwise apply pressure to the USB storage device while it is in a
USB port on the ultrasound system. The connector could break.

Caution: If the USB icon does not appear in the system status area on-screen, the USB storage
device may be defective or password-protected. Turn the system off and replace the
device.

To insert a USB storage device


™ Insert the USB storage device into any USB port on the system or mini‐dock. See Figure 1 on
page 1.
The USB storage device is ready when the USB icon appears.
To view information about the device, see “USB Devices setup” on page 30

To remove a USB storage device


Removing the USB storage device while the system is exporting to it may cause the exported
files to be corrupted or incomplete.
1 Wait five seconds after the USB animation stops.
2 Remove the USB storage device from the port.

8
System controls

1 14

2
15

Getting Started
3
4 16
5
17
18
6 19

20

8 9 10 11 12 13

1 Power switch Turns system on and off.

2 Alphanumeric Use to enter text and numbers.


keys

3 Annotation keys See “Alphanumeric keyboard” on page 14.

4 ZOOM Magnifies the image 100%.

5 DEPTH UP, Decreases and increases imaging depth.


DEPTH DOWN

6 AUTO GAIN Adjusts gain automatically.

Chapter 1: Getting Started 9


7 Gain

Near Adjusts the gain applied to the near field of the image.

Far Adjusts the gain applied to the far field of the image.

Gain/ In live imaging, adjusts the overall gain applied to the entire
Cine Buffer image. On a frozen image, moves the cine buffer.

8 AC power A steady light indicates that AC power is connected. A flashing


indicator light indicates that the system is asleep.

9 CALIPER Displays calipers on-screen for measuring.


CALCS Turns the calculations menu on and off.

10 Touchpad Selects, adjusts, and moves items on-screen.

11 FREEZE Stops live imaging and displays a frozen image.

12 SAVE Saves an image to internal storage. If configured, also saves


calculations to the report. See “Presets setup” on page 29.

13 CLIP Saves a clip to internal storage.

14 Control keys Control on-screen options.

15 Forms

SETUP Displays the system settings.

REPORT Accesses the patient report and EMED worksheets.

REVIEW Accesses the patient list, saved images, and archiving functions.

PATIENT Accesses patient information.

10
16 EXAM Opens exam menu.

17 Shortcut keys Keys that you can program to perform common tasks.

18 SET Sets a trace measurement.

SELECT Used with the touchpad to select items on-screen. Also switches
between Color and Doppler options, calipers for measurement,
pictograph-marker position and angle, frozen images in duplex
and dual screens, and arrow position and orientation.

Getting Started
SAVE CALC Saves calculations and their measurements to the patient report.

19 UPDATE Toggles between dual and duplex screens and imaging modes
in M Mode and Doppler (for example, between D-line and
Doppler spectral trace).

20 Imaging Modes

M MODE Turns M Mode on, toggles between M-line and M Mode trace.

DOPPLER Turns Doppler on, toggles between D-line and Doppler trace.

COLOR Turns CPD/Color on and off.

2D Turns 2D on.

Chapter 1: Getting Started 11


Screen layout
9
1
2
3
10
4

11

7
8

Figure 5 Screen Layout

1 Mode Data Area Current imaging mode information (for example, Gen, Res, THI,
and PW).

2 Orientation Provides indication for image orientation. In dual and duplex


Marker images, the orientation marker is green on the active screen.

3 Text Text entered using keyboard.

4 Picto Pictograph to indicate anatomy and transducer position.


Displays pictograph options allowing anatomy and screen
location selection.

5 Calculations Contains available measurements.


Menu

6 Image Ultrasound image.

7 Measurement Current data on measurements and calculations.


and Calculations
Data Area

8 On-screen Options available in the current context.


Options

12
9 Patient Header Includes current patient name, patient ID number, institution,
user, and date/time.

10 System Status Information on system status (for example, exam type,


transducer, AC connected, battery charging, and USB).

11 Depth Marker Marks in .5 cm, 1 cm, and 5 cm increments depending on depth.

Getting Started
General interaction
Touchpad and cursor
Use the touchpad to adjust and move objects on‐screen. The touchpad controls caliper position,
CPD or Color box position and size, the cursor, and more. The arrow keys control much of the
same functionality as the touchpad.
The cursor appears in the setup pages, the patient information form, and patient report. You
control the cursor through the touchpad. For example, in the patient information form, place
the cursor over the last name field and press the SELECT key to activate that field. Additionally,
you can use the cursor to select check boxes and items in lists.

On-screen options
The on‐screen options let you make adjustments and select settings. The options available
depend on context.
Each option is controlled by the pair of keys below it. Depending on the option, the control keys
function in one of four ways:
Cycle Moves through a list of settings continuously. The upper control key cycles upward. The
lower control key cycles downward.
Up-Down Moves through a list of settings, stopping at the top or bottom. The upper control key
moves upward. The lower control key moves downward. By default, a beep sounds when you
reach either end of the range. (See “To change audio and battery settings” on page 23.)
On-Off Turns a feature on or off. You can press either control key. In forms, you can instead
select the option by using the touchpad and the SELECT key.
Action Performs an action. You can press either control key. Or you can instead select the option
by using the touchpad and the SELECT key.

Figure 6 On-screen options (2D imaging shown)

Chapter 1: Getting Started 13


Annotation and text
Alphanumeric keyboard

10
1
2 11
3
4

5 6 7 8 9

1 TAB Moves cursor among fields in the forms, and tabs between text
position in dual screens.

2 CAPS LOCK Sets the keyboard to capital letters.

3 SHIFT Allows entry of capitalized characters and international characters.

4 TEXT Turns the keyboard on and off for text entry.

5 PICTO Turns pictographs on and off.

6 ARROW Displays an arrow graphic that can be moved and rotated within
the image area.

7 SPACEBAR Turns the keyboard on for text entry. In text entry, adds a space.

8 DELETE Removes all text from the screen during text entry and when not
measuring.

9 Arrow Keys Move highlighted selection in calculations menu, move cursor one
space when entering text, move caliper position, move cine buffer
forward and backward, and move among pages in image review
and reports.

10 BACKSPACE Removes the character left of the cursor in text-entry mode.

11 ENTER Moves cursor among fields in forms and saves calculations to


report.

14
Symbols
You can enter symbols and special characters in select fields and forms. The symbols and
special characters available depend on context.
Patient information form: Last, First, Middle, Patient ID, Accession, Indications, Procedure ID,
User, Reading Dr., Referring Dr., and Institution fields
DICOM or SiteLink configuration page: Alias and AE Title fields
A & B Key, Footswitch setup page: Text field

Getting Started
Text mode (imaging): Annotation field

Figure 7 Symbols Dialog Box

To enter symbols or special characters


1 Select the field, and then select Symbols.
2 Select the desired symbol or character.
You can also press the keys on the keyboard.
3 Select OK.

Chapter 1: Getting Started 15


Preparing transducers
WARNING: Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
Some gels and sterilants can cause an allergic reaction on some individuals.

Caution: To avoid damage to the transducer, use only gels recommended by SonoSite.
Using gels other than the one recommended by SonoSite can damage the
transducer and void the warranty. If you have questions about gel compatibility,
contact SonoSite or your local representative.
SonoSite recommends that you clean transducers after each use. See “Cleaning
and disinfecting transducers” on page 99.

Acoustic coupling gel must be used during exams. Although most gels provide suitable
acoustic coupling, some gels are incompatible with some transducer materials. SonoSite
recommends Aquasonic® gel and provides a sample with the system.
For general use, apply a liberal amount of gel between the transducer and the body. For
invasive or surgical use, install a transducer sheath.

WARNING: To prevent contamination, the use of sterile transducer sheaths and sterile
coupling gel is recommended for clinical applications of an invasive or surgical
nature. Do not apply the transducer sheath and gel until you are ready to
perform the procedure.

To install a transducer sheath


SonoSite recommends the use of market‐cleared, transducer sheaths for intracavitary or
surgical applications.To lessen the risk of contamination, install the sheath only when you are
ready to perform the procedure.
1 Place gel inside the sheath.
2 Insert the transducer into the sheath.
3 Pull the sheath over the transducer and cable until the sheath is fully extended.
4 Secure the sheath using the bands supplied with the sheath.
5 Check for and eliminate bubbles between the face of the transducer and the sheath.
Bubbles between the face of the transducer and the sheath may affect the ultrasound image.
6 Inspect the sheath to ensure that there are no holes or tears.

16
Chapter 2: System Setup

The system setup pages let you customize the system and set preferences.

To access the setup pages


™ Press the SETUP key.

To return to imaging from a setup page


™ Select Done on‐screen.

A & B Key, Footswitch setup


On the A & B Key, Footswitch setup page, you can program the shortcut keys and
footswitch to perform common tasks.

System Setup
To program the shortcut keys and footswitch
1 Press the SETUP key.
2 Select A & B Key, Footswitch.
3 Select from the lists:
A Key, B Key The function of the shortcut keys. By default, the A shortcut key is set to
Print and the B shortcut key is set to Record. The shortcut keys are below the
alphanumeric keypad.
Footswitch (L), Footswitch (R) The function of the left and right footswitches: Save Clip,
Record, Freeze, Save Image, or Print. See also “To connect the footswitch” on page 17

To connect the footswitch


The SonoSite footswitch allows hands‐free operation with a customizable two‐pedal
footswitch. The footswitch is an optional feature.

WARNING: To avoid contamination, do not use the footswitch in a sterile environment. The
footswitch is not sterilized.

1 Connect the cables:


• Y adapter cable to the ECG connector on the mini‐dock or docking system.
• Footswitch cable to Y adapter cable
2 On the A & B Key, Footswitch setup page, select a function for the left and right
footswitches.

Chapter 2: System Setup 17


Administration setup
On the Administration setup page, you can configure the system to require users to log in
and enter passwords. Required login helps protect patient data. You can also add and
delete users, change passwords, import and export user accounts, and view the event log.

Security settings
WARNING: Health care providers who maintain or transmit health information are required by
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the
European Union Data Protection Directive (95/46/EC) to implement appropriate
procedures: to ensure the integrity and confidentiality of information; to protect
against any reasonably anticipated threats or hazards to the security or integrity of
the information or unauthorized uses or disclosures of the information.

Security settings on the system allow you to meet the applicable security requirements
listed in the HIPAA standard. Users are ultimately responsible for ensuring the security
and protection of all electronic protected health information collected, stored, reviewed,
and transmitted on the system.

To log in as Administrator
1 Press the SETUP key.
2 Select Administration.
3 Type Administrator in the Name box.
4 Type the administrator password in the Password box.
If you don’t have the administrator password, contact SonoSite. (See “SonoSite Technical
Support” on page viii.)
5 Select Login.

To log out as Administrator


™ Turn off or restart the system.

To require user login


You can set the system to display the User Login screen at startup.
1 Log in as Administrator.
2 In the User Login list, select On.
• On requires a user name and password at startup.
• Off allows access to the system without a user name and password.

18
To change the administrator password or let users change passwords
1 Log in as Administrator.
2 Under User List, select Administrator.
3 Do any of the following:
• Change the administrator password: Under User Information, type the new
password in the Password box and Confirm box. (See “Choosing a secure password”
on page 21.)
• Let users change their passwords: Select the Password changes check box.
4 Select Save.

User setup
To add a new user
1 Log in as Administrator.

System Setup
2 Select New.
3 Under User Information, fill in the Name, Password, and Confirm boxes. (See “Choosing
a secure password” on page 21.)
4 (Optional) In the Sonographer box, type the user’s initials to display them in the patient
header and the User field in the patient information form.
5 (Optional) Select the Administration Access check box to allow access to all
administration privileges.
6 Select Save.

To modify user information


1 Log in as Administrator.
2 Under User List, select the user.
3 Under User Information, make changes as desired.
4 Select Save.
Any change to the user name replaces the previous name.

To delete a user
1 Log in as Administrator.
2 Under User List, select the user.
3 Select Delete.
4 Select Yes.

Chapter 2: System Setup 19


To change a user password
1 Log in as Administrator.
2 In the User List, select the user.
3 Type the new password in the Password box and Confirm box.
4 Select Save.

Exporting or importing user accounts


The export and import commands let you configure multiple systems and back up user
account information.

To export user accounts


1 Insert a USB storage device.
2 Log in as Administrator.
3 Select Export on‐screen. A list of USB devices appears.
4 Select the USB storage device, and select Export.
All user names and passwords are copied to the USB storage device.

To import user accounts


1 Insert the USB storage device that contains the accounts.
2 Log in as Administrator.
3 Select Import on‐screen.
4 Select the USB storage device, and select Import.
5 Select Done in the dialog box that appears.
The system restarts. All user names and passwords on the system are replaced with the
imported data.

Exporting and clearing the Event log


The Event log collects errors and events and can be exported to a USB storage device and
read on a PC.

To view the Event log


1 Log in as Administrator.
2 Select Log on‐screen.
The Event log appears.
To return to the previous screen, select Back.

20
To export the Event log
The Event log and the DICOM network log have the same file name (log.txt). Exporting
either one to a USB storage device overwrites any existing log.txt file.
1 Insert a USB storage device.
2 Select Log and then select Export on‐screen.
A list of USB devices appears.
3 Select the USB storage device, and select Export.
The Event log is a text file that you can open in a text‐editing application (for example,
Microsoft Word or Notepad).

To clear the Event log


1 View the Event log.
2 Select Clear on‐screen.

System Setup
3 Select Yes.

Logging in as user
If user login is required, the User Login screen appears when you turn on the system. (See
“To require user login” on page 18.)

To log in as user
1 Turn on the system.
2 In the User Login screen, type your name and password, and select OK.

To log in as guest
Guests can scan but can’t access system setup and patient information.
1 Turn on the system.
2 In the User Login screen, select Guest.

To change your password


1 Turn on the system.
2 In the User Login screen, select Password.
3 Type your old and new passwords, confirm the new password, and then select OK.

Choosing a secure password


To ensure security, choose a password that contains uppercase characters (A‐Z), lowercase
characters (a‐z), and numbers (0‐9). Passwords are case‐sensitive.

Chapter 2: System Setup 21


Annotations setup
On the Annotations setup page, you can customize predefined labels and set the preference
for managing text when unfreezing images.
For instructions to annotate images, see “Annotations” on page 43.

To predefine a label group


You can specify which labels are available for an exam type when annotating an image. (See
“To place text on an image” on page 44.)
1 Press the SETUP key.
2 Select Annotations.
3 In the Exam list, select the exam type whose labels you want to specify.
4 For Group, select A, B, or C for the label group you want associated with that exam.
The preset labels appear for the selected group.
5 Do any of the following:
• Add a custom label to the group: Type the label in the Text box, and select Add.
• Rename a label: Select the label, type the new name in the Text box, and select
Rename.
• Move a label within the group: Select the label, and then select the on‐screen up or
down arrow.
• Delete a label from a group: Select the label, and select Delete.
You can use symbols in labels. See “Symbols” on page 15.

To specify text retention when unfreezing


You can specify which text to keep when you unfreeze an image or change the imaging
layout.
1 Press the SETUP key.
2 Select Annotations.
3 In the Unfreeze list, select Keep All Text, Keep Home Text, or Clear All Text.
The default setting is Keep All Text. For information on setting the home position, see “To
reset the home position” on page 44.

To export predefined label groups


1 Insert a USB storage device.
2 Press the SETUP key.
3 Select Annotations.

22
4 Select Export. A list of USB devices appears.
5 Select the USB storage device, and select Export.
A copy of all predefined label groups for all exams saves to the USB storage device.

To import predefined label groups


1 Insert the USB storage device that contains the label groups.
2 Press the SETUP key.
3 Select Annotations.
4 Select Import on‐screen.
5 Select the USB storage device, and then select Import.
6 Select Done in the dialog box that appears.
The system restarts. All predefined label groups for all exams are replaced with those
from the USB storage device.

System Setup
Audio, Battery setup
On the Audio, Battery setup page, you can specify sounds and the length of time for Sleep
Delay and Power Delay.

To change audio and battery settings


1 Press the SETUP key.
2 Select Audio, Battery.
3 Specify options in the following lists:
Key click: Select On or Off for keys to click when pressed.
Beep alert: Select On or Off for the system to beep when saving, warning, starting, or
shutting down.
Sleep delay: Select Off, or 5 or 10 minutes to specify the period of inactivity before the
system goes into sleep mode.
Power delay: Select Off, or 15 or 30 minutes to specify the period of inactivity before the
system automatically turns off.

Cardiac Calculations setup


On the Cardiac Calculations setup page, you can specify measurement names that appear
in the Tissue Doppler Imaging (TDI) calculations menu and on the report page.
See also “Cardiac calculations” on page 68.

Chapter 2: System Setup 23


To specify cardiac measurement names
1 Press the SETUP key.
2 Select Cardiac Calculations.
3 In the TDI Walls lists, select names for each wall.

Connectivity setup
On the Connectivity setup page, you specify options for using devices and for alerts when
internal storage is full. You also specify settings (including Transfer Mode and Location)
for SiteLink and DICOM, which are optional features. Refer to the SiteLink and DICOM
documentation.

To configure the system for a printer


1 Set up the printer hardware. (See instructions included with the printer or docking
system.)
2 Press the SETUP key.
3 Select Connectivity.
4 In the Printer list, select the printer.

To configure the system for a DVD recorder, PC, or bar code scanner
1 Press the SETUP key.
2 Select Connectivity.
3 (DVD recorder) In the Video Mode list, select the video standard: NTSC or PAL.
4 In the Serial Port list, select the peripheral.
Note: Because these peripherals use the same RS‐232 connector on the mini‐dock, you can
connect only one of them at a time.
Computer (PC) allows report data to be sent as ASCII text from the system to a PC. The
PC must have third‐party software to acquire, view, or format the data into a report.
Check the compatibility of your software with SonoSite Technical Support. (See also
“Sending reports and viewing EMED worksheets” on page 94.)
5 Select Yes to restart the system.
6 Attach a serial cable (RS‐232) from the serial port on the mini‐dock or docking system to
the peripheral.

To receive storage alerts


1 Press the SETUP key.
2 Select Connectivity.

24
3 Select Internal Storage Capacity Alert.
The system displays a message if internal storage is near capacity when you end an
exam. The system then deletes archived patient exams if specified in DICOM.

Date and Time setup


WARNING: To obtain accurate obstetrics calculations, an accurate date and time are critical.
Verify that the date and time are accurate before each use of the system. The system
does not automatically adjust for daylight saving time changes.

To set the date and time


1 Press the SETUP key.
2 Select Date and Time.
3 In the Date box, type the current date.

System Setup
4 In the Time box, type the current time in 24 hour format (hours and minutes).

Display Information setup


On the Display Information setup page, you can specify which details appear on‐screen
during imaging.

To specify display information


1 Press the SETUP key.
2 Select Display Information.
3 Select settings in the following sections:
• Patient Header Information that appears in the patient header.
• Mode Data Imaging information.
• Network Status System status information.

IMT Calculations setup


On the IMT Calculations setup page, you can customize the IMT calculations menu. You
can specify up to eight measurement names for both right side and left side calculations.
The measurement names also appear in the patient report.
See also “IMT calculations” on page 80.

To customize the IMT calculations menu


1 Press the SETUP key.

Chapter 2: System Setup 25


2 Select IMT Calculations.
3 Under IMT Calculations, select measurement names from the lists, or select None.
The selected names appear in the calculations menu and in the patient report.
4 Type the desired width in the Region width (mm) box.

Network Status setup


The Network Status setup page displays information on system IP address, Location,
WLAN Profile, Active WLAN SSID, and Ethernet MAC address.

To display network status information


1 Press the SETUP key.
2 Select Network Status.

OB Calculations setup
On the OB Calculations setup page, you select authors for OB calculation tables. You can
also import or export additional OB calculation tables.
See also “OB calculations” on page 83.

Figure 1 OB Calculations Setup Page

26
To specify gestational age and growth analysis
1 Press the SETUP key.
2 Select OB Calculations.
3 In the measurement lists under Gestational Age and Growth Analysis, select the desired
OB authors, or select None.
Selecting an author places the associated measurement on the calculations menu.
4 (Optional) Select More to display the list of user‐defined custom measurements and to
associate a custom table for the custom measurement.
This option is available only when a user‐defined custom table has been created for the
custom measurement.

To export OB calculation tables


1 Insert a USB storage device.
2 Press the SETUP key.

System Setup
3 Select OB Calculations.
4 Select Export. A list of USB devices appears.
5 Select the USB storage device, and select Export.
All user‐defined tables and measurements are copied to the USB storage device.

To import OB calculation tables


Imported OB calculation tables replace all user‐defined tables and measurements on the
system.
1 Insert the USB storage device that contains the tables.
2 Press the SETUP key.
3 Select OB Calculations.
4 Select Import on‐screen.
5 Select the USB storage device, and then select Import.
6 Select Done in the dialog box that appears.
The system restarts.

OB Custom Measurements setup


On the OB Custom Measurements setup page, you can define measurements that appear
in the OB calculations menu and OB report. OB Custom Measurements is an optional
feature.
See also “OB calculations” on page 83.

Chapter 2: System Setup 27


To set up OB custom measurements
You can save up to five custom measurements that appear in the OB calculations menu
and OB report.
1 Press the SETUP key.
2 Select OB Custom Meas.
3 Select New.
4 In the Name box, type a unique name.
5 In the Type list, select the desired measurement type.
6 Select Save.

To delete an OB custom measurement


1 Press the SETUP key.
2 Select OB Custom Meas.
3 In the Custom Measurements list, highlight the last measurement.
4 Select Delete Last.
5 Select Yes.
Any tables and report data associated with the measurement are removed from the
system.

OB Custom Tables setup


On the OB Custom Tables setup pages, you can customize growth tables that appear in the
calculations menu and patient report.
Gestational Age Table Measurements The system provides gestational age measurements
by selected authors for CRL, GS, BPD, OFD, HC, AC, FL, APTD, TTD, FTA, and
5 additional custom measurement labels.
Growth Analysis Table Measurements The system provides growth graphs or curves for
BPD, HC, AC, FL, EFW, and HC/AC.

WARNING: Prior to use, verify that custom table data entries are correct. The system does not
confirm the accuracy of the custom table data entered by the user.

To view OB tables
1 Press the SETUP key.
2 Select OB Custom Meas. or OB Calculations.
3 Select Tables on‐screen.
4 Select the desired table and measurement/author.

28
To create a new OB custom table
You can create two custom tables for each OB measurement. Growth analysis tables cannot
be created for custom OB measurements.
1 Press the SETUP key.
2 Select OB Custom Meas. or OB Calculations.
3 Select Tables on‐screen.
4 Select the desired table (Gestational Age or Growth Analysis).
5 In the Measurement list, select the measurement for the custom table.
6 Select New on‐screen.
7 In the Author box, type a unique name.
8 Enter the data.
9 Select Save on‐screen.

System Setup
To display the measurement for the custom table in the calculations menu, see “To specify
gestational age and growth analysis” on page 27.

To edit or delete an OB custom table


1 Press the SETUP key.
2 Select OB Custom Meas. or OB Calculations.
3 Select Tables on‐screen.
4 Select the OB custom table.
5 Select one of the following on‐screen:
• Edit Enter data, and then select Save on‐screen.
• Delete to remove the custom table.

Presets setup
The Presets setup page has settings for general preferences.

To set presets
1 Press the SETUP key.
2 Select Presets.
3 Select from the lists:
Doppler Scale Select cm/s or kHz.
Duplex The layout for displaying M Mode trace and Doppler spectral trace:1/3 2D, 2/3
Trace; 1/2 2D, 1/2 Trace; or Full 2D, Full Trace.

Chapter 2: System Setup 29


Live Trace Select Peak or Mean.
Thermal Index You can select TIS, TIB, or TIC. The default setting is based on exam type:
OB is TIB, TCD is TIC, and all others are TIS.
Save Key Behavior of the SAVE key. Image Only saves the image to internal storage.
Image/Calcs saves the image to internal storage and saves the current calculation to the
report.
Dynamic Range Settings include -3, -2, -1, 0, +1, +2, or +3. Negative numbers show
higher contrast images, and positive numbers show lower contrast images.
Units Units for patient height and weight in cardiac exams: in/ft/lbs or cm/m/kg.
Language The system language. Changing the language requires restarting the system.
Color Scheme The background color of the display.
Auto save Pat. Form Automatically saves the patient information form as an image in the
patient’s file.

System Information setup


The System Information setup page displays system hardware and software versions, and
license information.
See also “To enter a license key” on page 97.

To display system information


1 Press the SETUP key.
2 Select System Information.

USB Devices setup


On the USB Devices setup page, you can view information about connected USB devices,
including space availability. You can also specify a file format for images and clips you
export to a USB storage device. (See “To export images or clips to a USB storage device” on
page 52.)

To specify a file format for exported images


1 Press the SETUP key.
2 Select USB Devices.
3 Select Export.
4 Under USB Export, select an export type:

30
• SiteLink organizes files in a SiteLink‐style folder structure. Clips export in H.264
video saved as MP4 files. To view them, SonoSite recommends QuickTime 7.0 or
later.
• DICOM creates files readable by a DICOM server. DICOM is an optional feature.
5 Select an image format for your export type. For JPEG image format, also select a JPEG
compression.
A high compression has a smaller file size but less detail.
For SiteLink export type, the image format affects only still images. For DICOM export
type, the image format affects both still images and clips.
6 For SiteLink export type, select a sort order under Sort By.
To return to the previous screen, select Devices.

Restoring default settings

System Setup
To restore default settings for a setup page
™ On the setup page, select Reset on‐screen.

To restore all default settings


1 Turn the system off.
2 Connect the system to AC power. (See “To operate the system using AC power” on
page 6.)
3 Simultaneously press 1 and the power key.
The system beeps several times.

Chapter 2: System Setup 31


32
Chapter 3: Imaging

Imaging modes
The system has a high‐performance LCD and advanced image‐optimization technology that
greatly simplifies user controls. Imaging modes available depend on the transducer and exam
type. See “Imaging modes and exams available by transducer” on page 42.

Adjusting depth and gain


To adjust depth
You can adjust the depth in all imaging modes but the trace modes. The vertical depth scale is
marked in 0.5 cm, 1 cm, and 5 cm increments, depending on the depth.
™ Press the following keys:
• UP DEPTH key to decrease the displayed depth.
• DOWN DEPTH key to increase the displayed depth.
As you adjust the depth, the maximum depth number changes in the lower right screen.

To adjust gain
™ Do one of the following:
• To adjust gain automatically, press the AUTO GAIN key. The gain adjusts each time you

Imaging
press this key.

• To adjust gain manually, turn the NEAR , FAR , and GAIN knobs. These knobs
increase or decrease the amount of gain applied to the near field, far field, or the overall
image. (Near and far correspond to the time gain compensation [TGC] controls on other
ultrasound systems.)
• In PW and CW Doppler imaging, the GAIN knob affects Doppler gain.
• In CPD or Color imaging, the GAIN knob affects the color gain applied to the region of
interest (ROI) box. The NEAR and FAR knobs affect only the 2D image.

Freezing, viewing frames, and zooming


To freeze or unfreeze an image
™ Press the FREEZE key.
On a frozen image, the cine icon and frame number appear in the system status area.

Chapter 3: Imaging 33
To move forward or backward in the cine buffer
™ Freeze the image, and do one of the following:

• Turn the knob.


• Use the touchpad. Right moves forward, and left moves backward.
• Press the LEFT ARROW and RIGHT ARROW keys.
The frame number changes as you move forward or backward. The total number of frames
in the buffer appears on‐screen in the system status area.

To zoom in on an image
You can zoom in 2D and Color imaging. You can freeze or unfreeze the image or change the
imaging mode at any time while zooming.
1 Press the ZOOM key. A ROI box appears.
2 Using the touchpad, position the ROI box as desired.
3 Press the ZOOM key again.
The image in the ROI box is magnified by 100%.
4 (Optional) If the image is frozen, use the touchpad or arrow keys to pan the image up, down,
left, and right. (You cannot pan in Dual.)
To exit zoom, press the ZOOM key again.

Changing the exam type


The exam types available depend on transducer used. See “Imaging modes and exams
available by transducer” on page 42.

To change the exam type


™ Do one of the following:
• Press the EXAM key, and select from the menu.
• On the patient information form, select from the Type list under Exam. (See “Patient
information form” on page 45.)

2D imaging
2D is the systemʹs default imaging mode. The system displays echoes in two dimensions by
assigning a brightness level based on the echo signal amplitude. To achieve the best possible
image quality, properly adjust the display brightness, gain, depth settings, viewing angle, and
exam type. Also, select an optimization setting that best matches your needs.

34
To display the 2D image
1 Do any of the following:
• Turn on the system.
• Press the 2D key.
2 Set options as desired. See “2D options.”

2D options
In 2D imaging, you can select the following on‐screen options.
2D options

Option Icon Description

Optimize Settings are as follows:


• Res provides the best possible resolution.
• Gen provides a balance between resolution and penetration.
• Pen provides the best possible penetration.
Some of the parameters optimized to provide the best image
include focal zones, aperture size, frequency (center and
bandwidth), and waveform. They cannot be adjusted by the user.
Dynamic Range Adjusts the grayscale range: -3, -2, -1, 0, +1, +2, +3.
The positive range increases the number of grays displayed, and

Imaging
the negative range decreases the number of grays displayed.
Dual Displays side-by-side 2D images.
Select Dual, and then press the UPDATE key to display the second
screen and to toggle between the screens. With both images
frozen, press the UPDATE key to toggle between the images.
To return to full-screen 2D imaging, select Dual or press the 2D
key.
LVO On, LVO On turns on Left Ventricular Opacification. LVO Off turns off
LVO Off this option.
Use LVO for cardiac exams in 2D imaging mode when using an
imaging contrast agent. LVO lowers the mechanical index (MI) of
the system to enhance visualization of the contrast agent and
endocardial border.
This option depends on transducer and exam type.
Orientation Select from four image orientations: U/R (Up/Right), U/L (Up/Left),
D/L (Down/Left), D/R (Down/Right).

Chapter 3: Imaging 35
2D options (Continued)

Option Icon Description

Brightness Adjusts the display brightness. Settings range from 1 to 10.


The display brightness affects battery life. To conserve battery life,
adjust brightness to a lower setting.
Biopsy Turns biopsy guidelines on and off.
This feature depends on transducer type. See the SonoSite Biopsy
user guide.
Biopsy is not available when the ECG cable is connected.
Guide Turns the guideline on and off.
This feature depends on transducer and exam type. See the user
guide for L25x transducer and needle guide.
SonoHD (S) S On and S Off turn SonoHD™ Imaging Technology on and off.
When SonoHD is on, S appears in the upper left-hand screen.
SonoHD is optional and depends on transducer and exam type.
SonoMB (MB) MB On and MB Off turn SonoMB™ multi-beam technology on and
off. When SonoMB is on, MB appears in the upper left-hand screen.
SonoMB depends on transducer and exam type.
ECG Displays the ECG trace. See “ECG Monitoring” on page 52.
This feature is optional and requires a SonoSite ECG cable.
Clips Displays the clips options. See “To capture and save a clip” on
page 48.
This feature is optional.
THI Turns Tissue Harmonic Imaging on and off.
When on, THI appears in the upper left-hand screen. This feature is
optional and depends on transducer and exam type.
Page x/x Indicates which page of options is displayed. Select to display the
next page.

M Mode imaging
Motion mode (M Mode) is an extension of 2D. It provides a trace of the 2D image displayed
over time. A single beam of ultrasound is transmitted, and reflected signals are displayed as
dots of varying intensities, which create lines across the screen.

To display the M-line


1 Press the M MODE key.
Note: If the M‐line does not appear, make sure that the system is in live imaging.

36
2 Use the touchpad to position the M‐line where desired.
3 Set options as desired.
Many optimization and depth options available in 2D imaging are also available in M Mode
imaging. See “2D options” on page 35.

To display the M Mode trace


1 Display the M‐line.
2 Adjust the depth if necessary. (See “To adjust depth” on page 33.)
3 Press the M MODE key.
The time scale above the trace has small marks at 200ms intervals and large marks at
one‐second intervals.
4 Do any of the following as needed:

• Select the sweep speed (Slow, Med, or Fast).


• Press the UPDATE key to toggle between the M‐line and M‐Mode trace.
• If using a duplex layout, press the M MODE key to toggle between the full‐screen M‐line
and the duplex layout.
To set a duplex layout, see “Presets setup” on page 29.

CPD and color Doppler imaging

Imaging
Color power Doppler (CPD) and color Doppler (Color) are optional features.
CPD is used to visualize the presence of detectable blood flow. Color is used to visualize the
presence, velocity, and direction of blood flow in a wide range of flow states.

To display the CPD or Color image


1 Press the COLOR key.
A ROI box appears in the center of the 2D image.
2 Select CPD or Color.
The current selection also appears in the upper left‐hand screen.
The Color indicator bar on the upper left‐hand screen displays velocity in cm/s in Color
imaging mode only.
3 Using the touchpad, position or resize the ROI box as needed. Press the SELECT key to
toggle between position and size.
While you position or resize the ROI box, a green outline shows the change. The ROI box
indicator on the left‐hand screen shows which touchpad function is active.
4 Set options as desired. See “CPD and Color options.”

Chapter 3: Imaging 37
CPD and Color options
In CPD or Color imaging, you can set the following on‐screen options.
CPD and Color options

Option Icon Description

Color, CPD Toggle between CPD and Color.


The current selection appears in the upper left-hand screen.

Color Shows or hides color information. You can select Show or Hide while in
Suppress live or frozen imaging. The setting shown on-screen is the current
selection.
Flow The current setting appears on-screen.
Sensitivity • Low optimizes the system for low flow states.
• Med optimizes the system for medium flow states.
• High optimizes the system for high flow states.
PRF Scale Select the desired pulse repetition frequency (PRF) setting by pressing
the control keys.
There is a wide range of PRF settings for each Flow Sensitivity setting
(Low, Med, and High).
Available on select transducers.
Wall Filter Settings include Low, Med, and High.
Available on select transducers.

Steering Select the steering angle setting of the color ROI box (-15, +0, or +15).
If adding PW Doppler, see “PW Doppler options” on page 40.
Available on select transducers.
Variance Turns variance on and off.
Available only for cardiac exam.

Invert Switches the displayed direction of flow.


Available in Color imaging.

Page x/x Indicates which page of options is displayed. Select to display the next
page.

38
PW and CW Doppler imaging
Pulsed wave (PW) Doppler and continuous wave (CW) Doppler imaging modes are optional
features.
PW Doppler is a Doppler recording of blood flow velocities in a range specific area along the
length of the beam. CW Doppler is a Doppler recording of blood flow velocities along the
length of the beam.
You can use PW/CW Doppler and CPD/Color and simultaneously. If CPD/Color imaging is on,
the color ROI box is tied to the D‐line. The SELECT key cycles among color ROI box position,
color ROI box size, the D‐line, and (in PW Doppler) angle correction. The active selection is
green. Also, the indicator on the left‐hand screen shows which touchpad function is active.

To display the D-line


The default Doppler imaging mode is PW Doppler. In cardiac exams, you can select the CW
Doppler on‐screen option.
1 Press the DOPPLER key.
Note: If the D‐line does not appear, make sure that the system is in live imaging.
2 Do any of the following as needed:
• Set options. See “PW Doppler options” on page 40.
• Using the touchpad, position the D‐line where desired.
• (PW Doppler) To correct the angle manually, press the SELECT key and then use the
touchpad to adjust the angle in 2° increments from ‐74° to +74°. Press the SELECT key

Imaging
again to set the desired angle.
The SELECT key toggles between the D‐line and angle correction.

To display the spectral trace


1 Display the D‐line.
2 Press the DOPPLER key.
The time scale above the trace has small marks at 200 ms intervals and large marks at
one‐second intervals.
3 Do any of the following as needed:
• Set options. See “Spectral trace options” on page 41.
• Press the UPDATE key to toggle between the D‐line and spectral trace.
• If using a duplex layout, press the DOPPLER key to toggle between the full‐screen D‐line
and the duplex layout.
To set a duplex layout, see “Presets setup” on page 29.

Chapter 3: Imaging 39
PW Doppler options
In PW Doppler imaging, you can set the following on‐screen options.
PW Doppler options

Option Icon Description

PW, CW (Cardiac exam only) Toggle between PW Doppler and CW Doppler.


The current selection appears in the upper left-hand screen.

Angle Corrects the angle to 0°, +60°, or -60°.


Correction

Gate Size Settings depend on transducer and exam type.

TDI On, Select TDI On to turn on tissue Doppler imaging. When on, TDI appears
TDI Off in the upper left-hand screen. The default is TDI off.
Available only in cardiac exams.
Steering Select the desired steering angle setting. The PW Doppler angle
correction automatically changes to the optimum setting.
• -15 has an angle correction of -60°.
• +0 has an angle correction of 0°.
• +15 has an angle correction of +60°.
You can manually correct the angle after selecting a steering angle
setting. (See “To display the D-line” on page 39.)
Available on select transducers.
Page x/x Indicates which page of options is displayed. Select to display the next
page.

40
Spectral trace options
In spectral trace imaging, you can set the following on‐screen options.
Spectral trace options

Option Icon Description

Scale Select the desired scale (pulse repetition frequency [PRF]) setting.
(To change the Doppler scale to cm/s or kHz, see “Presets setup” on
page 29.)
Line Sets the baseline position.
(On a frozen trace, the baseline can be adjusted if Live Trace is off.)

Invert Vertically flips the spectral trace.


(On a frozen trace, Invert is available if Live Trace is off.)

Volume Increases or decreases Doppler speaker volume (0-10).

Wall Filter Settings include Low, Med, High.

Sweep Speed Settings include Slow, Med, Fast.

Imaging
Live Trace Displays a live trace of the peak or mean. (See “Presets setup” on
page 29 to specify peak or mean.)

Page x/x Indicates which page of options is displayed. Select to display the next
page.

Chapter 3: Imaging 41
Imaging modes and exams available by transducer
WARNING: To prevent misdiagnosis or harm to the patient, understand your system’s
capabilities prior to use. The diagnostic capability differs for each transducer,
exam type, and imaging mode. In addition, transducers have been developed to
specific criteria depending on their physical application. These criteria include
biocompatability requirements.

The transducer you use determines which exam types are available. In addition, the exam type
you select determines which imaging modes are available.

Imaging modes and exams available by transducer

Imaging Mode

Exam 2D2 PW CW
Transducer CPD3 Color3
Type1 M Mode Doppler Doppler

C11x Abd X X X X —

Neo X X X X —

Nrv X X X X —

Vas X X X X —

C60x OB X X X X —

Gyn X X X X —

Abd X X X X —

Nrv X X X X —

HFL38x Bre X X X X —

SmP X X X X —

Vas X X X X —

Msk X X X X —

IMT X X X X —

Nrv X X X X —

Ven X X X X —

ICTx Gyn X X X X —

OB X X X X —

42
Imaging modes and exams available by transducer (Continued)

Imaging Mode

Exam 2D2 PW CW
Transducer CPD3 Color3
Type1 M Mode Doppler Doppler

L25x Msk X X X X —

Vas X X X X —

Nrv X X X X —

Sup X X X X —

Ven X X X X —

L38x Bre X X X X —

SmP X X X X —

Vas X X X X —

IMT X X X X —

Nrv X X X X —

Ven X X X X —

Imaging
P21x Abd X X X X —

OB X X X X —

Crd X — X X X
1. Exam type abbreviations are as follows: Abd = Abdomen, Bre = Breast, Crd = Cardiac, Gyn =
Gynecology, IMT = Intima Media Thickness, Msk = Muscle, Neo = Neonatal, Nrv = Nerve, OB =
Obstetrical, SmP = Small Parts, Sup = Superficial, Vas = Vascular, Ven = Venous
2. The optimization settings for 2D are Res, Gen, and Pen.
3. The optimization settings for CPD and Color are low, medium, and high (flow sensitivity) with a
range of PRF settings for Color depending on the setting selected.

Annotations
You can annotate live images as well as frozen images. (You cannot annotate a saved image.)
You can place text (including predefined labels), an arrow, or a pictograph. To set preferences
for annotations, see “Annotations setup” on page 22.

Chapter 3: Imaging 43
To place text on an image
You can place text in the following imaging layouts: full‐screen 2D, full‐screen trace, dual, or
duplex. You can place text manually or add a predefined label.
1 Press the TEXT key. A green cursor appears.
2 Move the cursor where desired:
• Use the touchpad or arrow keys.
• Select Home to move the cursor to the home position.
The default home position depends on the imaging screen layout. You can reset the home
position. See “To reset the home position” on page 44.
3 Using the keyboard, type text.
• The arrow keys move the cursor left, right, up, and down.
• The DELETE key deletes all text.

• The Word option removes a word.


• Select Symbols to enter special characters. See “Symbols” on page 15.
4 (Optional) To add a predefined label, select Label, and then select the desired label group (1/
x).
There are three label groups. See “Annotations setup” on page 22.
To turn off text entry, press the TEXT key.

To reset the home position


1 Press the TEXT key.
2 Using the touchpad or arrow keys, position the cursor where desired.
3 Select Home/Set.

To place an arrow on an image


You can add an arrow graphic to point out a specific part of the image.

1 Press the ARROW key .


2 If you need to adjust the arrowʹs orientation, press the SELECT key and then use the
touchpad. When the orientation is correct, press the SELECT key again.
3 Use the touchpad to move the arrow to the desired location.
4 Press the ARROW key to set the arrow.
The arrow changes from green to white.
To remove the arrow, press the ARROW key and then select Hide.

44
To place a pictograph on an image
The pictograph set available depends on transducer and exam type.
1 Press the PICTO key.

2 Select x/x to display the desired pictograph, and then press the SELECT key.
The first number shows which pictograph in the set has been selected. The second number
is the number of pictographs available.
3 Use the touchpad to position the pictograph marker.
4 (Optional) To rotate the pictograph marker, press the SELECT key and then use the
touchpad.
5 Select a screen location for the pictograph: U/L (Up/Left), D/L (Down/Left), D/R (Down/
Right), U/R (Up/Right).
In a duplex layout, the pictograph is restricted to upper left. In Dual, all four positions are
available.
To remove the pictograph, select Hide.

Patient information form


The patient information form lets you enter patient identification, exam, and clinical
information for the patient exam. This information automatically appears in the patient report.
When you create a new patient information form, all images and other data you save during

Imaging
the exam are linked to that patient. (See “Patient report” on page 92.)

To create a new patient information form


Note: Creating a new patient information form erases any unsaved patient information, including any
calculations and report page. To save this information, save the screen for each item.
1 Press the PATIENT key.

2 Select New.
3 Fill in the form fields. See “Patient information form fields” on page 46.
4 Select Done.

To edit a patient information form


You can edit patient information during the exam. However, if you change the patient name,
ID, date of birth, gender, or accession after saving an image, a new patient information form is
created.
1 Press the PATIENT key.
2 If you need to change the name, ID, date of birth, gender, or accession, save any data you
want to keep.

Chapter 3: Imaging 45
3 Make changes as desired.
4 Select one of the following:
• Cancel to undo changes and return to imaging.
• Done to save changes and return to imaging.

To end the exam


1 Make sure that you have saved images and other data you want to keep. (See “Saving images
and clips” on page 48.)
2 Press the PATIENT key.
3 Do one of the following:
• Select End Exam.

• Select New to begin a new patient information form. (See “To create a new patient
information form” on page 45.)

Patient information form fields


The patient information form fields available depend on exam type. In some fields you can
select Symbols to enter symbols and special characters. See “Symbols” on page 15.

Patient information form fields

Section Field Description

Patient

Last Patient name


First
Middle

ID Patient identification number

Accession Enter number, if applicable.

Date of Date of birth


birth

Gender Female, Male, Other, or blank

Indications Enter desired text

User User initials

More Displays the Reading Dr., Referring Dr., and Institution


button fields.
Select Back to save entries and return to previous screen.

46
Patient information form fields (Continued)

Section Field Description

Exam

Type Exam types available depend on transducer. See “Imaging


modes and exams available by transducer” on page 42. For
the definition of abbreviations, see “Glossary” on page 179.

LMP (OB or Gyn exam) In an OB exam, select LMP or Estab. DD


Estab. DD and then enter either the date of the last menstrual period or
the established due date. In a Gyn exam, enter the date of the
last menstrual period. The LMP date must precede the current
system date.

Twins (OB exam) Select the Twins check box to display Twin A and
Twin B measurements on the calculations menu and to have
Twin A and Twin B screens for previous exam data.

Previous (OB exam) Displays fields for five previous exams. The date for
Exams a previous exam must precede the current system date. For
button twins, select Twin A/B to toggle between Twin A and Twin B
screens. (If the Twin A/B option does not appear, select Back,
and make sure that the Twins check box is selected.)
Select Back to save changes and return to previous screen.

Imaging
BP (Cardiac, IMT, or Vascular exam)
Blood Pressure

HR (Heart (Cardiac or Vascular exam) Enter the beats per minute. Saving
Rate) the heart rate using a measurement overwrites this entry.

Height (Cardiac exam) The patient height in feet and inches or


meters and centimeters. (To change the units, see “Presets
setup” on page 29.)

Weight (Cardiac exam) The patient weight in pounds or kilos. (To


change the units, see “Presets setup” on page 29.)

BSA (Cardiac exam) Body Surface Area. Automatically calculated


after you enter height and weight.

Ethnicity (IMT exam) Ethnic origin

Chapter 3: Imaging 47
Patient information form fields (Continued)

Section Field Description

Procedure

Type Available if the DICOM Worklist feature is licensed and


configured. See the DICOM user guide.

ID Available if the DICOM Worklist feature is licensed and


configured. See the DICOM user guide.

Saving images and clips


Clips, an optional feature, lets you capture, preview, and save clips.
When you save an image or clip, it saves to internal storage. The system beeps afterward if Beep
Alert is on, and the percentage icon flashes. (See “Audio, Battery setup” on page 23.) To access
saved images and clips, open the patient list. (See “Patient list” on page 50.)
The percentage icon in the system status area shows the percentage of space used in internal
storage. To receive alerts when storage is near capacity, see “To receive storage alerts” on
page 24.

To save an image
™ Press the SAVE key.
The image saves to internal storage.
By default, the SAVE key saves only the image. As a shortcut during calculations, the SAVE key
can save both the image to internal storage and the calculation to the patient report. See “To set
presets” on page 29.

To capture and save a clip


1 Set Clips options. (See “To set Clips options” on page 49.)
2 Press the CLIP key.
One of the following occurs:
• If Prev/Off is selected, the clip saves directly to internal storage.
• If Prev/On is selected, the clip plays back in preview mode. You can select any of the
following on‐screen:

• A playback speed (1x, 1/2x, 1/4x)


• Pause to interrupt playback
• Left: x or Right: x to remove frames from the left or right sides of the clip (where x is the
beginning or ending frame number)

48
• Save to save the clip to internal storage
• Delete to delete the clip

To set Clips options


Setting Clips options ensures that clips are captured to your specifications.
1 In 2D imaging mode, select Clips on‐screen.
2 Set options as desired.

Clips options

Option Icon Description

Time, ECG Time and ECG share the same location on-screen.
• With Time, capturing is based on number of seconds. Select the
time duration.
• With ECG, capturing is based on the number of heart beats. Select
the number of beats.
Preview On, PrevOn and PrevOff turn the preview feature on and off.
Preview Off • With Prev/On, the captured clip automatically plays on-screen.
The clip can be trimmed, saved, or deleted.
• With Prev/Off, the clip saves to internal storage, and the trim and
delete options are not available.

Imaging
Prospective, Pro and Retro determine how clips are captured:
Retrospective • With Pro, a clip is captured prospectively, after you press the CLIP
key.
• With Retro, a clip is captured retrospectively, from pre-saved data
before you press the CLIP key.

Chapter 3: Imaging 49
Patient list
WARNING: To avoid damaging the USB storage device and losing patient data from it,
observe the following:
• Do not remove the USB storage device or turn off the ultrasound system while
the system is exporting.
• Do not bump or otherwise apply pressure to the USB storage device while it is
in a USB port on the ultrasound system. The connector could break.

Caution: If the internal storage icon does not appear in the system status area, internal
storage may be defective. Contact SonoSite Technical Support. (See “SonoSite
Technical Support” on page viii.)

The patient list lets you organize saved images and clips from a central location. You can delete,
view, print, or archive them. You can also copy them to a USB storage device.

Figure 1 Patient List

To open the patient list


1 Press the REVIEW key.
2 If there is a current patient, select List on‐screen.

50
To sort the patient list
After the system starts, the patient list is arranged by date and time, with the most recent
patient file first. You can re‐sort the patient list as needed.
™ Select the column heading that you want to sort by. Select it again if sorting
in reverse order.
Note: The column heading is selectable.

To select patients in the patient list


™ Using the touchpad, select the check box for one or more patients.
Select All selects all patients.
To deselect patients, select checked boxes or Clear All.

To review images and clips


You can review only one patient’s images and clips at a time.
1 In the patient list, highlight the patient whose images and clips you want to review.
2 Select Review on‐screen.

3 Select x/x to cycle to the image or clip you want to review.


4 (Clip Only) Select Play.
The clip plays automatically after loading. The load time depends on clip length.
You can select Pause to freeze the clip and can select a playback

Imaging
speed 1x, 1/2x, 1/4x.

5 Select x/x to cycle to the next image or clip you want to view.
To return to the patient list, select List. To return to imaging, select Done.

To print an image
1 Verify that a printer is selected. See “To configure the system for a printer” on page 24.
2 Do one of the following:
• In the patient list, review the patient’s images. Select Print when the image appears.
• With the image displayed, press the A shortcut key.
By default, the A shortcut key prints. To reprogram the A and B shortcut keys, see “To set
presets” on page 29.

To print multiple images


1 Verify that a printer is selected. See “To configure the system for a printer” on page 24.
2 Do one of the following:

Chapter 3: Imaging 51
• Print all images for multiple patients: Select one or more patients in the patient list. Then
select Print.
• Print all images for one patient: Highlight the patient in the patient list, and then select
Print.
Each image appears briefly on‐screen while printing.

To export images or clips to a USB storage device


A USB storage device is for temporary storage of images and clips. Patient exams should be
archived regularly. To specify file format, see “USB Devices setup” on page 30.
1 Insert the USB storage device.
2 In the patient list, select the patients whose images and clips you want to export.
3 Select Exp. USB on‐screen. A list of USB devices appears.
4 Select the USB storage device, and select Export.
Only available USB devices (for example, not password‐protected) are selectable.
The files are finished exporting approximately five seconds after the USB animation stops.
Removing the USB storage device or turning off the system while exporting may cause
exported files to be corrupted or incomplete. To stop in‐progress exporting, select
Cancel Export.

To delete images and clips


1 Select one or more patients in the patient list.
2 Select Delete to delete the selected patients. A confirmation screen appears.

To archive images and clips


You can send patient exams to a DICOM printer or archiver, or to a PC using SiteLink. DICOM
and SiteLink are optional features.
1 Select one or more patients in the patient list.
2 Select Archive.

ECG Monitoring
ECG Monitoring is an optional feature and requires a SonoSite ECG cable.

WARNING: To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms.
The SonoSite ECG option is a non-diagnostic feature.
To avoid electrical interference with aircraft systems, do not use the ECG cable
on aircraft. Such interference may have safety consequences.

52
Caution: Use only accessories recommended by SonoSite with the system. Your system
can be damaged by connecting an accessory not recommended by SonoSite.

To monitor ECG
1 Connect the ECG cable to the ECG connector on the ultrasound system, mini‐dock, or
docking system.
ECG Monitoring turns on automatically.
Note: An external ECG monitor may cause a lag in the timing of the ECG trace, corresponding with
the 2D image. Biopsy guidelines are not available when ECG is connected.
2 Select ECG on‐screen. (ECG may be on another page. It appears only if the ECG cable is
connected.)
3 Select options as desired.

ECG Monitoring options

Option Icon Description

Show/Hide Turns on and off ECG trace.

Gain Increases or decreases ECG gain. Settings are 0-20.

Imaging
Position Sets the position of the ECG trace.
Sweep Speed Settings are Slow, Med, and Fast.

Delay Displays Line and Save for clip acquisition delay. (For instructions to
capture clips, see “To capture and save a clip” on page 48.)
Line The position of the delay line on the ECG trace. The delay line indicates
where the clip acquisition is triggered.

Save Saves the current position of the delay line on the ECG trace. (You can
change the position of the delay line temporarily. Starting a new
patient information form or cycling system power reverts the delay line
to the most recently saved position.)
Select Delay to display these options.

Chapter 3: Imaging 53
54
Chapter 4: Measurements and Calculations

You can measure for quick reference, or you can measure within a calculation. You can perform
general calculations as well as calculations specific to an exam type.
Measurements are performed on frozen images. For references used, see Chapter 7,
“References.”

Measurements
You can perform basic measurements in any imaging mode and can save the image with the
measurements displayed. (See “To save an image” on page 48.) Except for the M Mode HR
measurement, the results do not automatically save to a calculation and the patient report. If
you prefer, you can first begin a calculation and then measure. See “Performing and saving
measurements in calculations” on page 62.
Some options may not apply to your system. Options available depend on your configuration,
transducer, and exam type.

To save a measurement to a calculation and patient report


1 With the measurement active (green), press the CALCS key.
2 From the calculations menu, select a measurement name.
Only measurement names available for the imaging mode and exam type are selectable.
3 Save the calculation. (See “To save a calculation” on page 62.)
To start a calculation before measuring, see “Performing and saving measurements in
calculations” on page 62.

Working with calipers

and Calculations
Measurements
When measuring, you work with calipers, often in pairs. Results based on the calipers’ position
appear at the bottom of the screen. The results update as you reposition the calipers by using
the touchpad. In trace measurements, the results appear after you complete the trace.
Outside a calculation, you can add calipers by pressing the CALIPER key. You can have
multiple sets of calipers and can switch from one set to another, repositioning them as needed.
Each set shows the measurement result. The active calipers and measurement result are
highlighted green. A measurement is complete when you finish moving its calipers.
Within a calculation, calipers appear when you select from the calculations menu. (See “To
select from the calculations menu” on page 61.)
For an accurate measurement, accurate placement of calipers is essential.

Chapter 4: Measurements and Calculations 55


To switch the active calipers
™ Do one of the following:
• To switch the active caliper within a set, press the SELECT key.
• To switch the active set when measuring outside a calculation, select Switch on‐screen.

To delete or edit a measurement


™ With the measurement active (highlighted), do one of the following:
• To delete, select Delete on‐screen.
• To edit, use the touchpad to move the calipers.
Note: Trace measurements cannot be edited once set.

To improve precision of caliper placement


™ Do any of the following:
• Adjust the display for maximum sharpness.
• Use leading edges (closest to the transducer) or borders for starting and stopping points.
• Maintain a consistent transducer orientation for each type of measurement.
• Make sure that the area of interest fills as much of the screen as possible.
• (2D) Minimize the depth, or zoom.

2D measurements
The basic measurements that you can perform in 2D imaging are as follows:
• Distance in cm
• Area in cm2
• Circumference in cm
You can also measure area or circumference by manually tracing.
You can perform a combination of distance, area, circumference, and manual trace
measurements at one time. The total number possible depends on their order and type.

56
Figure 1 2D image with two distance and one circumference measurement

To measure distance (2D)


You can perform up to eight distance measurements on a 2D image.
1 On a frozen 2D image, press the CALIPER key.
A pair of calipers appears, connected by a dotted line.
2 Using the touchpad, position the first caliper, and then press the SELECT key.
The other caliper becomes active.
3 Using the touchpad, position the other caliper.

and Calculations
Measurements
If you move the calipers close together, they shrink and the dotted line disappears.
See “To save a measurement to a calculation and patient report” on page 55.

To measure area or circumference (2D)


1 On a frozen 2D image, press the CALIPER key.
2 Select Ellipse on‐screen.
Note: If you exceed the allowed number of measurements, Ellipse is not available.
3 Use the touchpad to adjust the size and position of the ellipse. The SELECT key toggles
between position and size.
See “To save a measurement to a calculation and patient report” on page 55.

Chapter 4: Measurements and Calculations 57


To trace manually (2D)
1 On a frozen 2D image, press the CALIPER key.
2 Select Manual on‐screen.
Note: If you exceed the allowed number of measurements, Manual is not available.
3 Using the touchpad, position the caliper where you want to begin.
4 Press the SELECT key.
5 Using the touchpad, complete the trace, and press the SET key.
See “To save a measurement to a calculation and patient report” on page 55.

M Mode measurements
The basic measurements that you can perform in M Mode imaging are as follows:
• Distance in cm/Time in seconds
• Heart Rate (HR) in beats per minute (bpm)
The time scale above the trace has small marks at 200 ms intervals and large marks at
one‐second intervals.

To measure distance (M Mode)


You can perform up to four distance measurements on an image.
1 On a frozen M Mode trace, press the CALIPER key.
A single caliper appears.
2 Using the touchpad, position the caliper.
3 Press the SELECT key to display the second caliper.
4 Using the touchpad, position the second caliper.
See “To save a measurement to a calculation and patient report” on page 55.

To measure heart rate (M Mode)


1 On a frozen M Mode trace, press the CALIPER key.
2 Select HR on‐screen.
A vertical caliper appears.
3 Using the touchpad, position the vertical caliper at the peak of the heartbeat.
4 Press the SELECT key.
A second vertical caliper appears.
5 Using the touchpad, position the second vertical caliper at the peak of the next heartbeat.

58
See “To save a measurement to a calculation and patient report” on page 55. Saving the heart
rate measurement to the patient report overwrites any heart rate entered on the patient
information form.
See also “To measure fetal heart rate (M Mode)” on page 88.

Doppler measurements
The basic measurements that you can perform in Doppler imaging are Velocity (cm/s), Pressure
Gradient, Elapsed Time, +/x Ratio, Resistive Index (RI), and Acceleration. You can also trace
manually or automatically.
For Doppler measurements, the Doppler scale must be set to cm/s. See “Presets setup” on
page 29.

To measure Velocity (cm/s) and Pressure Gradient (Doppler)


1 On a frozen Doppler spectral trace, press the CALIPER key.
A single caliper appears.
2 Using the touchpad, position the caliper to a peak velocity waveform.
This measurement involves a single caliper from the baseline.
See “To save a measurement to a calculation and patient report” on page 55.

To measure Velocities, Elapsed Time, +/x Ratio, Resistive Index (RI), and Acceleration
(Doppler)
1 On a frozen Doppler spectral trace, press the CALIPER key.
A single caliper appears.
2 Using the touchpad, position the caliper to a peak systolic waveform.
3 Press the SELECT key.
A second caliper appears.

and Calculations
Measurements
4 Using the touchpad, position the second caliper at the end diastole on the waveform.
See “To save a measurement to a calculation and patient report” on page 55.

To trace manually (Doppler)


1 On a frozen Doppler spectral trace, press the CALIPER key.
2 Select Manual on‐screen.
A single caliper appears.
3 Using the touchpad, position the caliper at the beginning of the desired waveform, and press
the SELECT key.
If calipers are not positioned correctly, the result is inaccurate.

Chapter 4: Measurements and Calculations 59


4 Using the touchpad, trace the waveform.
To make a correction, select Undo on‐screen, backtrack with the touchpad, or press the
BACKSPACE key.
5 Press the SET key.
The measurement results appear.
See “To save a measurement to a calculation and patient report” on page 55.

To trace automatically (Doppler)


After tracing automatically, confirm that the system‐generated boundary is correct. If you are
not satisfied with the trace, obtain a high‐quality Doppler spectral trace image, or trace
manually. (See “To trace manually (Doppler)” on page 59.)
1 On a frozen Doppler spectral trace, press the CALIPER key.
2 Select Auto on‐screen.
A vertical caliper appears.
3 Using the touchpad, position the caliper at the beginning of the waveform.
If calipers are not positioned correctly, the calculation result is inaccurate.
4 Press the SELECT key.
A second vertical caliper appears.
5 Using the touchpad, position the second caliper at the end of the waveform.
6 Press the SET key.
The measurement results appear.
See “To save a measurement to a calculation and patient report” on page 55.
Automatic Trace Measurement Results for Exam Type (Doppler)

Exam Type

Automatic Trace Results Abdomen Cardiac Neo OB/Gyn Vascular

Velocity Time Integral (VTI) — X — — —

Peak Velocity (Vmax) X X — X X

Mean Pressure Gradient — X — — —


(PGmean)

Mean Velocity on Peak Trace — X — — —


(Vmean)

Pressure Gradient (PGmax) — X — — —

60
Automatic Trace Measurement Results for Exam Type (Doppler) (Continued)

Exam Type

Automatic Trace Results Abdomen Cardiac Neo OB/Gyn Vascular

Cardiac Output (CO) — X — — —

Peak Systolic Velocity (PSV) — — X — —

Time Average Mean (TAM)* — — X — —

+/× or Systolic/Diastolic (S/D) X — X X X

Pulsatility Index (PI) X — X X X

End Diastolic Velocity (EDV) X — X X X

Acceleration Time (AT) X — — — —

Resistive Index (RI) X — X X X

Time Average Peak (TAP) — — X — —

Gate Depth — — X — —
* The automatic trace tool must be used to calculate the TAM.

General calculations
Within calculations, you can save measurement results to the patient report. You can view,
repeat, and delete measurements from a calculation. Some measurements can be deleted
directly from the patient report pages. See “Patient report” on page 92.
Calculation packages depend on exam type and transducer.

and Calculations
Measurements
Calculations menu
The calculations menu contains measurements available for the imaging mode and exam type.
After you perform and save a measurement, the result saves to the patient report. (See “Patient
report” on page 92.) Also, a check mark appears next to the measurement name in the
calculations menu. If you highlight the checked measurement name, the results appear below
the menu. If you repeat the measurement, the results below the menu reflect either the last
measurement or the average, depending on the measurement.
Menu items followed by ellipses (. . .) have subentries.

To select from the calculations menu


1 On a frozen image, press the CALCS key.
The calculations menu appears.

Chapter 4: Measurements and Calculations 61


2 Using the touchpad or arrow keys, highlight the desired measurement name.
To display additional measurement names, highlight Next, Prev, or a measurement name
that has ellipses (. . .). Then press the SELECT key.
Only measurement names available for the imaging mode are selectable.
3 Press the SELECT key.
To close the calculations menu, press the CALCS key once (if the menu is active) or twice (if the
menu is inactive).

Performing and saving measurements in calculations


In performing a measurement within a calculation, you select from the calculations menu,
position the calipers that appear, and then save the calculation. Unlike measurements
performed outside a calculation, the calipers appear by selecting from the calculations menu,
not by pressing the CALIPER key. The type of calipers that appear depends on the
measurement.

To save a calculation
™ Do one of the following:
• Save the calculation only: Press the SAVE CALC key, or select Save on‐screen.
The calculation saves to the patient report. To save the image with the measurements
displayed, see “To save an image” on page 48.
• Save both the image and calculation: Press the SAVE key if the SAVE key functionality is
set to Image/Calcs. (See “To set presets” on page 29.)
The calculation saves to the patient report, and the image saves to internal storage with
the measurements displayed.

Viewing, repeating, and deleting saved measurements


in calculations
To view a saved measurement
™ Do one of the following:
• Highlight the measurement name in the calculations menu. The result appears below the
menu.
• Open the patient report. See “Patient report” on page 92.

To repeat a saved measurement


1 Highlight the measurement name in the calculations menu.
2 Press the SELECT key or the CALIPER key.

62
3 Perform the measurement again.
The new results appear on‐screen in the measurement and calculations data area. (See
“Screen layout” on page 12.) You can compare them to the saved results below the menu.
4 To save the new measurement, press the SAVE CALC key.
The new measurement saves to the patient report and overwrites the previously saved
measurement.

To delete a saved measurement


1 Select the measurement name from the calculations menu.
2 Select Delete on‐screen.
The measurement last saved is deleted from the patient report. If it is the only measurement,
the check mark is deleted from the calculations menu.
Some measurements can be deleted directly from the report pages. See “Patient report” on
page 92.

Percent reduction calculations


WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45

Transducers and Exam Types for Percent Reduction Calculations

and Calculations
Measurements
Transducer Exam Types

C11x Abdomen

C60x Abdomen

HFL38x IMT, Small Parts, Vascular

L25x Vascular, Muscle

L38x IMT, Small Parts, Vascular

P21x Abdomen

Chapter 4: Measurements and Calculations 63


Figure 2 Percent area reduction calculation of right carotid bulb

To calculate percent area reduction


The percent area reduction calculation involves two manual trace measurements.
1 On a frozen 2D image, press the CALCS key.
2 Do the following for A1 and then for A2:
a From the calculations menu, select the measurement name under Area Red.
b Using the touchpad, move the caliper to the trace starting point, and press the SELECT
key.
c Using the touchpad, trace the desired area.
To make a correction, select Undo on‐screen or press the BACKSPACE key.
d Complete the trace, and press the SET key.
e Save the calculation. See “To save a calculation” on page 62.
The percent area reduction result appears on‐screen in the measurement and calculation
data area and in the patient report.

To calculate percent diameter reduction


1 On a frozen 2D image, press the CALCS key.
2 Do the following for D1 and then for D2:
a From the calculations menu, select the measurement name under Dia Red.
b Position the calipers. (See “Working with calipers” on page 55.)

64
c Save the calculation. See “To save a calculation” on page 62.
The percent diameter reduction result appears in the measurement and calculation data area
and in the patient report.

Volume calculations
WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See“To create a new patient information form” on page 45

Transducers and Exam Types for Volume Calculations

Transducer Exam Types

C11x Abdomen, Nerve

C60x Gyn, Abdomen

HFL38x Breast, Nerve, Small Parts, Vascular

ICTx Gyn

L25x Nerve, Vascular, Superficial, Muscle

L38x Breast, Nerve, Small Parts, Vascular

P21x Abdomen

and Calculations
Measurements
To calculate volume
The volume calculation involves three 2D distance measurements: D1, D2, and D3. After all
measurements are saved, the result appears on‐screen and in the patient report.
™ Do the following for each image you need to measure:
a On the frozen 2D image, press the CALCS key.
b Do the following for each measurement you need to take:
i From the calculations menu, select the measurement name under Volume.
ii Position the calipers. (See “Working with calipers” on page 55.)
iii Save the measurement. See “To save a calculation” on page 62.

Chapter 4: Measurements and Calculations 65


Volume flow calculations
WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.

Transducers and Exam Types for Volume Flow Calculations

Transducer Exam Types

C11x Abdomen

C60x Abdomen

HFL38x Vascular

L25x Vascular

L38x Vascular

P21x Abdomen

The following table shows the measurements required to complete the volume flow
calculation. For definitions of acronyms, see “Glossary” on page 179.
Volume Flow Calculation

Menu Heading Measurement (Imaging Mode) Calculation Result

Vol Flow D (2D) VF (Volume Flow 1/min)


TAM (Doppler)

Both a 2D and a Doppler measurement are required for the volume flow calculation. The
Doppler sample volume should completely insonate the vessel.
Consider the following factors when performing volume flow measurements:
• Users should follow current medical practice for volume flow calculation applications.
• The accuracy of the volume flow calculation largely depends on the user.
• The factors identified in the literature that affect the accuracy are as follows:
• Using the diameter method for 2D area

66
• Difficulty ensuring uniform insonation of the vessel.
The system is limited to the following sample volume sizes:
• C11x transducer: 1, 2, 3 Gate Size (mm)
• C60x transducer: 2, 3, 5, 7, 10, 12 Gate Size (mm)
• HFL38x, L25x, and L38x transducers: 1, 3, 5, 7, 10, 12 Gate Size (mm)
• P21x transducer: 2, 3, 5, 7, 11.5, 14 Gate Size (mm)
• Precision in placing the caliper
• Accuracy in angle correction
The considerations and degree of accuracy for volume flow measurements and calculations are
discussed in the following reference:
Allan, Paul L. et al. Clinical Doppler Ultrasound, 4th Ed., Harcourt Publishers Limited, (2000)
36‐38.

To calculate volume flow


1 Perform the 2D measurement:
a On a frozen full‐screen 2D image or duplex image, press the CALCS key.
b From the calculations menu, select D (distance) under Vol Flow.
c Position the calipers. (See “Working with calipers” on page 55.)
d Save the calculation. See “To save a calculation” on page 62.
2 Perform the Doppler measurement:
a On a frozen Doppler spectral trace, press the CALCS key.
b From the calculations menu, select TAM under Vol Flow.
c Press the SELECT key to display a vertical caliper.

and Calculations
Measurements
d Using the touchpad, position the vertical caliper at the beginning of the waveform.
If calipers are not positioned correctly, the calculation result is inaccurate.
e Press the SELECT key to display a second vertical caliper.
f Using the touchpad, position the second vertical caliper at the end of the waveform.
g Press the SET key to complete the trace and to display the results.
h Save the calculation. See “To save a calculation” on page 62.
To view the volume flow calculation, see “Patient report” on page 92.

Chapter 4: Measurements and Calculations 67


Specialized calculations
In addition to the general calculations, there are calculations specific to the Cardiac,
Gynecology (Gyn), IMT, OB, Small Parts, and Vascular exam types.

Cardiac calculations
WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.

Transducers and Exam Type for Cardiac Calculations

Transducer Exam Type

P21x Cardiac

The following table shows the measurements required to complete different cardiac
calculations. For definitions of acronyms, see “Glossary” on page 179.
Cardiac Calculations

Menu Heading Cardiac Measurements (Imaging Mode) Calculation Results

LVd RVW (2D) CO


RVD (2D) EF
IVS (2D) SV
LVD (2D) LVESV
LVPW (2D) LVEDV

LVs RVW (2D) IVSFT

RVD (2D) LVPWFT

IVS (2D) LVDFS

LVD (2D) CI

LVPW (2D) SI

HRa needed for CO & CI

68
Cardiac Calculations (Continued)

Menu Heading Cardiac Measurements (Imaging Mode) Calculation Results

LV Ao (2D or M Mode) Ao
LA/Ao

AAo (2D) AAo

LA (2D or M Mode) LA
LA/Ao

LVOT D (2D) LVOT D


LVOT area

ACS (M Mode) ACS

LVET (M Mode) LVET

EF:Slope (M Mode) EF SLOPE

EPSS (M Mode) EPSS

LVd RVW (M Mode) CO


RVD (M Mode) EF
IVS (M Mode) SV
LVD (M Mode) LVESV
LVPW (M Mode) LVEDV
IVSFT
LVs RVW (M Mode)
LVPWFT
RVD (M Mode)
LVDFS
IVS (M Mode)
CI

and Calculations
Measurements
LVD (M Mode)
LVPW (M Mode) SI
LV Mass
HR HRa

Area AV (2D) AV Area

MV (2D) MV Area

Chapter 4: Measurements and Calculations 69


Cardiac Calculations (Continued)

Menu Heading Cardiac Measurements (Imaging Mode) Calculation Results

LV Vol A4Cd (2D) LV Vol


A4Cs (2D) LV Area
A2Cd (2D) EF
A2Cs (2D) CO
SV
CI
SI
Biplane

LV mass Epi (2D) LV Mass


Endo (2D) Epi Area
Apical (2D) Endo Area
D Apical

PISA Ann D (2D) PISA Area


Radius (Color) ERO
MR/VTI (Doppler) MV Rate
MV/VTI (Doppler) Regurgitant Volume
Regurgitant Fraction

Qp/Qs LVOT D (2D) D


RVOT D (2D) VTI
LVOT VTI (Doppler) VMax
RVOT VTI (Doppler) PGmax
Vmean
PGmean
SV
Qp/Qs

70
Cardiac Calculations (Continued)

Menu Heading Cardiac Measurements (Imaging Mode) Calculation Results

MV E (Doppler) E
A (Doppler) E PG
A
A PG
E:A

PHT (deceleration time) (Doppler) PHT


MVA
Decel time

VTI (Doppler) VTI


Vmax
PGmax
Vmean
PGmean

IVRT (Doppler) IVRT

MV >MR dP:dTb (CW Doppler) dP:dT

AV Vmax (Doppler) Vmax


PGmax

VTI (Doppler) VTI


Vmax
PGmax

and Calculations
Measurements
Vmean
PGmean

VTI or Vmax from LVOT (Doppler) AVA


VTI or Vmax from AV (Doppler)

LV LVOT D (2D)

AV VTI (Doppler) SV

LV LVOT D (2D)

Chapter 4: Measurements and Calculations 71


Cardiac Calculations (Continued)

Menu Heading Cardiac Measurements (Imaging Mode) Calculation Results

AV VTI (Doppler) CO

LV LVOT D (2D)

HR HRa

LVOT Vmax (Doppler) Vmax


PGmax

VTI (Doppler) VTI


Vmax
PGmax
Vmean
PGmean

AV > AI PHT (slope) (Doppler) AI PHT


AI slope

TV TRmax (Doppler) Vmax


PGmax

RA pressurec RVSP

PV Vmax (Doppler) Vmax


PGmax

VTI (Doppler) VTI


Vmax
PGmax
Vmean
PGmean
a. You can enter the HR measurement three ways: Patient information form, Doppler measurement (See
“To calculate Heart Rate (HR)” on page 78), or M Mode measurement (See “To measure heart rate (M
Mode)” on page 58).
b. Performed at 100 cm/s and 300 cm/s.
c. Specified on the cardiac report. See “To view a vascular or cardiac report” on page 92.

To measure LVd and LVs


1 On a frozen 2D image or M Mode trace, press the CALCS key.
2 From the calculations menu, select the measurement name.

72
3 Position the active (green) caliper at the starting point. (See “Working with calipers” on
page 55.)
4 Press the SELECT key, and position the second caliper.
5 Press the SELECT key.
Another caliper appears, and the calculations menu highlights the next measurement name.
6 Position the caliper, and press the SELECT key. Repeat for each measurement name in the
calculation group.
Each time you press the SELECT key, another caliper appears, and the calculations menu
highlights the next measurement name.
7 Save the calculation. (See “To save a calculation” on page 62.)

To measure Ao, LA, AAo, or LVOT D


1 On a frozen 2D image or M Mode trace, press the CALCS key.
2 From the calculations menu, select the measurement name.
3 Position the calipers. (See “Working with calipers” on page 55.)
4 Save the calculation. (See “To save a calculation” on page 62.)

To calculate LV Volume (Simpson’s Rule)


1 On a frozen 2D image, press the CALCS key.
2 Do the following for each measurement:
a From the calculations menu, select the desired view and phase.
b Position the caliper at the mitral annulus, and press the SELECT key to start the trace.
c Using the touchpad, trace the left ventricular (LV) cavity.
To make a correction, select Undo on‐screen or press the BACKSPACE key.

and Calculations
Measurements
d Complete the trace, and press the SET key.
e Save the calculation. (See “To save a calculation” on page 62.)

To calculate MV or AV area
1 On a frozen 2D image, press the CALCS key.
2 In the calculations menu, locate Area, and then select MV or AV.
3 Position the caliper where you want to begin the trace, and press the SELECT key.
4 Using the touchpad, trace the desired area.
To make a correction, select Undo on‐screen or press the BACKSPACE key.
5 Complete the trace, and press the SET key.
6 Save the calculation. (See “To save a calculation” on page 62.)

Chapter 4: Measurements and Calculations 73


To calculate LV Mass
1 On a frozen 2D image, press the CALCS key.
2 In the calculations menu, locate LV Mass.
3 Do the following for EPI and then for Endo:
a Select the measurement name from the calculations menu.
b Position the caliper where you want to begin the trace, and press the SELECT key.
c Using the touchpad, trace the desired area.
To make a correction, select Undo on‐screen or press the BACKSPACE key.
d Complete the trace, and press the SET key.
e Save the calculation. (See “To save a calculation” on page 62.).
4 Select Apical from the calculations menu.
5 Positioning the calipers, measure the ventricular length. (See “Working with calipers” on
page 55.)
6 Save the calculation.

To perform peak velocity measurements in the calculation package


For each cardiac measurement, the system saves up to five individual measurements and
calculates their average. If you take more than five measurements, the most recent
measurement replaces the fifth one. If you delete a saved measurement from the report, the
next measurement taken replaces the deleted one in the report.The most recently saved
measurement appears at the bottom of the calculations menu.
1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select MV, TV, or TDI.
3 Do the following for each measurement you want to take:
a Select the measurement name from the calculations menu.
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)

To calculate Velocity Time Integral (VTI)


Note: This calculation computes other results in addition to VTI. See the table “Cardiac Calculations”
on page 68.
1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select MV, AV, PV, or LVOT and then select VTI.
3 Position the caliper at the start of the waveform, and press the SELECT key to start the trace.

74
4 Using the touchpad, trace the waveform.
To make a correction, select Undo on‐screen, backtrack with the touchpad, or press the
BACKSPACE key.
5 Press the SET key to complete the trace.
6 Save the calculation. (See “To save a calculation” on page 62.)
For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 60.

To calculate Right Ventricular Systolic Pressure (RVSP)


1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select TV and then select TRmax.
3 Position the caliper. (See “Working with calipers” on page 55.)
4 Save the calculation. (See “To save a calculation” on page 62.)
5 To adjust the RA pressure, see “To view a vascular or cardiac report” on page 92.
Changing the RA pressure from the default 5 affects the RVSP calculation in the report.

To calculate Pressure Half Time (PHT) in MV or AV


1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select MV or AV, and then select PHT.
3 Position the first caliper at the peak, and press the SELECT key.
A second caliper appears.
4 Position the second caliper:
• In MV, position the caliper along the EF slope.
• In AV, position the caliper at the end diastole.

and Calculations
5 Save the calculation. (See “To save a calculation” on page 62.)

Measurements
To calculate Proximal Isovelocity Surface Area (PISA)
The PISA calculation requires a measurement in 2D, a measurement in Color, and two
measurements in Doppler spectral trace. After all measurements are saved, the result appears
in the patient report.
1 Measure from Ann D (2D):
a On a frozen 2D image, press the CALCS key.
b From the calculations menu, locate PISA, and then select Ann D.
c Position the calipers. (See “Working with calipers” on page 55.)
d Save the calculation. (See “To save a calculation” on page 62.).

Chapter 4: Measurements and Calculations 75


2 Measure from Radius (Color):
a On a frozen Color image, press the CALCS key.
b From the calculations menu, select Radius.
c Position the calipers.
d Save the calculation.
3 On a frozen Doppler spectral trace, press the CALCS key.
4 Do the following to measure from MR VTI and again to measure from MV VTI (Doppler):
a From the calculations menu, select PISA and then select MR VTI or MV VTI.
b Position the caliper at the start of the waveform, and press the SELECT key to start the
trace.
c Using the touchpad, trace the waveform.
To make a correction, select Undo on‐screen, backtrack with the touchpad, or press the
BACKSPACE key.
d Press the SET key to complete the trace.
e Save the calculation.
For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 60.

To calculate Isovolumic Relaxation Time (IVRT)


1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select MV and then select IVRT.
A vertical caliper appears.
3 Using the touchpad, position the caliper at the aortic valve closure.
4 Press the SELECT key.
A second vertical caliper appears.
5 Using the touchpad, position the second caliper at onset of mitral inflow.
6 Save the calculation. (See “To save a calculation” on page 62.)

To calculate Delta Pressure: Delta Time (dP:dT)


To perform the dP:dT measurements, the CW Doppler scale must include velocities of 300 cm/s
or greater on the negative side of the baseline. (See “Spectral trace options” on page 41.)
1 On a frozen CW Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select MV, and then select dP:dT.
A horizontal dotted line with an active caliper appears at 100 cm/s.
3 Position the first caliper along the waveform at 100 cm/s.

76
4 Press the SELECT key.
A second horizontal dotted line with an active caliper appears at 300 cm/s.
5 Position the second caliper along the waveform at 300 cm/s.
6 Save the calculation. (See “To save a calculation” on page 62.)

To calculate Aortic Valve Area (AVA)


The AVA calculation requires a measurement in 2D and two measurements in Doppler. After
the measurements are saved, the result appears in the patient report.
1 Measure from LVOT (2D):
a On a frozen 2D image, press the CALCS key.
b From the calculations menu, select LVOT D.
c Position the calipers. (See “Working with calipers” on page 55.)
d Save the calculation. (See “To save a calculation” on page 62.)
2 Measure from LVOT, and then measure from AV (Doppler):
• For Vmax, see “To perform peak velocity measurements in the calculation package” on
page 74. From the calculations menu, select AV, select sample site, and then select Vmax.
• For VTI, see “To calculate Velocity Time Integral (VTI)” on page 74. From the calculations
menu, select AV, select sample site, and then select VTI.

To calculate Qp/Qs
The Qp/Qs calculation requires two measurements in 2D and two measurements in Doppler.
After the measurements are saved, the result appears in the patient report.
1 On a frozen 2D image, press the CALCS key.
2 Do the following to measure from LVOT D and again to measure from RVOT D:

and Calculations
a From the calculations menu, locate Qp/Qs and then select LVOT D or RVOT D.

Measurements
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)
3 On a frozen Doppler spectral trace, press the CALCS key.
4 Do the following to measure from LVOT VTI and again to measure from RVOT VTI:
a From the calculations menu, select Qp/Qs and then select LVOT VTI or RVOT VTI.
b Press the SELECT key to start the trace.
c Using the touchpad, trace the waveform.
To make a correction, select Undo on‐screen, backtrack with the touchpad, or press the
BACKSPACE key.
d Press the SET key to complete the trace.

Chapter 4: Measurements and Calculations 77


e Save the calculation. (See “To save a calculation” on page 62.)
For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 60.

To calculate Stroke Volume (SV) or Stroke Index (SI)


The SV and SI calculations require a measurement in 2D and a measurement in Doppler. SI also
requires Body Surface Area (BSA). After the measurements are saved, the result appears in the
patient report.
1 (SI Only) Fill in the Height and Weight fields on the patient information form. The BSA is
calculated automatically. (See “To create a new patient information form” on page 45.)
2 Measure from LVOT (2D):
a On a frozen 2D image, press the CALCS key.
b From the calculations menu, select LVOT D.
c Position the calipers. (See “Working with calipers” on page 55.)
d Save the calculation. (See “To save a calculation” on page 62.)
3 Measure from aorta (Doppler). See “To calculate Velocity Time Integral (VTI)” on page 74.
From the calculations menu, select AV and then select VTI.
For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 60.

To calculate Heart Rate (HR)


Heart Rate is available in all cardiac packages. The Heart Rate is not calculated using the ECG
trace.
Saving the heart rate to the patient report overwrites any heart rate entered on the patient
information form.
1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select HR.
A vertical caliper appears.
3 Using the touchpad, position the first vertical caliper at the peak of the heartbeat.
4 Press the SELECT key.
A second vertical caliper appears. The active caliper is highlighted green.
5 Using the touchpad, position the second vertical caliper at the peak of the next heartbeat.
6 Save the calculation. (See “To save a calculation” on page 62.)

To calculate Cardiac Output (CO) or Cardiac Index (CI)


The CO and CI calculations require Stroke Volume and Heart Rate calculations. CI also requires
Body Surface Area (BSA). After the measurements are saved, the result appears in the patient
report.

78
1 (CI Only) Fill in the Height and Weight fields on the patient information form. The BSA is
calculated automatically. (See “To edit a patient information form” on page 45.)
2 Calculate SV. See “To calculate Stroke Volume (SV) or Stroke Index (SI)” on page 78.
3 Calculate HR. See “To calculate Heart Rate (HR)” on page 78.

To perform a Tissue Doppler Imaging (TDI) calculation


1 Ensure that TDI is on. (See “PW Doppler options” on page 40.)
2 On a frozen Doppler spectral trace, press the CALCS key.
3 From the calculations menu, select TDI, and then do the following for each measurement you
want to take:
a From the calculations menu, select the measurement name.
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)

Gynecology (Gyn) calculations


Gynecology (Gyn) calculations include Uterus, Ovary, Follicle, and Volume. For instructions to
calculate volume, see “Volume calculations” on page 65.

WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.

Transducers and Exam Types for Gynecology (Gyn) Calculations

and Calculations
Measurements
Transducer Exam Type

C60x Gyn

ICTx Gyn

To measure uterus or ovary


1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Gyn.
3 Do the following for each measurement you want to take:
a Select the measurement name from the calculations menu.
b Position the calipers. (See “Working with calipers” on page 55.)

Chapter 4: Measurements and Calculations 79


c Save the calculation. (See “To save a calculation” on page 62.)

To measure follicles
You can save up to six follicular measurements, one distance measurement for each of up to six
follicles.
1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Follicle.
3 Do the following for each follicle you want to measure:
a From the calculations menu, select the measurement name under Right Fol or Left Fol.
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)

IMT calculations
WARNING: To ensure high quality images, all patient images must be obtained by qualified and
trained individuals.
To avoid patient injury, IMT results should not be used as a sole diagnostic tool. All
IMT results should be interpreted in conjunction with other clinical information or
risk factors.
To avoid measurement errors, all measurements must be of the common carotid
artery (CCA). This tool is not intended for measuring the bulb or the internal carotid
artery (ICA).
To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.

Transducers and Exam Type for IMT Calculations

Transducer Exam Type

L38x IMT

HFL38x IMT

80
The following table shows available measurements for IMT calculations. The IMT
measurement names are specified on the IMT setup page. See “IMT Calculations setup” on
page 25.
IMT Calculations (2D)

Menu Heading Available Measurements

Right-IMT Ant N (Anterior Near Wall)


Left-IMT Ant F (Anterior Far Wall)
Lat N (Lateral Near Wall)
Lat F (Lateral Far Wall)
Post N (Posterior Near Wall)
Post F (Posterior Far Wall)
IMT 1
IMT 2
IMT 3
IMT 4
IMT 5
IMT 6
IMT 7
IMT 8

Plaque Plaq 1
Plaq 2

To calculate IMT automatically


1 On a frozen 2D image, press the CALCS key.

and Calculations
Measurements
2 From the calculations menu, select the measurement.
3 Using the touchpad or arrow keys, position the IMT tool over the area of interest until the
measurement results appear.
4 Adjust the tool, and edit as needed. See “IMT tool options” on page 82.
5 Save the calculation. (See “To save a calculation” on page 62.)

Chapter 4: Measurements and Calculations 81


IMT tool options
When using the IMT tool, you can select the following options on‐screen.
IMT Tool Options

Option Icon Description

Hide Use to check results. Hides the measurement results and


trace line. Select Show to redisplay them.

Move Repositions the tool horizontally by several pixels. The


upper key moves the tool right, and the lower key moves
the tool left.

Width Adjusts the tool width by 1 mm. The upper key increases
the width, and the lower key decreases the width.

Edit Displays Smooth, Adven, and Lumen.

Smooth Adjusts the IMT line smoothing.


Select Edit to display this option.

Adven Adjusts the adventitia-media line. The upper key moves


the line upward. The lower key moves the line downward.
Select Edit to display this option.

Lumen Adjusts the lumen-intima line. The upper key moves the
line upward. The lower key moves the line downward.
Each of the two IMT lines can be adjusted independently.
Select Edit to display this option.

To trace IMT manually


In manually tracing IMT, the user defines the location.
1 On a frozen 2D image, press the CALCS key
2 From the calculations menu, select a measurement name.
3 Select Edit on‐screen, and then select Manual, and then select Sketch.
A single caliper appears, and Trace appears next to the measurement.
4 Do the following for the desired adventitia‐media boundary and then for the lumen‐intima
boundary:
a Position the caliper at the beginning of the boundary, and press the SELECT key.
b Using the touchpad, mark points by moving the caliper to the next desired point and
pressing the SELECT key.

82
To make a correction, select Undo on‐screen or press the BACKSPACE key to delete the
last segment.
c Press the SET key to complete the trace line.
5 Save the calculation. (See “To save a calculation” on page 62.)

To sketch IMT
The IMT sketch measurement involves two user‐defined sketch lines that you can adjust
manually.
1 On a frozen 2D image, press the CALCS key
2 From the calculations menu, select a measurement name.
3 Select Edit on‐screen, and then select Manual.
A single caliper appears on‐screen, and Sketch appears next to the measurement.
4 Do the following for the desired adventitia‐media boundary and then for the lumen‐intima
boundary:
a Position the caliper at the beginning of the boundary and press the SELECT key.
b Using the touchpad, mark points by moving the caliper to the next desired point and
pressing the SELECT key.
To make a correction, select Undo on‐screen or press the BACKSPACE key to delete the
last segment.
c Press the SET key to complete the trace line.
d If necessary, adjust or edit the measurement. See “IMT tool options” on page 82.
e Save the calculation. (See “To save a calculation” on page 62.)

OB calculations

and Calculations
EFW is calculated only after appropriate measurements are completed. If any one of these

Measurements
parameters results in an EDD greater than what the OB tables provide, the EFW is not
displayed.

WARNING: Make sure that you have selected the OB exam type and the OB calculations author
for the OB table you intend to use. See “System-Defined OB Calculations and Table
Authors” on page 86.
To avoid incorrect obstetrics calculations, verify with a local clock and calendar that
the system’s date and time settings are correct before each use of the system. The
system does not automatically adjust for daylight savings time changes.

Chapter 4: Measurements and Calculations 83


To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.
Prior to use, verify that OB custom table data entries are correct. The system does
not confirm the accuracy of the custom table data entered by the user.

Transducers and Exam Types for OB Calculations

Transducer Exam Type

C60x OB

ICTx OB

P21x OB

OB Calculation Terms in Patient Report and Patient Information Form

Term
Acronym
Definition

AUA Average Ultrasound Age


Calculated by averaging the individual ultrasound ages for the fetal
biometry measurements performed during the exam. The measurements
used to determine the AUA are based on the selected OB calculation
authors.

EDD by AUA Estimated Date of Delivery by Average Ultrasound Age


The estimated date of delivery calculated from the measurements
performed during the exam.

EDD by LMP Estimated Date of Delivery by Last Menstrual Period


The due date calculated from the user-entered LMP.

EFW Estimated Fetal Weight


Calculated from the measurements performed during the exam. The
measurements used to determine EFW are defined by the currently
selected EFW calculation author.

Estab. DD Established Due Date


A user-entered due date based on previous exam data or other available
information. The LMP is derived from the Established Due Date and is
listed in the patient report as LMPd.

84
OB Calculation Terms in Patient Report and Patient Information Form (Continued)

Term
Acronym
Definition

GA by LMP Gestational Age by Last Menstrual Period


The fetal age calculated using the date of the Last Menstrual Period (LMP).

GA by LMPd Gestational Age by derived Last Menstrual Period


The fetal age calculated using the Last Menstrual Period (LMPd) derived
from the Estab. DD.

LMP Last Menstrual Period


The first day of the last menstrual period. Used to calculate gestational
age and EDD.

LMPd derived Last Menstrual Period


Calculated from the user-entered Estab. DD.

UA Ultrasound Age
Calculated on the mean measurements taken for a particular fetal
biometry.

If you change the calculation author during the exam, the common measurements are retained.

and Calculations
Measurements

Chapter 4: Measurements and Calculations 85


The following table shows the system‐defined measurements available for OB calculations by
author. For definition of the acronyms, see “Glossary” on page 179. To select authors, see “OB
Calculations setup” on page 26.
See also “OB Custom Measurements setup” on page 27 and “OB Custom Tables setup” on
page 28.
System-Defined OB Calculations and Table Authors

Gestational OB
Calculation Result Table Authors
Measurements

Gestational Agea GS Hansmann, Nyberg, Tokyo U.

CRL Hadlock, Hansmann, Osaka,


Tokyo U.

BPD Chitty, Hadlock, Hansmann,


Osaka, Tokyo U.

OFD Hansmann

HC Chitty, Hadlock, Hansmann

TTD Hansmann, Tokyo U.b

APTD Tokyo U.b

AC Hadlock, Hansmann, Tokyo U.

FTA Osaka

FL Chitty, Hadlock, Hansmann,


Osaka, Tokyo U.

Estimated Fetal Weight (EFW)c HC, AC, FL Hadlock 1

BPD, AC, FL Hadlock 2

AC, FL Hadlock 3

BPD, TTD Hansmann

BPD, FTA, FL Osaka U.

BPD, AC Shepard

BPD, TTD, APTD, FL Tokyo U.

86
System-Defined OB Calculations and Table Authors (Continued)

Gestational OB
Calculation Result Table Authors
Measurements

Ratios HC/AC Campbell

FL/AC Hadlock

FL/BPD Hohler

FL/HC Hadlock

Amniotic Fluid Index Q1, Q2, Q3, Q4 Jeng

Growth Analysis Tablesd BPD Chitty, Hadlock, Jeanty

HC Chitty, Hadlock, Jeanty

AC Chitty, Hadlock, Jeanty

FL Chitty, Hadlock, Jeanty

EFW Hadlock, Jeanty

HC/AC Campbell

a. The Gestational Age is automatically calculated and displayed next to the OB measurement you selected.
The average of the results is the AUA.
b. For Toyko U., APTD and TTD are used only to calculate EFW. No age or growth tables are associated with
these measurements.
c. The Estimated Fetal Weight calculation uses an equation that consists of one or more fetal biometry
measurements. The author for the OB tables, which you choose on a system setup page, determines the
measurements you must perform to obtain an EFW calculation. (See “OB Calculations setup” on page 26.)
Individual selections for Hadlock’s EFW equations 1, 2, and 3 are not determined by the user. The selected

and Calculations
equation is determined by the measurements that have been saved to the report with priority given to the

Measurements
order listed above.
d. The Growth Analysis tables are used by the Report Graphs feature. Three growth curves are drawn using
the table data for the selected growth parameter and published author. Growth tables are only available
with a user-entered LMP or Estab. DD.

To measure gestational growth (2D)


For each 2D OB measurement (except AFI), the system saves up to three individual
measurements and their average. If you take more than three measurements, the earliest
measurement is deleted.
1 In the patient information form, select OB exam type, and select LMP or Estab.DD. Select
Twins if appropriate.
2 On a frozen 2D image, press the CALCS key.

Chapter 4: Measurements and Calculations 87


3 Do the following for each measurement you want to take:
a From the calculations menu, select the measurement name. For twins, select Twin A or
Twin B, and then select the measurement name.
The caliper tool may change depending on the measurement selected, but the position
remains constant.
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)

To measure fetal heart rate (M Mode)


1 On a frozen M Mode trace, press the CALCS key.
2 Select FHR from the calculations menu.
A vertical caliper appears.
3 Using the touchpad, position the vertical caliper at the peak of the heartbeat.
4 Press the SELECT key.
A second vertical caliper appears.
5 Using the touchpad, position the second vertical caliper at the peak of the next heartbeat.
6 Save the calculation. (See “To save a calculation” on page 62.)
Saving the heart rate measurement to the patient report overwrites any heart rate entered on
the patient information form.
OB Doppler Calculations

Menu Heading OB Calculation Results

MCA (Middle Cerebral Artery) S/D, RI SD


RI

S/D, RI, PI* SD


RI
PI

Umb A (Umbilical Artery) S/D, RI SD


RI

S/D, RI, PI* SD


RI
PI
*Calculation requires a trace measurement.

88
To calculate MCA or Umba (Doppler)
Note: The system does not provide an MCA/UmbA ratio from the PI (Pulsatility Index).
1 Select OB exam type, and select LMP or Estab.DD in the patient information form.
2 On a frozen Doppler spectral trace, press the CALCS key.
3 Do the following for each measurement you need to take:
a From the calculations menu, select the measurement name under MCA (Middle Cerebral
Artery) or UmbA (Umbilical Artery).
b Position the calipers:
• For S/D, RI, position the first caliper at the peak systolic waveform. Press the SELECT
key, and position the second caliper at the end diastole on the waveform.
• For S/D, RI, PI, position the caliper at the beginning of the desired waveform, and press
the SELECT key. Use the touchpad to manually trace the desired area. Press the SET
key.
If calipers are not positioned correctly, the calculation result is inaccurate.
c Save the calculation. (See “To save a calculation” on page 62.)
Only one calculation (S/D, RI or S/D, RI, PI) can be saved.

Small Parts calculations


Small Parts calculations include volume, hip angle, and d:D ratio. For instructions to calculate
volume, see “Volume calculations” on page 65.
Transducers and Exam Types for Hip Angle and d:D Ratio Calculations

Transducer Exam Type

HFL38x Small Parts

and Calculations
L38x Small Parts

Measurements
To calculate hip angle
1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Right or Left.
3 Select Baseline under Hip Angle.
A baseline appears on‐screen.
4 Position the baseline, and press the SET key. (See “Working with calipers” on page 55.)
Line A (alpha line) appears on‐screen, and Line A is selected in the calculations menu.
5 Position Line A, and save the measurement. (See “To save a calculation” on page 62.)
Line B (beta line) appears on‐screen, and Line B is selected in the calculations menu.

Chapter 4: Measurements and Calculations 89


6 Position Line B, and save the measurement.

To calculate d:D ratio


1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Right or Left.
3 Under d:D Ratio, select Fem Hd (femoral head).
4 Using the touchpad, position and resize the circle. The SELECT key toggles between position
and size.
5 Press the SET key.
The baseline automatically appears with the left caliper active.
6 Position the caliper. (See “Working with calipers” on page 55.)
7 Save the measurement. (See “To save a calculation” on page 62.)

Vascular calculations
WARNING: To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.
To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.

Transducers and Exam Types for Vascular Calculations

Transducer Exam Type

HFL38x Vascular

L25x Vascular

L38x Vascular

P10x Vascular

90
The vascular measurements that you can save to the patient report are listed in the following
table. For definitions of acronyms, see “Glossary” on page 179.
Vascular Calculations

Menu Heading Vascular Measurement Calculation Results

CCA Prox s (systolic), d (diastolic)

Mid s (systolic), d (diastolic)

Dist s (systolic), d (diastolic)

Bulb s (systolic), d (diastolic)

ICA Prox s (systolic), d (diastolic)

Mid s (systolic), d (diastolic)

Dist s (systolic), d (diastolic)

ECA Prox s (systolic), d (diastolic)

Mid s (systolic), d (diastolic)

Dist s (systolic), d (diastolic)

VArty s (systolic), d (diastolic)

To perform a Vascular calculation


After you perform vascular measurements, values in the ICA/CCA ratios are selectable on the
vascular page of the patient report.
1 On a frozen Doppler spectral trace, press the CALCS key.
2 From the calculations menu, select Left or Right.

and Calculations
Measurements
3 Do the following for each measurement you want to take:
a From the calculations menu, select the measurement name.
b Using the touchpad, position the caliper at the peak systolic waveform.
c Press the SELECT key.
A second caliper appears.
d Using the touchpad, position the second caliper at the end diastole on the waveform.
e Save the calculation. (See “To save a calculation” on page 62.)

Chapter 4: Measurements and Calculations 91


Patient report
The patient report contains calculation results. The last page contains patient information. The
patient report for Cardiac, OB, and Vascular exams have additional details and features.
You can view the patient report at any time during the exam.
The value for a calculation appears only if the calculation has been performed. The pound
symbol (###) indicates a value that is out of range (for example, too large or small). Calculation
values that are out of range are not included in derived calculations (for example, mean).

To view a patient report


1 Press the REPORT key.

2 To view additional pages, select 1/x on‐screen.


3 (Optional) Press the SAVE key to save the current page of the patient report.
To exit the patient report and return to imaging, select Done.

Vascular and cardiac reports


To view a vascular or cardiac report
1 After or during the vascular or cardiac exam, press the REPORT key.
2 Do any of the following:

• To view additional pages, select 1/x on‐screen.


• To view details or the summary, select Details or Summary on‐screen. The mean of the
detail entries is used in the summary.
• To delete a measurement, use the touchpad on the Details page to select the
measurement. (The selected measurement is green.) Select Delete on‐screen.
Deleting some measurements also deletes related measurements. Deleted measurements
are not included in the summary information.
3 (Vascular Only) In the Ratio list, select measurements for the ICA/CCA ratio for both the
right and left sides.
4 (Cardiac Only) To adjust the RA pressure, select from the RA list.
Changing the RA pressure from the default number 5 affects the RVSP calculation result.

OB reports
The OB report pages have a signature space for signing printed reports.
To view the OB Twins report (individual)
1 After or during the OB exam, press the REPORT key.
2 Select Twin A/B on‐screen to view individual twin reports.

92
To view the OB Twins report (combined)
1 After or during the OB exam, press the REPORT key.
2 Select Compare on‐screen to view both twins in a single report.

To delete an OB measurement
1 After or during the OB exam, press the REPORT key.
2 Using the touchpad, select the desired OB measurement.
The selected measurement is highlighted green.
3 Select Delete on‐screen.
To delete all measurements, select the measurement label and press the SELECT key and
then select Delete on‐screen.

and Calculations
Measurements
Figure 3 OB Anatomy Checklist Page

To view the OB Anatomy Checklist page


1 After or during the OB exam, press the REPORT key.
2 On the page for Anatomy Demonstrated, select the check boxes to document reviewed
anatomy.
Press the TAB key to move between fields and the SPACEBAR to select and deselect items in
the checklist.

Chapter 4: Measurements and Calculations 93


To view the OB Biophysical Profile page
1 After or during the OB exam, press the REPORT key.
2 On page 2 of the report, select values for the biophysical profile (BPP) (0, 1, 2).
The total score is calculated when values are entered. NST (non‐stress test) is optional.

To view OB graphs
OB Graphs may be viewed if LMP or Estab. DD is entered in the patient information form.
1 After or during the OB exam, press the REPORT key.
2 Select Graphs on‐screen.
3 In the Graphs list, select the desired measurement/author.
The graph for the selected measurement appears. You can select another
measurement/author or select 1/x on‐screen.
For twins, both measurement sets are plotted on the same graph.
4 (Optional) Press the SAVE key to save the current graph page.
5 Select one of the following on‐screen:
• Report to return to the previous report page
• Done to return to live imaging.

Sending reports and viewing EMED worksheets


To send a report to a PC
You can send a report to a PC as a text file.
1 Ensure correct configuration. See “To configure the system for a DVD recorder, PC, or bar
code scanner” on page 24.
2 Select Send Rep. on‐screen.

To view EMED Worksheets


This feature is optional.
1 At the end of an exam, press the REPORT key.
2 Select EMED on‐screen.
3 Select the desired worksheet: AAA, FAST, Gallbladder (GB), Kidney.

94
Chapter 5: Troubleshooting and Maintenance

This chapter contains information to help correct problems with system operation, to enter a
software license, and to take proper care of the system, transducer, and accessories.

Troubleshooting
If you encounter difficulty with the system, use the following table to help troubleshoot the
problem. If the problem persists, contact SonoSite Technical Support. (See “SonoSite Technical
Support” on page viii.)
Troubleshooting

Symptom Solution

System does not turn on. Check all power connections.


Remove the DC input connector and battery, wait 10 seconds,
and then reinstall them.
Ensure that the battery is charged.

System image quality is poor. Adjust the LCD screen to improve viewing angle.
Adjust the brightness.
Adjust the gain.

No CPD image. Adjust the gain.

No Color image. Adjust the gain or the scale.

No OB measurement Select the OB exam type.


selections.

Print does not work. Select the printer on the Connectivity setup page. See “To
configure the system for a printer” on page 24.
Check the printer connections.
Ensure that the printer is turned on and set up properly. See
the printer manufacturer’s instructions, if necessary.

DVD recorder does not record. Check the DVD recorder connections.
Troubleshooting

Ensure that the DVD recorder is turned on and set up properly.


See the applicable SonoSite accessory user guide and the
manufacturers’ instructions.

Chapter 5: Troubleshooting and Maintenance 95


Troubleshooting (Continued)

Symptom Solution

External monitor does not Check the monitor connections.


work. Check the monitor to ensure that it is turned on and set up
properly. See the monitor manufacturers’ instructions, if
necessary.

System does not recognize the Disconnect and reconnect the transducer.
transducer.

System maintenance may be required. Record the number in


A maintenance icon
parentheses on the C: line and contact SonoSite or your
appears on the system screen.
SonoSite representative.

Software licensing
SonoSite software is controlled by a license key. After you install new software, the system
prompts you for a license key. You must obtain one key for each system or transducer that uses
the software.
The software will operate for a short time (the “grace period”) without a license key. During the
grace period, all system functions are available. After the grace period, the system is not usable
until you enter a valid license key. Grace period time is not used while the system is off or
asleep. Grace period time remaining appears on the license update screen.

Caution: After the grace period expires, all system functions except licensing are unavailable
until a valid license key is entered.

To obtain a license key for your software, contact SonoSite Technical Support. (See “SonoSite
Technical Support” on page viii.) You need to provide the following information. (See “System
Information setup” on page 30.)
Software License Key Information

System Software Transducer Software

Name of person installing the upgrade Name of person installing the upgrade

Serial number (on bottom of system) Transducer serial number

ARM version Transducer part number (REF)


or model number (for example, C60x)

PCBA serial number Transducer bundle version

After you obtain a license key, you must enter it into the system.

96
To enter a license key
1 Turn on the system.
The license update screen appears.
2 Enter the license key in the Enter license number field.
3 Select Done on‐screen.
If you entered a valid license key but the license update screen appears, verify that you
entered the license key correctly. If the license update screen still appears, contact SonoSite
Technical Support. (See “SonoSite Technical Support” on page viii.)

Maintenance
Use the recommendations in this section when cleaning or disinfecting your ultrasound
system, transducer, and accessories. Use the cleaning recommendations in the peripheral
manufacturer’s instructions when cleaning or disinfecting your peripherals.
No periodic or preventive maintenance is required for the system, transducer, or accessories
other than cleaning and disinfecting the transducer after every use. (See “Cleaning and
disinfecting transducers” on page 99.) There are no internal components that require periodic
testing or calibration. All maintenance requirements are described in this chapter and in the
ultrasound system service manual. Performing maintenance procedures not described in the
user guide or service manual may void the product warranty.
Contact SonoSite Technical Support for any maintenance questions. (See “SonoSite Technical
Support” on page viii.)

WARNING: Disinfectants and cleaning methods listed are recommended by SonoSite for
compatibility with product materials, not for biological effectiveness. Refer to the
disinfectant label instructions for guidance on disinfection efficacy and appropriate
clinical uses.
The level of disinfection required for a device is dictated by the type of tissue it will
contact during use. To avoid infection, ensure that the disinfectant type is
appropriate for the equipment. For information, see the disinfectant label
instructions and the recommendations of the Association for Professionals in
Infection Control and Epidemiology (APIC) and the U.S. Food and Drug
Administration (FDA).
To prevent contamination, the use of sterile transducer sheaths and sterile coupling
Troubleshooting

gel is recommended for clinical applications of an invasive or surgical nature. Do not


apply the transducer sheath and gel until you are ready to perform the procedure.

Caution: Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.

Chapter 5: Troubleshooting and Maintenance 97


Cleaning and disinfecting the ultrasound system
The exterior surface of the ultrasound system and the accessories can be cleaned and
disinfected using a recommended cleaner or disinfectant. See Table 1, “Disinfectants
Compatible with System and Transducers” on page 104.

WARNING: To avoid electrical shock, before cleaning, disconnect the system from the power
supply or remove from the mini-dock or docking system.
To avoid infection always use protective eyewear and gloves when performing
cleaning and disinfecting procedures.
To avoid infection, ensure that the solution expiration date has not passed.
To avoid infection, the level of disinfection required for a product is dictated by the
type of tissue it contacts during use. Ensure that the solution strength and duration
of contact are appropriate for the equipment. For information, see the disinfectant
label instructions and the recommendations of the Association for Professionals in
Infection Control and Epidemiology (APIC) and FDA.

Caution: Do not spray cleaners or disinfectant directly on the system surfaces. Doing so may
cause solution to leak into the system, damaging the system and voiding the
warranty.
Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since
these will damage the exterior surfaces.
Use only recommended cleaners or disinfectants on system surfaces.
Immersion-type disinfectants are not approved for use on system surfaces.
When you clean the system, ensure that the solution does not get inside the system
controls or the battery compartment.
Do not scratch the LCD screen.

To clean the LCD screen


™ Dampen a clean, non‐abrasive, cotton cloth with an ammonia‐based window cleaner, and
wipe the screen clean.
Apply the cleaner to the cloth rather than the surface of the screen.

To clean and disinfect system surfaces


1 Turn off the system.
2 Disconnect the system from the power supply, or remove it from the mini‐dock or docking
system.
3 Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent
cleaning solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.

98
4 Mix the disinfectant solution compatible with the system, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
5 Wipe surfaces with the disinfectant solution.
6 Air dry or towel dry with a clean cloth.

Cleaning and disinfecting transducers


To disinfect the transducer and its cable, use the immersion method or the wipe method.
Immersible transducers can be disinfected only if the product labeling indicates they can be
used with an immersion method.
See Table 1, “Disinfectants Compatible with System and Transducers” on page 104.

WARNING: To avoid electrical shock, before cleaning, disconnect the transducer from the
system.
To avoid injury, always use protective eyewear and gloves when performing
cleaning and disinfecting procedures.
To avoid infection, ensure that the solution expiration date has not passed.
To avoid infection, the level of disinfection required for a transducer is dictated by
the type of tissue it contacts during use. Ensure that the solution strength and
duration of contact are appropriate for the equipment. SonoSite tests products for
compatibility of materials only. SonoSite does not test for biological effectiveness.
For information, see the disinfectant label instructions and the recommendations of
the Association for Professionals in Infection Control and Epidemiology (APIC) and
FDA.

Caution: Transducers must be cleaned after every use. Cleaning transducers is necessary prior
to effective disinfection. Ensure that you follow the manufacturer's instructions
when using disinfectants.
Do not use a surgeon's brush when cleaning transducers. Even the use of soft
brushes can damage a transducer. Use a soft cloth.
Using a non-recommended cleaning or disinfection solution, incorrect solution
strength, or immersing a transducer deeper or for a longer period of time than
recommended can damage or discolor the transducer and void the transducer
warranty.
Do not allow cleaning solution or disinfectant into the transducer connector.
Troubleshooting

Do not allow disinfectant to contact metal surfaces. Use a soft cloth lightly
dampened in a mild soap or compatible cleaning solution to remove any
disinfectant that remains on metal surfaces.
Attempting to disinfect a transducer or transducer cable using a method other than
the one included here can damage the transducer and void the warranty.

Chapter 5: Troubleshooting and Maintenance 99


To clean and disinfect a transducer (wipe method)
1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning
solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Rinse with water or wipe with water‐dampened cloth, then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
6 Wipe surfaces with the disinfectant solution.
7 Air dry or towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local
representative.

To clean and disinfect a transducer (immersion method)


1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the surface using a soft cloth lightly dampened in a mild soap or compatible cleaning
solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Rinse with water or a wipe with water‐dampened cloth, and then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
6 Immerse the transducer into the disinfection solution not more than 12‐18 inches (31‐46 cm)
from the point where the cable enters the connector.
Follow the instructions on the disinfectant label for the duration of the transducer
immersion.
7 Using the instructions on the disinfectant label, rinse to the point of the previous immersion,
and then air dry or towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local
representative.

100
Cleaning and disinfecting transducer cables
The transducer cable can be disinfected using a recommended wipe or immersion disinfectant.
Before disinfecting, orient the cable to ensure that the transducer and system do not get
immersed.

WARNING: To avoid infection, ensure that the solution expiration date has not passed.

Caution: Attempting to disinfect a transducer cable using a method other than the one
included here can damage the transducer and void the warranty.

To clean and disinfect a transducer cable (wipe method)


1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the transducer cable using a soft cloth lightly dampened in a mild soap or detergent
cleaning solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Rinse with water or wipe with water‐dampened cloth, then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer cable, following disinfectant
label instructions for solution strengths and disinfectant contact duration.
6 Wipe surfaces with the disinfectant solution.
7 Air dry or towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local
representative.
To clean and disinfect a transducer cable (immersion method)
1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the transducer cable using a soft cloth lightly dampened in a mild soap or compatible
cleaning solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Rinse with water or a wipe with water‐dampened cloth, then wipe with a dry cloth.
Troubleshooting

5 Mix the disinfectant solution compatible with the transducer cable, following disinfectant
label instructions for solution strengths and disinfectant contact duration.
6 Immerse the transducer cable into the disinfection solution.
Follow the instructions on the disinfectant label for the duration of the transducer cable
immersion.

Chapter 5: Troubleshooting and Maintenance 101


7 Using the instructions on the disinfectant label, rinse the transducer cable, and then air dry
or towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local
representative.

Cleaning and disinfecting the battery


Caution: To avoid damaging the battery, do not allow cleaning solution or disinfectant to
come in contact with the battery terminals.

To clean and disinfect a battery (wipe method)


1 Remove the battery from the system.
2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning
solution.
Apply the solution to the cloth rather than the surface.
3 Wipe the surfaces with the disinfection solution. Theracide disinfectant is recommended.
4 Air dry or towel dry with a clean cloth.

Cleaning the footswitch


Caution: To avoid damaging the footswitch, do not sterilize. It is not intended for use in a
sterile environment.

To clean the footswitch


1 Dampen a non‐abrasive cloth with one of the following products:
• Isopropyl alcohol
• Soap and water
• Cidex
• Sodium Hypochlorite 5.25% (Bleach) diluted 10:1
2 Wring out cloth until slightly wet and then gently rub soiled area until clean.

Cleaning and disinfecting ECG cables


Caution: To avoid damaging the ECG cable, do not sterilize.

To clean and disinfect the ECG cable (wipe method)


1 Remove the cable from the system.

102
2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning
solution.
Apply the solution to the cloth rather than the surface.
3 Wipe the surfaces with any of the following products:
• Bleach (sodium hypochlorite)
• Cidex disinfectants
• Green soap
• Theracide
4 Air dry or towel dry with a clean cloth.

Troubleshooting

Chapter 5: Troubleshooting and Maintenance 103


104
Table 1 does not have the following regulatory information for disinfectants:
• EPA Registration
• FDA 510(k) clearance (liquid sterilant, high level disinfectant)
• CE approval
Prior to use, confirm that the regulatory status of the disinfectant is appropriate for
your jurisdiction and use.

See www.sonosite.com for updated cleaning and disinfectant information. Click Quick Link, and then click
Documentation.

Table 1: Disinfectants Compatible with System and Transducers

Disinfection and Country C60x/ICTx/ C11x/ System


Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces

AbcoCide 14 USA Liquid Gluteraldehyde A A A U

Accel Wipes CAN Wipe Hydrogen Peroxide A A A U

Accel Plus CAN Wipe Hydrogen Peroxide N N N U

Accel TB CAN Wipe Hydrogen Peroxide N N N U

Aidal Plus AUS Liquid Gluteraldehyde A A A U

Alkacide FRA Liquid Gluteraldehyde A A A U

Alkazyme FRA Liquid Quat. Ammonia A A A U

Aquatabs (1000) IRL Tablet Sodium A N A U


Dichloroisocyanurate

Aquatabs (2000) IRL Tablet Sodium A N A U


Dichloroisocyanurate

Aquatabs (5000) IRL Tablet Sodium N N N U


Dichloroisocyanurate
Table 1: Disinfectants Compatible with System and Transducers (Continued)

Disinfection and Country C60x/ICTx/ C11x/ System


Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces

Anioxyde 1000 FRA Liquid Peracetic Acid N N N U

Ascend USA Liquid Quat Ammonia A A A U

Asepti-HB USA Liquid Quat Ammonia A A A U

Asepti-Steryl USA Spray Ethanol A A A U

Asepti-Wipes USA Wipe Propanol (Isopropyl A A A A


Alcohol

Bacillocid rasant DEU Liquid Glut./Quat. Ammonia A A A U

Banicide USA Liquid Gluteraldehyde A U A U

Betadine USA Liquid Providone-Iodine N N A U

Bleach USA Liquid NaCl Hypochlorite A A A U

Cavicide USA Liquid Isopropyl A A A U

Caviwipes USA Wipes Isopropanol A A N A

Chlor-Clean GBR Liquid Sodium A N A U


Dichloroisocyanurate

Cidex USA Liquid Gluteraldehyde A A A A

Cidex OPA USA Liquid Ortho-phthaldehyde A A A U

Cidex Plus USA Liquid Gluteraldehyde A A A A

Cleanisept DEU Wipes Quat. Ammonia A A A A

Clorox Wipes USA Wipes Isopropanol A A A U

Chapter 5: Troubleshooting and Maintenance


Control III USA Liquid Quat. Ammonia A A N U

105
Troubleshooting
Table 1: Disinfectants Compatible with System and Transducers (Continued)

106
Disinfection and Country C60x/ICTx/ C11x/ System
Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces

Coverage Spray USA Spray Quat. Ammonia A A N N

DentaSept FRA Liquid Quat. Ammonia N N N U

Denatured Alcohol USA Liquid Ethanol N N N U

DisCide Wipes USA Wipes Isopropyl Alcohol A A A N

DisCide Ultra USA Wipes Isopropyl Alcohol U U U N


Disinfecting
Towelettes

DisOPA JPN Liquid Ortho-phthaldehyde A A A A

Dispatch USA Spray NaCl Hypochlorite A A A U

End-Bac II USA Liquid Quat. Ammonia A A A A

Endozime AW Plus FRA Liquid Propanol A A A U

Envirocide USA Liquid Isopropyl A U N U

Enzol USA Cleaner Ethylene Glycol A A A U

Expose USA Liquid Isopropyl A A A U

Gigasept AF DEU Liquid Quat. Ammonia A A A U

Gigasept FF DEU Liquid Bersteinsaure N N N U

Gluteraldehyde SDS USA Liquid Gluteraldehyde A U A U

Hexanios FRA Liquid Polyhexanide/Quat. A A A U


Ammonia

Hi Tor Plus USA Liquid Chloride A A N U

Hibiclens USA Cleaner Chlorhexidine A A A U


Table 1: Disinfectants Compatible with System and Transducers (Continued)

Disinfection and Country C60x/ICTx/ C11x/ System


Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces

Hydrogen Peroxide USA Liquid Hydrogen Peroxide A A A A

Isopropanol Alcohol ALL Liquid Alcohol N N N U

Kodan Tücher DEU Liquid Propanol A A A N

Kohrsolin ff DEU Liquid Gluteraldehyde A U A U

Korsolex basic DEU Liquid Gluteraldehyde N N N U

LpHse USA Liquid O-phenylphenol A A A U

Lysol USA Spray Ethanol N N N U

Lysol IC USA Liquid O-phenylphenol A N A U

Madacide 1 USA Liquid Isopropanol A A N N

Matar USA Liquid O-phenylphenol A U A U

MetriCide 14 USA Liquid Gluteraldehyde A A A U

MetriCide 28 USA Liquid Gluteraldehyde A A A U

MetriZyme USA Cleaner Propylene Glycol A A A U

Mikrobak forte DEU Liquid Ammonium Chloride A A A U

Mikrozid Wipes DEU Wipe Ethanol/Propanol A A A N

Nuclean FRA Spray Alcohol/Biguanide A A A U

Precise USA Spray O-phenylphenol N N N U

Ruthless USA Spray Quat. Ammonia A A N U

Chapter 5: Troubleshooting and Maintenance


Sagrosept Wipe DEU Wipe Propanol A A A U

Salvanios pH 7 FRA Liquid Quat. Ammonia A A A U

107
Troubleshooting
Table 1: Disinfectants Compatible with System and Transducers (Continued)

108
Disinfection and Country C60x/ICTx/ C11x/ System
Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces

Sani-Cloth HB USA Wipe Quat. Ammonia A A N A

Sani-Cloth Plus USA Wipe Quat. Ammonia A A A A

Sklar USA Liquid Isopropanol A A N U

Sporicidin USA Liquid Phenol A A A U

Sporicidin Wipes USA Wipe Phenol A A A N

Staphene USA Spray Ethanol A N A N

Steranios FRA Liquid Gluteraldehyde A A A U

Super Sani-Cloth USA Wipe Isopropyl Alcohol N N N N

T-Spray USA Spray Quat. Ammonia A A N N

T-Spray II USA Spray Alkyl/Chloride A A A U

TASK 105 USA Spray Quat. Ammonia A A A U

TBQ USA Liquid Alkyl A A A U

Theracide Plus USA Liquid Quat. Ammonia A A A A

Theracide Plus USA Wipe Quat. Ammonia A A A A


Wipes

Tor USA Liquid Quat. Ammonia A A N U

Transeptic USA Cleaner Alcohol N N N U

Tristel GBR Liquid Chlorine Dioxide A A A U

Tristel Wipes GBR Wipe Chlorine Dioxide N N N A


Table 1: Disinfectants Compatible with System and Transducers (Continued)

Disinfection and Country C60x/ICTx/ C11x/ System


Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces

Vesphene II USA Liquid Sodium/ A A A U


o-Phenylphenate

Virex II 256 USA Liquid Ammonium Chloride A A A U

Virex TB USA Liquid Quat. Ammonia A A N N

Virox 5 CAN Wipe Hydrogen Peroxide A A A A

Wavicide -01 USA Liquid Gluteraldehyde N N N U

Wavicide -06 USA Liquid Gluteraldehyde A A A U

Wex-Cide USA Liquid O-phenylphenol A A A U


A = Acceptable
N = No (Do not use)
U = Untested (Do not use)

Chapter 5: Troubleshooting and Maintenance


109
Troubleshooting
110
Chapter 6: Safety

Safety
This chapter contains information required by regulatory agencies, including information
about the ALARA (as low as reasonably achievable) principle, the output display standard,
acoustic power and intensity tables, and other safety information. The information applies to
the ultrasound system, transducer, accessories, and peripherals.

Ergonomic safety
These healthy scanning guidelines are intended to assist you in the comfort and effective use
of your ultrasound system.

WARNING: To prevent musculoskeletal disorders, follow the guidelines in this section.


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

a.Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. “Work-related Musculoskeletal Complaints
in Sonologists.” Occupational Environmental Medicine. 41:11 (1999), 981-988.
b.Craig, M. “Sonography: An Occupational Hazard?” Journal of Diagnostic Medical Sonography. 3 (1985),
121-125.
c.Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. “Musculoskeletal Pain in Cardiac Ultrasonographers:
Results of a Random Survey.” Journal of American Society of Echocardiography. (May1997), 357-362.
d.Wihlidal, L.M. and S. Kumar. “An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta.”
International Journal of Industrial Ergonomics. 19 (1997), 205-216.

Chapter 6: Safety 111


e.Habes, D.J. and S. Baron. “Health Hazard Report 99-0093-2749.” University of Medicine and Dentistry of New
Jersey. (1999).
f.Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. “Prevalence of Carpal Tunnel Syndrome and Other
Work-related Musculoskeletal Problems in Cardiac Sonographers.” Journal of Medicine. 35:6 (1993), 605-610.

Position the system


Promote comfortable shoulder, arm, and hand postures
• Use a stand to support the weight of the ultrasound system.

Minimize eye and neck strain


• When the exam or procedure allows, position the system within reach.
• Adjust the angle of the system and display to minimize glare from overhead or outside
lighting.
• If using a stand, adjust its height so that the display is at or slightly below eye level.

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

Minimize reaching and twisting


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

Promote comfortable shoulder and arm postures


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

Minimize neck bending and twisting


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

112
Promote comfortable hand, wrist, and finger postures
• Hold the transducer lightly in your fingers.

Safety
• Minimize the pressure applied on the patient.
• Keep your wrist in a straight position.

Take breaks, exercise, and vary activities


• Minimizing scanning time and taking breaks can effectively allow your body to recover from
physical activity and help you avoid MSDs. Some ultrasound tasks may require longer or
more frequent breaks. One way of taking a break is to stop and relax. However, simply
changing tasks can help some muscle groups relax while others remain or become active.
• Work efficiently by using the software and hardware features correctly.
• Keep moving. Avoid sustaining the same posture by varying your head, neck, body, arm,
and leg positions.
• Targeted exercises can strengthen muscle groups, which may help you avoid MSDs. Contact
a qualified health professional to determine stretches and exercises that are right for you.

Electrical safety classification


Class I equipment Ultrasound system powered from power supply or part
of the Mobile Docking System

Internally powered equipment Ultrasound system not connected to the power supply
(battery only)

Type BF applied parts Ultrasound transducers

Type CF applied parts ECG module/ECG leads

IPX-7 (watertight equipment) Ultrasound transducers

IPX-8 (watertight equipment) Footswitch

Non AP/APG Ultrasound system power supply, Mobile Docking


System, and peripherals. Equipment is not suitable for
use in the presence of flammable anaesthetics.

Electrical safety
This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type
BF isolated patient‐applied parts safety requirements.

Chapter 6: Safety 113


This system complies with the applicable medical equipment requirements published in the
Canadian Standards Association (CSA), European Norm Harmonized Standards, and
Underwriters Laboratories (UL) safety standards. See Chapter 8, “Specifications.”
For maximum safety observe the following warnings and cautions.

WARNING: To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the
patient.
Under certain circumstances, the transducer connector and back of the display
enclosure can reach temperatures that exceed EN60601-1 limits for patient contact,
therefore only the operator shall handle the system. This does not include the
transducer face.
To avoid discomfort or minor risk of operator injury when handling the transducer
connector, the system should not be operated for more than 60 minutes
continuously in a live-scan mode (as opposed to freeze or sleep modes).
To avoid the risk of electrical shock or injury, do not open the system enclosures. All
internal adjustments and replacements, except battery replacement, must be made
by a qualified technician.
To avoid the risk of injury, do not operate the system in the presence of flammable
gasses or anesthetics. Explosion can result.
To avoid the risk of electrical shock, use only properly grounded equipment. Shock
hazards exist if the power supply is not properly grounded. Grounding reliability can
only be achieved when equipment is connected to a receptacle marked “Hospital
Only” or “Hospital Grade” or the equivalent. The grounding wire must not be
removed or defeated.
To avoid the risk of electrical shock, when using the system in an environment where
the integrity of the protective earth conductor arrangement is in doubt, operate the
system on battery power only without using the power supply.
To avoid the risk of electrical shock, do not connect the system’s power supply or a
docking system to an MPSO or extension cord.
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.
To avoid the risk of electrical shock, always disconnect the power supply from the
system before cleaning the system.
To avoid the risk of electrical shock, do not use any transducer that has been
immersed beyond the specified cleaning or disinfection level. See Chapter 5,
“Troubleshooting and Maintenance.”
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.

114
To avoid the risk of electrical shock and fire hazard, the power cord set that connects
the power supply of the ultrasound system or MDS to mains power must only be
used with the power supply or MDS, and cannot be used to connect other devices to

Safety
mains power.
To avoid the risk of electrical shock, use only accessories and peripherals
recommended by SonoSite, including the power supply. Connection of accessories
and peripherals not recommended by SonoSite could result in electrical shock.
Contact SonoSite or your local representative for a list of accessories and peripherals
available from or recommend by SonoSite.
To avoid the risk of electrical shock, use commercial grade peripherals
recommended by SonoSite on battery power only. Do not connect these products
to AC mains power when using the system to scan or diagnose a patient/subject.
Contact SonoSite or your local representative for a list of the commercial grade
peripherals available from or recommended by SonoSite.
To avoid the risk of electrical shock, inspect cables and power cords used within the
system on a regular basis for damage.
To avoid the risk of electrical shock to the patient/subject, do not touch the system
battery contacts while simultaneously touching a patient/subject.
To prevent injury to the operator/bystander, the transducer must be removed from
patient contact before the application of a high-voltage defibrillation pulse.
To avoid possible electrical shock or electromagnetic interference, verify proper
operation and compliance with relevant safety standards for all equipment before
clinical use. Connecting additional equipment to the ultrasound system constitutes
configuring a medical system. SonoSite recommends verifying that the system, all
combinations of equipment, and accessories connected to the ultrasound system
comply with JACHO installation requirements and/or safety standards such as
AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and electromagnetic compatibility
standard IEC 60601-1-2 (Electromagnetic compatibility), and are certified according
to IEC Standard 60950 (Information Technology Equipment (ITE)).

Caution: Do not use the system if an error message appears on the image display: note the
error code; call SonoSite or your local representative; turn off the system by pressing
and holding the power key until the system powers down.
To avoid increasing the system and transducer connector temperature, do not block
the airflow to the ventilation holes on the side of the system.

Chapter 6: Safety 115


Equipment safety
To protect your ultrasound system, transducer, and accessories, follow these precautions.

Caution: Excessive bending or twisting of cables can cause a failure or intermittent operation.
Improper cleaning or disinfecting of any part of the system can cause permanent
damage. For cleaning and disinfecting instructions, see Chapter 5, “Troubleshooting
and Maintenance.”
Do not submerge the transducer connector in solution. The cable is not liquid-tight
beyond the transducer connector/cable interface.
Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of
the system.
Remove the battery from the system if the system is not likely to be used for some
time.
Do not spill liquid on the system.

Battery safety
To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury
or equipment damage, observe the following precautions.

WARNING: The battery has a safety device. Do not disassemble or alter the battery.
Charge the batteries only when the ambient temperature is between 0° and 40°C
(32° and 104°F).
Do not short-circuit the battery by directly connecting the positive and negative
terminals with metal objects.
Do not heat the battery or discard it in a fire.
Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire
and other heat sources.
Do not charge the battery near a heat source, such as a fire or heater.
Do not leave the battery in direct sunlight.
Do not pierce the battery with a sharp object, hit it, or step on it.
Do not use a damaged battery.
Do not solder a battery.
The polarity of the battery terminals are fixed and cannot be switched or reversed.
Do not force the battery into the system.
Do not connect the battery to an electrical power outlet.

116
WARNING: Do not continue recharging the battery if it does not recharge after two successive
six hour charging cycles.

Safety
If the battery leaks or emits an odor, remove it from all possible flammable sources.

Caution: To avoid the battery bursting, igniting, or emitting fumes from the battery and
causing equipment damage, observe the following precautions:
Do not immerse the battery in water or allow it to get wet.
Do not put the battery into a microwave oven or pressurized container.
If the battery emits an odor or heat, is deformed or discolored, or in any way appears
abnormal during use, recharging or storage, immediately remove it and stop using
it. If you have any questions about the battery, consult SonoSite or your local
representative.
Store the battery between -20°C (-4°F) and 60°C (140°F).
Use only SonoSite batteries.
Do not use or charge the battery with non-SonoSite equipment. Only charge the
battery with the system.

Biological safety
Observe the following precautions related to biological safety.

WARNING: To avoid device damage or patient injury, do not use the P10/P17 needle guide
bracket on patients with pacemakers or medical electronic implants. The needle
guide bracket for the P10 and P17 transducers contains a magnet that is used to
ensure the bracket is correctly oriented on the transducer. The magnetic field in
direct proximity to the pacemaker or medical electronic implant may have an
adverse effect.
Non-medical (commercial) grade peripheral monitors have not been verified or
validated by SonoSite as being suitable for diagnosis.
To avoid the risk of a burn hazard, do not use the transducer with high frequency
surgical equipment. Such a hazard may occur in the event of a defect in the high
frequency surgical neutral electrode connection.
Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in
the scanning sequence are indicative of a hardware failure that must be corrected
before use.
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.

Chapter 6: Safety 117


WARNING: Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably
achievable) principle and follow the prudent use information concerning MI and TI.
SonoSite does not currently recommend a specific brand of acoustic standoff. If an
acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz.
Some SonoSite transducers are approved for intraoperative applications if a
market-cleared sheath is used.

Electromagnetic compatibility
The ultrasound system has been tested and found to comply with the electromagnetic
compatibility (EMC) limits for medical devices to IEC 60601‐1‐2:2001. These limits are designed
to provide reasonable protection against harmful interference in a typical medical installation.

Caution: Medical electrical equipment requires special precautions regarding EMC and must
be installed and operated according to these instructions. It is possible that high
levels of radiated or conducted radio-frequency electromagnetic interference (EMI)
from portable and mobile RF communications equipment or other strong or nearby
radio-frequency sources, could result in performance disruption of the ultrasound
system. Evidence of disruption may include image degradation or distortion, erratic
readings, equipment ceasing to operate, or other incorrect functioning. If this occurs,
survey the site to determine the source of disruption, and take the following actions
to eliminate the source(s).
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or re-orient interfering equipment.
• Increase distance between interfering equipment and your ultrasound system.
• Manage use of frequencies close to ultrasound system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within facility control (such as paging
systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in areas with
devices susceptible to EMI.
• Share relevant EMI information with others, particularly when evaluating new
equipment purchases which may generate EMI.
• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.

118
Caution: To avoid the risk of increased electromagnetic emissions or decreased immunity, use
only accessories and peripherals recommended by SonoSite. Connection of
accessories and peripherals not recommended by SonoSite could result in

Safety
malfunctioning of your ultrasound system or other medical electrical devices in the
area. Contact SonoSite or your local representative for a list of accessories and
peripherals available from or recommended by SonoSite. See the SonoSite
accessories user guide.
Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon.
ESD is common in conditions of low humidity, which can be caused by heating or air
conditioning. Static shock is a discharge of the electrical energy from a charged
body to a lesser or non-charged body. The degree of discharge can be significant
enough to cause damage to a transducer or an ultrasound system. The following
precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on
linoleum, and anti-static mats.

Manufacturer’s declaration
Table 1 and Table 2 document the intended use environment and EMC compliance levels of the
system. For maximum performance, ensure that the system is used in the environments
described in this table.
The system is intended for use in the electromagnetic environment specified below.
Table 1: Manufacturer’s Declaration - Electromagnetic Emissions

Emissions Test Compliance Electromagnetic Environment

RF emissions Group 1 The SonoSite ultrasound system uses RF energy only


ClSPR 11 for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions Class A The SonoSite ultrasound system is suitable for use in


ClSPR 11 all establishments other than domestic and those
directly connected to the public low-voltage power
supply network which supplies buildings used for
domestic purposes.

Harmonic emissions Class A


IEC 61000-3-2

Voltage fluctuations/ Complies


flicker emissions
IEC 61000-3-3

Chapter 6: Safety 119


The system is intended for use in the electromagnetic environment specified below.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity

Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment

Electrostatic 2.0KV, 4.0KV, 6.0KV 2.0KV, 4.0KV, 6.0KV Floors should be wood,
Discharge (ESD) contact contact concrete or ceramic tile. If
IEC 61000-4-2 2.0KV, 4.0KV, 8.0KV air 2.0KV, 4.0KV, 8.0KV floors are covered with
air synthetic material, the relative
humidity should be at least
30%.

Electrical fast 2KV on the mains 2KV on the mains Mains power quality should
Transient burst 1KV on signal lines 1KV on signal lines be that of a typical
commercial or hospital
IEC 61000-4-4
environment.

Surge 0.5KV, 1.0KV, 2.0KV on 0.5KV, 1.0KV, 2.0KV Mains power quality should
IEC 61000-4-5 AC power lines to on AC power lines be that of a typical
ground to ground commercial or hospital
0.5KV, 1.0KV on AC 0.5KV, 1.0KV on AC environment.
power lines to lines power lines to
lines

Voltage dips, >5% UT >5% UT Mains power quality should


short (>95% dip in UT ) for (>95% dip in UT ) be that of a typical
interruptions commercial or hospital
0.5 cycle for 0.5 cycle
and voltage environment. If the user of the
variations on 40% UT 40% UT SonoSite ultrasound system
power supply (60% dip in UT ) for 5 (60% dip in UT ) for requires continued operation
input lines cycles 5 cycles during power mains
IEC 61000-4-11 interruptions, it is
70% UT 70% UT recommended that the
(30% dip in UT ) for 25 (30% dip in UT ) for SonoSite ultrasound system
cycles 25 cycles be powered from an
uninterruptible power supply
>5% UT >5% UT
or a battery.
(>95% dip in UT ) for 5s (>95% dip in UT )
for 5s

120
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level

Safety
Environment

Power 3 A/m 3 A/m If image distortion occurs, it


Frequency may be necessary to position
Magnetic Field the SonoSite ultrasound
IEC 61000-4-8 system further from sources of
power frequency magnetic
fields or to install magnetic
shielding. The power
frequency magnetic field
should be measured in the
Intended installation location
to assure that it is sufficiently
low.

Conducted RF 3 Vrms 3 Vrms Portable and mobile RF


IEC 61000-4-6 150 kHz to 80 MHz communications equipment
should be used no closer to
any part of the SonoSite
ultrasound system including
cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended Separation
Distance
d = 1.2 P

Radiated RF 3 Vim 3 V/m d = 1.2 P


IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).

Chapter 6: Safety 121


Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)

Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment

Radiated RF Field strengths from fixed RF


IEC 61000-4-3 transmitters, as determined by
an electromagnetic Site
(continued)
surveya, should be less than
the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:

(IEC 60417 No. 417-IEC-5140:


“Source of non-ionizing
radiation”)
Note: UT is the AC mains voltage prior to application of the test level.
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a.Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite
ultrasound system should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system.
b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

ALARA principle
ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other
qualified ultrasound users, using good judgment and insight, determine the exposure that is
“as low as reasonably achievable.” There are no set rules to determine the correct exposure for
every situation. The qualified ultrasound user determines the most appropriate way to keep
exposure low and bioeffects to a minimum, while obtaining a diagnostic examination.
A thorough knowledge of the imaging modes, transducer capability, system setup and
scanning technique is necessary. The imaging mode determines the nature of the ultrasound
beam. A stationary beam results in a more concentrated exposure than a scanned beam, which
spreads that exposure over that area. The transducer capability depends upon the frequency,

122
penetration, resolution, and field of view. The default system presets are reset at the start of
each new patient. It is the scanning technique of the qualified ultrasound user along with
patient variability that determines the system settings throughout the exam.

Safety
The variables which affect the way the qualified ultrasound user implements the ALARA
principle include: patient body size, location of the bone relative to the focal point, attenuation
in the body, and ultrasound exposure time. Exposure time is an especially useful variable,
because the qualified ultrasound user can control it. The ability to limit the exposure over time
supports the ALARA principle.

Applying ALARA
The system imaging mode selected by the qualified ultrasound user is determined by the
diagnostic information required. 2D imaging provides anatomical information; CPD imaging
provides information about the energy or amplitude strength of the Doppler signal over time
at a given anatomical location and is used for detecting the presence of blood flow; Color
imaging provides information about the energy or amplitude strength of the Doppler signal
over time at a given anatomical location and is used for detecting the presence, velocity, and
direction of blood flow; Tissue Harmonic Imaging uses higher received frequencies to reduce
clutter, artifact, and improve resolution on the 2D image. Understanding the nature of the
imaging mode used allows the qualified ultrasound user to apply the ALARA principle.
Prudent use of ultrasound requires that patient exposure to ultrasound be limited to the lowest
ultrasound output for the shortest time necessary to achieve acceptable diagnostic results.
Decisions that support prudent use are based on the type of patient, exam type, patient history,
ease or difficulty of obtaining diagnostically useful information, and potential localized
heating of the patient due to transducer surface temperature.
The system has been designed to ensure that temperature at the face of the transducer will not
exceed the limits established in Section 42 of EN 60601‐2‐37: Particular requirement for the
safety of ultrasound medical diagnostic and monitoring equipment. See “Transducer surface
temperature rise” on page 128. In the event of a device malfunction, there are redundant
controls that limit transducer power. This is accomplished by an electrical design that limits
both power supply current and voltage to the transducer.
The sonographer uses the system controls to adjust image quality and limit ultrasound output.
The system controls are divided into three categories relative to output: controls that directly
affect output, controls that indirectly affect output, and receiver controls.

Direct controls
The system does not exceed a spatial peak temporal average intensity (ISPTA) of 720 mW/cm2
for all imaging modes. (For opthalmic use the Orb exam mode is limited to the following
values: ISPTA does not exceed 50 mW/cm2; TI does not exceed 1.0, and MI does not exceed
0.23.) The mechanical index (MI) and thermal index (TI) may exceed values greater than 1.0 on
some transducers in some imaging modes. One may monitor the MI and TI values and adjust
the controls to reduce these values. See “Guidelines for reducing MI and TI” on page 124.

Chapter 6: Safety 123


Additionally, one means for meeting the ALARA principle is to set the MI or TI values to a low
index value and then modifying this level until a satisfactory image or Doppler mode is
obtained. For more information on MI and TI, see BS EN 60601‐2‐37:2001: Annex HH.

Indirect controls
The controls that indirectly affect output are controls affecting imaging mode, freeze, and
depth. The imaging mode determines the nature of the ultrasound beam. Tissue attenuation is
directly related to transducer frequency. The higher the PRF (pulse repetition frequency), the
more output pulses occur over a period of time.

Receiver controls
The receiver controls are the gain controls. Receiver controls do not affect output. They should
be used, if possible, to improve image quality before using controls that directly or indirectly
affect output.

Acoustic artifacts
An acoustic artifact is information, present or absent in an image, that does not properly
indicate the structure or flow being imaged. There are helpful artifacts that aid in diagnosis and
those that hinder proper interpretation. Examples of artifacts include:
• Shadowing
• Through transmission
• Aliasing
• Reverberations
• Comet tails
For more information on detecting and interpreting acoustic artifacts, see the following
reference:
Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B.
Saunders Company, (Oct. 17, 2005).

Guidelines for reducing MI and TI


The following are general guidelines for reducing MI or TI. If multiple parameters are given,
then the best results may be achieved by minimizing these parameters simultaneously. In some
modes changing these parameters will not affect MI or TI. Changes to other parameters may
also result in MI and TI reductions. Please note the ‘MI’ or ‘TI’ read out on the right side of the
LCD screen.
“↓” means to decrease or lower setting of parameter to reduce MI or TI.

124
“↑” means to raise or increase setting of parameter to reduce MI or TI
Table 3: MI

Safety
Transducer Depth

C11x ↑

C60x ↑

HFL38x ↑

ICTx ↑

L25x ↑

L38x ↑

P21x ↑

Table 4: TI (TIS, TIC, TIB)

Color Power Doppler Settings PW Settings


Transducer
Box Box Box Opti-
PRF Depth
Width Height Depth mize

C11x ↑ ↓ ↑ ↓ (Depth)

C60x ↓ ↑ ↓ ↑ ↓ (PRF)

HFL38x ↑ ↑ ↑ ↓ (Depth)

ICTx Exam
↑ ↑ ↓ ↓ (PRF)
Gyn

L25x ↓ ↑ ↓ (PRF)

L38x ↓ ↓ (Depth)

P21x ↓ ↓ ↑ ↓ (PRF)

Chapter 6: Safety 125


Output display
The system meets the AIUM output display standard for MI and TI (see last reference listed in
“Related guidance documents” below). Table 5 indicates for each transducer and operating
mode when either the TI or MI is greater than or equal to a value of 1.0, thus requiring display.
Table 5: Cases Where Either a Thermal or Mechanical Index is ≥ 1.0

2D/ CPD/ PW CW
Transducer Model Index
M Mode Color Doppler Doppler

C11x/8-5 MI No No No —

TIC,TIB, or TIS No Yes Yes —

C60x/5-2 MI Yes No No —

TIC, TIB, or TIS No No Yes —

HFL38x/13-6 MI No Yes No —

TIC, TIB, or TIS No Yes Yes —

ICTx/8-5 MI No No No —

TIC, TIB, or TIS No No Yes —

L25x/13-6 MI No No No —

TIC,TIB, or TIS No No Yes —

L38x/10-5 MI No Yes Yes —

TIC, TIB, or TIS No Yes Yes —

P21x/5-1 MI Yes Yes Yes No

TIC, TIB, or TIS Yes Yes Yes Yes

Even when MI is less than 1.0, the system provides a continuous real‐time display of MI
whenever a transducer is operated in a 2D imaging mode. The index is displayed in increments
of 0.1.
The system meets the output display standard for TI. A continuous real‐time display of TI is
provided for the operator whenever a transducer is operated in a CPD, Color, M Mode, or PW
Doppler imaging mode. The index is displayed in increments of 0.1.
The thermal index consists of three user selectable indices, and only one of these is displayed
at any one time. In order to display properly and meet the ALARA principle, the user selects
an appropriate TI based on the specific exam being performed. SonoSite provides the AIUM
Medical Ultrasound Safety reference which contains guidance on how to determine which TI
is appropriate (see second reference listed in “Related guidance documents” on page 127).

126
Mechanical and thermal indices output display accuracy
The accuracy result for the mechanical index (MI) is stated statistically. With 90% confidence,
90% of the measured MI values will be within +16% to –31% of the displayed MI value, or +0.2

Safety
of the displayed value, whichever value is larger.
The accuracy result for the thermal index (TI) is stated statistically. With 90% confidence, 90%
of the measured TI values will be within +26% to –50% of the displayed TI value, or +0.2 of the
displayed value, whichever value is larger. The values equate to +1dB to –3dB.
A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than
0.05.

Factors that contribute to display uncertainty


The net uncertainty of the displayed indices is derived by combining the quantified uncertainty
from three sources; measurement uncertainty, system and transducer variability, and
engineering assumptions and approximations made when calculating the display values.
Measurement errors of the acoustic parameters when taking the reference data are the major
source of error that contributes to the display uncertainty. The measurement error is described
in “Acoustic measurement precision and uncertainty” on page 149.
The displayed MI and TI values are based on calculations that use a set of acoustic output
measurements that were made using a single reference ultrasound system with a single
reference transducer that is representative of the population of transducers of that type. The
reference system and transducer are chosen from a sample population of systems and
transducers taken from early production units, and they are selected based on having an
acoustic output that is representative of the nominal expected acoustic output for all
transducer/system combinations that might occur. Of course every transducer/system
combination has its own unique characteristic acoustic output, and will not match the nominal
output on which the display estimates are based. This variability between systems and
transducers introduces an error into displayed value. By doing acoustic output sampling
testing during production, the amount of error introduced by the variability is bounded. The
sampling testing ensures that the acoustic output of transducers and systems being
manufactured stays within a specified range of the nominal acoustic output.
Another source of error arises from the assumptions and approximations that are made when
deriving the estimates for the display indices. Chief among these assumptions is that the
acoustic output, and thus the derived display indices, are linearly correlated with the transmit
drive voltage of the transducer. Generally, this assumption is very good, but it is not exact, and
thus some error in the display can be attributed to the assumption of voltage linearity.

Related guidance documents


• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers, FDA, 1997.
• Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. (A
copy is included with each system.)

Chapter 6: Safety 127


• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA
UD2‐2004.
• Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound
Equipment, American Institute of Ultrasound in Medicine, 1993.
• Standard for Real‐Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, NEMA UD3‐2004.
• Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH,
BS EN 60601‐2‐37 reprinted at P05699.

Transducer surface temperature rise


Table 6 and Table 7 list the measured surface temperature rise from ambient* of transducers
used on the ultrasound system. The temperatures were measured in accordance with EN
60601‐2‐37 section 42 where controls and settings were positioned to give maximum
temperatures
Test 1: The transducer surface temperature test on tissue mimicking material (TMM) is based
on the following standard: 42.3(a) 1, Test Method B (IEC 60601‐2‐37, Amendment 1). The limit
is a 10°C rise from ambient, as measured on the TMM.
Test 2: The transducer surface temperature test in air is based on the following standard:
42.3(a) 2 (IEC 60601‐2‐37, Amendment 1). The limit is a 27°C rise from ambient.
Test 3: The transducer surface temperature test on TMM is based on the following standard:
42.3(a) 1, Test Method B (IEC 60601‐2‐37, Amendment 1). The limit is a 6°C rise from ambient,
as measured on the TMM.
*The ambient temperature shall be 23°C ± 3°C.
Table 6: Transducer Surface Temperature Rise EN 60601-2-37 (External Use)

Test C11x C60x HFL38x L25x L38x P21x

1 9.2°C 9.0°C 9.5°C 9.5°C 9.6°C 9.0°C

2 19.0°C 18.0°C 19.0°C 18.2°C 20.0°C 20.0°C

Table 7: Transducer Surface Temperature Rise IEC 60601-2-37 (Internal Use)

Test ICTx

3 5.5°C

2 12.0°C

128
Acoustic output measurement
Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)

Safety
from ultrasound exposure have been studied by various scientific and medical institutions. In
October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report
prepared by its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic
Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as
the Stowe Report, which reviewed available data on possible effects of ultrasound exposure.
Another report “Bioeffects and Safety of Diagnostic Ultrasound,” dated January 28, 1993
provides more current information.
The acoustic output for this ultrasound system has been measured and calculated in
accordance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment” (NEMA UD2‐2004), and the “Standard for Real‐Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA
UDe3‐2004).

In Situ, derated, and water value intensities


All intensity parameters are measured in water. Since water does not absorb acoustic energy,
these water measurements represent a worst case value. Biological tissue does absorb acoustic
energy. The true value of the intensity at any point depends on the amount, type of tissue, and
the frequency of the ultrasound passing through the tissue. The intensity value in the tissue,
In Situ, has been estimated by using the following formula:
In Situ= Water [e‐(0.23alf)]
where:
In Situ = In Situ intensity value
Water = Water intensity value
e = 2.7183
a = attenuation factor (dB/cm MHz)
Attenuation factor (a) for various tissue types are given below:
brain = 0.53
heart = 0.66
kidney = 0.79
liver = 0.43
muscle = 0.55
l = skinline to measurement depth in cm
f = center frequency of the transducer/system/mode combination in MHz

Chapter 6: Safety 129


Since the ultrasonic path during the exam is likely to pass through varying lengths and types
of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used
for general reporting purposes; therefore, the In Situ value commonly reported uses the
formula:
In Situ (derated) = Water [e ‐(0.069lf)]
Since this value is not the true In Situ intensity, the term “derated” is used to qualify it.
The maximum derated and the maximum water values do not always occur at the same
operating conditions; therefore, the reported maximum water and derated values may not be
related by the In Situ (derated) formula. For example: a multi‐zone array transducer that has
maximum water value intensities in its deepest zone, but also has the smallest derating factor
in that zone. The same transducer may have its largest derated intensity in one of its shallowest
focal zones.

Tissue models and equipment survey


Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from
measurements of acoustic output made in water. Currently, available models may be limited in
their accuracy because of varying tissue paths during diagnostic ultrasound exposures and
uncertainties in the acoustic properties of soft tissues. No single tissue model is adequate for
predicting exposures in all situations from measurements made in water, and continued
improvement and verification of these models is necessary for making exposure assessments
for specific exam types.
A homogeneous tissue model with attenuation coefficient of 0.3 dB/cm MHz throughout the
beam path is commonly used when estimating exposure levels. The model is conservative in
that it overestimates the In Situ acoustic exposure when the path between the transducer and
site of interest is composed entirely of soft tissue. When the path contains significant amounts
of fluid, as in many first and second‐trimester pregnancies scanned transabdominally, this
model may underestimate the In Situ acoustic exposure. The amount of underestimation
depends upon each specific situation.
Fixed‐path tissue models, in which soft tissue thickness is held constant, sometimes are used to
estimate In Situ acoustic exposures when the beam path is longer than 3 cm and consists largely
of fluid. When this model is used to estimate maximum exposure to the fetus during
transabdominal scans, a value of 1 dB/cm MHz may be used during all trimesters.
Existing tissue models that are based on linear propagation may underestimate acoustic
exposures when significant saturation due to non‐linear distortion of beams in water is present
during the output measurement.
The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad
range of values:
• A survey of 1990‐equipment models yielded MI values between 0.1 and 1.0 at their highest
output settings. Maximum MI values of approximately 2.0 are known to occur for currently
available equipment. Maximum MI values are similar for real‐time 2D and M Mode imaging.

130
• Computed estimates of upper limits to temperature elevations during transabdominal scans
were obtained in a survey of 1988 and 1990 pulsed Doppler equipment. The vast majority of
models yielded upper limits less than 1° and 4°C (1.8° and 7.2°F) for exposures of

Safety
first‐trimester fetal tissue and second‐trimester fetal bone, respectively. The largest values
obtained were approximately 1.5°C (2.7°F) for first‐trimester fetal tissue and 7°C (12.6°F) for
second‐trimester fetal bone. Estimated maximum temperature elevations given here are for
a “fixed path” tissue model and are for devices having ISPTA values greater than 500 mW/
cm2. The temperature elevations for fetal bone and tissue were computed based on
calculation procedures given in Sections 4.3.2.1‐4.3.2.6 in “Bioeffects and Safety of Diagnostic
Ultrasound” (AIUM, 1993).

Acoustic output tables


Table 8 through Table 23 indicate the acoustic output for the system and transducer
combinations with a thermal index or mechanical index equal to or greater than one. These
tables are organized by transducer model and imaging mode. For a definition of terms used in
the tables, see “Terms used in the acoustic output tables” on page 148.

Chapter 6: Safety 131


Table 8: Transducer Model: C11x/8-5 Operating Mode: CPD/Color

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) (a) — — — 1.2
pr.3 (MPa) #
W0 (mW) # — — 40.50
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) # —
deq(zsp) (cm) —
fc (MHz) # # — — — 4.38
Dim of Aaprt X (cm) # — — — 0.36
Y (cm) # — — — 0.5
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) —
Focal Length FLx (cm) # — — 1.56
FLy (cm) # — — 2.5
IPA.3@MImax (W/cm2) #
Control 1: Mode CPD
Conditions
Operating
Control

Control 2: Exam Type Vas


Control 3: PRF 2841
Control 4: Optimization/Depth Med/2.0
Control 5: Color Box Top/
Position/ Size Short

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

132
Table 9: Transducer Model: C11x/8-5 Operating Mode: PW Doppler

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.8 1.7
pr.3 (MPa) #
W0 (mW) — # 26.29 24.65
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) # 1.1
deq(zsp) (cm) 0.236
fc (MHz) # — # — 4.36 4.36
Dim of Aaprt X (cm) — # — 0.28 0.2
Y (cm) — # — 0.5 0.5
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) 0.226
Focal Length FLx (cm) — # — 0.77
FLy (cm) — # — 2.5
IPA.3@MImax (W/cm2) #
Control 1: Exam Type Any Any
Conditions
Operating
Control

Control 2: Sample Volume 2 mm 3 mm


Control 3: PRF 3906 ≥3906
Control 4: Sample Volume Position Zone 1 Zone 0

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 133


Table 10: Transducer Model: C60x/5-2 Operating Mode: 2D

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.0 (a) — — — (b)
pr.3 (MPa) 1.59
W0 (mW) # — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 5.3 —
deq(zsp) (cm) —
fc (MHz) 2.86 # — — — #
Dim of Aaprt X (cm) # — — — #
Y (cm) # — — — #
PD (μsec) 0.579
PRF (Hz) 7923
Other Information

pr@PIImax (MPa) 2.679


deq@Pllmax (cm) —
Focal Length FLx (cm) # — — #
FLy (cm) # — — #
IPA.3@MImax (W/cm2) 197.7
Control 1: Exam Type Any
Conditions
Operating
Control

Control 2: Optimization Pen


Control 3: Depth 6.6 cm
Control 4: THI On

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

134
Table 11: Transducer Model: C60x/5-2 Operating Mode: M Mode

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.0 — (a) — (a) (b)
pr.3 (MPa) 1.62
W0 (mW) — # # #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 4.7 #
deq(zsp) (cm) #
fc (MHz) 2.85 — # — # #
Dim of Aaprt X (cm) — # — # #
Y (cm) — # — # #
PD (μsec) 0.577
PRF (Hz) 800
Other Information

pr@PIImax (MPa) 2.576


deq@Pllmax (cm) #
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm2) 184.3
Control 1: Exam Type Any
Conditions
Operating
Control

Control 2: Optimization Pen


Control 3: Depth 7.8 cm
Control 4: MB (Multi Beam) Off or
On

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 135


Table 12: Transducer Model: C60x/5-2 Operating Mode: PW Doppler

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 3.1 (b)
pr.3 (MPa) #
W0 (mW) — # 85.64 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) # 1.255
deq(zsp) (cm) 0.51
fc (MHz) # — # — 2.233 #
Dim of Aaprt X (cm) — # — 0.6552 #
Y (cm) — # — 1.3 #
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) 0.415
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm ) 2
#
Control 1: Exam Type Abd
Conditions
Operating
Control

Control 2: PRF Any


Control 3: Sample Volume 12 mm
Control 4: Sample Volume Position Zone 1

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

136
Table 13: Transducer Model: HFL38x/13-6 Operating Mode: CPD/Color

TIS TIB

Safety
Index Label M.I. Non-scan Non- TIC
Scan
Aaprt≤1 Aaprt>1 scan

Global Maximum Index Value 1.1 1.0 — — — (b)


pr.3 (MPa) 2.556
W0 (mW) 53.49 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 1.2 —
deq(zsp) (cm) —
fc (MHz) 5.328 5.324 — — — #
Dim of Aaprt X (cm) 0.44 — — — #
Y (cm) 0.4 — — — #
PD (μsec) 0.525
PRF (Hz) 2597
Other Information

pr@PIImax (MPa) 3.187


deq@Pllmax (cm) —
Focal Length FLx (cm) 1.32 — — #
FLy (cm) 2.5 — — #
IPA.3@MImax (W/cm2) 325.5
Control 1: Mode Color Color
Control 2: Exam Type Any Any
Conditions
Operating

Control 3: Optimization/Depth/PRF Med/


Control

Low/3.3 cm/
2.7 cm/
393
1938
Control 4: Color Box Position/Size Top/
Any
Short

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 137


Table 14: Transducer Model: HFL38x/13-6 Operating Mode: PW Doppler

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — 1.2 — 2.2 (b)
pr.3 (MPa) #
W0 (mW) — 46.55 46.55 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) # 1.1
deq(zsp) (cm) 0.33
fc (MHz) # — 5.33 — 5.33 #
Dim of Aaprt X (cm) — 1.04 — 1.04 #
Y (cm) — 0.4 — 0.4 #
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) 0.46
Focal Length FLx (cm) — 3.72 — #
FLy (cm) — 2.5 — #
IPA.3@MImax (W/cm2) #
Control 1: Exam Type Vas/Ven/ Vas/Ven/
Conditions
Operating

IMT IMT
Control

Control 2: Sample Volume 12 mm 12 mm


Control 3: PRF 10417 10417
Control 4: Sample Volume Position Zone 7 Zone 7

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

138
Table 15: Transducer Model: ICTx/8-5 Operating Mode: PW Doppler

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.2 (a)
pr.3 (MPa) #
W0 (mW) — # 16.348 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) # 1.6
deq(zsp) (cm) 0.192
fc (MHz) # — # — 4.36 #
Dim of Aaprt X (cm) — # — 0.6 #
Y (cm) — # — 0.5 #
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) 0.187
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm ) 2
#
Control 1: Exam Type Any
Conditions
Operating
Control

Control 2: Sample Volume 3 mm


Control 3: PRF Any
Control 4: Sample Volume Position Zone 1

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 139


Table 16: Transducer Model L25x/13-6 Operating Mode: PW Doppler

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.6 (b)
pr.3 (MPa) #
W0 (mW) — # 14.02 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) # 0.6
deq(zsp) (cm) 0.155
fc (MHz) # — # — 6.00 #
Dim of Aaprt X (cm) — # — 0.16 #
Y (cm) — # — 0.3 #
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) 0.1549
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm ) 2
#
Control 1: Exam Type Vas/Nrv/
Conditions
Operating

Ven
Control

Control 2: Sample Volume 12 mm


Control 3: PRF 20833
Control 4: Sample Volume Position Zone 0

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

140
Table 17: Transducer Model: L38x/10-5 Operating Mode: CPD/Color

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.3 1.0 — — — (b)
pr.3 (MPa) 2.89
W0 (mW) 64.88 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 1.1 —
deq(zsp) (cm) —
fc (MHz) 4.91 4.91 — — — #
Dim of Aaprt X (cm) 0.54 — — — #
Y (cm) 0.4 — — — #
PD (μsec) 0.529
PRF (Hz) 9547
Other Information

pr@PIImax (MPa) 3.48


deq@Pllmax (cm) —
Focal Length FLx (cm) 1.5 — — #
FLy (cm) 2.5 — — #
IPA.3@MImax (W/cm2) 439.3
Control 1: Mode Color CPD
Control 2: Exam Type Any Bre
Conditions
Operating
Control

Control 3: PRF 331 2137


Control 4: Optimization/Depth Any/3.1 Med/3.1
Control 5: Color Box Position/Size Def/
Any
Def/Def

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 141


Table 18: Transducer Model: L38x/10-5 Operating Mode: PW Doppler

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.04 — 2.0 — 2.6 (b)
pr.3 (MPa) 2.345
W0 (mW) — 84.94 84.94 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 0.8 1.3
deq(zsp) (cm) 0.4685
fc (MHz) 5.01 — 5.05 — 5.05 #
Dim of Aaprt X (cm) — 1.80 — 1.80 #
Y (cm) — 0.4 — 0.4 #
PD (μsec) 1.29
PRF (Hz) 1008
Other Information

pr@PIImax (MPa) 2.693


deq@Pllmax (cm) 0.2533
Focal Length FLx (cm) — 5.54 — #
FLy (cm) — 2.5 — #
IPA.3@MImax (W/cm2) 284.5
Control 1: Exam Type Any Vas Vas
Conditions
Operating

Control 2: Sample Volume 1 mm 12 mm 12 mm


Control

Control 3: PRF 1008 Any Any


Control 4: Sample Volume Position Zone 0
Zone 7 Zone 7
(top)

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

142
Table 19: Transducer Model: P21x/5-1 Operating Mode: 2D

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.3 1.1 — — — (b)
pr.3 (MPa) 1.83
W0 (mW) 122.87 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 5.1 —
deq(zsp) (cm) —
fc (MHz) 1.84 1.88 — — — #
Dim of Aaprt X (cm) 0.590 — — — #
Y (cm) 1.3 — — — #
PD (μsec) 0.963
PRF (Hz) 4421
Other Information

pr@PIImax (MPa) 2.574


deq@Pllmax (cm) —
Focal Length FLx (cm) 1.55 — — #
FLy (cm) 5.5 — — #
IPA.3@MImax (W/cm2) 209.0
Control 1: Exam Type Card Abd/OB
Control 2: Optimization Pen/
Conditions
Operating

Any
Control

Gen
Control 3: Depth 4.7/7.6
4.7
cm
Control 4: THI On On

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 143


Table 20: Transducer Model: P21x/5-1 Operating Mode: M Mode

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.5 — (a) — (a) (a)
pr.3 (MPa) 2.10
W0 (mW) — # # #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 3.645 #
deq(zsp) (cm) #
fc (MHz) 1.93 — # — # #
Dim of Aaprt X (cm) — # — # #
Y (cm) — # — # #
PD (μsec) 0.904
PRF (Hz) 800
Other Information

pr@PIImax (MPa) 2.679


deq@Pllmax (cm) #
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm2) 237.4
Control 1: Exam Type Abd/
Conditions
Operating

OB
Control

Control 2: Optimization Gen/


Res
Control 3: Depth 7.5 cm
Control 4: THI On
Control 5: MB On

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

144
Table 21: Transducer Model: P21x/5-1 Operating Mode: CPD/Color

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.5 1.3 — — — (b)
pr.3 (MPa) 2.19
W0 (mW) 136.91 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic

z1 (cm) —
Parameter

zbp (cm) —
zsp (cm) 4.5 —
deq(zsp) (cm) —
fc (MHz) 2.15 2.16 — — — #
Dim of Aaprt X (cm) 0.918 — — — #
Y (cm) 1.3 — — — #
PD (μsec) 1.20
PRF (Hz) 1063
Other Information

pr@PIImax (MPa) 2.574


deq@Pllmax (cm) —
Focal Length FLx (cm) 3.68 — — #
FLy (cm) 5.5 — — #
IPA.3@MImax (W/cm2) 330.4
Control 1: Mode Color CPD
Control 2: Exam Type Abd/
Conditions
Operating

OB
Control

OB
Control 3: PRF/Depth 300/10 850/7.5
Control 4: Color Optimization Any Med
Control 5: THI On Off
Control 6: Color Box Size Short and
Any
Narrow

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 145


Table 22: Transducer Model: P21x/5-1 Operating Mode: PW Doppler

TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.2 — — 1.3 3.9 (b)
pr.3 (MPa) 1.844
W0 (mW) — — 93.28 #
min of [W.3(z1),ITA.3(z1)] (mW) 120.13
Associated Acoustic

z1 (cm) 3.1
Parameter

zbp (cm) 2.66


zsp (cm) 3.718 0.6
deq(zsp) (cm) 0.49
fc (MHz) 2.16 — — 2.22 2.23 #
Dim of Aaprt X (cm) — — 1.9 0.459 #
Y (cm) — — 1.3 1.3 #
PD (μsec) 1.21
PRF (Hz) 1562.5
Other Information

pr@PIImax (MPa) 2.432


deq@Pllmax (cm) 0.49
Focal Length FLx (cm) — — 13.84 #
FLy (cm) — — 5.5 #
IPA.3@MImax (W/cm2) 187.5
Control 1: Exam Type Card Card Any
Conditions
Operating
Control

Control 2: Sample Volume 1mm 3mm 14mm


Control 3: PRF 1563 3906 10417
Control 4: Sample Volume Position Zone 1 Zone 4 Zone 0

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

146
Table 23: Transducer Model: P21x/5-1 Operating Mode: CW Doppler

TIS TIB

Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — — 1.0 3.4 (b)
pr.3 (MPa) #
W0 (mW) — — 88.30 #
min of [W.3(z1),ITA.3(z1)] (mW) 102.54
Associated Acoustic

z1 (cm) 1.386
Parameter

zbp (cm) 1.71


zsp (cm) # 1.255
deq(zsp) (cm) 0.49
fc (MHz) # — — 2.00 2.00 #
Dim of Aaprt X (cm) — — 0.7865 0.6554 #
Y (cm) — — 1.3 1.3 #
PD (μsec) #
PRF (Hz) #
Other Information

pr@PIImax (MPa) #
deq@Pllmax (cm) 0.45
Focal Length FLx (cm) — — 13.84 #
FLy (cm) — — 5.5 #
IPA.3@MImax (W/cm2) #
Control 1: Exam Type Card Card
Conditions
Operating
Control

Control 2: Zone
Zone 4 Zone 1

(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.

Chapter 6: Safety 147


Terms used in the acoustic output tables
Table 24: Acoustic Output Terms and Definitions

Term Definition

ISPTA.3 Derated spatial peak, temporal average intensity in units of milliwatts/cm2.

TI type Applicable thermal index for the transducer, imaging mode, and exam type.

TI value Thermal index value for the transducer, imaging mode, and exam type.

MI Mechanical index.

Ipa.3@MImax Derated pulse average intensity at the maximum MI in units of W/cm2.

TIS (Soft tissue thermal index) is a thermal index related to soft tissues. TIS scan is
the soft tissue thermal index in an auto-scanning mode. TIS non-scan is the
soft tissue thermal index in the non-autoscanning mode.

TIB (Bone thermal index) is a thermal index for applications in which the
ultrasound beam passes through soft tissue and a focal region is in the
immediate vicinity of bone. TIB non-scan is the bone thermal index in the
non-autoscanning mode.

TIC (Cranial bone thermal index) is the thermal index for applications in which
the ultrasound beam passes through bone near the beam entrance into the
body.

Aaprt Area of the active aperture measured in cm2.

Pr.3 Derated peak rarefactional pressure associated with the transmit pattern
giving rise to the value reported under MI (Megapascals).

Wo Ultrasonic power, except for TISscan, in which case it is the ultrasonic power
passing through a one centimeter window in units of milliwatts.

W.3(z1) Derated ultrasonic power at axial distance z1 in units of milliwatts.

ISPTA.3(z1) Derated spatial-peak temporal-average intensity at axial distance z1


(milliwatts per square centimeter).

z1 Axial distance corresponding to the location of maximum [min(W.3(z), ITA.3(z)


x 1 cm2)], where z > zbp in centimeters.

zbp 1.69 ( A a p r t ) in centimeters.


zsp For MI, the axial distance at which pr.3 is measured. For TIB, the axial distance
at which TIB is a global maximum (for example, zsp = zb.3) in centimeters.

148
Table 24: Acoustic Output Terms and Definitions (Continued)

Term Definition

Safety
deq(z) Equivalent beam diameter as a function of axial distance z, and is equal to
( 4 ⁄ ( π ) ) ( ( Wo ) ⁄ ( I TA ( z ) ) ) , where ITA(z) is the temporal-average intensity as a
function of z in centimeters.

fc Center frequency in MHz.

Dim. of Aaprt Active aperture dimensions for the azimuthal (x) and elevational (y) planes in
centimeters.

PD Pulse duration (microseconds) associated with the transmit pattern giving


rise to the reported value of MI.

PRF Pulse repetition frequency associated with the transmit pattern giving rise to
the reported value of MI in Hertz.

pr@PIImax Peak rarefactional pressure at the point where the free-field, spatial-peak
pulse intensity integral is a maximum in Megapascals.

deq@PIImax Equivalent beam diameter at the point where the free-field, spatial-peak
pulse intensity integral is a maximum in centimeters.

FL Focal length, or azimuthal (x) and elevational (y) lengths, if different


measured in centimeters.

Acoustic measurement precision and uncertainty


All table entries have been obtained at the same operating conditions that give rise to the
maximum index value in the first column of the table. Measurement precision and uncertainty
for power, pressure, intensity, and other quantities that are used to derive the values in the
acoustic output table are shown in the table below. In accordance with Section 6.4 of the Output
Display Standard, the following measurement precision and uncertainty values are
determined by making repeat measurements and stating the standard deviation as a
percentage.
Table 25: Acoustic Measurement Precision and Uncertainty

Precision Uncertainty
Quantity
(% of standard deviation) (95% confidence)

Pr 1.9% +11.2%

Pr.3 1.9% +12.2%

Wo 3.4% +10%

fc 0.1% +4.7%

Chapter 6: Safety 149


Table 25: Acoustic Measurement Precision and Uncertainty (Continued)

Precision Uncertainty
Quantity
(% of standard deviation) (95% confidence)

PII 3.2% +12.5 to -16.8%

PII.3 3.2% +13.47 to -17.5%

Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 26: Labeling Symbols

Symbol Definition
Alternating Current (AC)

Class 1 device indicating manufacturer’s declaration of conformance with


Annex VII of 93/42/EEC

Class 1 device requiring verification by the Notified Body of sterilization or


measurement features, or to a Class IIa, IIb, or III device requiring verification or
auditing by the Notified Body to applicable Annex(es) of 93/42/EEC

Attention, see the user guide

Device complies with relevant Australian regulations for electronic devices.

Batch code, date code, or lot code type of control number


LOT
Biological risk

Device complies with relevant Brazilian regulations for electro-medical devices.

Canadian Standards Association. The “C” and “US” indicators next to this mark
signify that the product has been evaluated to the applicable CSA and ANSI/UL
Standards, for use in Canada and the US, respectively.

150
Table 26: Labeling Symbols (Continued)

Symbol Definition

Safety
REF Catalog number

Collect separately from other household waste (see European Commission


Directive 93/86/EEC). Refer to local regulations for disposal.

STERILE EO Contents sterilized using ethylene oxide process.

Corrugated recycle

Dangerous voltage

Date of manufacture

Direct Current (DC)

Do not get wet.

Do not stack over 2 high.

Do not stack over 5 high.

Do not stack over 10 high.

Electrostatic sensitive devices

Device complies with relevant FCC regulations for electronic devices.

Chapter 6: Safety 151


Table 26: Labeling Symbols (Continued)

Symbol Definition
Fragile

GEL STERILE R Gel sterilized by radiation.

Hot

Indoor use only

Device emits a static (DC) magnetic field.

Non-ionizing radiation

Paper recycle

SN Serial number type of control number

Storage temperature conditions

Submersible. Protected against the effects of temporary immersion.

Water-Tight Equipment. Protected against the effects of extended immersion.

Handle transducer with care.

Follow manufacturer’s instructions for disinfecting time.

Disinfect transducer.

152
Table 26: Labeling Symbols (Continued)

Symbol Definition

Safety
Type BF patient applied part
(B = body, F = floating applied part)

Underwriter’s Laboratories labeling

Pollution Control Logo. (Applies to all parts/products listed in the China RoHS
disclosure table. May not appear on the exterior of some parts/products
because of space limitations.)

China Compulsory Certificate mark (“CCC Mark”). A compulsory safety mark for
compliance to Chinese national standards for many products sold in the
People’s Republic of China.
Contains mercury. (Applies to the LCD and may apply to other components in
the ultrasound system.)
WARNING: WARNING: Connect Only
Connect Only
Accessories and Accessories and Peripherals
Peripherals
Recommended by Recommended by SonoSite
SonoSite

Chapter 6: Safety 153


154
Chapter 7: References

Measurement accuracy
The measurements provided by the system do not define a specific physiological or anatomical
parameter. Rather, the measurements are of a physical property such as distance for evaluation
by the clinician. The accuracy values require that you can place the calipers over one pixel. The
values do not include acoustic anomalies of the body.

References
The 2D linear distance measurement results are displayed in centimeters with one place past
the decimal point, if the measurement is ten or greater; two places past the decimal point, if the
measurement is less than ten.
The linear distance measurement components have the accuracy and range shown in the
following tables.

Table 1: 2D Measurement Accuracy and Range

2D Measure Accuracy System Accuracy Test


Range (cm)
and Range Tolerancea By Methodb

Axial Distance < ±2% plus 1% of Acquisition Phantom 0-26 cm


full scale

Lateral Distance < ±2% plus 1% of Acquisition Phantom 0-35 cm


full scale

Diagonal Distance < ±2% plus 1% of Acquisition Phantom 0-44 cm


full scale

Areac < ±4% plus (2% of Acquisition Phantom 0.01-720 cm2


full scale/smallest
dimension) * 100
plus 0.5%

Circumferenced < ±3% plus (1.4% Acquisition Phantom 0.01-96 cm


of full scale/
smallest
dimension) * 100
plus 0.5%

a.Full scale for distance implies the maximum depth of the image.
b.An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used.
c.The area accuracy is defined using the following equation:
% tolerance = ((1 + lateral error) * (1 + axial error) – 1) * 100 + 0.5%.

Chapter 7: References 155


d.The circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following
equation:
% tolerance = ( 2 (maximum of 2 errors) * 100) + 0.5%.

Table 2: M Mode Measurement and Calculation Accuracy and Range

M Mode Measurement System Accuracy Test


Range
Accuracy and Range Tolerance By Method

Distance < +/- 2% plus 1% Acquisition Phantomb 0-26 cm


of full scalea

Time < +/- 2% plus 1% Acquisition Phantomd 0.01-10 sec


of full scalec

Heart Rate < +/- 2% plus (Full Acquisition Phantomd 5-923 bpm
Scalec * Heart
Rate/100) %

a.Full scale for distance implies the maximum depth of the image.
b.An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used.
c.Full scale for time implies the total time displayed on the scrolling graphic image.
d.SonoSite special test equipment was used.

Table 3: PW Doppler Mode Measurement and Calculation Accuracy and Range

Doppler Mode
System Accuracy Test
Measurement Accuracy Range
Tolerance By Methoda
and Range

Velocity cursor < +/- 2% plus 1% Acquisition Phantom 0.01 cm/sec-


of full scaleb 550 cm/sec

Frequency cursor < +/- 2% plus 1% Acquisition Phantom 0.01kHz-20.8 kHz


of full scaleb

Time < +/- 2% plus 1% Acquisition Phantom 0.01-10 sec


of full scalec

a.SonoSite special test equipment was used.


b.Full scale for frequency or velocity implies the total frequency or velocity magnitude, displayed on the
scrolling graphic image.
c.Full scale for time implies the total time displayed on the scrolling graphic image.

156
Sources of measurement errors
In general, two types of errors can be introduced into the measurement:
Acquisition Error Includes errors introduced by the ultrasound system electronics relating to
signal acquisition, signal conversion, and signal processing for display. Additionally,
computational and display errors are introduced by the generation of the pixel scale factor,
application of that factor to the caliper positions on the screen, and the measurement display.
Algorithmic Error The error introduced by measurements, which are input to higher order
calculations. This error is associated with floating‐point versus integer‐type math, which is

References
subject to errors introduced by rounding versus truncating results for display of a given level
of significant digit in the calculation.

Measurement publications and terminology


The following sections list the publications and terminology used for each calculation result.
Terminology and measurements comply with AIUM published standards.

Cardiac references
Acceleration (ACC) in cm/s2
Zwiebel, W.J. Introduction to Vascular Ultrasonography. 4th ed., W.B. Saunders Company, (2000),
52.
ACC = abs (delta velocity/delta time)

Acceleration Time (AT) in msec


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 219.

Aortic Valve Area (AVA) by Continuity Equation in cm2


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 393, 442.
A2 = A1 * V1/V2
where: A2 = Ao valve area
A1 = LVOT area; V1 = LVOT velocity; V2 = Ao valve velocity
LVOT = Left Ventricular Outflow Tract
AVA (PVLVOT/PVAO) * CSALVOT
AVA (VTILVOT/VTIAO) * CSALVOT

Chapter 7: References 157


Body Surface Area (BSA) in m2
Grossman, W. Cardiac Catheterization and Angiography. Philadelphia: Lea and Febiger, (1980), 90.
BSA = 0.007184 * Weight0.425 * Height0.725
Weight = kilograms
Height = centimeters

Cardiac Index (CI) in l/min/m2


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and
Company, (1999), 59.
CI = CO/BSA
where: CO = Cardiac Output
BSA = Body Surface Area

Cardiac Output (CO) in l/min


Oh, J.K., J.B. Seward, A.J. Tajik The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 59.
CO = (SV * HR)/1000
where: CO = Cardiac Output
SV = Stroke Volume
HR = Heart Rate

Cross Sectional Area (CSA) in cm2


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 383.
CSA = 0.785 * D2
where: D = diameter of the anatomy of interest

Deceleration Time in msec


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 453.
|time a ‐ time b|

Delta Pressure: Delta Time (dP:dT) in mmHg/s


Otto, C.M. Textbook of Clinical Echocardiography. 2nd ed., W.B. Saunders Company, (2000), 117,
118.
32 mmHg/time interval in seconds

158
E:A Ratio in cm/sec
E:A = velocity E/velocity A

E/Ea Ratio
Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 225.
E Velocity/Ea velocity
where: E velocity = Mitral Valve E velocity

References
Ea = annular E velocity, also known as: E prime

Effective Regurgitant Orifice (ERO) in mm2


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 455.
ERO = 6.28 (r2) * Va/MR Vel
where: r = radius
Va = aliasing velocity

Ejection Fraction (EF), percent


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 40.
EF = ((LVEDV – LVESV)/LVEDV) * 100%
where: EF = Ejection Fraction
LVEDV = Left Ventricular End Diastolic Volume
LVESV = Left Ventricular End Systolic Volume

Elapsed Time (ET) in msec


ET = time between velocity cursors in milliseconds

Heart Rate (HR) in bpm


HR = 3 digit value input by user or measured on M Mode and Doppler image in one heart cycle

Interventricular Septum (IVS) Fractional Thickening, percent


Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus
Nijhoff, (1981), 71.
IVSFT = ((IVSS – IVSD)/IVSD) * 100%
where: IVSS = Interventricular Septal Thickness at Systole
IVSD = Interventricular Septal Thickness at Diastole

Chapter 7: References 159


Isovolumic Relaxation Time (IVRT) in msec
Reynolds, Terry. The Echocardiographer’s Pocket Reference. School of Cardiac Ultrasound, Arizona
Heart Institute, (1993), 146.
|time a ‐ time b|

Left Atrium/Aorta (LA/Ao)


Feigenbaum, H. Echocardiography. Philadelphia: Lea and Febiger, (1994), 206, Figure 4‐49.

Left Ventricular End Volumes (Teichholz) in ml


Teichholz, L.E., T. Kreulen, M.V. Herman, et. al. “Problems in echocardiographic volume
determinations: echocardiographic‐angiographic correlations in the presence or absence of
asynergy.” American Journal of Cardiology, (1976), 37:7.
LVESV = (7.0 * LVDS3)/(2.4 + LVDS)
where: LVESV = Left Ventricular End Systolic Volume
LVDS = Left Ventricular Dimension at Systole
LVEDV = (7.0 * LVDD3)/(2.4 + LVDD)
where: LVEDV = Left Ventricular End Diastolic Volume
LVDD = Left Ventricular Dimension at Diastole

Left Ventricular Mass in gm


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and
Company, (1999), 39.
LV Mass = 1.04 [(LVID + PWT + IVST)3 – LVID3] * 0.8 + 0.6
where: LVID = Internal Dimension
PWT = Posterior Wall Thickness
IVST = Interventricular Septal Thickness
1.04 = Specific gravity of the myocardium
0.8 = Correction factor

Left Ventricular Volume: Biplane Method in ml


Schiller, N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantitation of the Left
Ventricle by Two‐Dimensional Echocardiography.” Journal of American Society of
Echocardiography. September‐October 1989, 2:362.
n
π L
V = ⎛ ---⎞ ∑ ai bi ⎛⎝ --n-⎞⎠
⎝ 4⎠
i=1

where: V = Volume in ml
a = Diameter
b = Diameter

160
n = Number of segments (n=20)
L = Length
i = Segment

Left Ventricular Volume: Single Plane Method in ml


Schiller, N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantitation of the Left
Ventricle by Two‐Dimensional Echocardiography.” Journal of American Society of
Echocardiography. September‐October 1989, 2:362.
n

References
π 2 ⎛ L⎞
V = ⎛ ---⎞ ∑ ai ---
⎝ 4⎠ ⎝ n⎠
i=1

where: V = Volume
a = Diameter
n = Number of segments (n=20)
L = Length
i = Segment

Left Ventricular Dimension (LVD) Fractional Shortening, percent


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. Boston: Little, Brown and Company, (1994),
43‐44.
LVDFS = ((LVDD – LVDS)/LVDD) * 100%
where: LVDD = Left Ventricle Dimension at Diastole
LVDS = Left Ventricle Dimension at Systole

Left Ventricular Posterior Wall Fractional Thickening (LVPWFT), percent


Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus
Nijhoff, (1981), 71.
LVPWFT = ((LVPWS – LVPWD)/LVPWD) * 100%
where: LVPWS = Left Ventricular Posterior Wall Thickness at Systole
LVPWD = Left Ventricular Posterior Wall Thickness at Diastole

Mean Velocity (Vmean) in cm/s


Vmean = mean velocity

Mitral Valve Area (MVA) in cm2


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 391, 452.
MVA = 220/PHT
where: PHT = pressure half time

Chapter 7: References 161


Note: 220 is an empirical derived constant and may not accurately predict mitral valve area in mitral
prosthetic heart valves. The mitral valve area continuity equation may be utilized in mitral prosthetic
heart valves to predict effective orifice area.

MV Flow Rate in cc/sec


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 396.
Flow = 6.28 (r2) * Va
where: r = radius
Va = aliasing Velocity

Pressure Gradient (PGr) in mmHG


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 64.
PGr = 4 * (Velocity)2
Peak E Pressure Gradient (E PG)
E PG = 4 * PE2
Peak A Pressure Gradient (A PG)
A PG = 4 * PA2
Peak Pressure Gradient (PGmax)
PGmax = 4 * PV2
Mean Pressure Gradient (PGmean)
PGmean = Average of pressure gradients/Duration of flow

Pressure Half Time (PHT) in msec


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 391.
PHT = DT * 0.29
where: DT = deceleration time

Proximal Isovelocity Surface Area (PISA) in cm2


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Boston: Little, Brown and Company,
(1999), 125.
PISA = 2 π r2

where: 2 π = 6.28
r = aliasing radius

162
Qp/Qs
Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 400.
Qp/Qs = SV Qp site/SV Qs site
SV sites will vary depending upon the location of the shunt.

Regurgitant Fraction (RF) in percent


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. Boston: Little, Brown and Company, (1999),

References
125.
RF = RV/ MV SV
where: RV = Regurgitant Volume
MV SV = Mitral Stroke Volume

Regurgitant Volume (RV) in cc


Reynolds, Terry. The Echocardiographer’s Pocket Reference. School of Cardiac Ultrasound, Arizona
Heart Institute, (2000), 396, 455.
RV = ERO * MR VTI

Right Ventricular Systolic Pressure (RVSP) in mmHg


Reynolds, Terry. The Echocardiographer’s Pocket Reference. School of Cardiac Ultrasound, Arizona
Heart Institute, (1993), 152.
RVSP = 4 * (Vmax TR)2 + RAP
where: RAP = Right Atrial Pressure

Stroke Index (SI) in cc/m2


Mosby’s Medical, Nursing, & Allied Health Dictionary, 4th ed., (1994), 1492.
SI = SV/BSA
where: SV = Stroke Volume
BSA = Body Surface Area

Stroke Volume (SV) Doppler in ml


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 40, 59, 62.
SV = (CSA * VTI)
where CSA = Cross Sectional Area of the orifice (LVOT area)
VTI = Velocity Time Integral of the aortic valve

Chapter 7: References 163


Stroke Volume (SV) 2D and M Mode in ml
Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Boston: Little, Brown and Company,
(1994), 44.
SV = (LVEDV – LVESV)
where: SV = Stroke Volume
LVEDV = End Diastolic Volume
LVEDSV = End Systolic Volume

Velocity Time Integral (VTI) in cm


Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 383.
VTI = sum of abs (velocities [n])
where: Auto Trace – distance (cm) blood travels with each ejection period. Velocities
are absolute values.

Obstetrical references
Amniotic Fluid Index (AFI)
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.

Average Ultrasound Age (AUA)


The system provides an AUA derived from the component measurements from the
measurement tables.

Estimated Date of Delivery (EDD) by Average Ultrasound Age (AUA)


Results are displayed as month/day/year.
EDD = system date + (280 days – AUA in days)

Estimated Date of Delivery (EDD) by Last Menstrual Period (LMP)


The date entered into the patient information for LMP must precede the current date.
Results are displayed as month/day/year.
EDD = LMP date + 280 days

Estimated Fetal Weight (EFW)


Hadlock, F., et al. “Estimation of Fetal Weight with the Use of Head, Body, and Femur
Measurements, A Prospective Study.” American Journal of Obstetrics and Gynecology, 151:3
(February 1, 1985), 333‐337.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986), 154.

164
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.
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 880, Equation 1.

Gestational Age (GA) by Last Menstrual Period (LMP)


The gestational age derived from the LMP date entered on the patient information form.

References
Results are displayed in weeks and days, and is calculated as follows:
GA(LMP) = System date – LMP date

Gestational Age (GA) by Last Menstrual Period (LMPd) Derived from Established Due Date
(Estab. DD)
Same as GA by Estab. DD.
The gestational age derived from the system derived LMP using the Established Due Date
entered on the patient information form.
Results are displayed in weeks and days, and is calculated as follows:
GA(LMPd) = System Date – LMPd

Last Menstrual Period Derived (LMPd) by Established Due Date (Estab. DD)
Results are displayed as month/day/year.
LMPd(Estab. DD) = Estab. DD – 280 days

Gestational age tables


Abdominal Circumference (AC)
Hadlock, F., et al. “Estimating 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.
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885.

WARNING: The gestational age calculated by your SonoSite system does not match the age in
the aforementioned reference at the 20.0 cm and 30.0 cm abdominal circumference
(AC) measurements. The implemented algorithm extrapolates the gestational age
from the slope of the curve of all table measurements, rather than decreasing the
gestational age for a larger AC measurement indicated in the referenced table. This
results in the gestational age always increasing with an increase in AC.

Chapter 7: References 165


Anteroposterior Trunk Diameter (APTD)
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885.

Biparietal Diameter (BPD)


Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy.” Ultrasound in
Obstetrics and Gynecology 10: (1997), 174‐179, Table 3.
Hadlock, F., et al. “Estimating 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.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 98.
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885.

Crown Rump Length (CRL)


Hadlock, F., et al. “Fetal Crown‐Rump Length: Re‐evaluation of Relation to Menstrual Age
(5‐18 weeks) with High‐Resolution, Real‐Time Ultrasound.” Radiology, 182: (February 1992),
501‐505.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986), 439.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 20 and 96.
Tokyo University. “Gestational Weeks and Computation Methods.” Ultrasound Imaging
Diagnostics, 12:1 (1982‐1), 24‐25, Table 3.

Femur Length (FL)


Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy.” Ultrasound in
Obstetrics and Gynecology 10: (1997), 174‐179, Table 8, 186.
Hadlock, F., et al. “Estimating 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.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 101‐102.
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 886.

Fetal Trunk Cross-Sectional Area (FTA)


Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 99‐100.

166
Gestational Sac (GS)
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.
Gestational sac measurements provide a fetal age based on the mean of one, two, or three
distance measurements; however, Nyberg’s gestational age equation requires all three
distance measurements for an accurate estimate.
Tokyo University. “Gestational Weeks and Computation Methods.” Ultrasound Imaging

References
Diagnostics, 12:1 (1982‐1).

Head Circumference (HC)


Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy.” Ultrasound in
Obstetrics and Gynecology 10: (1997), 174‐191, Table 5, 182.
Hadlock, F., et al. “Estimating Fetal Age: Computer‐Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152: (1984), 497‐501.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986), 431.

Occipito-Frontal Diameter (OFD)


Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986), 431.

Transverse Trunk Diameter (TTD)


Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986), 431.
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885.

Growth analysis tables


Abdominal Circumference (AC)
Chitty, Lyn S. et al. “Charts of Fetal Size: 3. Abdominal Measurements.” British Journal of
Obstetrics and Gynaecology 101: (February 1994), 131, Appendix: AC‐Derived.
Hadlock, F., et al. “Estimating Fetal Age: Computer‐Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152: (1984), 497‐501.
Jeanty P., E. Cousaert, and F. Cantraine. “Normal Growth of the Abdominal Perimeter.”
American Journal of Perinatology, 1: (January 1984), 129‐135.
(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in
Obstetrics and Gynecology. Springer‐Verlag, New York, (1986), 179, Table 7.13.)

Chapter 7: References 167


Biparietal Diameter (BPD)
Chitty, Lyn S. et al. “Charts of Fetal Size: 2. Head Measurements.” British Journal of Obstetrics
and Gynaecology 101: (January 1994), 43, Appendix: BPD‐Outer‐Inner.
Hadlock, F., et al. “Estimating Fetal Age: Computer‐Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152: (1984), 497‐501.
Jeanty P., E. Cousaert, and F. Cantraine. “A Longitudinal Study of Fetal Limb Growth.”
American Journal of Perinatology, 1: (January 1984), 136‐144, Table 5.
(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in
Obstetrics and Gynecology. Springer‐Verlag, New York, (1986), 176, Table 7.8.)

Estimated Fetal Weight (EFW)


Hadlock F., et al. “In Utero Analysis of Fetal Growth: A Sonographic Weight Standard.”
Radiology, 181: (1991), 129‐133.
Jeanty, Philippe, F. Cantraine, R. Romero, E. Cousaert, and J. Hobbins. “A Longitudinal Study
of Fetal Weight Growth.” Journal of Ultrasound in Medicine, 3: (July 1984), 321‐328, Table 1.
(Also published in Hansmann, Hackeloer, Staudach, and Wittman. Ultrasound Diagnosis in
Obstetrics and Gynecology. Springer‐Verlag, New York, (1986), 186, Table 7.20.)

Femur Length (FL)


Chitty, Lyn S. et al. “Charts of Fetal Size: 4. Femur Length.” British Journal of Obstetrics and
Gynaecology 101: (February 1994), 135.
Hadlock, F., et al. “Estimating Fetal Age: Computer‐Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152: (1984), 497‐501.
Jeanty P, E. Cousaert, and F. Cantraine. “A Longitudinal Study of Fetal Limb Growth.” American
Journal of Perinatology, 1: (January 1984), 136‐144, Table 5.
(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in
Obstetrics and Gynecology. Springer‐Verlag, New York, (1986), 182, Table 7.17.)

Head Circumference (HC)


Chitty, Lyn S., et al. “Charts of Fetal Size: 2. Head Measurements.” British Journal of Obstetrics
and Gynaecology 101: (January 1994), 43, Appendix: HC‐Derived.
Hadlock, F., et al. “Estimating Fetal Age: Computer‐Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152: (1984), 497‐501.
Jeanty P, E. Cousaert, and F. Cantraine. “A longitudinal study of Fetal Head Biometry.”
American J of Perinatology, 1: (January 1984), 118‐128, Table 3.
(Also published in Hansmann, Hackeloer, Staudach, Wittman. Ultrasound Diagnosis in
Obstetrics and Gynecology. Springer‐Verlag, New York, (1986), 176, Table 7.8.)

168
Head Circumference (HC)/Abdominal Circumference (AC)
Campbell S., Thoms 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.

Ratio calculations
FL/AC Ratio
Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker, and S.K. Park. “A Date Independent

References
Predictor of Intrauterine Growth Retardation: Femur Length/Abdominal Circumference
Ratio,” American Journal of Roentgenology, 141: (November 1983), 979‐984.

FL/BPD Ratio
Hohler, C.W., and 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
Hadlock F.P., R. B. Harrist, Y. Shah, and 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
Campbell S., Thoms 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.

General references
+/x or S/D Ratio
+/x = abs (Velocity A/Velocity B)
where A = velocity cursor +
B = velocity cursor x

Acceleration Index (ACC)


Zwiebel, W.J. Introduction to Vascular Ultrasonography, 4th ed., W.B. Saunders Company, (2000),
52.
ACC = abs (delta velocity/delta time)

Elapsed Time (ET)


ET = time between velocity cursors in milliseconds

Chapter 7: References 169


Hip Angle/d:D Ratio
Graf, R. “Fundamentals of Sonographic Diagnosis of Infant Hip Dysplasia.” Journal of Pediatric
Orthopedics, Vol. 4, No. 6: 735‐740, 1984.
Morin, C., Harcke, H., MacEwen, G. “The Infant Hip: Real‐Time US Assessment of Acetabular
Development.” Radiology 177: 673‐677, December 1985.

Intima Media Thickness (IMT)


Howard G, Sharrett AR, Heiss G, Evans GW, Chambless LE, Riley WA, et al. “Carotid Artery
Intima‐Medial Thickness Distribution in General Populations As Evaluated by B‐Mode
Ultrasound.” ARIC Investigators. Atherosclerosis Risk in Communities. Stroke. (1993),
24:1297‐1304.
O’Leary, Daniel H., MD and Polak, Joseph, F., MD, et al. “Use of Sonography to Evaluate
Carotid Atherosclerosis in the Elderly. The Cardiovascular Health Study.” Stroke. (September
1991), 22,1155‐1163.
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.

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.
% Area Reduction = (1 ‐ A2(cm2)/A1(cm2)) * 100
where: A1 = original area of the vessel in square cm
A2 = reduced area of the vessel in square cm

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.
% Diameter Reduction = (1 ‐ D2(cm)/D1(cm)) * 100
where: D1 = original diameter of the vessel in cm
D2 = reduced diameter of the vessel in cm

Pressure Gradient (PGr) in mmHG


Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 64.
4 * (Velocity)2
Peak E Pressure Gradient (E PG)

170
E PG = 4 * PE2
Peak A Pressure Gradient (A PG)
A PG = 4 * PA2
Peak Pressure Gradient (PGmax)
PGmax = 4 * PV2
Mean Pressure Gradient (PGmean)
PGmean = 4 * Vmax2

References
Pulsatility Index (PI)
Kurtz, A.B., W.D. Middleton. Ultrasound‐the Requisites. Mosby Year Book, Inc., (1996), 469.
PI = (PSV – EDV)/V
where PSV = peak systolic velocity
EDV = end diastolic velocity
V = mean flow velocity throughout the entire cardiac cycle

Resistive Index (RI)


Kurtz, A.B., W.D. Middleton. Ultrasound‐the Requisites. Mosby Year Book, Inc., (1996), 467.
RI = abs ((Velocity A – Velocity B)/Velocity A) in measurements
where A = velocity cursor +
B = velocity cursor x

Time Averaged Mean (TAM) in cm/s


TAM = mean (mean Trace)

Volume (Vol)
Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987), 131.

Volume Flow (VF) in l/m


Allan, Paul L. et al. Clinical Doppler Ultrasound, 4th ed., Harcourt Publishers Limited. (2000),
36‐38.
VF = CSA * TAM * .06

Chapter 7: References 171


172
Chapter 8: Specifications

This chapter contains system and accessory specifications and standards. The
specifications for recommended peripherals are in the manufacturers’ instructions.

Dimensions
System Display

Length: 11.8 in. (29.97 cm) Length: 8.4 in. (21.34 cm)
Width: 10.8 in. (27.43 cm) Height: 6.3 in. (16 cm)
Height: 3.1 in. (7.87 cm) Diagonal: 10.4 in. (26.4 cm)
Weight: 8.5 lbs. (3.9 kg) with the C60x

Specifications
transducer and battery installed

Supported transducers
• C11x/8‐5 MHz (6 ft/1.8 m) • L25x/13‐6 MHz (7.5 ft/2.3 m)
• C60x/5‐2 MHz (5.5 ft/1.7 m) • L38x/10‐5 MHz (5.5 ft/1.7 m)
• HFL38x/13‐6 MHz (5.6 ft/1.7 m) • P21x/5‐1 MHz(6 ft/1.8 m)
• ICTx/8‐5 MHz (5.5 ft/1.7 m)

Imaging modes
• 2D (256 gray shades) • Pulsed wave (PW) Doppler
• Color power Doppler (CPD) (256 • Continuous wave (CW) Doppler
colors)
• Tissue Doppler Imaging (TDI)
• Color Doppler (Color) (256 colors)
• Tissue Harmonic Imaging (THI)
• M Mode

Chapter 8: Specifications 173


Images and clips storage
Internal storage: The number of images and clips you can save depends on imaging mode
and file format.

Accessories
The following items are either included with or available for use on the ultrasound system.
• Battery
• Biopsy Guide
• Carry case
• ECG cable (6 ft/1.8 m)
• External display
• Footswitch
• Mini‐Dock
• Mobile Docking System M Series (MDSm)
• Mobile Docking System Lite II (MDS Lite II)
• Needle Guide
• Power supply
• SiteLink Image Manager
• SonoCalc IMT
• System AC power cord (10 ft/3.1 m)
• Triple Transducer Connect

Peripherals
See the manufacturer’s specifications for the following peripherals.

Medical • Black‐and‐white printer


grade
Recommended sources for printer paper: Contact Sony at 800‐686‐7669
or www.sony.com/professional to order supplies or to find the local
distributor.
• Color printer
• DVD recorder

174
Non-medical Kensington Security Cable
grade

Temperature and humidity limits


Note: The temperature, pressure, and humidity limits apply only to the ultrasound system,
transducers, and battery.

Operating limits

System Battery Transducer

10–40°C (50–104°F), 10–40°C (50–104°F), 10–40°C (50–104°F),


15–95% R.H. 15–95% R.H. 15–95% R.H.
700 to 1060hPa (0.7 to 700 to 1060hPa (0.7 to

Specifications
1.05 ATM) 1.05 ATM)

Shipping and storage limits

System without
Battery Transducer
Battery

-35–65°C (-31–149°F), -20–60°C (-4–140°F), -35–65°C (-31–149°F),


15–95% R.H. 15–95% R.H.* 15–95% R.H.
500 to 1060hPa (0.5 to 500 to 1060hPa (0.5 to
1.05 ATM) 1.05 ATM)
* For storage longer than 30 days, store at or below room temperature.

Electrical
Power Supply Input 100‐240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC

Power Supply Output #1 15 VDC, 5.0 A Max

Power Supply Output #2 12 VDC, 2.3 A Max

Battery
The battery comprises six lithium‐ion cells plus electronics, a temperature sensor, and
battery contacts.
Run time is up to two hours, depending on imaging mode and display brightness.

Chapter 8: Specifications 175


Electromechanical safety standards
EN 60601‐1:1997, European Norm, Medical Electrical Equipment–Part 1. General
Requirements for Safety.
EN 60601‐1‐1:2001, European Norm, Medical Electrical Equipment–Part 1. General
Requirements for Safety–Section 1‐1. Collateral Standard. Safety Requirements for Medical
Electrical Systems.
EN 60601‐2‐37:2001 + Amendment A1:2005, European Norm, Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment.
CAN/CSA C22.2, No. 601.1‐M90, Canadian Standards Association, Medical Electrical
Equipment–Part 1. General Requirements for Safety (including CSA 601.1 Supplement
1:1994 and CSA 601.1 Amendment 2:1998).
CEI/IEC 61157:1992, International Electrotechnical Commission, Requirements for the
Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment.
UL 60601‐1 (1st Edition), Underwriters Laboratories, Medical Electrical Equipment‐Part 1:
General Requirements for Safety.

EMC standards classification


EN 60601‐1‐2:2001, European Norm, Medical Electrical Equipment. General Requirements
for Safety‐Collateral Standard. Electromagnetic Compatibility. Requirements and Tests.
CISPR11:2004, International Electrotechnical Commission, International Special
Committee on Radio Interference. Industrial, Scientific, and Medical (ISM)
Radio‐Frequency Equipment Electromagnetic Disturbance Characteristics‐Limits and
Methods of Measurement.
The Classification for the ultrasound system, docking system, accessories, and peripherals
when configured together is: Group 1, Class A.

Airborne equipment standards


RTCA/DO‐160E:2004, Radio Technical Commission for Aeronautics, Environmental
Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio
Frequency Energy, Category B.

DICOM standard
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)‐Part 15:
Security Profiles.

176
HIPAA standard
The Health Insurance and Portability and Accountability Act, Pub.L. No. 104‐191 (1996).
45 CFR 160, General Administrative Requirements.
45 CFR 164, Security and Privacy.

Specifications

Chapter 8: Specifications 177


178
Glossary

Terms
For ultrasound terms not included in this glossary, refer to Recommended Ultrasound
Terminology, Second Edition, published in 1997 by the American Institute of Ultrasound in
Medicine (AIUM).

as low as reasonably The guiding principle of ultrasound use, which states that you should
achievable (ALARA) keep patient exposure to ultrasound energy as low as reasonably
achievable for diagnostic results.

curved array Identified by the letter C (curved or curvilinear) and a number (60). The
transducer number corresponds to the radius of curvature of the array expressed
in millimeters. The transducer elements are electrically configured to
control the characteristics and direction of the acoustic beam. For
example, C15, C60e.

depth Refers to the depth of the display. A constant speed of sound of


1538.5 meters/second is assumed in the calculation of echo position in
the image.

in situ In the natural or original position.

LCD liquid crystal display

Glossary
linear array Identified by the letter L (linear) and a number (38). The number
transducer corresponds to the radius of width of the array expressed in
millimeters. The transducer elements are electrically configured to
control the characteristics and direction of the acoustic beam. For
example, L38.

mechanical index An indication of the likelihood of mechanical bioeffects occurring: the


(MI) higher the MI, the greater the likelihood of mechanical bioeffects. See
Chapter 6, “Safety,” for a more complete description of MI.

MI/TI See mechanical index (MI) and thermal index (TI).

NTSC National Television Standards Committee. A video format setting. See


also PAL.

PAL Phase Alternating Line. A video format setting. See also NTSC.

phased array A transducer designed primarily for cardiac scanning. Forms a sector
image by electronically steering the beam direction and focus.

Glossary 179
skinline A depth on the display that corresponds to the skin/transducer
interface.

SonoHD A subset of the 2D imaging mode in which the 2D image is enhanced


by reducing speckle noise artifact at tissue margins and improving
contrast resolution by reducing artifacts and improving visualization of
texture patterns within the image.

SonoMB A subset of the 2D imaging mode in which the 2D image is enhanced


by looking at a target from three angles and then merging or averaging
the scanned data together to improve overall image quality and, in
parallel, reducing noise and artifacts.

Tissue Doppler A pulsed wave Doppler technique used to detect myocardial motion.
Imaging (TDI)

thermal index (TI) The ratio of total acoustic power to the acoustic power required to raise
tissue temperature by 1°C under defined assumptions. See Chapter 6,
“Safety,” for a more complete description of TI.

TIB (bone thermal A thermal index for applications in which the ultrasound beam passes
index) through soft tissue and a focal region is in the immediate vicinity of
bone.

TIC (cranial bone A thermal index for applications in which the ultrasound beam passes
thermal index) through bone near the beam entrance into the body.

TIS (soft tissue A thermal index related to soft tissues.


thermal index)

Tissue Harmonic Transmits at one frequency and receives at a higher harmonic


Imaging frequency to reduce noise and clutter and improve resolution.

transducer A device that transforms one form of energy into another form of
energy. Ultrasound transducers contain piezoelectric elements, which
when excited electrically, emit acoustic energy. When the acoustic
energy is transmitted into the body, it travels until it encounters an
interface, or change in tissue properties. At the interface, an echo is
formed that returns to the transducer, where this acoustic energy is
transformed into electrical energy, processed, and displayed as
anatomical information.

variance Displays a variation in Color Doppler flow imaging within a given


sample. Variance is mapped to the color green and is used to detect
turbulence.

180
Abbreviations
Abbreviations in User Interface

Abbreviation Definition

+/× “+” Caliper/”×” Caliper Ratio

A “A” Wave Peak Velocity

A PG “A” Wave Peak Pressure Gradient

A2Cd Apical 2 Chamber diastolic

A2Cs Apical 2 Chamber systolic

A4Cd Apical 4 Chamber diastolic

A4Cs Apical 4 Chamber systolic

AAo Ascending Aorta

Abd Abdomen

abs Absolute value

AC Abdominal Circumference

ACA Anterior Cerebral Artery

Glossary
ACC Acceleration Index

ACoA Anterior Communicating Artery

ACS Aortic Valve Cusp Separation

AFI Amniotic Fluid Index

AI Aortic Insufficiency

AI PHT Aortic Insufficiency Pressure Half Time

AL Atlas Loop

Ann D Annulus Diameter

ANT F Anterior Far

ANT N Anterior Near

Ao Aorta

AoD Aortic Root Diameter

Glossary 181
Abbreviations in User Interface (Continued)

Abbreviation Definition

Apical Apical View

APTD Anteroposterior Trunk Diameter

AT Acceleration (Deceleration) Time

AUA Average Ultrasound Age

AV Aortic Valve

AV Area Aortic Valve Area

AVA Aortic Valve Area

BA Basilar Artery

Bifur Bifurcation

BP Blood Pressure

BPD Biparietal Diameter

BPM Beats per Minute

Bre Breast

BSA Body Surface Area

CCA Common Carotid Artery

CI Cardiac Index

CO Cardiac Output

CPD Color Power Doppler

Crd Cardiac

CRL Crown Rump Length

CW Continuous Wave Doppler

D Diameter

D Apical Distance Apical

DCCA Distal Common Carotid Artery

DECA Distal External Carotid Artery

182
Abbreviations in User Interface (Continued)

Abbreviation Definition

DICA Distal Internal Carotid Artery

Dist Distal

dP:dT Delta Pressure: Delta Time

E “E” Wave Peak Velocity

E PG “E” Wave Peak Pressure Gradient

E/e’ E velocity = Mitral Valve E velocity divided by the annular e’ velocity

E:A E:A Ratio

ECA External Carotid Artery

ECG Electrocardiogram

ECICA Extracranial Internal Carotid Artery

ECVA Extracranial Vertebral Artery

EDD Estimated Date of Delivery

EDD by AUA Estimated Date of Delivery by Average Ultrasound Age

Glossary
EDD by LMP Estimated Date of Delivery by Last Menstrual Period

EDV End Diastolic Velocity

EF Ejection Fraction

EF:SLOPE E-F Slope

EFW Estimated Fetal Weight

Endo Endocardial

Epi Epicardial

EPSS “E” Point Septal Separation

Estab. DD Established Due Date

ET Elapsed Time

FH Femoral Head

FHR Fetal Heart Rate

Glossary 183
Abbreviations in User Interface (Continued)

Abbreviation Definition

FL Femur Length

FM (Right and Left) Foramen Magnum (same as SO)

FTA Fetal Trunk Area

GA Gestational Age

GA by LMP Gestational Age by Last Menstrual Period

GA by LMPd Gestational Age by derived Last Menstrual Period

Gate Depth of Doppler Gate

GS Gestational Sac

Gyn Gynecology

HC Head Circumference

HR Heart Rate

ICA Internal Carotid Artery

IMT Intima Media Thickness

IVRT Iso Volumic Relaxation Time

IVS Interventricular Septum

IVSd Interventricular Septum Diastolic

IVSFT Interventricular Septum Fractional Shortening

IVSs Interventricular Septum Systolic

LA Left Atrium

LA/Ao Left Atrium/Aorta Ratio

LAT F Lateral Far

LAT N Lateral Near

LMP Last Menstrual Period

LMPd derived Last Menstrual Period

LV Left Ventricular

184
Abbreviations in User Interface (Continued)

Abbreviation Definition

LV Area Left Ventricular Area

LV mass Left Ventricular mass

LV Volume Left Ventricular Volume

LVd Left Ventricular diastolic

LVD Left Ventricular Dimension

LVDd Left Ventricular Dimension Diastolic

LVDFS Left Ventricular Dimension Fractional Shortening

LVDs Left Ventricular Dimension Systolic

LVEDV Left Ventricular End Diastolic Volume

LVESV Left Ventricular End Systolic Volume

LVET Left Ventricular Ejection Time

LVO Left Ventricular Opacification

LVOT Left Ventricular Outflow Tract

Glossary
LVOT Area Left Ventricular Outflow Tract Area

LVOT D Left Ventricular Outflow Tract Diameter

LVOT VTI Left Ventricular Outflow Tract Velocity Time Integral

LVPW Left Ventricular Posterior Wall

LVPWd Left Ventricular Posterior Wall Diastolic

LVPWFT Left Ventricular Posterior Wall Fractional Thickening

LVPWs Left Ventricular Posterior Wall Systolic

LVs Left Ventricular systolic

MB SonoMB

MCA Middle Cerebral Artery

MCCA Mid Common Carotid Artery

MECA Mid External Carotid Artery

Glossary 185
Abbreviations in User Interface (Continued)

Abbreviation Definition

MI Mechanical Index

MICA Mid Internal Carotid Artery

Mid Middle

MM M Mode

MR PISA Mitral Regurgitation Proximal Iso Velocity Surface Area

MR/VTI Mitral Regurgitation/Velocity Time Integral

Msk Muscle

MV Mitral Valve

MV Area Mitral Valve Area

MV ERO Mitral Valve Effective Regurgitant Orifice

MV PISA Area Mitral Valve Proximal Iso Velocity Surface Area

MV Rate Mitral Valve Rate

MV Regurgitant Mitral Valve Regurgitant Fraction


Fraction

MV Regurgitant Volume Mitral Valve Regurgitant Volume

MV/VTI Mitral Valve/Velocity Time Integral

MVA Mitral Valve Area

Neo Neonatal

Nrv Nerve

NTSC National Television Standards Committee

OA Ophthalmic Artery

OB Obstetrical

OFD Occipital Frontal Diameter

Orb Orbital

PAL Phase Alternating Line

PCAp Posterior Cerebral Artery Peak

186
Abbreviations in User Interface (Continued)

Abbreviation Definition

PCCA Proximal Common Carotid Artery

PCoA Posterior Communicating Artery

PECA Proximal External Carotid Artery

PGmax Maximum Pressure Gradient

PGmean Mean Pressure Gradient

PGr Pressure Gradient

PHT Pressure Half Time

PI Pulsatility Index

PICA Proximal Internal Carotid Artery

PISA Proximal Isovelocity Surface Area

Plaq Plaque

POST F Posterior Far

POST N Posterior Near

Glossary
PRF Pulse Repetition Frequency

Prox Proximal

PSV Peak Systolic Velocity

PV Pulmonic Valve

PW Pulsed Wave Doppler

Qp/Qs Pulmonary blood flow divided by systemic blood flow

RA Right Atrial (pressure)

RI Resistive Index

RVD Right Ventricular Dimension

RVDd Right Ventricular Dimension Diastolic

RVDs Right Ventricular Dimension Systolic

RVOT D Right Ventricular Outflow Tract Diameter

Glossary 187
Abbreviations in User Interface (Continued)

Abbreviation Definition

RVOT VTI Right Ventricular Outflow Tract Velocity Time Integral

RVSP Right Ventricular Systolic Pressure

RVW Right Ventricular Free Wall

RVWd Right Ventricular Free Wall Diastolic

RVWs Right Ventricular Free Wall Systolic

S SonoHD

S/D Systolic/Diastolic Ratio

SI Stroke Index

Siphon Siphon (internal carotid artery)

SM Submandibular

SmP Small Parts

SO Suboccipital

Sup Superficial

SV Stroke Volume

TAM Time Average Mean

TAP Time Average Peak

TCD Transcranial Doppler

TDI Tissue Doppler Imaging

THI Tissue Harmonic Imaging

TI Thermal Index

TICA Terminal Internal Carotid Artery

TO Transorbital

TRmax Tricuspid Regurgitation (peak velocity)

TT Transtemporal

TTD Transverse Trunk Diameter

188
Abbreviations in User Interface (Continued)

Abbreviation Definition

TV Tricuspid Valve

UA Ultrasound Age

Umb A Umbilical Artery

VA Vertebral Artery

VArty Vertebral Artery

Vas Vascular

Ven Venous

VF Volume Flow

Vmax Peak Velocity

Vmean Mean Velocity

Vol Volume

VTI Velocity Time Integral

Glossary

Glossary 189
190
Index

Symbols specifications 175


biological safety 117
+/x measurement 59
biopsy 36
bodymarker. See pictographs
Numerics brightness 36
2D imaging 34
2D options 35 C
cables
A clean and disinfect ECG 102
clean and disinfect transducer 101
A & B shortcut keys 17 connect power 6
abbreviations 181 calculations
abdominal, intended uses 2 authors 86
AC power indicator 10 cardiac. See cardiac calculations
acceleration (ACC) index 59 delete measurement 62, 63
accessories list 174 general 61
acoustic measurement precision 149 gynecology (Gyn) 79
acoustic output IMT 80
measurement 129 menu 12, 61
tables 131–??, 148 OB 83
acquisition error 157 percent area 64
add new user 19 percent diameter 64
Administrator 18 percent reduction 63
age, gestational 86 perform measurement 62
airborne equipment standards 176 performing 62
ALARA principle 122, 123, 179 repeat measurement 62
alphanumeric keys 9 save 62
angle correction 39, 40 small parts 89
annotations specialized 68
keys 9 vascular 90
place 43 view measurement 62
predefine label groups 22

Index
volume 65
setup 22 volume flow 66
aorta (Ao) 73 calipers 55
aortic valve area (AVA) 77 cardiac calculations
arrow graphic 44 AAo 73
ascending aorta (AAo) 73 Ao 73
audio 23 AVA 77
CI 78
CO 78
B dP:dT 76
baseline 41 HR 78
battery IVRT 71
clean 102 LA 73
safety 116 LV volume (Simpson’s Rule) 73
setup 23

Index 191
LVd 72 default settings 31
LVOT D 73 delta pressure:delta time (dP:dT) 76
LVs 72 depth
MV/AV area 73 adjust 33
overview 68 definition 179
PHT 75 keys 9
PISA 70 marker 13
Qp/Qs 70 DICOM standard 176
RVSP 75 dimensions, system and display 173
setup 23 disinfect
SV 78 battery 102
TDI 79 ECG cable 102
VTI 74 system 98
cardiac index (CI) 78 transducer cables 101
cardiac output (CO) 78 transducers 99
cardiac references 157 disinfectants, compatibility 104
cardiac, intended uses 2 display setup 25
cautions, definition vii distance measurements
cine buffer 10, 34 2D 57
clean M mode 58
battery 102 D-line 39
ECG cable 102 Doppler
footswitch 102 measurements 59
LCD screen 98 scale setup 29
system 98 dual images 35
transducer cables 101 duplex 29
transducers 99 DVD recorder 24, 95
clip acquisition delay 53 Dynamic Range 30
clips
See also images and clips
options 36, 49 E
color Doppler (Color) imaging 37 ECG
color power Doppler (CPD) imaging 37 Monitoring 36, 52
color scheme, background 30 options 53
color suppress 38 elapsed time (ET) measurement 59
Color. See color Doppler (Color) imaging electrical
connectivity setup 24 safety 113
continuous wave (CW) Doppler imaging 39, 40 specifications 175
controls electromagnetic compatibility 118
direct 123 electromechanical safety standards 176
indirect 124 EMC classification standards 176
receiver 124 EMED worksheets 94
CPD. See color power Doppler (CPD) imaging equipment safety 116
customer assistance vii error message 115
CW Doppler. See continuous wave (CW) Doppler errors
imaging acquisition 157
algorithmic 157
measurement 157
D estimated date of delivery (EDD) 164
date 25 estimated fetal weight (EFW) 164

192 Index
Event log 20 I
exam
image quality, poor 95
change type 34
images and clips
end 46
archive 52
type and transducer 42
delete 52
export and import
export to USB 52
OB calculation tables 27
review 51
predefined label groups 22
imaging modes
user accounts 20
list of 173
transducer 42
F import. See export and import
IMT. See Intima Media Thickness (IMT)
far 10
in situ, definition 179
fetal heart rate (FHR) 88
infertility, intended uses 3
flow sensitivity 38
intended uses 2–4
focal zones, optimize 35
intensity
footswitch setup 17
derated 129
forms 10
in situ 129
freeze 33
water-value 129
interventional, intended uses 3
G Intima Media Thickness (IMT)
calculations 25, 80
gain sketch 83
adjust 33 trace 83
ECG 53 intraoperative, intended uses 3
knob 10 invert
gate size 40 Color 38
gestational age spectral trace 41
setup 27 iso volumic relaxation time (IVRT) 71
tables, references 165
gestational growth, measure 87
grace period 96 K
grayscale 35
keys 9
growth analysis
knobs 9
setup 27
tables, references 167

Index
guidance documents, related 127 L
guideline 36
labeling symbols 150
gynecology, intended uses 3
language 30
layout 29
H LCD screen
clean 98
heart rate 47
output 127
heart rate (HR) 58, 78, 88
left atrium (LA) 73
HIPAA standard 177
left ventricular diastolic (LVd) 72
home position 44
left ventricular outflow tract diameter (LVOT D) 73
humidity limits 175
left ventricular systolic (LVs) 72
left ventricular volume (LV volume) 73
license key 96
live trace 30, 41

Index 193
login O
Administrator 18
OB
user 18
calculations 26, 83
LVO (Left Ventricular Opacification) 35
custom measurements setup 27
custom tables setup 28
M graphs 94
intended uses 3
M Mode imaging 36
references 164
maintenance 97
tables setup 28
measurements
on-screen controls 10
See also calculations
optimize 35
+/x Ratio, Doppler 59
orientation
2D 56
marker 12
about 55
option 35
Acceleration, Doppler 59
output display 127
accuracy 55, 155
area, 2D 57
automatic trace, Doppler 60 P
circumference, 2D 57
PAL
delete 56
definition 179
distance, 2D 57
option 24
distance, M Mode 58
password 19, 20, 21
Doppler 59
patient header 13, 25
edit 56
patient information form 45
Elapsed Time, Doppler 59
patient list 50
errors 157
patient report
fetal heart rate 88
about 92
heart rate 58, 88
cardiac 92
M Mode 58
general 92
manual trace 58, 59
OB 92
Pressure Gradient, Doppler 59
save measurement to 55
publications 157
vascular 92
Resistive Index, Doppler 59
PC 24
save to calculation and report 55
pediatric, intended uses 3
terminology 157
percent reduction calculation 63
vascular 90
peripherals 174
Velocities, Doppler 59
pictographs
mechanical index (MI) 127, 179
PICTO key 12
mitral valve/aortic valve (MV/AV) 73
placing 45
M-line 36
power delay 23
mode data 12, 25
power key 9
modes, keys 11
precision, acoustic measurement 149
preferences 29
N presets 29
pressure half time (PHT) 75
near 10
pressure limits 175
network 26
PRF 38, 41
NTSC
print 51
definition 179
printer
option 24
problem 95

194 Index
setup 24 software license 96
probe. See transducer SonoHD 36, 180
prostate, intended uses 4 SonoMB 36, 180
proximal isovelocity surface area (PISA) 70 specifications 173
pulsed wave (PW) Doppler imaging 39 spectral trace 39
PW Doppler. See pulsed wave (PW) Doppler imaging standards
airborne equipment 176
DICOM 176
Q electromechanical 176
Qp/Qs 70 EMC classification 176
HIPAA 177
steering
R CPD 38
recording problem 95 Doppler 40
references storage specifications
cardiac 157 equipment 175
general 169 images 174
gestational age tables 165 stroke volume (SV) 78
growth analysis tables 167 superficial, intended uses 4
obstetrical 164 sweep speed
ratio calculations 169 Doppler 41
report, patient 92 ECG 53
resistive index (RI) measurement 59 M Mode 37
right ventricular systolic pressure (RVSP) 75 symbols, labeling 150
system
clean and disinfect 98
S controls 9
safety software 2
battery 116 status 13, 25
biological 117 wake up 6
electrical 113
electromagnetic compatibility 118
equipment 116
T
save Technical Support viii
calculations 62 temperature limits 175
image 10 text 44

Index
measurements 55 text description 12
SAVE key 30 thermal index (TI) 30, 127, 180
scale 41 THI 36
scanhead. See transducer time setup 25
screen layout 12 tissue Doppler imaging (TDI) 40, 79
security 18 tissue models 130
serial port 24 touchpad 10, 13
setup pages 17 transducer
shipping specifications 175 cables, clean and disinfect 101
shortcut keys 17 clean and disinfect 99
Simpson’s Rule 73 curved array 179
skin line, definition 180 definition 180
sleep delay 23 disinfect 99
small parts calculations 89 exam type 42

Index 195
general use 16
imaging modes 42
invasive or surgical use 16
linear array 179
preparation 16
problems 96
specifications 173
troubleshoot 95

U
ultrasound terminology 179
unfreeze text 22
USB storage device, export to 52
user account 20
user guide, conventions used vii
user setup 19
uses, intended 2–4

V
variance 38
vascular
calculations 90
intended uses 4
velocity measurement 59
velocity time integral (VTI) 74
volume
calculation 65
Doppler, adjust 41
volume flow 66

W
wall filter 38, 41
warnings, definition vii
worksheets, EMED 94

Z
zoom 34

196 Index
P07662-01
*P07662-01*

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