SparkLAN Communications 0685R04070 Wireless 11g Compact USB Adapter User Manual M Turbo Ultrasound System User Guide

SparkLAN Communications, Inc. Wireless 11g Compact USB Adapter M Turbo Ultrasound System User Guide

User Manual M Turbo

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Document ID	1089473
Application ID	QLdBh4XUym4I/+0X/QnM7g==
Document Description	User Manual M Turbo
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	155.1kB (1938797 bits)
Date Submitted	2009-04-01 00:00:00
Date Available	2009-04-01 00:00:00
Creation Date	2008-10-24 11:40:46
Producing Software	Acrobat Distiller 8.1.0 (Windows)
Document Lastmod	2008-10-24 15:15:59
Document Title	M-Turbo Ultrasound System User Guide
Document Creator	FrameMaker 8.0
Document Author:	SonoSite

M-Turbo
Ultrasound System
TM
User Guide
M-Turbo
Ultrasound System
TM
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, SonoSite, and the SonoSite logo 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.
The SonoSite product(s) referenced in this document may be covered by one or more of the following US patents: 5722412, 5817024,
5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982,
6835177, 6962566, 7169108, D456509, D461895, D509900, D538432, D544962, D558351, D559390, and by the following counterpart
foreign patents: AU727381, AU730822, CA2373065, CN98106133.8, CN98108973.9, DE60021552.0, DE60029777.2, DE60034670.6,
DE69730563.5, DE6980539.6, DE69831698.3, FR0875203, FR0881492, FR0815793, FR1180970, FR1175713, GB0875203, GB0881492,
GB0815793, GB1180970, GB1180971, GB1175713, IT0881492, IT0815793, IT1175713, KR532359, KR528102, NZ542968,
RCD000897368-0001, SP0881492, SP0815793. Patents pending.
P07662‐02 10/2008
Copyright 2008 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
Preparing the system ................................................................................................... 1
Installing or removing the battery ................................................................. 1
Using AC power and charging the battery ................................................. 2
Turning the system on or off ............................................................................ 3
Connecting transducers .................................................................................... 3
Inserting and removing USB storage devices ............................................ 4
System controls .............................................................................................................. 5
Screen layout .................................................................................................................. 7
General interaction ....................................................................................................... 8
Touchpad and cursor .......................................................................................... 8
On-screen options ............................................................................................... 8
Annotation and text ............................................................................................ 9
Preparing transducers ...............................................................................................10
Training videos .............................................................................................................11
Intended uses ...............................................................................................................11
Chapter 2: System Setup
Displaying the setup pages .....................................................................................15
Restoring default settings ........................................................................................15
A & B Key, Footswitch setup ....................................................................................15
Administration setup .................................................................................................15
Security settings .................................................................................................16
User setup .............................................................................................................16
Exporting or importing user accounts .......................................................17
Exporting and clearing the Event log .........................................................17
Logging in as user ..............................................................................................18
Choosing a secure password .........................................................................18
Annotations setup ......................................................................................................18
Audio, Battery setup ...................................................................................................19
Cardiac Calculations setup ......................................................................................19
Connectivity setup ......................................................................................................19
Date and Time setup ..................................................................................................20
Display Information setup ........................................................................................20
IMT Calculations setup ..............................................................................................20
Network Status setup .................................................................................................20
iii
OB Calculations setup ................................................................................................ 20
OB Custom Measurements setup .......................................................................... 21
OB Custom Tables setup ........................................................................................... 22
Presets setup ................................................................................................................. 22
System Information setup ........................................................................................ 23
USB Devices setup ...................................................................................................... 23
Limitations of JPEG format ............................................................................. 23
Chapter 3: Imaging
Imaging modes ............................................................................................................ 25
2D imaging ........................................................................................................... 25
M Mode imaging ................................................................................................ 26
CPD and color Doppler imaging ................................................................... 27
PW and CW Doppler imaging ........................................................................ 28
Adjusting depth and gain ........................................................................................ 30
Freezing, viewing frames, and zooming ............................................................. 30
Imaging modes and exams available by transducer ...................................... 31
Annotating images ..................................................................................................... 32
Patient information form .......................................................................................... 33
Images and clips .......................................................................................................... 35
Saving images and clips .................................................................................. 35
Reviewing patient exams ............................................................................... 36
Printing, exporting, and deleting images and clips ............................... 37
ECG Monitoring ............................................................................................................ 38
Chapter 4: Measurements and Calculations
Measurements .............................................................................................................. 41
Working with calipers ....................................................................................... 41
2D measurements .............................................................................................. 42
M Mode measurements ................................................................................... 43
Doppler measurements ................................................................................... 43
General calculations ................................................................................................... 45
Calculations menu ............................................................................................. 45
Performing and saving measurements
in calculations ...................................................................................................... 45
Displaying, repeating, and deleting
saved measurements in calculations .......................................................... 46
EMED calculations .............................................................................................. 46
Percent reduction calculations ...................................................................... 46
Volume calculations .......................................................................................... 48
Volume flow calculations ................................................................................ 48
Exam-based calculations .......................................................................................... 50
Cardiac calculations .......................................................................................... 50
Gynecology (Gyn) calculations ...................................................................... 58
IMT calculations .................................................................................................. 59
OB calculations ................................................................................................... 61
iv
Small Parts calculations ....................................................................................64
Transcranial Doppler and Orbital calculations ........................................65
Vascular calculations .........................................................................................67
Patient report ................................................................................................................68
Vascular and cardiac patient reports ...........................................................69
TCD patient report .............................................................................................69
OB patient report ...............................................................................................69
EMED worksheets ...............................................................................................70
Chapter 5: Troubleshooting and Maintenance
Troubleshooting ..........................................................................................................71
Software licensing .......................................................................................................71
Maintenance .................................................................................................................72
Cleaning and disinfecting the ultrasound system .................................73
Cleaning and disinfecting transducers .......................................................74
Cleaning and disinfecting the battery .......................................................75
Cleaning the footswitch ...................................................................................75
Cleaning and disinfecting ECG cables ........................................................76
Recommended disinfectants ..................................................................................77
Chapter 6: Safety
Ergonomic safety .........................................................................................................85
Position the system ...........................................................................................86
Position yourself .................................................................................................86
Take breaks, exercise, and vary activities ...................................................87
Electrical safety classification ..................................................................................87
Electrical safety .............................................................................................................88
Equipment safety ........................................................................................................90
Battery safety ................................................................................................................ 90
Clinical safety ................................................................................................................92
Hazardous materials ...................................................................................................93
Electromagnetic compatibility ...............................................................................93
Manufacturer’s declaration .............................................................................94
ALARA principle ...........................................................................................................97
Applying ALARA .................................................................................................98
Direct controls .....................................................................................................98
Indirect controls ..................................................................................................99
Receiver controls ................................................................................................99
Acoustic artifacts .........................................................................................................99
Guidelines for reducing MI and TI .........................................................................99
Output display ........................................................................................................... 102
MI and TI output display accuracy ............................................................ 103
Factors that contribute to display uncertainty ..................................... 103
Related guidance documents ..................................................................... 104
Transducer surface temperature rise ................................................................ 104
Acoustic output measurement ............................................................................ 105
In Situ, derated, and water value intensities ...........................................105
Tissue models and equipment survey ......................................................106
Acoustic output tables ............................................................................................107
Terms used in the acoustic output tables ...............................................132
Acoustic measurement precision and uncertainty ..............................133
Labeling symbols ......................................................................................................134
Chapter 7: References
Measurement accuracy ...........................................................................................139
Sources of measurement errors ...........................................................................140
Measurement publications and terminology .................................................141
Cardiac references ............................................................................................141
Obstetrical references .....................................................................................145
Gestational age tables ....................................................................................146
Growth analysis tables ...................................................................................148
Ratio calculations .............................................................................................149
General references ...........................................................................................149
Chapter 8: Specifications
Dimensions ..................................................................................................................153
System ..................................................................................................................153
Display ..................................................................................................................153
Supported transducers ...........................................................................................153
Imaging modes ..........................................................................................................153
Image and clip storage ............................................................................................153
Accessories ..................................................................................................................153
Peripherals ..........................................................................................................154
Temperature and humidity limits ........................................................................154
Operating ............................................................................................................154
Shipping and storage .....................................................................................154
Electrical .......................................................................................................................154
Battery ...........................................................................................................................154
Electromechanical safety standards ...................................................................154
EMC standards classification .................................................................................155
Airborne equipment standards ............................................................................155
DICOM standard ........................................................................................................155
HIPAA standard ..........................................................................................................155
Glossary
Terms .............................................................................................................................157
Abbreviations .............................................................................................................159
Index ...........................................................................................................................169
vi
Introduction
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.
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 comments@sonosite.com.
For technical support, please contact SonoSite as
follows:
SonoSite Technical Support
Phone (US or
Canada):
877-657-8118
Phone (Outside
US and Canada):
Conventions, symbols, and
terms
425-951-1330
Or call your local
representative.
Fax:
425-951-6700
The user guide follows these conventions:
E-mail:
service@sonosite.com
• A WARNING describes precautions necessary
to prevent injury or loss of life.
Web site:
www.sonosite.com
Click Support & Service.
• A Caution describes precautions necessary to
protect the products.
Europe
Service
Center:
+44-(0)1462-444-800
uk.service@sonosite.com
• Numbered steps in procedures must be
performed in order.
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.
• Items in bulleted lists do not require a
sequence.
• Single‐step procedures begin with .
Symbols and terms used on the system and
transducer are explained in Chapter 1, Chapter 5,
Chapter 6, and Glossary.
vii
viii
Customer comments
Chapter 1: Getting Started
About the system
A license key is required to activate the software.
See “Software licensing” on page 71. 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.
Getting Started
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 depend on system configuration,
transducer, and exam type.
Figure 2 System Back Connectors:
(1) DC input connector, (2) I/O connector, (3) Battery,
and (4) ECG connector
To use the ultrasound system
1 Attach a transducer.
2 Turn the system on. (For power switch
location, see “System controls” on page 5.)
3 Press the PATIENT key, and complete the
patient information form.
4 Press an imaging mode key: 2D, M MODE,
COLOR, or DOPPLER
Preparing the system
Installing or removing the battery
Figure 1 System Front Features:
(1) Control panel, (2) Handle, (3) Display, (4) USB
ports for storage, updates, importing, and exporting
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.
Chapter 1: Getting Started
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.
Locking levers
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.
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.
Figure 3 Install the Battery
Preparing the system
The system can run on battery power for up to
two hours, depending on the imaging mode and
the display brightness. When running on battery
power, the system may not restart if the battery is
low. To continue, connect the system to AC
power.
Connecting transducers
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 154.
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
WARNING:
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 5.)
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 19.
Press a key, touch the touchpad, or open the
lid.
Figure 4 Connect the Transducer
Chapter 1: Getting Started
To connect a transducer
1 Remove the system from the mini‐dock (if
present), and turn it upside down.
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.
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.
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.
Note: The system does not support password‐
protected USB storage devices. Make sure that the
USB storage device you use does not have password
protection enabled.
Preparing the system
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 23.
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.
System controls
14
15
Getting Started
16
17
18
19
20
10
11
12 13
Power switch
Turns system on and off.
Alphanumeric keys
Use to enter text and numbers.
Annotation keys
See “Alphanumeric keyboard” on page 9.
ZOOM
Magnifies the image 100%.
DEPTH UP,
DEPTH DOWN
Decreases and increases imaging depth.
AUTO GAIN
Adjusts gain automatically.
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/
Cine Buffer
In live imaging, adjusts the overall gain applied to the entire image. On a
frozen image, moves the cine buffer.
Chapter 1: Getting Started
6
AC power indicator
A steady light indicates that AC power is connected. A flashing light
indicates that the system is asleep.
CALIPER
CALCS
Displays calipers on-screen for measuring.
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 22.
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.
16
EXAM
Opens exam menu.
17
A & B 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.
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.
System controls
Screen layout
10
Getting Started
11
Figure 1 Screen Layout
Mode Data Area
Current imaging mode information (for example, Gen, Res, THI, and PW).
Orientation Marker
Provides indication for image orientation. In dual and duplex images, the
orientation marker is green on the active screen.
Text
Text entered using keyboard.
Pictograph
Pictograph to indicate anatomy and transducer position. You can select
anatomy and screen location.
Calculations Menu
Contains available measurements.
Image
Ultrasound image.
Measurement and
Calculations Data Area
Current data on measurements and calculations.
On-screen Options
Options available in the current context.
Patient Header
Includes current patient name, 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.
Chapter 1: 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.
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 “Audio, Battery
setup” on page 19.)
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.
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:
General interaction
Figure 5 On-screen options (2D imaging shown)
Annotation and text
Alphanumeric keyboard
10
Getting Started
11
TAB
Moves cursor among fields
in the forms, and tabs
between text position in
dual screens.
CAPS LOCK
Sets the keyboard to
capital letters.
SHIFT
Allows entry of capitalized
characters and
international characters.
TEXT
Turns the keyboard on and
off for text entry.
PICTO
Turns pictographs on and
off.
ARROW
Displays an arrow graphic
that can be moved and
rotated within the image
area.
SPACEBAR
Turns the keyboard on for
text entry. In text entry,
adds a space.
DELETE
Removes all text from the
screen during text entry
and when not measuring.
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.
Chapter 1: Getting Started
Symbols
You can enter symbols and special characters in
select fields and forms. The symbols and special
characters available depend on context.
Preparing transducers
WARNING:
Patient information form: Last, First, Middle,
Patient ID, Accession, Indications, Procedure ID,
User, Reading Dr., Referring Dr., and Institution
fields
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.
DICOM or SiteLink configuration page: Alias and
AE Title fields
A & B Key, Footswitch setup page: Text field
Text mode (imaging): Annotation field
Figure 6 Symbols Dialog Box
To enter symbols or special characters
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 74.
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.
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, apply a transducer
sheath.
10
Preparing transducers
4 Select the Videos tab.
WARNING:
To apply a transducer sheath
SonoSite recommends the use of market‐cleared,
transducer sheaths for intracavitary or surgical
applications.To lessen the risk of contamination,
apply 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.
5 If the list does not appear, select the correct
USB device:
a Select Select USB.
b In the Select USB device for media
playback dialog box, select the Education
Key USB device (“Training” appears under
Type), and then select Select.
Note: Image Gallery is an unsupported feature.
To view a video
1 Display the list of videos.
2 Select the video.
3 Select View on‐screen.
The video begins playing.
4 Select any of the following, as needed:
•
Adjusts the volume. The higher the
number, the louder the sound. Zero is
mute.
• Back Rewinds the video 10 seconds.
• Pause Pauses the video.
• Play Resumes playing of a paused video.
• Forward Advances the video 10 seconds.
To exit a video
Select one of the following:
• List to return to the video list.
Training videos
The SonoSite® Education Key™ training videos
are an optional feature.
To display the list of videos
1 Insert the Education Key USB device into a
USB port on the system.
2 Press the REVIEW key.
3 If there is an active exam, select List on‐screen.
• Done to return to 2D imaging.
Intended uses
This system transmits ultrasound energy into
various parts of the patient’s body to obtain
ultrasound images, as follows.
For the intended transducer and imaging modes
for each exam type, see “Imaging modes and
exams available by transducer” on page 31.
Chapter 1: Getting Started
11
Getting Started
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.
Abdominal Imaging Applications You can assess
the liver, kidneys, pancreas, spleen, gallbladder,
bile ducts, transplanted organs, abdominal
vessels, and surrounding anatomical structures
for the presence or absence of pathology
transabdominally.
Cardiac Imaging Applications You can assess the
heart, cardiac valves, great vessels, surrounding
anatomical structures, overall cardiac
performance, and heart size for the presence or
absence of pathology.
You can obtain the patient’s electrocardiogram
(ECG). The ECG is used for timing of cardiac
events.
WARNING:
The ECG is not used to diagnose
cardiac arrhythmias and is not
designed for long term cardiac
rhythm monitoring.
Gynecology and Infertility Imaging Applications
You can assess the uterus, ovaries, adnexa, and
surrounding anatomical structures for the
presence or absence of pathology
transabdominally or transvaginally.
Interventional Imaging Applications You can use
the system for ultrasound guidance in 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 You can assess
the fetal anatomy, viability, estimated fetal
weight, gestational age, amniotic fluid, and
surrounding anatomical structures for the
presence or absence of pathology
transabdominally or transvaginally. CPD and
Color imaging are intended for high‐risk
pregnant women. High‐risk pregnancy
indications include, but are not limited to,
12
Intended uses
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 and Neonatal Imaging Applications
You can assess the pediatric and neonatal
abdominal, pelvic and cardiac anatomy, pediatric
hips, neonatal head, and surrounding anatomical
structures for the presence or absence of
pathology.
Superficial Imaging Applications You can assess
the breast, thyroid, testicle, lymph nodes,
hernias, musculoskeletal structures, soft tissue
structures, ophthalmic structures, and
surrounding anatomical structures for the
presence or absence of pathology. You can use the
system for ultrasound guidance in biopsy and
drainage procedures, vascular line placement,
peripheral nerve blocks, and spinal nerve blocks
and taps.
WARNING:
Getting Started
To avoid injury to the patient, use
only an Orbital (Orb) or
Ophthalmic (Oph) exam type when
performing imaging through the
eye. The FDA has established lower
acoustic energy limits for
ophthalmic use. The system will
not exceed these limits only if the
Orb or Oph exam type is selected.
Transcranial Imaging Applications You can
assess the anatomical structures and vascular
anatomy of the brain for presence or absence of
pathology. You can use imaging temporally,
trans‐occipitally, or trans‐orbitally.
WARNING:
To avoid injury to the patient, use
only an Orbital (Orb) or
Ophthalmic (Oph) exam type when
performing imaging through the
eye. The FDA has established lower
acoustic energy limits for
opthalmic use. The system will not
exceed these limits only if the Orb
or Oph exam type is selected.
Vascular Imaging Applications You can assess 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 for the presence or
absence of pathology.
Chapter 1: Getting Started
13
14
Intended uses
Chapter 2: System Setup
The system setup pages let you customize the
system and set preferences.
Displaying the setup pages
To display a setup page
1 Press the SETUP key.
2 Select the setup page under Setup Pages.
To return to imaging from a setup page, select
Done on‐screen.
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.”
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.
Setup
Restoring default settings
1 Connect the cables:
To restore default settings for a setup page
On the setup page, select Reset on‐screen.
• Y adapter cable to the ECG connector on
the mini‐dock or docking system
To restore all default settings
• Footswitch cable to Y adapter cable
1 Turn the system off.
2 Connect the system to AC power. (See “To
operate the system using AC power” on
page 3.)
3 Simultaneously press 1 and the power key.
The system beeps several times.
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. Select from the following
lists:
2 On the A & B Key, Footswitch setup page,
select a function for the left and right
footswitches.
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.
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.
Chapter 2: System Setup
15
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.
2 In the User Login list, select On.
• On requires a user name and password at
startup.
• Off allows access to the system without a
user name and password.
To change the administrator password or let
users change passwords
1 Log in as Administrator.
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 18.)
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.
4 Select Save.
To log in as Administrator
To add a new user
1 On the Administration setup page, type
Administrator in the Name box.
1 Log in as Administrator.
2 Type the administrator password in the
Password box.
3 Under User Information, fill in the Name,
Password, and Confirm boxes. (See “Choosing
a secure password” on page 18.)
If you don’t have the administrator password,
contact SonoSite. (See “SonoSite Technical
Support” on page vii.)
3 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.
16
Administration setup
• Let users change their passwords: Select
the Password changes check box.
User setup
2 Select New.
4 (Optional) In the User 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.
2 Log in as Administrator.
3 Under User Information, make changes as
desired.
3 Select Import on‐screen.
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.
To change a user password
2 In the User List, select the user.
5 Restart the system.
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 display the Event log
1 Log in as Administrator.
2 Select Log on‐screen.
The Event log appears.
3 Type the new password in the Password box
and Confirm box.
To return to the previous screen, select Back.
4 Select Save.
To export the Event log
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.
Setup
1 Log in as Administrator.
4 Select the USB storage device, and select
Import.
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 Display the Event log.
To import user accounts
2 Select Clear on‐screen.
1 Insert the USB storage device that contains the
accounts.
3 Select Yes.
Chapter 2: System Setup
17
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 16.)
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.
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
“Annotating images” on page 32.
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 32.)
18
Annotations setup
1 In the Exam list on the Annotations setup
page, select the exam type whose labels you
want to specify.
2 For Group, select A, B, or C for the label group
you want associated with that exam.
The preset labels appear for the selected group.
3 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 10.
To specify text retention when unfreezing
You can specify which text to keep when you
unfreeze an image or change the imaging layout.
In the Unfreeze list on the Annotations setup
page, 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 33.
To export predefined label groups
1 Insert a USB storage device.
2 On the Annotations setup page, select Export.
A list of USB devices appears.
3 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 On the Annotations setup page, select Import
on‐screen.
3 Select the USB storage device, and then select
Import.
4 Select Done in the dialog box that appears.
All predefined label groups for all exams are
replaced with those from the USB storage
device.
Audio, Battery setup
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 50.
To specify cardiac measurement names
On the Connectivity setup page, you specify
options for using non‐USB devices and for alerts
when internal storage is full. You also import
wireless certificates and 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 In the Printer list on the Connectivity setup
page, select the printer.
To configure the system for a DVD recorder,
PC, or serial bar code scanner
1 On the Connectivity setup page, do the
following:
• (DVD recorder) In the Video Mode list,
select the video standard: NTSC or PAL.
• In the Serial Port list, select the peripheral.
Computer (PC) allows patient 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 “To send a patient
report to a PC” on page 69.)
Note: Because these peripherals use the same
RS‐232 connector on the mini‐dock, you can
connect only one of them at a time.
2 Restart the system.
3 Attach a serial cable (RS‐232) from the serial
port on the mini‐dock or docking system to
the peripheral.
Under TDI Walls on the Cardiac Calculations
setup page, select a name for each wall.
Chapter 2: System Setup
19
Setup
On the Audio, Battery setup page, you can select
options in the following lists:
Connectivity setup
To receive storage alerts
On the Connectivity setup page, select
Internal Storage Capacity Alert.
The system displays a message if internal
storage is near capacity when you end an
exam. The system then deletes archived
patient exams if specified in DICOM.
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
On the Date and Time setup page, do the
following:
• In the Date box, type the current date.
• 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. You can select settings in the following
sections:
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 59.
To customize the IMT calculations menu
On the IMT Calculations setup page, do the
following:
• 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.
• 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,
Ethernet MAC address, and the wireless
connection if any.
OB Calculations setup
Patient Header Information that appears in the
patient header.
On the OB Calculations setup page, you select
authors for OB calculation tables. You can also
import or export additional OB calculation tables.
Mode Data Imaging information.
See also “OB calculations” on page 61.
System Status System status information.
20
Date and Time setup
To import OB calculation tables
Tables that you import are added to those already
on the system.
1 Insert the USB storage device that contains the
tables.
2 On the OB Calculations setup page, select
Import on‐screen.
3 Select the USB storage device, and then select
Import.
4 Select OK in the dialog box that appears.
The system restarts.
Figure 1 OB Calculations Setup Page
1 On the OB Calculations setup page, select the
desired OB authors (or select None) in the
measurement lists under Gestational Age and
Growth Analysis.
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.
Selecting an author places the associated
measurement on the calculations menu.
See also “OB calculations” on page 61.
2 (Optional) Select More to display the list of
user‐defined custom measurements and to
associate a custom table for the custom
measurement.
To set up OB custom measurements
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 On the OB Calculations setup page, select
Export. A list of USB devices appears.
3 Select the USB storage device, and select
Export.
All user‐defined tables and measurements are
copied to the USB storage device.
You can save up to five custom measurements
that appear in the OB calculations menu and OB
report.
1 On the OB Custom Measurements setup page,
select New.
2 In the Name box, type a unique name.
3 In the Type list, select the desired
measurement type.
4 Select Save.
To delete an OB custom measurement
If you delete an OB custom measurement during
an exam, the exam ends.
1 On the OB Custom Measurements setup page,
highlight the measurement in the Custom
Measurements list.
2 Select Delete Last.
Chapter 2: System Setup
21
Setup
To specify gestational age and growth
analysis
4 Select New on‐screen.
3 Select Yes.
The exam ends, and any tables and report
data associated with the measurement are
removed from the system.
5 In the Author box, type a unique name.
6 Enter the data.
7 Select Save on‐screen.
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 On the OB Calculations or OB Custom
Measurements setup page, select Tables
on‐screen.
2 Select the desired table and
measurement/author.
To create a new OB custom table
You can create two custom tables for each OB
measurement.
1 On the OB Calculations or OB Custom
Measurements setup page, select Tables
on‐screen.
2 Select the desired table (Gestational Age or
Growth Analysis).
3 In the Measurement list, select the
measurement for the custom table.
22
OB Custom Tables setup
To display the measurement for the custom table
in the calculations menu, see “To specify
gestational age and growth analysis” on page 21.
To edit or delete an OB custom table
1 On the OB Calculations or OB Custom
Measurements setup page, select Tables
on‐screen.
2 Select the OB custom table.
3 Select one of the following on‐screen:
• Edit Enter data, and then select Save
on‐screen.
• Delete to remove the custom table. Select
Yes.
Presets setup
The Presets setup page has settings for general
preferences. You can select from the following
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.
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 patient 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.
compression. (See also “Limitations of JPEG
format.”)
Units Units for patient height and weight in
cardiac exams: in/ft/lbs or cm/m/kg.
A high compression has a smaller file size but
less detail.
Language The system language. Changing the
language requires restarting the system.
For SiteLink export type, the image format
affects only still images. For DICOM export
type, the image format affects both still
images and clips.
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
See also “To enter a license key” on page 72.
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 in patient exams
that you export to a USB storage device. (See “To
export patient exams to a USB storage device” on
page 38.)
To specify a file format for exported images
1 On the USB Devices setup page, select Export.
2 Under USB Export, select an export type:
• 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
reader. DICOM is an optional feature.
3 Select an image format for your export type.
For JPEG image format, also select a JPEG
To return to the previous screen, select Devices.
Limitations of JPEG format
When transferring or exporting images in JPEG
format, the system uses lossy compression. Lossy
compression may create images that have less
absolute detail than BMP format and that don’t
render identically to the original images.
In some circumstances, lossy‐compressed images
may be inappropriate for clinical use. For
example, if you use images in SonoCalc IMT
software, you should transfer or export them
using BMP format. SonoCalc IMT software uses a
sophisticated algorithm to measure images, and
lossy compression may cause errors.
For more information on using lossy‐compressed
images, consult the industry literature, including
the following references:
“Physics in Medicine and Biology, Quality
Assessment of DSA, Ultrasound and CT
Digital Images Compressed with the JPEG
Protocol,” D Okkalides et al 1994 Phys Med
Biol 39 1407‐1421 doi:
10.1088/0031‐9155/39/9/008
www.iop.org/EJ/abstract/0031‐9155/39/9/008
“Canadian Association of Radiologists, CAR
Standards for Irreversible Compression in
Digital Diagnostic Imaging within
Radiology,” Approved: June 2008.
www.car.ca/Files/%5CLossy_Compression.
pdf
Chapter 2: System Setup
23
Setup
The System Information setup page displays
system hardware and software versions, and
license information.
4 For SiteLink export type, select a sort order
under Sort By.
24
USB Devices setup
Chapter 3: Imaging
Imaging modes
The system has a high‐performance display and
advanced image‐optimization technology that
significantly simplifies user controls. Imaging
modes available depend on the transducer and
exam type. See “Imaging modes and exams
available by transducer” on page 31.
2D options
In 2D imaging, you can select the following
on‐screen options.
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 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.
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.
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.”
Chapter 3: Imaging
Imaging
Optimize
25
LVO On,
LVO Off
LVO On turns on Left Ventricular
Opacification. LVO Off turns 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).
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.
Sector
(Cardiac exam) Specifies the sector
width.
SonoMB On is available only for
Sector Full.
SonoMB
(MB)
MB On and MB Off turn SonoMB™
multi-beam imaging 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 38.
This feature is optional and requires
a SonoSite ECG cable.
Clips
Displays the clips options. See “To
capture and save a clip” on page 35.
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 image isn’t frozen.
2 Use the touchpad to position the M‐line where
desired.
26
Imaging modes
2 Select CPD or Color.
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 25.
To display the M Mode trace
1 Display the M‐line.
2 Adjust the depth if necessary. (See “To adjust
depth” on page 30.)
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
Fast).
(Slow, Med, or
• Press the UPDATE key to toggle between
the M‐line and M‐Mode trace.
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.”
CPD and Color options
In CPD or Color imaging, you can set the
following on‐screen options.
Toggle between CPD and Color.
The current selection appears in the
upper left-hand screen.
To set a duplex layout, see “Presets setup”
on page 22.
Color
Suppress
Shows or hides color information.
You can select Show or Hide while
in live or frozen imaging. The
setting shown on-screen is the
current selection.
Flow
Sensitivity
The current setting appears
on-screen.
• Low optimizes the system for low
flow states.
• Med optimizes the system for
medium flow states.
• High optimizes the system for
high flow states.
CPD and color Doppler imaging
Color power Doppler (CPD) and color Doppler
(Color) are optional features.
CPD is used to visualize the presence of
detectable blood flow. Color is used to visualize
the presence, velocity, and direction of blood flow
in a wide range of flow states.
To display the CPD or Color image
1 Press the COLOR key.
A ROI box appears in the center of the 2D
image.
Chapter 3: Imaging
27
Imaging
Color, CPD
• If using a duplex layout, press the M MODE
key to toggle between the full‐screen
M‐line and the duplex layout.
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
Variance
Invert
Select the steering angle setting of
the color ROI box (-15, 0, or +15). If
adding PW Doppler, see “PW
Doppler options” on page 29.
Available on select transducers.
Turns variance on and off.
Available only for cardiac exam.
Switches the displayed direction of
flow.
Available in Color imaging.
Sector
(Cardiac exam) Specifies the sector
width.
Page x/x
Indicates which page of options is
displayed. Select to display the next
page.
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
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 29.
• 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 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 29.
• Press the UPDATE key to toggle between
the D‐line and spectral trace.
28
Imaging modes
• If using a duplex layout, press the
DOPPLER key to toggle between the
full‐screen D‐line and the duplex layout.
• 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 28.)
Available on select transducers.
To set a duplex layout, see “Presets setup”
on page 22.
PW Doppler options
In PW Doppler imaging, you can set the
following on‐screen options.
PW, CW
Angle
Correction
Gate Size
Steering
Corrects the angle to 0°, +60°, or
-60°.
Settings depend on transducer and
exam type.
In TCD or Orb exams, use the
touchpad to specify the Doppler
gate depth (the depth of the center
of the gate in the Doppler image).
The Doppler gate depth indicator is
on the lower right-hand screen.
Select TDI On to turn on tissue
Doppler imaging. When on, TDI
appears in the upper left-hand
screen. The default is TDI off.
Available only in cardiac exams.
Select the desired steering angle
setting. The PW Doppler angle
correction automatically changes
to the optimum setting.
• -15 has an angle correction of
-60°.
Page x/x
Indicates which page of options is
displayed. Select to display the next
page.
Spectral trace options
In spectral trace imaging, you can set the
following on‐screen options.
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 22.)
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.
Chapter 3: Imaging
29
Imaging
TDI On,
TDI Off
(Cardiac exam only) Toggle
between PW Doppler and CW
Doppler.
The current selection appears in the
upper left-hand screen.
Live Trace
Page x/x
Displays a live trace of the peak or
mean. (See “Presets setup” on
page 22 to specify peak or mean.)
Indicates which page of options is
displayed. Select to display the next
page.
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 automatically
Press the AUTO GAIN key. The gain adjusts
each time you press this key.
To adjust gain manually
Turn a gain knob:
box. In PW and CW Doppler imaging, the
the GAIN knob affects Doppler gain.
Near and far correspond to the time gain
compensation (TGC) controls on other
ultrasound systems.
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.
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
• NEAR
adjusts the gain applied to the
near field of the 2D 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.
adjusts the gain applied to the far
• FAR
field of the 2D image.
1 Press the ZOOM key. A ROI box appears.
adjusts the overall gain applied
• GAIN
to the entire image. In CPD or Color
imaging, the GAIN knob affects the color
gain applied to the region of interest (ROI)
3 Press the ZOOM key again.
2 Using the touchpad, position the ROI box as
desired.
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,
30
Adjusting depth and gain
down, left, and right. (You cannot pan in
Dual.)
Imaging modes and exams available by
transducer
To exit zoom, press the ZOOM key again.
CPD3
Color3
PW Doppler4
CW Doppler
Abd
—
Neo
—
Nrv
—
Vas
—
OB
—
Gyn
—
Abd
—
Nrv
—
D2x
Crd
—
—
—
—
HFL38x
Bre
—
SmP
—
Vas
—
The transducer you use determines which exam
types are available. In addition, the exam type
you select determines which imaging modes are
available.
Msk
—
IMT
—
Nrv
—
To change the exam type
Ven
—
Gyn
—
OB
—
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 biocompatibility
requirements.
To avoid injury to the patient, use
only an Orbital (Orb) or Ophthalmic
(Oph) when performing imaging
through the eye. The FDA has
established lower acoustic energy
limits for ophthalmic use. The
system will not exceed these limits
only if the Orb or Oph exam type is
selected.
Do one of the following:
• Press the EXAM key, and select from the
menu.
C60x
ICTx
2D2
M Mode
Exam Type1
C11x
Imaging modes and exams
available by transducer
Imaging
Transducer
Imaging Mode
• On the patient information form, select
from the Type list under Exam. (See
“Patient information form” on page 33.)
Chapter 3: Imaging
31
CW Doppler
CPD3
Color3
PW Doppler4
CW Doppler
—
Vas
—
Vas
—
Ven
—
Nrv
—
TEEx
Crd
—
Oph
—
Sup
—
Ven
—
Bre
—
SmP
—
Vas
—
IMT
—
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, Oph = Ophthalmic, Orb =
Orbital, SmP = Small Parts, Sup = Superficial, TCD =
Transcranial Doppler, 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.
4. For the cardiac exam type, PW TDI is also available. See
“PW Doppler options” on page 29.
Nrv
—
Ven
—
Abd
—
Crd
—
Neo
—
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 18.
Abd
—
To place text on an image
OB
—
Crd
—
TCD
—
Orb
—
Msk
—
• Use the touchpad or arrow keys.
Nrv
—
Sup
—
• Select Home to move the cursor to the
home position.
L38x
P10x
P21x
SLAx
32
Annotating images
2D2
M Mode
PW Doppler4
Exam Type1
Color3
Msk
Transducer
CPD3
L25x
2D2
M Mode
Exam Type1
Imaging Mode
Transducer
Imaging Mode
Annotating images
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:
The default home position depends on the
imaging screen layout. You can reset the
home position. See “To reset the home
position” on page 33.
3 Using the keyboard, type text.
• The arrow keys move the cursor left, right,
up, and down.
• The DELETE key deletes all text.
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.
To place a pictograph on an image
The pictograph set available depends on
transducer and exam type.
1 Press the PICTO key.
• The
Word option removes a word.
• Select Symbols to enter special characters.
See “Symbols” on page 10.
4 (Optional) To add a predefined label, select
Label, and then select the desired label group:
, or
. Select the group again for
the desired label.
The first number shows which label in the
group is selected. The second number is the
number of labels available.
See “Annotations setup” on page 18.
To reset the home position
1 Press the TEXT key.
2 Using the touchpad or arrow keys, position
the cursor where desired.
The first number shows which pictograph in
the set is selected. The second number is the
number of pictographs available.
3 Using the touchpad, 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.
3 Select Home/Set.
To place an arrow on an image
Patient information form
You can add an arrow graphic to point out a
specific part of the image.
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.
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 Using the touchpad, position the arrow where
desired.
When you create a new patient information form,
all images, clips, and other data you save during
the exam are linked to that patient. (See “Patient
report” on page 68.)
Chapter 3: Imaging
33
Imaging
To turn off text entry, press the TEXT key.
2 Select
x/x to display the desired
pictograph, and then press the SELECT key.
To create a new patient information form
• ID Patient identification number
1 Press the PATIENT key.
• Accession Enter number, if applicable.
2 Select
• Date of birth
New/End.
• Gender
3 Fill in the form fields. See “Patient
information form fields” on page 34.
• Indications Enter desired text
4 Select Done.
• User User initials
See also “To append images and clips to a patient
exam” on page 37.
• Procedure (button) Available if the DICOM
Worklist feature is licensed and configured.
See the DICOM user guide.
To edit a patient information form
You can edit patient information if the exam has
not been archived or exported and if the
information is not from a worklist.
See also “To edit patient information from the
patient list” on page 36.
1 Press the PATIENT key.
2 Make changes as desired.
3 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 35.)
2 Press the PATIENT key.
3 Select
New/End.
A new patient information form appears.
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 10.
Patient
• Last, First, Middle Patient name
34
Patient information form
Select Back to save entries and return to the
previous screen.
Exam
• Type Exam types available depend on
transducer. See “Imaging modes and exams
available by transducer” on page 31.
• LMP Estab. DD (OB or Gyn exam) In an OB
exam, select LMP or 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 for access to Twin
A and Twin B screens for previous exam data.
• Previous Exams (button) (OB exam) Displays
fields for five previous exams. The date for a
previous exam must precede the current
system date. For 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 the
previous screen.
• BP (Cardiac, IMT, Orbital, Transcranial, or
Vascular exam) Blood Pressure
• HR (Cardiac, Orbital, Transcranial, or Vascular
exam) Heart Rate. Enter the beats per minute.
Saving 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 22.)
• Weight (Cardiac exam) The patient weight in
pounds or kilos. (To change the units, see
“Presets setup” on page 22.)
• BSA (Cardiac exam) Body Surface Area.
Automatically calculated after you enter
height and weight.
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 “Presets
setup” on page 22.
To capture and save a clip
Clips, an optional feature, lets you capture,
preview, and save clips.
1 Set Clips options. (See “To set Clips options”
on page 35.)
2 Press the CLIP key.
• Ethnicity (IMT exam) Ethnic origin
One of the following occurs:
•
Reading Dr.
• If Prev/Off is selected, the clip saves
directly to internal storage.
•
Referring Dr.
• Institution
Images and clips
Saving images and clips
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 20.
To access saved images and clips, open the
patient list. See “Reviewing patient exams” on
page 36.
• 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)
Imaging
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 19.) To access
saved images and clips, open the patient list. (See
“Reviewing patient exams” on page 36.)
• If Prev/On is selected, the clip plays back
in preview mode. You can select any of the
following on‐screen:
• 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.
To save an image
Press the SAVE key.
The image saves to internal storage.
Chapter 3: Imaging
35
Clips options
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,
Preview Off
PrevOn and PrevOff turn the
preview feature on and 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.
Prospective,
Retrospective
Pro and Retro determine how
clips are captured:
• 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.
Figure 1 Patient List
To display the patient list
1 Press the REVIEW key.
2 If there is an active exam, select List on‐screen.
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
Reviewing patient exams
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 vii.)
The patient list organizes saved images and clips
in patient exams. You can delete, view, print, or
archive exams. You can also copy them to a USB
storage device.
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 edit patient information from the patient
list
You can edit the patient name and ID from the
patient list instead of from the patient
information form if the exam has not been
exported or archived.
1 In the patient list, select the patient.
36
Images and clips
2 Select Edit.
3 Fill in the form fields, and select OK.
To append images and clips to a patient
exam
Although you cannot add images and clips to a
patient exam that is ended, exported, or archived,
you can automatically start a new patient exam
that has the same patient information.
Depending on your archiver, the two exams
appear as one study when exported or archived.
1 Select the exam in the patient list.
2 Select Append on‐screen.
A new patient information form appears. The
form has the same information as the exam
you selected.
To review images and clips
You can review images and clips in only one
patient exam at a time.
1 In the patient list, highlight the patient exam
whose images and clips you want to review.
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 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.
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.
To print an image
1 Verify that a printer is selected. See “To
configure the system for a printer” on
page 19.
2 Do one of the following:
• In the patient list, review the patient’s
images. Select Print when the image
appears.
Imaging
2 Select Review on‐screen.
Printing, exporting, and deleting images
and clips
• 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
“Presets setup” on page 22.
To print multiple images
1 Verify that a printer is selected. See “To
configure the system for a printer” on
page 19.
2 Do one of the following:
• 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.
Chapter 3: Imaging
37
Each image appears briefly on‐screen
while printing.
To display information about a patient exam
1 On the patient list, select the exam.
To export patient exams to a USB storage
device
2 Select Info.
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 23.
ECG Monitoring
1 Insert the USB storage device.
ECG Monitoring is an optional feature and
requires a SonoSite ECG cable.
WARNING:
2 In the patient list, select the patient exams you
want to export.
3 Select Exp. USB on‐screen. A list of USB
devices appears.
To avoid electrical interference with
aircraft systems, do not use the ECG
cable on aircraft. Such interference
may have safety consequences.
4 Select the USB storage device. If you want to
hide patient information, deselect Include
patient information on images and clips.
Only available USB devices are selectable.
5 Select Export.
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 manually 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. For more
information about archiving, see the SiteLink and
DICOM documentation.
1 Select one or more patients in the patient list.
2 Select Archive.
38
ECG Monitoring
To prevent misdiagnosis, do not use
the ECG trace to diagnose cardiac
rhythms. The SonoSite ECG option
is a non-diagnostic feature.
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
Show/Hide
Turns on and off ECG trace.
Gain
Increases or decreases ECG gain.
Settings are 0-20.
Position
Sets the position of the ECG trace.
Sweep Speed Settings are Slow, Med, and Fast.
Displays Line and Save for clip
acquisition delay. (For instructions
to capture clips, see “To capture and
save a clip” on page 35.)
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.
Imaging
Delay
Chapter 3: Imaging
39
40
ECG Monitoring
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 35.) 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 45.
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.
3 Save the calculation. (See “To save a
calculation” on page 45.)
To start a calculation before measuring, see
“Performing and saving measurements in
calculations” on page 45.
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 45.)
For an accurate measurement, accurate
placement of calipers is essential.
To switch the active calipers
Do one of the following:
• To switch the active caliper within a set,
press the SELECT key.
• 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.
Chapter 4: Measurements and Calculations
41
Measurements
Only measurement names available for the
imaging mode and exam type are selectable.
Working with calipers
To improve precision of caliper placement
Do any of the following:
• Adjust the display for maximum
sharpness.
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.
• Use leading edges (closest to the
transducer) or borders for starting and
stopping points.
To measure distance (2D)
• Maintain a consistent transducer
orientation for each type of measurement.
1 On a frozen 2D image, press the CALIPER key.
• 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
tracing manually.
You can perform up to eight distance
measurements on a 2D image.
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.
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 41.
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 41.
To trace manually (2D)
1 On a frozen 2D image, press the CALIPER key.
2 Select Manual on‐screen.
Figure 1 2D image with two distance and one
circumference measurement
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.
42
Measurements
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 41.
M Mode measurements
The basic measurements that you can perform in
M Mode imaging are as follows:
• Distance in cm/Time in seconds
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.
See “To save a measurement to a calculation and
patient report” on page 41. Saving the heart rate
measurement to the patient report overwrites
any heart rate entered on the patient information
form.
• Heart Rate (HR) in beats per minute (bpm)
See also “To measure fetal heart rate (M Mode)”
on page 63.
The time scale above the trace has small marks at
200 ms intervals and large marks at one‐second
intervals.
Doppler measurements
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.
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 22.
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.
To measure heart rate (M Mode)
This measurement involves a single caliper from
the baseline.
1 On a frozen M Mode trace, press the CALIPER
key.
2 Select HR on‐screen.
See “To save a measurement to a calculation and
patient report” on page 41.
A vertical caliper appears.
3 Using the touchpad, position the vertical
caliper at the peak of the heartbeat.
Chapter 4: Measurements and Calculations
43
Measurements
See “To save a measurement to a calculation and
patient report” on page 41.
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.
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 41.
To trace automatically (Doppler)
See “To save a measurement to a calculation and
patient report” on page 41.
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 44.)
To measure time duration (Doppler)
1 On a frozen Doppler spectral trace, press the
CALIPER key.
1 On a Doppler spectral trace, press the CALIPER
key.
2 Select Auto on‐screen.
4 Using the touchpad, position the second
caliper at the end diastole on the waveform.
2 Press Time on‐screen.
3 A vertical caliper appears.
4 Using the touchpad, position the caliper
where desired, and press the SELECT key.
5 A second caliper appears.
6 Using the touchpad, position the second
caliper where desired, and press the SELECT
key.
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.
44
Measurements
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 41.
Automatic trace results
Depending on the exam type, the results from
automatic tracing include the following:
• Velocity Time Integral (VTI)
• Peak Velocity (Vmax)
• Mean Pressure Gradient (PGmean)
• Mean Velocity on Peak Trace (Vmean)
Menu items followed by ellipses (. . .) have
subentries.
• Pressure Gradient (PGmax)
To select from the calculations menu
• Cardiac Output (CO)
1 On a frozen image, press the CALCS key.
• Peak Systolic Velocity (PSV)
• Time Average Mean (TAM)*
• +/× or Systolic/Diastolic (S/D)
• Pulsatility Index (PI)
• End Diastolic Velocity (EDV)
• Acceleration Time (AT)
• Resistive Index (RI)
The calculations menu appears.
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.
• Time Average Peak (TAP)
3 Press the SELECT key.
• Gate Depth
To close the calculations menu, press the CALCS
key once (if the menu is active) or twice (if the
menu is inactive).
General calculations
Within calculations, you can save measurement
results to the patient report. You can display,
repeat, and delete measurements from a
calculation. Some measurements can be deleted
directly from the patient report pages. See
“Patient report” on page 68.
Calculation packages depend on exam type and
transducer.
Calculations menu
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.
Measurements
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 68.) 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.
Performing and saving measurements
in calculations
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 35.
• Save both the image and calculation: Press
the SAVE key if the SAVE key functionality
Chapter 4: Measurements and Calculations
45
is set to Image/Calcs. (See “Presets setup”
on page 22.)
The calculation saves to the patient report,
and the image saves to internal storage
with the measurements displayed.
Displaying, repeating, and deleting
saved measurements in calculations
To display a saved measurement
Do one of the following:
• Highlight the measurement name in the
calculations menu. The result appears
below the menu.
Some measurements can be deleted directly from
the patient report pages. See “Patient report” on
page 68.
EMED calculations
The results from EMED calculations
automatically appear in the EMED worksheets.
All EMED calculations are available for each
exam type.
To perform an EMED calculation:
1 Press the CALCS key.
2 Select EMED on‐screen.
The calculations menu becomes the EMED
calculations menu.
Open the patient report. See “Patient report” on
page 68.
3 Select the calculation name.
To repeat a saved measurement
4 Perform a distance measurement.
1 Highlight the measurement name in the
calculations menu.
5 Save the measurement.
2 Press the SELECT key or the CALIPER key.
To return to the calculations menu, select Calcs
on‐screen.
3 Perform the measurement again.
The new results appear on‐screen in the
measurement and calculations data area. (See
“Screen layout” on page 7.) 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.
46
General calculations
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 34.
Transducer
Exam Types
b Using the touchpad, move the caliper to
the trace starting point, and press the
SELECT key.
C11x
Abdomen
c Using the touchpad, trace the desired area.
C60x
Abdomen
To make a correction, select Undo
on‐screen or press the BACKSPACE key.
HFL38x
IMT, Small Parts, Vascular
L25x
Vascular, Muscle
L38x
IMT, Small Parts, Vascular
P10x
Abdomen
P21x
Abdomen
SLAx
Muscle, Vascular
d Complete the trace, and press the SET key.
e Save the calculation. See “To save a
calculation” on page 45.
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 41.)
c Save the calculation. See “To save a
calculation” on page 45.
The percent diameter reduction result appears in
the measurement and calculation data area and
in the patient report.
Figure 2 Percent area reduction calculation of right
carotid bulb
Measurements
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.
Chapter 4: Measurements and Calculations
47
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 34.
Transducer
Exam Types
C11x
Abdomen, Nerve
C60x
Abdomen, Gyn, Nerve
HFL38x
Breast, Nerve, Small Parts,
Vascular
ICTx
Gyn
L25x
Muscle, Nerve, Vascular,
Superficial,
L38x
Breast, Nerve, Small Parts,
Vascular
P10x
Abdomen, Neonatal
P21x
Abdomen
SLAx
Muscle, Nerve, Superficial,
Vascular
48
General calculations
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:
From the calculations menu, select the
measurement name under Volume. (If
Volume is not available in a Gyn exam,
select Gyn and then select Volume.)
ii Position the calipers. (See “Working
with calipers” on page 41.)
iii Save the measurement. See “To save a
calculation” on page 45.
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 34.
Transducer
Exam Types
C11x
Abdomen
C60x
Abdomen
HFL38x
Vascular
L25x
Vascular
L38x
Vascular
P10x
Abdomen
P21x
Abdomen
SLAx
Vascular
• 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 and P10x transducers: 2, 3, 5, 7,
10, 12 Gate Size (mm)
• HFL38x, L25x, L38x, and SLAx
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 following table shows the measurements
required to complete the volume flow
calculation. For definitions of acronyms, see
“Glossary” on page 157.
Volume Flow Calculations
Menu
Heading
Vol Flow
Measurement
(Imaging
Mode)
Calculation
Result
D (2D)
TAM (Doppler)
VF (Volume
Flow l/min)
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 41.)
Consider the following factors when performing
volume flow measurements:
d Save the calculation. See “To save a
calculation” on page 45.
• 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:
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.
A vertical caliper appears.
• Using the diameter method for 2D area
Chapter 4: Measurements and Calculations
49
Measurements
Both a 2D and a Doppler measurement are
required for the volume flow calculation. The
Doppler sample volume should completely
insonate the vessel.
c Using the touchpad, position the vertical
caliper at the beginning of the waveform.
If calipers are not positioned correctly, the
calculation result is inaccurate.
d Press the SELECT key to display a second
vertical caliper.
e Using the touchpad, position the second
vertical caliper at the end of the waveform.
Press the SET key to complete the trace and
to display the results.
g Save the calculation. See “To save a
calculation” on page 45.
To display the volume flow calculation, see
“Patient report” on page 68.
Exam-based calculations
In addition to the general calculations, there are
calculations specific to the Cardiac, Gynecology
(Gyn), IMT, OB, Orbital, Small Parts, Transcranial
Doppler (TCD), and Vascular exam types.
Transducer
Exam Type
D2x
Cardiac
P10x
Cardiac
P21x
Cardiac
TEEx
Cardiac
The following table shows the measurements
required to complete different cardiac
calculations. For definitions of acronyms, see
“Glossary” on page 157.
Cardiac Calculations
Menu
Heading
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 34.
50
Exam-based calculations
Calculation
Results
CO
EF
SV
LVESV
LVEDV
IVSFT
LVPWFT
LVDFS
CI
SI
LV…LVd
RVW (2D)
RVD (2D)
IVS (2D)
LVD (2D)
LVPW (2D)
…LVs
RVW (2D)
RVD (2D)
IVS (2D)
LVD (2D)
LVPW (2D)
HRa needed for
CO & CI
Ao/LA
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
Cardiac calculations
WARNING:
Cardiac
Measurements
(Imaging Mode)
Cardiac
Measurements
(Imaging Mode)
Cardiac
Measurements
(Imaging Mode)
Calculation
Results
Menu
Heading
ACS (M Mode)
ACS
PISA
LVET (M Mode)
LVET
EF:Slope
(M Mode)
EF SLOPE
Ann D (2D)
Radius (Color)
MR/VTI (Doppler)
MV/VTI (Doppler)
EPSS (M Mode)
EPSS
PISA Area
ERO
MV Rate
Regurgitant
Volume
Regurgitant
Fraction
LV…LVd
RVW (M Mode)
RVD (M Mode)
IVS (M Mode)
LVD (M Mode)
LVPW (M Mode)
Qp/Qs
…LVs
RVW (M Mode)
RVD (M Mode)
IVS (M Mode)
LVD (M Mode)
LVPW (M Mode)
CO
EF
SV
LVESV
LVEDV
IVSFT
LVPWFT
LVDFS
CI
SI
LV Mass
LVOT D (2D)
RVOT D (2D)
LVOT VTI
(Doppler)
RVOT VTI
(Doppler)
VTI
VMax
PGmax
Vmean
PGmean
SV
Qp/Qs
TDI
(Wall) e’ and a’
(Doppler)
(Wall) e’ and a’
(Doppler)
(Wall) e’ and a’
(Doppler)
(Wall) e’ and a’
(Doppler)
(Wall) ‘e and a’
(Doppler)
E(MV)/e’ ratio
Menu
Heading
MV
HRa
Area
AV (2D)
AV Area
MV (2D)
MV Area
LV Vol
(EF)
A4Cd (2D)
A4Cs (2D)
A2Cd (2D)
A2Cs (2D)
LV Vol
LV Area
EF
CO
SV
CI
SI
Biplane
LV mass
Epi (2D)
Endo (2D)
Apical (2D)
LV Mass
Epi Area
Endo Area
D Apical
Measurements
HR
Calculation
Results
Chapter 4: Measurements and Calculations
51
Menu
Heading
Cardiac
Measurements
(Imaging Mode)
Calculation
Results
Menu
Heading
Cardiac
Measurements
(Imaging Mode)
P. Vein
A (Doppler)
VMax
AV
Vmax (Doppler)
Adur (Doppler)
time
Vmax
PGmax
S (Doppler)
VMax
S/D ratio
VTI (Doppler)
VTI
Vmax
PGmax
Vmean
PGmean
VTI or Vmax from
LVOT (Doppler)
VTI or Vmax from
AV (Doppler)
AVA
D (Doppler)
MV
E (Doppler)
A (Doppler)
Adur (Doppler)
time
PHT (Doppler)
PHT
MVA
Decel time
VTI (Doppler)
MV…MR
E PG
A PG
E:A
VTI
Vmax
PGmax
Vmean
PGmean
IVRT (Doppler)
time
dP:dTb (CW
Doppler)
dP:dT
Ao/LA
LVOT D (2D)
AV
VTI (Doppler)
Ao/LA
LVOT D (2D)
AV
VTI (Doppler)
Ao/LA
LVOT D (2D)
HR
HRa
LVOT
Vmax (Doppler)
Vmax
PGmax
VTI (Doppler)
VTI
Vmax
PGmax
Vmean
PGmean
PHT (slope)
(Doppler)
AI PHT
AI slope
AV…AI
52
Exam-based calculations
Calculation
Results
SV
CO
To measure LVd and LVs
Menu
Heading
Cardiac
Measurements
(Imaging Mode)
TV
TRmax (Doppler)
Vmax
PGmax
E (Doppler)
A (Doppler)
E PG
A PG
E:A
PHT (Doppler)
VTI (Doppler)
PV
Calculation
Results
PHT
MVA
Decel time
VTI
Vmax
PGmax
Vmean
PGmean
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 active (green) caliper at the
starting point. (See “Working with calipers”
on page 41.)
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.
RA pressurec
RVSP
7 Save the calculation. (See “To save a
calculation” on page 45.)
Vmax (Doppler)
Vmax
PGmax
To measure Ao, LA, AAo, or LVOT D
VTI (Doppler)
AT (Doppler)
a. You can enter the HR measurement three ways: Patient
information form, Doppler measurement (See “To
calculate Heart Rate (HR)” on page 57), or M Mode
measurement (See “To measure heart rate (M Mode)” on
page 43).
b. Performed at 100 cm/s and 300 cm/s.
c. Specified on the cardiac patient report. See “To delete a
vascular or cardiac measurement” on page 69.
2 From the calculations menu, select the
measurement name.
3 Position the calipers. (See “Working with
calipers” on page 41.)
Measurements
VTI
Vmax
PGmax
Vmean
PGmean
AT
1 On a frozen 2D image or M Mode trace, press
the CALCS key.
4 Save the calculation. (See “To save a
calculation” on page 45.)
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.
Chapter 4: Measurements and Calculations
53
c Using the touchpad, trace the left
ventricular (LV) cavity.
To make a correction, select Undo on‐screen
or press the BACKSPACE key.
6 Save the calculation.
d Complete the trace, and press the SET key.
To measure peak velocity
e Save the calculation. (See “To save a
calculation” on page 45.)
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 patient report, the next
measurement taken replaces the deleted one in
the patient report. The most recently saved
measurement appears at the bottom of the
calculations menu.
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 45.)
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 45.).
4 Select Apical from the calculations menu.
54
5 Positioning the calipers, measure the
ventricular length. (See “Working with
calipers” on page 41.)
Exam-based calculations
1 On a frozen Doppler spectral trace, press the
CALCS key.
2 From the calculations menu, select MV, TV, or
TDI, or P. Vein.
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 41.)
c Save the calculation. (See “To save a
calculation” on page 45.)
To calculate Velocity Time Integral (VTI)
Note: This calculation computes other results in
addition to VTI. See the table “Cardiac Calculations”
on page 50.
1 On a frozen Doppler spectral trace, press the
CALCS key.
2 From the calculations menu, select VTI under
MV, AV, TV, PV, or LVOT.
3 Position the caliper at the start of the
waveform, and press the SELECT key to start
the trace.
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 45.)
For information on the automatic trace tool, see
“To trace automatically (Doppler)” on page 44.
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 41.)
4 Save the calculation. (See “To save a
calculation” on page 45.)
5 To adjust the RA pressure, see “To delete a
vascular or cardiac measurement” on page 69.
Changing the RA pressure from the default 5
affects the RVSP calculation in the patient
report.
To calculate Pressure Half Time (PHT) in MV,
AI, or TV
2 From the calculations menu, select MV, AV, or
TV, 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.
5 Save the calculation. (See “To save a
calculation” on page 45.)
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 41.)
d Save the calculation. (See “To save a
calculation” on page 45.)
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.
Chapter 4: Measurements and Calculations
55
Measurements
1 On a frozen Doppler spectral trace, press the
CALCS key.
• In AV, position the caliper at the end
diastole.
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.
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.
For information on the automatic trace tool, see
“To trace automatically (Doppler)” on page 44.
6 Save the calculation. (See “To save a
calculation” on page 45.)
To calculate Isovolumic Relaxation Time
(IVRT)
To calculate Aortic Valve Area (AVA)
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 45.)
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 41.)
d Save the calculation. (See “To save a
calculation” on page 45.)
2 Measure from LVOT, and then measure from
AV (Doppler):
To calculate Delta Pressure: Delta Time
(dP:dT)
• For Vmax, see “To measure peak velocity”
on page 54. From the calculations menu,
select AV, select sample site, and then
select Vmax.
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 29.)
• For VTI, see “To calculate Velocity Time
Integral (VTI)” on page 54. From the
calculations menu, select AV, select sample
site, and then select VTI.
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.
56
Exam-based calculations
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:
a From the calculations menu, locate Qp/Qs
and then select LVOT D or RVOT D.
c Position the calipers. (See “Working with
calipers” on page 41.)
b Position the calipers. (See “Working with
calipers” on page 41.)
d Save the calculation. (See “To save a
calculation” on page 45.)
c Save the calculation. (See “To save a
calculation” on page 45.)
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.
e Save the calculation. (See “To save a
calculation” on page 45.)
For information on the automatic trace tool, see
“To trace automatically (Doppler)” on page 44.
To calculate Stroke Volume (SV) or Stroke
Index (SI)
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 34.)
2 Measure from LVOT (2D):
a On a frozen 2D image, press the CALCS key.
b From the calculations menu, select LVOT D.
For information on the automatic trace tool, see
“To trace automatically (Doppler)” on page 44.
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 45.)
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.
Chapter 4: Measurements and Calculations
57
Measurements
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.
3 Measure from aorta (Doppler). See “To
calculate Velocity Time Integral (VTI)” on
page 54. From the calculations menu, select
AV and then select VTI.
1 (CI 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 34.)
WARNING:
2 Calculate SV. See “To calculate Stroke Volume
(SV) or Stroke Index (SI)” on page 57.
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 34.
3 Calculate HR. See “To calculate Heart Rate
(HR)” on page 57.
To measure a Tissue Doppler Imaging (TDI)
waveform
1 Ensure that TDI is on. (See “PW Doppler
options” on page 29.)
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 41.)
c Save the calculation. (See “To save a
calculation” on page 45.)
To avoid incorrect calculations,
verify that the patient information,
date, and time settings are
accurate.
Transducer
Exam Type
C60x
Gyn
ICTx
Gyn
To measure uterus or ovary
1 On a frozen 2D image, press the CALCS key.
Gynecology (Gyn) calculations
Gynecology (Gyn) calculations include Uterus,
Ovary, Follicle, and Volume. For instructions to
calculate volume, see “Volume calculations” on
page 48.
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 41.)
c Save the calculation. (See “To save a
calculation” on page 45.)
58
Exam-based calculations
To measure follicles
To avoid incorrect calculations,
verify that the patient information,
date, and time settings are
accurate.
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.
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 34.
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 41.)
c Save the calculation. (See “To save a
calculation” on page 45.)
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.
Transducer
Exam Type
L38x
IMT
HFL38x
IMT
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 20.
Measurements
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).
Chapter 4: Measurements and Calculations
59
IMT tool options
IMT Calculations (2D)
Menu Heading
Available Measurements
Right-IMT
Left-IMT
Ant N (Anterior Near Wall)
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
When using the IMT tool, you can select the
following options on‐screen.
Option
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 calculate IMT automatically
1 On a frozen 2D image, press the CALCS key.
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 60.
5 Save the calculation. (See “To save a
calculation” on page 45.)
60
Exam-based calculations
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.
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 45.)
To sketch IMT
The IMT sketch measurement involves two
user‐defined sketch lines that you can adjust
manually.
2 From the calculations menu, select a
measurement name.
3 Select Edit on‐screen, and then select Manual.
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 60.
e Save the calculation. (See “To save a
calculation” on page 45.)
OB calculations
EFW is calculated only after appropriate
measurements are completed. If any one of these
parameters results in an EDD greater than what
the OB calculation tables provide, the EFW is not
displayed.
WARNING:
Make sure that you have selected
the OB exam type and the OB
author for the OB calculation table
you intend to use. See “Results from
System-Defined OB Measurements
and Table Authors” on page 62.
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.
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:
Chapter 4: Measurements and Calculations
61
Measurements
1 On a frozen 2D image, press the CALCS key
a Position the caliper at the beginning of the
boundary and press the SELECT key.
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 34.
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.
Transducer
Exam Type
C60x
OB
ICTx
OB
P21x
OB
If you change the calculation author during the
exam, the common measurements are retained.
The following table shows the system‐defined
measurements available for OB calculations by
author. For definition of the acronyms, see
“Glossary” on page 157. To select authors, see
“OB Calculations setup” on page 20.
Results from System-Defined OB Measurements
and Table Authors
Calculation
Result
Gestational OB
Measurements
Table
Authors
Gestational
Agea
YS
—
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.
CX L
—
See also “OB Custom Measurements setup” on
page 21 and “OB Custom Tables setup” on
page 22.
62
Exam-based calculations
Calculation
Result
Gestational OB
Measurements
Table
Authors
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.
HC/AC
Campbell
FL/AC
Hadlock
FL/BPD
Hohler
FL/HC
Hadlock
page, determines the measurements you must perform to
obtain an EFW calculation. (See “OB Calculations setup” on
page 20.)
Individual selections for Hadlock’s EFW equations 1, 2, and 3
are not determined by the user. The selected equation is
determined by the measurements that have been saved to
the patient report with priority given to the 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)
Ratios
Amniotic Fluid
Index
Q ,Q ,Q ,Q
Jeng
Growth Analysis
Tablesd
BPD
Chitty,
Hadlock,
Jeanty
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 Tokyo 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
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.
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 41.)
c Save the calculation. (See “To save a
calculation” on page 45.)
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.
Chapter 4: Measurements and Calculations
63
Measurements
HC
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.
Cerebral Artery) or UmbA (Umbilical
Artery).
3 Using the touchpad, position the vertical
caliper at the peak of the heartbeat.
b Position the calipers:
4 Press the SELECT key.
• 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.
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 45.)
• 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.
OB Doppler Calculations
Menu
Heading
OB
Calculation
MCA (Middle
Cerebral
Artery)
S/D, RI
SD
RI
S/D, RI, PI*
SD
RI
PI
S/D, RI
SD
RI
S/D, RI, PI*
SD
RI
PI
Umb A
(Umbilical
Artery)
Results
c Save the calculation. (See “To save a
calculation” on page 45.)
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 48.
Transducer
Exam Type
HFL38x
Small Parts
L38x
Small Parts
*Calculation requires a trace measurement.
To calculate MCA or Umba (Doppler)
Note: The system does not provide an MCA/UmbA
ratio from the PI (Pulsatility Index).
To calculate hip angle
1 Select OB exam type, and select LMP or
Estab.DD in the patient information form.
2 From the calculations menu, select Right or
Left.
2 On a frozen Doppler spectral trace, press the
CALCS key.
3 Select Baseline under Hip Angle.
3 Do the following for each measurement you
need to take:
a From the calculations menu, select the
measurement name under MCA (Middle
64
Exam-based calculations
1 On a frozen 2D image, press the CALCS key.
A baseline appears on‐screen.
4 Position the baseline, and press the SET key.
(See “Working with calipers” on page 41.)
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 45.)
Line B (beta line) appears on‐screen, and Line
B is selected in the calculations menu.
Transcranial Doppler and Orbital
calculations
WARNING:
6 Position Line B, and save the measurement.
To calculate d:D ratio
To avoid injury to the patient, use
only an Orbital (Orb) exam type
when performing imaging through
the eye.
Verify that the patient information,
date, and time settings are
accurate.
1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Right or
Left.
To avoid carrying over
measurements from the previous
patient, start a new patient
information form for each new
patient before you perform
calculations on the new patient.
See “To create a new patient
information form” on page 34.
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 41.)
7 Save the measurement. (See “To save a
calculation” on page 45.)
Transducer
Exam Types
P21x
Transcranial (TCD), Orbital
(Orb)
The following table shows the measurements
required to complete Transcranial Doppler (TCD)
and Orbital (Orb) calculations. For definitions of
acronyms, see “Glossary” on page 157.
Measurements
Chapter 4: Measurements and Calculations
65
Transcranial and Orbital Calculations
Transcranial and Orbital Calculations
Menu Heading
TT
MCA
TCD and Orb
Measurements
Dist
Mid
Prox
Bifur*
ACA
ACoA*
TICA
TT
PCAp1
PCAp2
PCoA
TO
OA
Siphon
SM
ECICA
Menu Heading
TCD and Orb
Measurements
FM
VA
Results
TAP
PSV
EDV
PI
RI
S/D
Gate Size
TAP
PSV
EDV
PI
RI
S/D
Gate Size
TAP
PSV
EDV
PI
RI
S/D
Gate Size
FM
BA
AL
Prox
Mid
Dist
ECVA
Results
TAP
PSV
EDV
PI
RI
S/D
Gate Size
TAP
PSV
EDV
PI
RI
S/D
Gate Size
*Available but not required
WARNING:
To avoid injury to the patient, use
only an Orbital (Orb) or
Ophthalmic (Oph) when
performing imaging through the
eye. The FDA has established
lower acoustic energy limits for
opthalmic use. The system will not
exceed these limits only if the
Orbital or Ophthalmic exam type
is selected.
To perform a Transcranial Doppler or Orbital
calculation
1 Select the correct exam type:
• Orbital (Orb) to measure Opthalmic Artery
and Siphon
• Transcranial (TCD) for other measurements
See “To change the exam type” on page 31.
66
Exam-based calculations
2 On a frozen Doppler spectral trace, press the
CALCS key.
3 From the calculations menu, select Left or
Right.
Vascular calculations
WARNING:
4 Do the following for each measurement you
want to take:
a From the calculations menu, select the
measurement. (You may need to select
Next or Prev to locate the measurement.)
b Do one of the following:
• For a manual trace measurement, use the
touchpad to position the caliper. Press the
SELECT key. Use the touchpad to trace the
waveform.
To avoid incorrect calculations,
verify that the patient information,
date, and time settings are
accurate.
If you need to make a correction, select
Undo on‐screen or press the BACKSPACE
key.
• For an auto trace measurement, select
Auto on‐screen, and use the touchpad to
position the first caliper at the beginning
of the waveform. Press the SELECT key, and
position the second caliper at the end of
the waveform.
Confirm that the system‐generated
boundary is correct. If you are not satisfied
with the trace, obtain a higher quality
Doppler spectral trace image, or trace
manually.
c Press the SET key.
Transducer
Exam Type
C11x
Vascular
HFL38x
Vascular
L25x
Vascular
L38x
Vascular
SLAx
Vascular
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 157
Chapter 4: Measurements and Calculations
67
Measurements
d Save the calculation. (See “To save a
calculation” on page 45.)
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 34.
3 Do the following for each measurement you
want to take:
Vascular Calculations
a From the calculations menu, select the
measurement name.
Menu
Heading
Vascular
Measurement
Calculation
Results
CCA
Prox
s (systolic),
d (diastolic)
Mid
s (systolic),
d (diastolic)
Dist
s (systolic),
d (diastolic)
d Using the touchpad, position the second
caliper at the end diastole on the
waveform.
Bulb
s (systolic),
d (diastolic)
e Save the calculation. (See “To save a
calculation” on page 45.)
Prox
s (systolic),
d (diastolic)
ICA
ECA
Mid
s (systolic),
d (diastolic)
Dist
s (systolic),
d (diastolic)
Prox
s (systolic),
d (diastolic)
Mid
s (systolic),
d (diastolic)
Dist
s (systolic),
d (diastolic)
VArty
s (systolic),
d (diastolic)
b Using the touchpad, position the caliper at
the peak systolic waveform.
c Press the SELECT key.
A second caliper appears.
Patient report
The patient report contains calculation results
and patient information. For Cardiac, OB,
Transcranial, and Vascular exams, the patient
report has additional details and features.
You can display the patient report at any time
during the exam.
The value for a calculation appears only if the
calculation is 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 display a patient report
1 Press the REPORT key.
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.
68
Patient report
2 Do any of the following:
• To display additional pages, select
on‐screen.
1/x
• (Cardiac, Vascular, or TCD) Select Details
or Summary on‐screen. The mean of the
detail entries is used in the summary.
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.
To send a patient report to a PC
You can send a patient report to a PC as a text file.
1 Ensure correct configuration. See “To
configure the system for a DVD recorder, PC,
or serial bar code scanner” on page 19.
Make sure to use the connection cable
supplied by SonoSite. Other connection cables
may cause audio interference, including an
inaudible Doppler signal.
2 Select Send Rep. on‐screen.
To delete a row of TCD measurements
1 On the Details page of the TCD patient report,
select the row’s TAP measurement using the
touchpad. (The selected measurement is
green.)
2 Select Delete on‐screen.
Deleted measurements are not included in the
summary information.
OB patient report
The OB patient report pages have a space for
signing printed reports.
To display the OB Twins patient report
Vascular and cardiac patient reports
To delete a vascular or cardiac measurement
1 On the Details page of the patient report,
select the measurement by using the
touchpad. (The selected measurement is
green.)
2 Select Delete on‐screen.
Deleting some measurements also deletes
related measurements. Deleted
measurements are not included in the
summary information.
(Vascular) To modify the ICA/CCA ratio
In the Ratio list in the vascular patient report,
select measurements for the ICA/CCA ratio
for both the right and left sides.
On the OB patient report, select one of the
following on‐screen:
• Twin A/B for individual twin patient
reports
• Compare for both twins in one patient
report
To delete an OB measurement
1 On the OB patient report, select the OB
measurement by using the touchpad.
The selected measurement is green.
2 Select Delete on‐screen.
To delete all measurements, select the
measurement label and press the SELECT key
and then select Delete on‐screen.
Measurements
(Cardiac) To adjust the RA pressure
On the Summary page of the cardiac patient
report, select from the RA list.
Changing the RA pressure from the default 5
affects the RVSP calculation result.
TCD patient report
The maximum values for the TAP calculation
appear on the summary page.
Chapter 4: Measurements and Calculations
69
measurement/author or select
on‐screen.
1/x
For twins, both measurement sets are plotted
on the same graph.
3 (Optional) Press the SAVE key to save the
current graph page.
4 Select one of the following on‐screen:
• Report to return to the previous patient
report page
• Done to return to live imaging.
Figure 3 OB Anatomy Checklist Page
EMED worksheets
To fill out the OB anatomy checklist
EMED worksheets contain results from EMED
calculations and checklists that you can complete.
You can document reviewed anatomy.
On the Anatomy Checklist page in the OB
patient report, select the check boxes.
Press the TAB key to move between fields and
the SPACEBAR to select and deselect items in
the checklist.
To complete the OB biophysical profile
On page 2 of the OB patient report, select
values under BPP.
The total is calculated when values are
selected. NST (non‐stress test) is optional.
To display OB graphs
You can display OB graphs if the LMP or Estab.
DD fields are complete in the patient information
form.
1 On the OB patient report, select Graphs
on‐screen.
2 In the Graphs list, select the desired
measurement/author.
The graph for the selected measurement
appears. You can select another
70
Patient report
To display an EMED worksheet
This feature is optional.
1 After or during the exam, press the REPORT
key.
2 Select EMED on‐screen.
3 Select the worksheet from the Worksheet list
or by selecting
x/x on‐screen.
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.
Ensure that the DVD recorder is turned on and
set up properly. See the applicable SonoSite
accessory user guide and the manufacturers’
instructions.
External monitor does not work.
Troubleshooting
If you encounter difficulty with the system, use
the following list to help troubleshoot the
problem. If the problem persists, contact SonoSite
Technical Support. (See “SonoSite Technical
Support” on page vii.)
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 display
to improve viewing angle.
Adjust the brightness.
Adjust the gain.
No CPD image. Adjust the gain.
No Color image. Adjust the gain or the PRF scale.
No OB measurement selections.
Select the OB exam type.
Print does not work. Select the printer on the
Connectivity setup page. See “To configure the
system for a printer” on page 19.
Check the printer connections.
DVD recorder does not record. Check the DVD
recorder connections.
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 transducer.
Disconnect and reconnect the transducer.
A maintenance icon
appears on the system
screen. System maintenance may be required.
Record the number in parentheses on the C: line
and contact SonoSite or your 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:
Troubleshooting
Ensure that the printer is turned on and set up
properly. See the printer manufacturer’s
instructions, if necessary.
Check the monitor connections.
After the grace period expires, all
system functions except licensing
are unavailable until a valid license
key is entered.
Chapter 5: Troubleshooting and Maintenance
71
To obtain a license key for your software, contact
SonoSite Technical Support. (See “SonoSite
Technical Support” on page vii.) You need to
provide the following information. (See “System
Information setup” on page 23.)
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
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 vii.)
Maintenance
Use the recommendations in this section when
cleaning or disinfecting your ultrasound system,
transducer, and accessories. Use the cleaning
Maintenance
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 74.) 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 vii.)
Transducer bundle version
After you obtain a license key, you must enter it
into the system.
72
recommendations in the peripheral
manufacturer’s instructions when cleaning or
disinfecting your peripherals.
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 contacts during use. To
avoid infection, ensure that the
disinfectant type and the solution
strength and duration 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 the FDA.
WARNING:
Caution:
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.
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.
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
“Recommended disinfectants” on page 77.
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.
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 ethanolic‐based 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.
4 Mix the disinfectant solution compatible with
the system, following disinfectant label
Chapter 5: Troubleshooting and Maintenance
73
Troubleshooting
To avoid infection, ensure that the
solution expiration date has not
passed.
Caution:
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, “Disinfectant Compatibility with
System and Transducers” on page 77.
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.
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.
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.
To clean and disinfect a transducer (wipe
method)
1 Disconnect the transducer from the system.
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.
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.
74
Maintenance
7 Air dry.
8 Examine the transducer and cable for damage
such as cracks, splitting, or fluid leaks.
Cleaning and disinfecting the battery
Caution:
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 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.
8 Examine the transducer and cable for damage
such as cracks, splitting, or fluid leaks.
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. Sani‐Cloth HB, Sani‐Cloth Wipes, or
70% isopropyl alcohol is recommended.
4 Air dr.
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
Troubleshooting
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.
To avoid damaging the battery, do
not allow cleaning solution or
disinfectant to come in contact
with the battery terminals.
2 Wring out cloth until slightly wet and then
gently rub soiled area until clean.
If damage is evident, discontinue use of the
transducer, and contact SonoSite or your local
representative.
Chapter 5: Troubleshooting and Maintenance
75
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.
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
4 Air dry or towel dry with a clean cloth.
76
Maintenance
Recommended disinfectants
Table 1 does not have the following regulatory information for disinfectants:
• EPA Registration
• FDA 510(k) clearance (liquid sterilant, high level disinfectant)
• CE approval
Before using a disinfectant, confirm that its regulatory status is appropriate for your jurisdiction and use. Verify
expiration dates on chemicals.
When disposing of chemicals, follow manufacturer recommendations and EPA regulations.
See www.sonosite.com for updated cleaning and disinfectant information.
Table 1: Disinfectant Compatibility with System and Transducers
Chapter 5: Troubleshooting and Maintenance
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
C60x
ICTx
L38x
P10x
P21x
SLAx
AbcoCide 14
USA
Liquid
Gluteraldehyde
Accel Plus
CAN
Wipe
Accel TB
CAN
Accel Wipes
C11x/
L25x
System
Surfaces
Hydrogen Peroxide
Wipe
Hydrogen Peroxide
CAN
Wipe
Hydrogen Peroxide
Aidal Plus
AUS
Liquid
Gluteraldehyde
Alkacide
FRA
Liquid
Gluteraldehyde
Alkazyme
FRA
Liquid
Quat. Ammonia
Anioxyde 1000
FRA
Liquid
Peracetic Acid
Aquatabs (1000)
IRL
Tablet
Sodium
Dichloroisocyanurate
77
HFL38x
D2x
Troubleshooting
78
Table 1: Disinfectant Compatibility with System and Transducers (continued)
C60x
ICTx
L38x
P10x
P21x
SLAx
D2x
HFL38x
C11x/
L25x
System
Surfaces
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Aquatabs (2000)
IRL
Tablet
Sodium
Dichloroisocyanurate
Aquatabs (5000)
IRL
Tablet
Sodium
Dichloroisocyanurate
Ascend
USA
Liquid
Quat Ammonia
Asepti-HB
USA
Liquid
Quat Ammonia
Asepti-Steryl
USA
Spray
Ethanol
Asepti-Wipes
USA
Wipe
Propanol (Isopropyl
Alcohol
Bacillocid rasant
DEU
Liquid
Glut./Quat. Ammonia
Bacoban
DEU
Liquid
Ethanol Isopropanol
Bacoban WB
DEU
Liquid
Benzalkoniumchloride
Diethylenglycol
Banicide
USA
Liquid
Gluteraldehyde
Betadine
USA
Liquid
Providone-Iodine
Bleach
USA
Liquid
NaCl Hypochlorite
Cavicide
USA
Liquid
Isopropyl
Caviwipes
USA
Wipes
Isopropanol
Chlor-Clean
GBR
Liquid
Sodium
Dichloroisocyanurate
Table 1: Disinfectant Compatibility with System and Transducers (continued)
C60x
ICTx
L38x
P10x
P21x
SLAx
D2x
HFL38x
C11x/
L25x
System
Surfaces
Chapter 5: Troubleshooting and Maintenance
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Cidalkan
FRA
Liquid
Alkylamine, isopropanol
Cidalkan Lingettes
FRA
Wipes
Ethyl Alcohol
Cidex
USA
Liquid
Gluteraldehyde
Cidex OPA
USA
Liquid
Ortho-phthaldehyde
Cidex Plus
USA
Liquid
Gluteraldehyde
Cleanisept
DEU
Wipes
Quat. Ammonia
Clorox Wipes
USA
Wipes
Isopropanol
Control III
USA
Liquid
Quat. Ammonia
Coverage Spray
USA
Spray
Quat. Ammonia
Denatured Alcohol USA
Liquid
Ethanol
DentaSept
FRA
Liquid
Quat. Ammonia
DisCide Ultra
Disinfecting
Towelettes
USA
Wipes
Isopropyl Alcohol
DisCide Wipes
USA
Wipes
Isopropyl Alcohol
DisOPA
JPN
Liquid
Ortho-phthaldehyde
Dispatch
USA
Spray
NaCl Hypochlorite
Dynacide PA
FRA
Liquid
Peracetic Acid
79
Troubleshooting
80
Table 1: Disinfectant Compatibility with System and Transducers (continued)
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
C60x
ICTx
L38x
P10x
P21x
SLAx
End-Bac II
USA
Liquid
Quat. Ammonia
Endozime AW Plus
FRA
Liquid
Propanol
Envirocide
USA
Liquid
Isopropyl
Enzol
USA
Cleaner
Ethylene Glycol
Expose
USA
Liquid
Isopropyl
Gigasept AF
DEU
Liquid
Quat. Ammonia
Gigasept FF
DEU
Liquid
Bersteinsaure
Gluteraldehyde SDS USA
Liquid
Gluteraldehyde
Hexanios
FRA
Liquid
Polyhexanide/Quat.
Ammonia
Hi Tor Plus
USA
Liquid
Chloride
Hibiclens
USA
Cleaner
Chlorhexidine
Hydrogen Peroxide USA
Liquid
Hydrogen Peroxide
Isopropanol Alcohol ALL
Liquid
Alcohol
Kodan Tücher
DEU
Liquid
Propanol
Kohrsolin ff
DEU
Liquid
Gluteraldehyde
Korsolex basic
DEU
Liquid
Gluteraldehyde
Lem-O-Quat
USA
Liquid
Alkyl/Chloride
D2x
HFL38x
C11x/
L25x
System
Surfaces
Table 1: Disinfectant Compatibility with System and Transducers (continued)
81
Country
of Origin
Type
Active Ingredient
LpHse
USA
Liquid
O-phenylphenol
Lysol
USA
Spray
Ethanol
Lysol IC
USA
Liquid
O-phenylphenol
Madacide 1
USA
Liquid
Isopropanol
Matar
USA
Liquid
O-phenylphenol
MetriCide 14
USA
Liquid
Gluteraldehyde
MetriCide 28
USA
Liquid
Gluteraldehyde
MetriZyme
USA
Cleaner
Propylene Glycol
Mikrobak forte
DEU
Liquid
Ammonium Chloride
Mikrozid Wipes
DEU
Wipe
Ethanol/Propanol
Nuclean
FRA
Spray
Alcohol/Biguanide
Precise
USA
Spray
O-phenylphenol
Ruthless
USA
Spray
Quat. Ammonia
Sagrosept Wipe
DEU
Wipe
Propanol
Salvanios pH 7
FRA
Liquid
Quat. Ammonia
Sani-Cloth HB
USA
Wipe
Quat. Ammonia
Sani-Cloth Plus
USA
Wipe
Quat. Ammonia
Sekusept
DEU
Liquid
Gluteraldehyde
Troubleshooting
Chapter 5: Troubleshooting and Maintenance
Disinfection and
Cleaning Solutions
C60x
ICTx
L38x
P10x
P21x
SLAx
D2x
HFL38x
C11x/
L25x
System
Surfaces
82
Table 1: Disinfectant Compatibility with System and Transducers (continued)
C60x
ICTx
L38x
P10x
P21x
SLAx
D2x
HFL38x
C11x/
L25x
System
Surfaces
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Sklar
USA
Liquid
Isopropanol
Sporicidin
USA
Liquid
Phenol
Sporicidin Wipes
USA
Wipe
Phenol
Staphene
USA
Spray
Ethanol
Steranios
FRA
Liquid
Gluteraldehyde
Super Sani-Cloth
USA
Wipe
Isopropyl Alcohol
T-Spray
USA
Spray
Quat. Ammonia
T-Spray II
USA
Spray
Alkyl/Chloride
TASK 105
USA
Spray
Quat. Ammonia
TBQ
USA
Liquid
Alkyl
Theracide Plus
Wipes
USA
Wipe
Quat. Ammonia
Tor
USA
Liquid
Quat. Ammonia
Transeptic
USA
Cleaner
Alcohol
Tristel
GBR
Liquid
Chlorine Dioxide
Tristel Duo
GBR
Tristel Solo
GBR
Foam
Hexamethylenebiguanide
Tristel Wipes
GBR
Wipe
Chlorine Dioxide
Table 1: Disinfectant Compatibility with System and Transducers (continued)
C60x
ICTx
L38x
P10x
P21x
SLAx
D2x
HFL38x
C11x/
L25x
System
Surfaces
Chapter 5: Troubleshooting and Maintenance
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Vesphene II
USA
Liquid
Sodium/
o-Phenylphenate
Virex II 256
USA
Liquid
Ammonium Chloride
Virex TB
USA
Liquid
Quat. Ammonia
Virox 5
CAN
Wipe
Hydrogen Peroxide
Virufen
FRA
Liquid
Alkyl Ammonium Chloride
Wavicide -01
USA
Liquid
Gluteraldehyde
Wavicide -06
USA
Liquid
Gluteraldehyde
Wet Wipe
Disinfection
DNK
Wipe
Guanidinium-chloride
Wex-Cide
USA
Liquid
O-phenylphenol
A = Acceptable
N = No (Do not use)
U = Untested (Do not use)
83
Troubleshooting
84
Chapter 6: Safety
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 disorders (MSDs)a,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 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
85
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.
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
• If possible, position the system within reach.
• Adjust the angle of the system and display to minimize glare.
• 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 supports your lower back, that adjusts to your work surface height, that
promotes a natural body posture, and that allows quick height adjustments.
• Always sit or stand upright. 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.
• Position the ultrasound system or display directly in front of you.
• Provide an auxiliary monitor for patient viewing.
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.
86
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. 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.
• Do targeted exercises. 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, docking system, and
peripherals. Equipment is not suitable for use in the
presence of flammable anaesthetics.
Chapter 6: Safety
87
Electrical safety
This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type
BF isolated patient‐applied parts safety requirements.
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.
88
WARNING:
Safety
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 to the patient, do not simultaneously touch the
patient and the ungrounded signal input/output connectors on the back of the
ultrasound system.
To avoid the risk of electrical shock and fire hazard, inspect the power supply, AC
power cords, cables, and plugs on a regular basis. Ensure that they are not damaged.
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 docking system, and cannot be used to connect
other devices to 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 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
89
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 touch battery contacts.
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.
90
Do not connect the battery to an electrical power outlet.
WARNING:
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.
Chapter 6: Safety
91
Safety
Do not continue recharging the battery if it does not recharge after two successive
six hour charging cycles.
Clinical safety
WARNING:
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.
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.
To avoid injury or reduce the risk of infection to the patient, observe the following:
• • Follow Universal Precautions when inserting and maintaining a medical device
for interventional and intraoperative procedures.
• Appropriate training in interventional and intraoperative procedures as dictated
by current relevant medical practices as well as in proper operation of the
ultrasound system and transducer is required. During vascular access, the
potential exists for serious complications including without limitation the
following: pneumothorax, arterial puncture, guidewire misplacement, and risks
normally associated with local or general anesthesia, surgery, and post-operative
recovery.
To avoid device damage or patient injury, do not use the P10x, P17x, or P21x needle
guide bracket on patients with pacemakers or medical electronic implants. The
needle guide bracket for the P10x, P17x, and P21x 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.
92
Hazardous materials
The liquid crystal display (LCD) contains mercury. Dispose of the LCD properly in
accordance with local regulations.
Safety
WARNING:
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.
Chapter 6: Safety
93
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
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
for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
The SonoSite ultrasound system is suitable for use in
all establishments other than domestic and those
directly connected to the public low-voltage power
supply network which supplies buildings used for
domestic purposes.
ClSPR 11
RF emissions
ClSPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
94
Complies
The system is intended for use in the electromagnetic environment specified below.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity
IEC 60601 Test Level
Compliance Level
Electrostatic
Discharge (ESD)
2.0KV, 4.0KV, 6.0KV
contact
2.0KV, 4.0KV, 6.0KV
contact
IEC 61000-4-2
2.0KV, 4.0KV, 8.0KV air
2.0KV, 4.0KV, 8.0KV
air
Electrical fast
2KV on the mains
2KV on the mains
Transient burst
1KV on signal lines
1KV on signal lines
0.5KV, 1.0KV, 2.0KV on
AC power lines to
ground
0.5KV, 1.0KV, 2.0KV
on AC power lines
to ground
0.5KV, 1.0KV on AC
power lines to lines
0.5KV, 1.0KV on AC
power lines to
lines
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
>5% UT
>5% UT
(>95% dip in UT ) for
0.5 cycle
(>95% dip in UT )
for 0.5 cycle
40% UT
40% UT
(60% dip in UT ) for 5
cycles
(60% dip in UT ) for
5 cycles
IEC 61000-4-11
70% UT
70% UT
(30% dip in UT ) for 25
cycles
(30% dip in UT ) for
25 cycles
>5% UT
>5% UT
(>95% dip in UT ) for 5s
(>95% dip in UT )
for 5s
IEC 61000-4-4
Surge
IEC 61000-4-5
Safety
Immunity Test
Electromagnetic
Environment
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of the
SonoSite ultrasound system
requires continued operation
during power mains
interruptions, it is
recommended that the
SonoSite ultrasound system
be powered from an
uninterruptible power supply
or a battery.
Chapter 6: Safety
95
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
Electromagnetic
Environment
Immunity Test
IEC 60601 Test Level
Compliance Level
Power
Frequency
Magnetic Field
3 A/m
3 A/m
If image distortion occurs, it
may be necessary to position
the SonoSite ultrasound
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
IEC 61000-4-6
150 kHz to 80 MHz
Portable and mobile RF
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.
IEC 61000-4-8
Recommended Separation
Distance
d = 1.2 P
Radiated RF
3 Vim
IEC 61000-4-3
80 MHz to 2.5 GHz
3 V/m
d = 1.2 P
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).
96
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
Radiated RF
IEC 61000-4-3
(continued)
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment
Safety
Immunity Test
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic Site
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,
Chapter 6: Safety
97
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.
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 104. 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 either the Ophthalmic or Orbital exam, the acoustic output 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”
98
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,
the best results may be achieved by minimizing these parameters simultaneously. In some
modes changing these parameters does not affect MI or TI. Changes to other parameters may
also result in MI and TI reductions. Please note the MI and TI values on the right side of the
screen.
Chapter 6: Safety
99
Safety
on page 99. 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.
Table 3: MI
Transducer
Depth
C11x
↑
C60x
↑
HFL38x
↑
ICTx
↑
L25x
↑
L38x
↑
P10x
↑
P21x
↑
SLAx
↑
TEEx
↑
↓Decrease or lower setting of parameter to reduce MI.
↑Increase or raise setting of parameter to reduce MI.
Table 4: TI (TIS, TIC, TIB)
Color Power Doppler Settings
Transducer
Box
Width
Box
Height
C11x
C60x
↓
HFL38x
↑
ICTx
L25x
PRF
Depth
↑
↓
↑
↓ (Depth)
↑
↓
↑
↓ (PRF)
↑
↑
↑
↓ (Depth)
↑
↓
↓
P21x
100
Optimize
Exam Gyn
↑
—
—
↓
↑
↓ (PRF)
↓ (PRF)
↓
L38x
P10x
PW Settings
Box
Depth
↓ (Depth)
↓
—
↓
↑
—
↓ (PRF)
↓ (PRF)
Table 4: TI (TIS, TIC, TIB)
Transducer
PW Settings
Box
Width
Box
Height
Box
Depth
PRF
Depth
Optimize
SLAx
—
—
↑
↓
↑
—
↓ (PRF)
TEEx
—
—
—
↓
↓
—
↓ (PRF)
↓Decrease or lower setting of parameter to reduce MI.
↑Increase or raise setting of parameter to reduce MI.
Chapter 6: Safety
101
Safety
Color Power Doppler Settings
Output display
The system meets the AIUM output display standard for MI and TI (see last reference 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.
Note: The D2x transducer has a static continuous wave (CW) output. This output is fixed. Therefore,
TI and MI values cannot be changed by any system controls available to the user.
Table 5: TI or MI ≥ 1.0
CPD/
Color
PW
Doppler
CW
Doppler
MI
No
No
No
—
TIC,TIB, or TIS
No
Yes
Yes
—
MI
Yes
No
No
—
TIC, TIB, or TIS
No
No
Yes
—
MI
—
—
—
No
TIC,TIB, or TIS
—
—
—
Yes
MI
No
Yes
Yes
—
TIC, TIB, or TIS
No
Yes
Yes
—
MI
No
No
No
—
TIC, TIB, or TIS
No
No
Yes
—
MI
No
Yes
No
—
TIC,TIB, or TIS
No
No
Yes
—
MI
No
Yes
Yes
—
TIC, TIB, or TIS
No
Yes
Yes
—
MI
No
Yes
Yes
No
TIC, TIB, or TIS
Yes
Yes
Yes
Yes
MI
Yes
Yes
Yes
No
TIC, TIB, or TIS
Yes
Yes
Yes
Yes
MI
No
No
No
—
TIC, TIB, or TIS
No
No
Yes
—
Index
C11x/8-5
C60x/5-2
D2x/2
HFL38x/13-6
ICTx/8-5
L25x/13-6
L38x/10-5
P10x/8-4
P21x/5-1
SLAx/13-6
102
2D/
M Mode
Transducer Model
Table 5: TI or MI ≥ 1.0 (Continued)
CPD/
Color
PW
Doppler
CW
Doppler
MI
No
No
No
No
TIC, TIB, or TIS
No
No
Yes
Yes
Index
TEEx/8-3
Even when MI is less than 1.0, the system provides a continuous real‐time display of MI in all
imaging modes, in increments of 0.1.
The system meets the output display standard for TI and provides a continuous real‐time
display of TI in all imaging modes, in increments of 0.1.
The TI consists of three user‐selectable indices, and only one of these is displayed at any one
time. In order to display TI properly and meet the ALARA principle, the user selects an
appropriate TI based on the specific exam being performed. SonoSite provides a copy of AIUM
Medical Ultrasound Safety, which contains guidance on determining which TI is appropriate (See
“Related guidance documents” on page 104).
MI and TI output display accuracy
The accuracy result for the MI is stated statistically. With 95% confidence, 95% of the measured
MI values will be within +18% to ‐25% of the displayed MI value, or +0.2 of the displayed value,
whichever value is larger.
The accuracy result for the TI is stated statistically. With 95% confidence, 95% of the measured
TI values will be within +21% to ‐40% 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 133.
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
Chapter 6: Safety
103
Safety
2D/
M Mode
Transducer Model
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.)
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 (23°C ± 3°C) of
transducers used on the ultrasound system. The temperatures were measured in accordance
with EN 60601‐2‐37 section 42 with controls and settings positioned to give maximum
temperatures
Table 6: Transducer Surface Temperature Rise, External Use (°C)
104
Test
C11x
C60x
D2
HFL38x
L25x
L38x
P10x
P21x
Still air
17.6
16.2
8.3
15.5
16.1
16.3
15.6
16.8
Simulated
Use
9.1
8.8
1.9
7.9
8.5
9.6
9.8
9.0
Table 7: Transducer Surface Temperature Rise, Internal Use (°C )
ICTx
SLAx
TEEx
Still air
9.2
9.5
9.3
Simulated
Use
5.2
4.8
5.8
Safety
Test
Acoustic output measurement
Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)
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 from
its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J
Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement). The report, sometimes referred to as
the Stowe Report, 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 “Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment” (NEMA UD2‐2004), and “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)
Chapter 6: Safety
105
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
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.
106
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.
• 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
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 31 indicate the acoustic output for the system and transducer
combinations with a TI or MI equal to or greater than one. These tables are organized by
transducer model and imaging mode. For a definition of terms used in the tables, see “Terms
used in the acoustic output tables” on page 132.
Chapter 6: Safety
107
Safety
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.
Table 8: Transducer Model: C11x/8-5
Operating Mode: CPD/Color
TIS
Index Label
M.I.
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
(MPa)
(a)
TIB
Non-scan
TIC
—
1.2
—
40.50
—
—
—
—
—
—
—
—
—
—
—
4.38
0.36
0.5
(cm)
—
FLx (cm)
—
—
1.56
FLy (cm)
—
—
2.5
(W/cm2)
Control 1: Mode
Control 2: Exam Type
Control 3: PRF
Control 4: Optimization/Depth
Control 5: Color Box
Position/ Size
CPD
Vas
2841
Med/2.0
Top/
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.
108
Table 9: Transducer Model: C11x/8-5
Operating Mode: PW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
1.8
1.7
26.29
24.65
1.1
0.236
—
—
—
—
—
—
4.36
0.28
0.5
4.36
0.2
0.5
(cm)
0.226
FLx (cm)
—
—
0.77
FLy (cm)
—
—
2.5
(W/cm2)
Control 1: Exam Type
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
Any
2 mm
3906
Zone 1
Any
3 mm
≥3906
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
109
Safety
Index Label
TIB
Table 10: Transducer Model: C60x/5-2
Operating Mode: 2D
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.0
1.69
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Non-scan
TIC
—
(b)
—
—
4.7
—
2.84
—
—
—
—
—
—
—
—
—
deq@Pllmax
X (cm)
Y (cm)
(μsec) 0.579
(Hz) 5440
(MPa) 2.679
(cm)
Focal Length
FLx (cm)
—
—
FLy (cm)
—
—
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Control 1: Exam Type
Operating
Control
Conditions
M.I.
TIB
Control 2: Optimization
Control 3: Depth
Control 4: THI
Control 5: MB (Multi Beam)
—
(W/cm2) 197.7
Abd/
OB
Any
11/
13 cm
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.
110
Table 11: Transducer Model: C60x/5-2
Operating Mode: M Mode
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.0
1.62
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Non-scan
TIC
(a)
(b)
4.7
2.85
—
—
—
—
—
—
deq@Pllmax
X (cm)
Y (cm)
(μsec) 0.577
(Hz) 800
(MPa) 2.576
(cm)
Focal Length
FLx (cm)
—
—
FLy (cm)
—
—
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
M.I.
Control 1: Exam Type
Control 2: Optimization
Control 3: Depth
Control 4: MB (Multi Beam)
(W/cm2) 184.3
Any
Pen
7.8 cm
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
111
Safety
Index Label
TIB
Table 12: Transducer Model: C60x/5-2
Operating Mode: PW Doppler
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
3.1
(b)
85.64
1.255
0.51
—
—
—
—
—
—
2.233
0.6552
1.3
(cm)
0.415
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm )
Control 1: Exam Type
Control 2: PRF
Control 3: Sample Volume
Control 4: Sample Volume Position
Abd
Any
12 mm
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.
112
Table 13: Transducer Model: D2x/2
Operating Mode: CW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
Control 1: Exam Type
Control 2: Depth
Control 3: Zone
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
2.6
(b)
90.52
1.1
0.66
—
—
—
—
—
—
2.00
0.8
0.4
(cm)
0.54
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm2)
Crd
Fixed
Fixed
(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
113
Safety
Index Label
TIB
Table 14: Transducer Model: HFL38x/13-6
Operating Mode: CPD/Color
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.1
2.556
Non-scan
Aaprt≤1
Aaprt>1
1.0
—
—
—
(b)
53.49
—
—
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
TIC
Nonscan
Scan
W0
Dim of Aaprt
Operating
Control
Conditions
M.I.
TIB
—
1.2
—
5.328
5.324
0.44
0.4
—
—
—
—
—
—
—
—
—
0.525
2597
3.187
(cm)
—
FLx (cm)
1.32
—
—
FLy (cm)
2.5
—
—
(W/cm2)
Control 1: Mode
Control 2: Exam Type
Control 3: Optimization/Depth/PRF
Control 4: Color Box Position/Size
325.5
Color
Any
Low/3.3 cm/
393
Any
Color
Any
Med/
2.7 cm/
1938
Top/
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.
114
Table 15: Transducer Model: HFL38x/13-6
Operating Mode: PW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
(MPa)
Aaprt≤1
Aaprt>1
—
1.2
—
—
46.55
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
2.2
(b)
46.55
1.1
0.9
0.33
5.32
—
—
—
5.33
1.04
0.4
—
—
—
5.33
1.04
0.4
1.29
1008
2.404
(cm)
0.46
FLx (cm)
—
3.72
—
FLy (cm)
—
2.5
—
(W/cm2)
Control 1: Exam Type
Operating
Control
Conditions
1.0
2.37
Non-scan
Scan
W0
Dim of Aaprt
Other Information
M.I.
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
323.35
Bre/Vas
SmP/IMT
1 mm
1008
Zone 2
Vas/Ven/
IMT
12 mm
10417
Zone 7
Vas/Ven/
IMT
12 mm
10417
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.
Chapter 6: Safety
115
Safety
Index Label
TIB
Table 16: Transducer Model: ICTx/8-5
Operating Mode: PW Doppler
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
1.2
(a)
16.348
1.6
0.192
—
—
—
—
—
—
4.36
0.6
0.5
(cm)
0.187
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm2)
Control 1: Exam Type
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
Any
3 mm
Any
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.
116
Table 17: Transducer Model L25x/13-6
Operating Mode: PW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
(MPa)
Aaprt≤1
Aaprt>1
—
(a)
—
—
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
1.6
(b)
14.02
0.6
0.155
—
—
—
—
—
—
6.00
0.16
0.3
(cm)
0.1549
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm2)
Control 1: Exam Type
Operating
Control
Conditions
(a)
Non-scan
Scan
W0
Dim of Aaprt
Other Information
M.I.
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
Vas/Nrv/
Ven
12 mm
20833
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
117
Safety
Index Label
TIB
Table 18: Transducer Model: L38x/10-5
Operating Mode: CPD/Color
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.3
2.89
Non-scan
Scan
Aaprt≤1 Aaprt>1
1.0
—
64.88
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
—
(b)
—
—
1.1
—
4.91
4.91
0.54
0.4
—
—
—
—
—
—
—
—
—
0.529
9547
3.48
(cm)
—
FLx (cm)
1.5
—
—
FLy (cm)
2.5
—
—
(W/cm2)
Control 1: Mode
Control 2: Exam Type
Control 3: PRF
Control 4: Optimization/Depth
Control 5: Color Box Position/Size
439.3
Color
Any
331
Any/3.1
Any
CPD
Bre
2137
Med/3.1
Def/
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.
118
Table 19: Transducer Model: L38x/10-5
Operating Mode: PW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.04
2.345
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
2.0
—
—
84.94
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
2.6
(b)
84.94
1.3
0.8
0.4685
5.01
—
—
—
5.05
1.80
0.4
—
—
—
5.05
1.80
0.4
1.29
1008
2.693
(cm)
0.2533
FLx (cm)
—
5.54
—
FLy (cm)
—
2.5
—
(W/cm2)
Control 1: Exam Type
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
284.5
Any
1 mm
1008
Zone 0
(top)
Vas
12 mm
Any
Vas
12 mm
Any
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.
Chapter 6: Safety
119
Safety
Index Label
TIB
Table 20: Transducer Model: P10x/8-4
Operating Mode: 2D Mode
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
Control 1: Exam Type
Control 2: Optimization
Control 3: Depth
Control 4: MB/SonoHD
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
—
1.0
—
35.24
—
—
—
—
—
—
—
—
—
—
—
4.84
0.416
0.7
(cm)
—
FLx (cm)
—
—
1.67
FLy (cm)
—
—
5.0
(W/cm2)
Neo
Gen
2.0
Off/Off
(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.
120
Table 21: Transducer Model: P10x/8-4
Operating Mode: Color
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.0
2.02
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
TIC
—
1.3
—
41.38
—
2.4
—
3.90
—
—
—
—
—
—
—
—
—
3.91
0.608
0.7
0.70
2772
2.80
(cm)
—
FLx (cm)
—
—
2.48
FLy (cm)
—
—
5.0
(W/cm2)
Control 1: Mode
Control 2: Exam Type
Control 3: Optimization/Depth/PRF
Control 4: Color Box Pos/Size
Non-scan
252
Color
Neo
Low/
3.7/
772
Any/
Tall
Color
Abd
Med/
2.0/
2315
Short/
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
121
Safety
Index Label
TIB
Table 22: Transducer Model: P10x/8-4
Operating Mode: PW Doppler
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.0
2.03
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
1.2
—
—
36.25
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Non-scan
TIC
2.0
1.8
34.4
31.5
0.8
2.1
0.32
3.87
—
—
—
6.86
0.992
0.7
—
—
—
3.84
0.416
0.7
3.86
.224
0.7
deq@Pllmax
X (cm)
Y (cm)
(μsec) 1.28
(Hz) 1563
(MPa) 2.70
(cm)
Focal Length
FLx (cm)
—
6.74
—
0.92
FLy (cm)
—
5.0
—
5.0
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
(W/cm2)
Control 1: Exam Type
Control 2: Sample Volume
Control 3: PRF/TDI
Control 4: Sample Volume Position
0.25
233
Crd
1 mm
1563/
Off
Zone 3
Crd
7 mm
Any/
On
Zone 6
Neo
12 mm
15625/
Off
Zone 2
Crd
1 mm
5208/
Off
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.
122
Table 23: Transducer Model: P10x/8-4
Operating Mode: CW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
Control 1: Exam Type
Control 2: Depth
Control 3: Zone
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
2.1
2.0
40.72
30.00
0.7
0.36
—
—
—
—
—
—
4.00
0.320
0.7
4.00
0.16
0.7
(cm)
0.27
FLx (cm)
—
—
0.92
FLy (cm)
—
—
5.0
(W/cm2)
Card
Any
Card
Any
Zone 3
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
123
Safety
Index Label
TIB
Table 24: Transducer Model: P21x/5-1
Operating Mode: 2D
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.4
1.92
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Non-scan
TIC
—
2.3
—
171.53
—
5.1
—
1.93
—
—
—
—
—
—
—
—
—
1.94
1.9
1.3
deq@Pllmax
X (cm)
Y (cm)
(μsec) 0.842
(Hz) 4000
(MPa) 2.53
(cm)
Focal Length
FLx (cm)
—
—
18.46
FLy (cm)
—
—
5.5
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
Control 1: Exam Type
Control 2: Optimization
Control 3: Depth
Control 4: THI
Control 5: Sector Width
—
(W/cm2) 355.1
Card
Res
4.7/7.5
cm
On
Narrow
Card
Pen
27 cm
Off
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.
124
Table 25: Transducer Model: P21x/5-1
Operating Mode: M Mode
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.5
2.10
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm) 3.645
(cm)
deq(zsp)
fc
(MHz)
1.93
Non-scan
TIC
1.4
1.1
40.08
29.71
4.9
0.343
—
—
—
—
—
—
1.93
1.835
1.3
1.94
1.9
1.3
deq@Pllmax
X (cm)
Y (cm)
(μsec) 0.904
(Hz) 800
(MPa) 2.679
(cm)
Focal Length
FLx (cm)
—
—
18.46
FLy (cm)
—
—
5.5
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Control 1: Exam Type
Operating
Control
Conditions
M.I.
Control 2: Optimization
Control 3: Depth
Control 4: THI
Control 5: MB
(Multibeam)
0.341
(W/cm2) 237.4
Abd/
OB
Any
7.5 cm
On
Gen/Res
10/13 cm
On
On
On or Off
Abd/OB
Abd/OB
/Card
Pen
27 cm
Off
On or
Off
(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
125
Safety
Index Label
TIB
Table 26: Transducer Model: P21x/5-1
Operating Mode: CPD/Color
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
(MPa)
Aaprt≤1 Aaprt>1
1.3
—
136.91
—
—
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Non-scan
TIC
—
2.4
—
137.5
—
4.5
—
2.15
2.16
0.918
1.3
—
—
—
—
—
—
—
—
—
2.16
0.918
1.3
deq@Pllmax
X (cm)
Y (cm)
(μsec) 1.20
(Hz) 1063
(MPa) 2.574
(cm)
Focal Length
FLx (cm)
3.68
—
—
3.68
FLy (cm)
5.5
—
—
5.5
PD
PRF
pr@PIImax
IPA.3@MImax
—
(W/cm2) 330.4
Control 1: Mode
Control 2: Exam Type
Operating
Control
Conditions
1.5
2.19
Non-scan
Scan
W0
Dim of Aaprt
Other Information
M.I.
TIB
Control 3: PRF/Depth
Control 4: Color Optimization
Control 5: THI
Control 6: Color Box Size
Color
Abd/
OB
300/10
Any
On
Any
CPD
Color
OB
Abd
850/7.5
Med
Off
Short and
Narrow
751/7.5
Med
Off
Short and
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.
126
Table 27: Transducer Model: P21x/5-1
Operating Mode: PW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
—
1.3
—
—
W0
1.2
(MPa) 1.844
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
120.13
z1
(cm)
3.1
zbp
(cm)
2.66
zsp
(cm) 3.718
(cm)
deq(zsp)
fc
(MHz)
2.16
Non-scan
TIC
4.0
2.7
95.55
95.55
0.6
0.49
—
—
—
—
—
—
2.22
1.9
1.3
2.23
0.459
1.3
2.23
0.459
1.3
deq@Pllmax
X (cm)
Y (cm)
(μsec) 1.21
(Hz) 1562.5
(MPa) 2.432
(cm)
Focal Length
FLx (cm)
—
—
13.84
1.55
FLy (cm)
—
—
5.5
5.5
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
M.I.
0.49
(W/cm2) 187.5
Control 1: Exam Type
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
Card
1mm
1563
Zone 1
Card
3mm
3906
Zone 4
TCD
14mm
12500
Zone 0
TCD
14mm
12500
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
127
Safety
Index Label
TIB
Table 28: Transducer Model: P21x/5-1
Operating Mode: CW Doppler
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
—
1.0
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
102.54
z1
(cm)
1.386
zbp
(cm)
1.71
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
Control 1: Exam Type
Control 2: Zone
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
3.4
2.9
88.30
101.73
1.255
0.49
—
—
—
—
—
—
2.00
0.786
1.3
2.00
0.655
1.3
2.00
0.459
1.3
(cm)
0.45
FLx (cm)
—
—
13.84
1.55
FLy (cm)
—
—
5.5
5.5
(W/cm2)
Card
Card
Card
Zone 4
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.
128
Table 29: Transducer Model: SLAx/13-6
Operating Mode: PW Doppler
Index Label
M.I.
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Aaprt>1
—
(a)
—
—
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD
PRF
pr@PIImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
deq@Pllmax
Focal Length
IPA.3@MImax
Non-scan
TIC
1.2
(b)
8.75
0.65
0.13
—
—
—
—
—
—
6.00
0.24
0.3
(cm)
0.13
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm )
Control 1: Exam Type
Operating
Control
Conditions
(a)
Aaprt≤1
W0
Dim of Aaprt
Other Information
(MPa)
TIB
Non-scan
Scan
Safety
TIS
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Vol. Position
Vas, Nrv,
Ven
5 mm
20833
Zone 2
(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
129
Table 30: Transducer Model: TEEx/8-3
Operating Mode: PW Doppler
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
1.7
(b)
29.29
0.6
0.34
—
—
—
—
—
—
3.84
0.261
0.9
(cm)
0.34
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm2)
Control 1: Exam Type
Control 2: Sample Volume
Control 3: PRF
Control 4: Sample Volume Position
Crd
1 mm
≥ 2604
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.
130
Table 31: Transducer Model: TEEx/8-3
Operating Mode: CW Doppler
TIS
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
(a)
Non-scan
Scan
Aaprt≤1
Aaprt>1
—
(a)
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
Control 1: Exam Type
Control 2: Depth
Control 3: Zone
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Non-scan
TIC
1.2
(b)
27.23
1.1
0.39
—
—
—
—
—
—
4.00
0.435
0.9
(cm)
0.34
FLx (cm)
—
—
FLy (cm)
—
—
(W/cm2)
Crd
Any
Zone 3
(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
131
Safety
Index Label
TIB
Terms used in the acoustic output tables
Table 32: Acoustic Output Terms and Definitions
132
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
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.
( A a p r t ) in centimeters.
Table 32: Acoustic Output Terms and Definitions (Continued)
Definition
deq(z)
Equivalent beam diameter as a function of axial distance z, and is equal to
Safety
Term
( 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.
Chapter 6: Safety
133
Table 33: Acoustic Measurement Precision and Uncertainty
Precision
(% of standard deviation)
Uncertainty
(95% confidence)
Pr
1.9%
+11.2%
Pr.3
1.9%
+12.2%
Wo
3.4%
+10%
fc
0.1%
+4.7%
PII
3.2%
+12.5 to -16.8%
PII.3
3.2%
+13.47 to -17.5%
Quantity
Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 34: 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.
LOT
Batch code, date code, or lot code type of control number
Biological risk
134
Table 34: Labeling Symbols (Continued)
Symbol
Definition
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.
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.
Chapter 6: Safety
135
Safety
Device complies with relevant Brazilian regulations for electro-medical devices.
Table 34: Labeling Symbols (Continued)
Symbol
Definition
Do not stack over 10 high.
Electrostatic sensitive devices
Device complies with relevant FCC regulations for electronic devices.
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.
136
Table 34: Labeling Symbols (Continued)
Symbol
Definition
Safety
Handle transducer with care.
Follow manufacturer’s instructions for disinfecting time.
Disinfect transducer.
Type BF patient applied part
(B = body, F = floating applied part)
Defibrillator proof type CF patient 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:
Connect Only
Accessories and
Peripherals
Recommended by
SonoSite
WARNING: Connect Only
Accessories and Peripherals
Recommended by SonoSite
Chapter 6: Safety
137
138
Chapter 7: 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.
Range (cm)
Test Methodb
Accuracy
By
System
Tolerancea
Axial
Distance
< ±2% plus
1% of full
scale
Acquisition Phantom
0-26 cm
Lateral
Distance
< ±2% plus
1% of full
scale
Acquisition Phantom
0-35 cm
Diagonal
Distance
< ±2% plus
1% of full
scale
Acquisition Phantom
0-44 cm
Areac
Acquisition Phantom
< ±4% plus
(2% of full
scale/smallest
dimension) *
100 plus 0.5%
0.01-720
cm2
Circumferenced
Acquisition Phantom
< ±3% plus
(1.4% of full
scale/
smallest
dimension) *
100 plus 0.5%
0.01-96
cm
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%.
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%.
Chapter 7: References
139
References
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.
Table 1: 2D Measurement Accuracy and Range
2D Measure
Accuracy
and Range
Measurement accuracy
Heart Rate
< +/2%
plus
1% of
full
scalec
Acquisition Phantomd
0-26 cm
0.01-10
sec
Acquisition Phantomd 5-923
< +/bpm
2%
plus
(Full
Scalec *
Heart
Rate/1
00) %
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.
Doppler Mode
Measurement
Accuracy and Range
< +/- 2%
plus 1% of
full scaleb
Acquisition
Phantom
0.01
cm/sec550 cm/s
ec
Frequency
cursor
< +/- 2%
plus 1% of
full scaleb
Acquisition
Phantom
0.01kHz20.8 kHz
Time
< +/- 2%
plus 1% of
full scalec
Acquisition
Phantom
0.01-10
sec
Range
Velocity
cursor
System
Tolerance
Range
Test Method
Acquisition Phantomb
Test
Methoda
Time
< +/2%
plus
1% of
full
scalea
Table 3: PW Doppler Mode Measurement and
Calculation Accuracy and Range
Accuracy By
Distance
Accuracy By
System Tolerance
M Mode Measurement
Accuracy and Range
Table 2: M Mode Measurement and
Calculation Accuracy and Range
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.
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
140
Sources of measurement errors
floating‐point versus integer‐type math, which is
subject to errors introduced by rounding versus
truncating results for display of a given level of
significant digit in the calculation.
Measurement publications
and terminology
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
Terminology and measurements comply with
AIUM published standards.
Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual.
2nd Edition, Boston: Little, Brown and Company,
(1999), 59.
Cardiac references
CI = CO/BSA
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.
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
Aortic Valve Area (AVA) by Continuity
Equation in cm2
Cross Sectional Area (CSA) in cm2
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 393, 442.
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 383.
A2 = A1 * V1/V2
CSA = 0.785 * D2
where:
A2 = Ao valve area
where:
A1 = LVOT area; V1 = LVOT velocity;
V2 = Ao valve velocity
Deceleration Time in msec
D = diameter of the anatomy of
interest
LVOT = Left Ventricular Outflow
Tract
AVA (PVLVOT/PVAO) * CSALVOT
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 453.
AVA (VTILVOT/VTIAO) * CSALVOT
|time a ‐ time b|
Chapter 7: References
141
References
The following sections list the publications and
terminology used for each calculation result.
Delta Pressure: Delta Time (dP:dT) in
mmHg/s
Otto, C.M. Textbook of Clinical Echocardiography.
2nd ed., W.B. Saunders Company, (2000), 117,
118.
32 mmHg/time interval in seconds
E:A Ratio in cm/sec
E:A = velocity E/velocity A
E/Ea Ratio
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 225.
E Velocity/Ea velocity
where:
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
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:
142
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:
E velocity = Mitral Valve E velocity
Ea = annular E velocity, also known
as: E prime
Effective Regurgitant Orifice (ERO) in mm2
where:
Elapsed Time (ET) in msec
EF = Ejection Fraction
LVEDV = Left Ventricular End
Diastolic Volume
LVESV = Left Ventricular End
Systolic Volume
Measurement publications and terminology
IVSS = Interventricular Septal
Thickness at Systole
IVSD = Interventricular Septal
Thickness at Diastole
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
Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual.
2nd Edition, Boston: Little, Brown and Company,
(1999), 39.
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.
π
V = ⎛⎝ ---⎞⎠
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.
π
V = ⎛⎝ ---⎞⎠
∑ ai bi ⎛⎝ --n-⎞⎠
i=1
where:
V = Volume in ml
a = Diameter
b = Diameter
n = Number of segments (n=20)
L = Length
i = Segment
∑ ai
2 ⎛ L⎞
--⎝ n⎠
i=1
where:
LV Mass = 1.04 [(LVID + PWT + IVST)3 – LVID3] *
0.8 + 0.6
where:
References
Left Ventricular Mass in gm
Left Ventricular Volume: Single Plane
Method in ml
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
Chapter 7: References
143
Mitral Valve Area (MVA) in cm2
Pressure Half Time (PHT) in msec
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 391, 452.
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 391.
MVA = 220/PHT
PHT = DT * 0.29
where:
PHT = pressure half time
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.
where:
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)
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
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
E PG = 4 * PE2
Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual.
Boston: Little, Brown and Company, (1999), 125.
Peak A Pressure Gradient (A PG)
RF = RV/ MV SV
A PG = 4 * PA2
where:
Peak Pressure Gradient (PGmax)
RV = Regurgitant Volume
MV SV = Mitral Stroke Volume
PGmax = 4 * PV2
Regurgitant Volume (RV) in cc
Mean Pressure Gradient (PGmean)
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. School of Cardiac Ultrasound, Arizona
Heart Institute, (2000), 396, 455.
PGmean = Average of pressure
gradients/Duration of flow
144
Measurement publications and terminology
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:
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:
RAP = Right Atrial Pressure
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 217.
Velocity Time Integral (VTI) in cm
S velocity/ D velocity
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 383.
where:
VTI = sum of abs (velocities [n])
S velocity = Pulmonary vein S wave
D velocity= Pulmonary vein D wave
Stroke Index (SI) in cc/m2
Mosby’s Medical, Nursing, & Allied Health
Dictionary, 4th ed., (1994), 1492.
SI = SV/BSA
where:
Auto Trace – distance (cm) blood
travels with each ejection period.
Velocities are absolute values.
Obstetrical references
Amniotic Fluid Index (AFI)
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
where:
CSA = Cross Sectional Area of the
orifice (LVOT area)
VTI = Velocity Time Integral of the
aortic valve
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.
Tricuspid Valve Area (TVA)
EDD = system date + (280 days – AUA in days)
Reynolds, Terry. The Echocardiographer’s Pocket
Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 55, 391, 452.
Estimated Date of Delivery (EDD) by Last
Menstrual Period (LMP)
TVA = 220 / PHT
The date entered into the patient information for
LMP must precede the current date.
Results are displayed as month/day/year.
Chapter 7: References
145
References
S/D
SV = Stroke Volume
LVEDV = End Diastolic Volume
LVEDSV = End Systolic Volume
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.
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.
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
146
Measurement publications and terminology
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.
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.
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.
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)
University of Tokyo, Shinozuka, N. FJSUM, et al.
“Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics,
23:12 (1996), 885.
Osaka University. Ultrasound in Obstetrics and
Gynecology. (July 20, 1990), 99‐100.
Crown Rump Length (CRL)
Hansmann, M., et al. Ultrasound Diagnosis in
Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986).
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.
Gestational Sac (GS)
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
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.
Chapter 7: References
147
References
Hadlock, F., et al. “Estimating Fetal Age:
Computer‐Assisted Analysis of Multiple Fetal
Growth Parameters.” Radiology, 152: (1984),
497‐501.
Hadlock, F., et al. “Estimating Fetal Age:
Computer‐Assisted Analysis of Multiple Fetal
Growth Parameters.” Radiology, 152: (1984),
497‐501.
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.)
148
Measurement publications and terminology
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.)
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.)
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.
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.
Ratio calculations
ACC = abs (delta velocity/delta time)
FL/AC Ratio
Elapsed Time (ET)
Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker,
and S.K. Park. “A Date Independent Predictor of
Intrauterine Growth Retardation: Femur
ET = time between velocity cursors in
milliseconds
Chapter 7: References
149
References
Head Circumference (HC)
Length/Abdominal Circumference Ratio,”
American Journal of Roentgenology, 141: (November
1983), 979‐984.
Hip Angle/d:D Ratio
Percent Diameter Reduction
Graf, R. “Fundamentals of Sonographic
Diagnosis of Infant Hip Dysplasia.” Journal of
Pediatric Orthopedics, Vol. 4, No. 6: 735‐740, 1984.
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.
Morin, C., Harcke, H., MacEwen, G. “The Infant
Hip: Real‐Time US Assessment of Acetabular
Development.” Radiology 177: 673‐677, December
1985.
% Diameter Reduction = (1 ‐ D2(cm)/D1(cm)) *
100
where:
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.
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.
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.
4 * (Velocity)2
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.
A PG = 4 * PA2
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:
150
A1 = original area of the vessel in
square cm
A2 = reduced area of the vessel in
square cm
Measurement publications and terminology
Peak E Pressure Gradient (E PG)
E PG = 4 * PE2
Peak A Pressure Gradient (A PG)
Peak Pressure Gradient (PGmax)
PGmax = 4 * PV2
Mean Pressure Gradient (PGmean)
PGmean = 4 * Vmax2
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)
References
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
151
152
Measurement publications and terminology
Chapter 8: Specifications
This chapter contains system and accessory
specifications and standards. The specifications
for recommended peripherals are in the
manufacturers’ instructions.
Dimensions
System
Imaging modes
• 2D (256 gray shades)
• Color power Doppler (CPD) (256 colors)
• Color Doppler (Color) (256 colors)
• M Mode
• Pulsed wave (PW) Doppler
• Continuous wave (CW) Doppler
Width: 10.8 in. (27.43 cm)
• Tissue Doppler Imaging (TDI)
Height: 3.1 in. (7.87 cm)
• Tissue Harmonic Imaging (THI)
Weight: 8.5 lbs. (3.9 kg) with the C60x transducer
and battery installed
Image and clip storage
Display
Length: 8.4 in. (21.34 cm)
Internal storage: The number of images and clips
you can save depends on imaging mode and file
format.
Height: 6.3 in. (16 cm)
Diagonal: 10.4 in. (26.4 cm)
Accessories
Supported transducers
The following items are either included with or
available for use on the ultrasound system:
• C11x/8‐5 MHz (6 ft/1.8 m)
• Battery
• C60x/5‐2 MHz (5.5 ft/1.7 m)
• Biopsy Guide
• D2x/2 MHz (5.5 ft/1.7 m)
• Carry case
• HFL38x/13‐6 MHz (5.6 ft/1.7 m)
• ECG cable (6 ft/1.8 m)
• ICTx/8‐5 MHz (5.5 ft/1.7 m)
• Education keys
• L25x/13‐6 MHz (7.5 ft/2.3 m)
• External display
• L38x/10‐5 MHz (5.5 ft/1.7 m)
• Footswitch
• P10x/8‐4 MHz (6 ft/1.8 m)
• Mini‐Dock
• P21x/5‐1 MHz(6 ft/1.8 m)
• Mobile Docking System M Series (MDSm)
• SLAx/13‐6 MHz (7.5 ft/2.3 m)
• Mobile Docking System Lite II (MDS Lite II)
• TEEx/8‐3 MHz (7.2 ft./2.2 m)
• Needle Guide
Chapter 8: Specifications
153
Specifications
Length: 11.8 in. (29.97 cm)
• 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.
Shipping and storage
System and transducer
‐35–65°C (‐31–149°F), 15–95% R.H.
500 to 1060hPa (0.5 to 1.05 ATM)
Battery
‐20–60°C (‐4–140°F), 15–95% R.H. (For storage
longer than 30 days, store at or below room
temperature.)
500 to 1060hPa (0.5 to 1.05 ATM)
Medical grade
• Bar code scanner, serial
• Bar code scanner, USB
• Black‐and‐white printer
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.
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
• Color printer
Battery
• DVD recorder
The battery comprises six lithium‐ion cells plus
electronics, a temperature sensor, and battery
contacts.
Non-medical grade
• Kensington security cable
• USB storage device
Run time is up to two hours, depending on
imaging mode and display brightness.
Temperature and humidity
limits
Electromechanical safety
standards
Note: The temperature, pressure, and humidity limits
apply only to the ultrasound system, transducers, and
battery.
EN 60601‐1:1997, European Norm, Medical
Electrical Equipment–Part 1. General
Requirements for Safety.
Operating
System, battery, and transducer
10–40°C (50–104°F), 15–95% R.H.
700 to 1060hPa (0.7 to 1.05 ATM)
154
Temperature and humidity limits
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.
EMC standards classification
EN 60601‐1‐2:2007, European Norm, Medical
Electrical Equipment. General Requirements for
Safety‐Collateral Standard. Electromagnetic
Compatibility. Requirements and Tests.
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.
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.
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.
Chapter 8: Specifications
155
Specifications
UL 60601‐1 (1st Edition), Underwriters
Laboratories, Medical Electrical
Equipment‐Part 1: General Requirements for
Safety.
Airborne equipment
standards
156
HIPAA standard
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).
The guiding principle of ultrasound use, which states that you should
keep patient exposure to ultrasound energy as low as reasonably
achievable for diagnostic results.
curved array
transducer
Identified by the letter C (curved or curvilinear) and a number (60). The
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
linear array
transducer
Identified by the letter L (linear) and a number (38). The number
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
(MI)
An indication of the likelihood of mechanical bioeffects occurring: the
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
Glossary
as low as reasonably
achievable (ALARA)
157
158
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 multiple angles and then merging or
averaging the scanned data together to improve overall image quality
and, in parallel, reducing noise and artifacts.
Tissue Doppler
Imaging (TDI)
A pulsed wave Doppler technique used to detect myocardial motion.
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
index)
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.
TIC (cranial bone
thermal index)
A thermal index for applications in which the ultrasound beam passes
through bone near the beam entrance into the body.
TIS (soft tissue
thermal index)
A thermal index related to soft tissues.
Tissue Harmonic
Imaging
Transmits at one frequency and receives at a higher harmonic
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.
Abbreviations
Abbreviations in User Interface
Definition
+/×
“+” Caliper/”×” Caliper Ratio
“A” Wave Peak Velocity
A PG
“A” Wave Peak Pressure Gradient
A2Cd
Apical 2 Chamber diastolic
A2Cs
Apical 2 Chamber systolic
A4Cd
Apical 4 Chamber diastolic
A4Cs
Apical 4 Chamber systolic
AAA
Abdominal Aortic Aneurysm
AAo
Ascending Aorta
Abd
Abdomen
abs
Absolute value
AC
Abdominal Circumference
ACA
Anterior Cerebral Artery
ACC
Acceleration Index
ACoA
Anterior Communicating Artery
ACS
Aortic Valve Cusp Separation
Adur
“A” wave duration
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
Glossary
Abbreviation
Glossary
159
Abbreviations in User Interface (Continued)
160
Abbreviation
Definition
Ao
Aorta
AoD
Aortic Root Diameter
Apical
Apical View
APTD
Anteroposterior Trunk Diameter
AT
Acceleration (Deceleration) Time
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.
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
Abbreviations in User Interface (Continued)
Definition
Cx L
Cervix Length
Diameter
D Apical
Distance Apical
DCCA
Distal Common Carotid Artery
DECA
Distal External Carotid Artery
DICA
Distal Internal Carotid Artery
Dist
Distal
dP:dT
Delta Pressure: Delta Time
“E” Wave Peak Velocity
E PG
“E” Wave Peak Pressure Gradient
E:A
E:A Ratio
E/e’
E velocity = Mitral Valve E velocity divided by the annular e’ velocity
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
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.
EDV
End Diastolic Velocity
EF
Ejection Fraction
EF:SLOPE
E-F Slope
Glossary
Abbreviation
Glossary
161
Abbreviations in User Interface (Continued)
162
Abbreviation
Definition
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.
Endo
Endocardial
Epi
Epicardial
EPSS
“E” Point Septal Separation
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.
ET
Elapsed Time
FH
Femoral Head
FHR
Fetal Heart Rate
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
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.
Gate
Depth of Doppler Gate
GS
Gestational Sac
Gyn
Gynecology
HC
Head Circumference
HR
Heart Rate
Abbreviations in User Interface (Continued)
Definition
ICA
Internal Carotid Artery
IMT
Intima Media Thickness
IVRT
Iso Volumic Relaxation Time
IVS
Interventricular Septum
IVSd
Interventricular Septum Diastolic
IVSFT
Interventricular Septum Fractional Thickening
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
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.
LV
Left Ventricular
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
Glossary
163
Glossary
Abbreviation
Abbreviations in User Interface (Continued)
164
Abbreviation
Definition
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
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
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
Abbreviations in User Interface (Continued)
Definition
MV Area
Mitral Valve Area
MV Regurgitant
Fraction
Mitral Valve Regurgitant Fraction
MV Regurgitant Volume
Mitral Valve Regurgitant Volume
MV/VTI
Mitral Valve/Velocity Time Integral
MVA
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
Neo
Neonatal
Nrv
Nerve
NST
Non-stress test
NTSC
National Television Standards Committee
OA
Ophthalmic Artery
OB
Obstetrical
OFD
Occipital Frontal Diameter
Oph
Ophthalmic
Orb
Orbital
PAL
Phase Alternating Line
PCAp
Posterior Cerebral Artery Peak
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
Glossary
Abbreviation
Glossary
165
Abbreviations in User Interface (Continued)
166
Abbreviation
Definition
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
PRF
Pulse Repetition Frequency
Prox
Proximal
PSV
Peak Systolic Velocity
PV
Pulmonic Valve
P. Vein
Pulmonary Vein
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
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
Abbreviations in User Interface (Continued)
Definition
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
TV
Tricuspid Valve
TVA
Tricuspid Valve Area
UA
Ultrasound Age
Calculated on the mean measurements taken for a particular fetal
biometry.
Umb A
Umbilical Artery
Glossary
Abbreviation
Glossary
167
Abbreviations in User Interface (Continued)
168
Abbreviation
Definition
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
YS
Yolk Sac
Index
Symbols
+/x measurement 44
Numerics
2D imaging 25
2D options 25
bar code scanner 19
baseline 29
battery
clean 75
safety 90
cables
clean and disinfect ECG 76
connect power 3
calculations
cardiac. See cardiac calculations
delete measurement 46
general 45
gynecology (Gyn) 58
IMT 59
menu 7, 45
OB 61
percent area 47
percent diameter 47
percent reduction 46
perform measurement 45
performing 45
repeat measurement 46
save 45
small parts 64
specialized 50
vascular 67
view measurement 46
volume 48
volume flow 48, 49
calipers 41
cardiac calculations
AAo 53
Ao 53
AVA 56
CI 57
CO 57
dP:dT 56
HR 57
IVRT 52
LA 53
LV volume (Simpson’s Rule) 53
Index
A & B shortcut keys 15
abbreviations 159
abdominal, intended uses 12
AC power indicator 6
acceleration (ACC) index 44
accessories list 153
acoustic measurement precision 133
acoustic output
measurement 105
tables 107, 132
acquisition error 140
add new user 16
Administrator 16
age, gestational 62
airborne equipment standards 155
ALARA principle 97, 98, 157
alphanumeric keys 5
angle correction 28, 29
annotations
keys 5
place 32
predefine label groups 18
setup 18
aorta (Ao) 53
aortic valve area (AVA) 56
arrow graphic 33
ascending aorta (AAo) 53
audio 19
setup 19
specifications 154
beeps 19
biological safety 92
biopsy 26
bodymarker. See pictographs
brightness 26
Index
169
LVd 53
LVOT D 53
LVs 53
MV/AV area 54
overview 50
PHT 55
PISA 51
RVSP 55
setup 19
SV 57
TDI 58
VTI 54
cardiac index (CI) 57
cardiac output (CO) 57
cardiac references 141
cardiac, intended uses 12
cautions, definition vii
cine buffer 5, 30
clean
battery 75
ECG cable 76
footswitch 75
LCD screen 73
system 73
transducers 74
clip acquisition delay 39
clips
See also images and clips
options 26, 35
color Doppler (Color) imaging 27
color power Doppler (CPD) imaging 27
color scheme, background 23
color suppress 27
Color. See color Doppler (Color) imaging
connectivity setup, wireless certificates 19
continuous wave (CW) Doppler imaging 28, 29
controls
direct 98
indirect 99
receiver 99
CPD. See color power Doppler (CPD) imaging
customer assistance vii
CW Doppler. See continuous wave (CW) Doppler
imaging
date 20
default settings 15
delta pressure:delta time (dP:dT) 56
170
Index
depth
adjust 30
definition 157
keys 5
marker 7
DICOM standard 155
disinfect
battery 75
ECG cable 76
system 73
transducers 74
disinfectants, compatibility 77
display setup 20
distance measurements
2D 42
M mode 43
D-line 28
Doppler
Doppler gate depth 29
measurements 43
scale setup 22
dual images 25
duplex 22
DVD recorder 19, 71
Dynamic Range 22
ECG
Monitoring 26, 38
elapsed time (ET) measurement 44
electrical
safety 88
specifications 154
electromagnetic compatibility 93
electromechanical safety standards 154
EMC classification standards 155
EMED worksheets 70
equipment safety 90
error message 89
errors
acquisition 140
algorithmic 140
measurement 140
estimated date of delivery (EDD) 145
estimated fetal weight (EFW) 146
Event log 17
exam
change type 31
end 34
type and transducer 31
export and import
OB calculation tables 21
predefined label groups 18
user accounts 17
far 5
fetal heart rate (FHR) 63
flow sensitivity 27
focal zones, optimize 25
footswitch setup 15
forms 6
freeze 30
gain
adjust 30
ECG 39
knob 5
gate size 29
gestational age
setup 21
tables, references 146
gestational growth, measure 63
grace period 71
grayscale 25
growth analysis
setup 21
tables, references 148
guidance documents, related 104
guideline 26
gynecology, intended uses 12
heart rate 34
heart rate (HR) 43, 57, 63
HIPAA standard 155
home position 33
humidity limits 154
image quality, poor 71
images and clips
archive 38
delete 38
keys 5
knobs 5
labeling symbols 134
language 23
layout 22
LCD screen
clean 73
output 103
left atrium (LA) 53
left ventricular diastolic (LVd) 53
left ventricular outflow tract diameter (LVOT D) 53
left ventricular systolic (LVs) 53
left ventricular volume (LV volume) 53
license key 71
live trace 22, 30
login
Administrator 16
user 16
LVO (Left Ventricular Opacification) 26
Index
171
Index
export to USB 38
review 37
imaging modes
list of 153
transducer 31
import. See export and import
IMT. See Intima Media Thickness (IMT)
in situ, definition 157
infertility, intended uses 12
intended uses 11–13
intensity
derated 105
in situ 105
water-value 105
interventional, intended uses 12
Intima Media Thickness (IMT)
calculations 20, 59
sketch 61
trace 61
intraoperative, intended uses 12
invert
Color 28
spectral trace 29
iso volumic relaxation time (IVRT) 52
M
M Mode imaging 26
maintenance 72
measurements
+/x Ratio, Doppler 44
See also calculations
2D 42
about 41
Acceleration, Doppler 44
accuracy 41, 139
area, 2D 42
automatic trace, Doppler 44
circumference, 2D 42
delete 41
distance, 2D 42
distance, M Mode 43
Doppler 43
edit 41
Elapsed Time, Doppler 44
errors 140
fetal heart rate 63
heart rate 43, 63
M Mode 43
manual trace 42, 44
Pressure Gradient, Doppler 43
publications 141
Resistive Index, Doppler 44
save to calculation and report 41
terminology 141
vascular 67
Velocities, Doppler 44
mechanical index (MI) 103, 157
mitral valve/aortic valve (MV/AV) 54
M-line 26
mode data 7, 20
modes, keys 6
near 5
network 20
NTSC
definition 157
option 19
OB
calculations 20, 61
custom measurements setup 21
172
Index
custom tables setup 22
graphs 70
intended uses 12
references 145
tables setup 22
on-screen controls 6
optimize 25
orientation
marker 7
option 26
output display 103
PAL
definition 157
option 19
password 16, 17, 18
patient header 7, 20
patient information form 33, 36, 37
patient list 36
patient report
about 68
cardiac 69
general 68
OB 69
save measurement to 41
vascular 69
PC 19
pediatric, intended uses 12
percent reduction calculation 46
peripherals 154
pictographs
PICTO key 7
placing 33
power delay 19
power key 5
precision, acoustic measurement 133
preferences 22
presets 22
pressure half time (PHT) 55
pressure limits 154
PRF 28, 29
print 37
printer
problem 71
setup 19
probe. See transducer
proximal isovelocity surface area (PISA) 51
pulsed wave (PW) Doppler imaging 28
PW Doppler. See pulsed wave (PW) Doppler imaging
recording problem 71
references
cardiac 141
general 149
gestational age tables 146
growth analysis tables 148
obstetrical 145
ratio calculations 149
report, patient 68
resistive index (RI) measurement 44
right ventricular systolic pressure (RVSP) 55
Technical Support vii
temperature limits 154
text 32
text description 7
thermal index (TI) 22, 103, 158
THI 26
time setup 20
tissue Doppler imaging (TDI) 29, 58
tissue models 106
touchpad 6, 8
transcranial, intended uses 13
transducer
clean and disinfect 74
curved array 157
definition 158
disinfect 74
exam type 31
general use 10
imaging modes 31
invasive or surgical use 10
linear array 157
preparation 10
problems 71
specifications 153
troubleshoot 71
Index
safety
battery 90
biological 92
electrical 88
electromagnetic compatibility 93
equipment 90
save
calculations 45
image 6
measurements 41
SAVE key 22
scale 29
scanhead. See transducer
screen layout 7
security 15, 16
serial port 19
setup pages 15
shipping specifications 154
shortcut keys 15
Simpson’s Rule 53
skin line, definition 158
sleep delay 19
small parts calculations 64
software license 71
SonoHD 158
SonoMB 26, 158
specifications 153
spectral trace 28
standards
airborne equipment 155
DICOM 155
electromechanical 154
EMC classification 155
HIPAA 155
steering
CPD 28
Doppler 29
storage specifications
equipment 154
images 153
stroke volume (SV) 57
superficial, intended uses 12
sweep speed
Doppler 29
ECG 39
M Mode 27
symbols, labeling 134
system
clean and disinfect 73
controls 5
software 1
status 7, 20
wake up 3
Index
173
U
ultrasound terminology 157
unfreeze text 18
USB storage device, export to 38
user account 17
user guide, conventions used vii
user setup 16
uses, intended 11–13
variance 28
vascular
calculations 67
intended uses 13
velocity measurement 44
velocity time integral (VTI) 54
volume
calculation 48
Doppler, adjust 29
volume flow 48
wall filter 28, 29
warnings, definition vii
worksheets, EMED 70
zoom 30
174
Index
P07662-02
*P07662-02*

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SparkLAN Communications 0685R04070 Wireless 11g Compact USB Adapter User Manual M Turbo Ultrasound System User Guide

SparkLAN Communications, Inc. Wireless 11g Compact USB Adapter M Turbo Ultrasound System User Guide

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User Manual M Turbo

FCC ID Filing: RYK-0685R04070

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