M Turbo User Manual
M Turbo User Manual
Ultrasound System
User Guide
M-Turbo TM
Ultrasound System
User Guide
SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021
USA
T: 1‐888‐482‐9449 or 1‐425‐951‐1200
F: 1‐425‐951‐1201
SonoSite Ltd
Alexander House
40A Wilbury Way
Hitchin
Herts SG4 0AP
UK
T: +44‐1462‐444800
F: +44‐1462‐444801
Caution: Federal (United States) law restricts this device to sale by or on the order of a physician.
M-Turbo, SiteLink, SonoCalc, SonoHD, SonoMB, and SonoSite are registered trademarks or trademarks of SonoSite, Inc.
DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital
communications of medical information.
Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.
Protected by U.S. patents: 5722412, 5817024, 5893363, 6135961, 6364839, 6371918, 6383139, 6416475, 6471651, 6569101, 6648826,
6962566, 7169108, D456509, D538432. Patents pending.
P07662‐01 11/2007
Copyright 2007 by SonoSite, Inc.
All rights reserved.
ii
Contents
Introduction
iii
OB Custom Measurements setup .......................................................................... 27
OB Custom Tables setup ........................................................................................... 28
Presets setup ................................................................................................................. 29
System Information setup ........................................................................................ 30
USB Devices setup ...................................................................................................... 30
Restoring default settings ........................................................................................ 31
Chapter 3: Imaging
Measurements .............................................................................................................. 55
Working with calipers ....................................................................................... 55
2D measurements .............................................................................................. 56
M Mode measurements ................................................................................... 58
Doppler measurements ................................................................................... 59
General calculations ................................................................................................... 61
Calculations menu ............................................................................................. 61
Performing and saving measurements in calculations ........................ 62
Viewing, repeating, and deleting saved measurements
in calculations ...................................................................................................... 62
Percent reduction calculations ...................................................................... 63
Volume calculations .......................................................................................... 65
Volume flow calculations ................................................................................ 66
Specialized calculations ............................................................................................ 68
Cardiac calculations .......................................................................................... 68
Gynecology (Gyn) calculations ...................................................................... 79
IMT calculations .................................................................................................. 80
OB calculations ................................................................................................... 83
Small Parts calculations ................................................................................... 89
Vascular calculations ......................................................................................... 90
Patient report ................................................................................................................ 92
Vascular and cardiac reports .......................................................................... 92
iv
OB reports .............................................................................................................92
Sending reports and viewing EMED worksheets ....................................94
Troubleshooting ..........................................................................................................95
Software licensing .......................................................................................................96
Maintenance .................................................................................................................97
Cleaning and disinfecting the ultrasound system .................................98
Cleaning and disinfecting transducers .......................................................99
Cleaning and disinfecting transducer cables ........................................ 101
Cleaning and disinfecting the battery .................................................... 102
Cleaning the footswitch ................................................................................ 102
Cleaning and disinfecting ECG cables ..................................................... 102
Chapter 6: Safety
v
Chapter 7: References
Chapter 8: Specifications
Dimensions ..................................................................................................................173
Supported transducers ...........................................................................................173
Imaging modes ..........................................................................................................173
Images and clips storage ........................................................................................174
Accessories ..................................................................................................................174
Peripherals ...................................................................................................................174
Temperature and humidity limits ........................................................................175
Operating limits ................................................................................................175
Shipping and storage limits .........................................................................175
Electrical .......................................................................................................................175
Battery ...........................................................................................................................175
Electromechanical safety standards ...................................................................176
EMC standards classification .................................................................................176
Airborne equipment standards ............................................................................176
DICOM standard ........................................................................................................176
HIPAA standard ..........................................................................................................177
Glossary
Terms .............................................................................................................................179
Abbreviations .............................................................................................................181
Index ...........................................................................................................................191
vi
Introduction
Introduction
This M‐Turbo Ultrasound System User Guide provides information on preparing and using the
M‐Turbo™ ultrasound system and on cleaning and disinfecting the system and transducers. It
also provides references for calculations, system specifications, and safety and acoustic output
information.
The user guide is for a reader familiar with ultrasound techniques. It does not provide training
in sonography or clinical practices. Before using the system, you must have ultrasound
training.
See the applicable SonoSite accessory user guide for information on using accessories and
peripherals. See the manufacturer’s instructions for specific information about peripherals.
Customer comments
Questions and comments are encouraged. SonoSite is interested in your feedback regarding the
system and the user guide. Please call SonoSite at 888‐482‐9449 in the US. Outside the US, call
the nearest SonoSite representative. You can also e‐mail SonoSite at [email protected].
Introduction vii
For technical support, please contact SonoSite as follows:
Fax: 425-951-6700
E-mail: [email protected]
viii
Chapter 1: Getting Started
Getting Started
depend on system configuration, transducer, and exam type.
4
1
2 3 4
Intended uses
The intended uses for each exam type are as follows. For the intended transducer for each exam
type, see “Imaging modes and exams available by transducer” on page 42.
Abdominal Imaging Applications This system transmits ultrasound energy into the abdomen
of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue
Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The
liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal
vessels, and surrounding anatomical structures can be assessed for the presence or absence of
pathology transabdominally.
Cardiac Imaging Applications This system transmits ultrasound energy into the thorax of
patients using 2D, M Mode, color Doppler (Color), Tissue Harmonic Imaging (THI), pulsed
wave (PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW)
2
Doppler to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding
anatomical structures, overall cardiac performance, and heart size can be assessed for the
presence or absence of pathology.
The patient’s electrocardiogram (ECG) may be obtained and is used for timing of diastolic and
systolic function.
WARNING: The ECG is not used to diagnose cardiac arrhythmias and is not designed for long
term cardiac rhythm monitoring.
Getting Started
Gynecology and Infertility Imaging Applications This system transmits ultrasound energy in
the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler
(Color), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound
images. The uterus, ovaries, adnexa, and surrounding anatomical structures can be assessed for
the presence or absence of pathology transabdominally or transvaginally.
Interventional Imaging Applications This system transmits ultrasound energy into the various
parts of the body using 2D, color Doppler (Color), color power Doppler (CPD), Tissue
Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images that
provide guidance during interventional procedures. This system can be used to provide
ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral
nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical
procedures, and provide assistance during abdominal, breast, and neurological surgery.
Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of
pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD),
Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images.
The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and
surrounding anatomical structures can be assessed for the presence or absence of pathology
transabdominally or transvaginally. CPD and color Doppler (Color) imaging is intended for
high‐risk pregnant women. High‐risk pregnancy indications include, but are not limited to,
multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension,
diabetes, and lupus.
WARNING: To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical
Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been
validated to be proven effective for these two uses.
CPD or Color images can be used as an adjunctive method, not as a screening tool,
for the detection of structural anomalies of the fetal heart and as an adjunctive
method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation
(IUGR).
Pediatric Imaging Applications This system transmits ultrasound energy into the pediatric
patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), pulsed wave
(PW) Doppler, pulsed wave tissue Doppler (TDI PW), and continuous wave (CW) Doppler to
4
Preparing the system
Installing or removing the battery
WARNING: To avoid injury to the operator and to prevent damage to the ultrasound system,
inspect the battery for leaks prior to installing.
To avoid data loss and to conduct a safe system shutdown, always keep a battery in
the system.
Getting Started
Locking levers
WARNING: The equipment shall be connected to a center-tapped single phase supply circuit
when users in the United States connect the equipment to a 240V supply system.
Caution: Verify that the hospital supply voltage corresponds to the power supply voltage
range. See “Electrical” on page 175.
6
Connecting transducers
WARNING: To avoid injury to the patient, do not place the connector on the patient. Operate
the ultrasound system in a docking system or on a flat hard surface to allow air flow
past the connector.
Caution: To avoid damaging the transducer connector, do not allow foreign material in the
connector.
Getting Started
Figure 4 Connect the Transducer
To connect a transducer
1 Remove the system from the mini‐dock (if present), and turn it upside down.
2 Pull the transducer latch up, and rotate it clockwise.
3 Align the transducer connector with the connector on the bottom of the system.
4 Insert the transducer connector into the system connector.
5 Turn the latch counterclockwise.
6 Press the latch down, securing the transducer connector to the system.
To remove a transducer
1 Pull the transducer latch up, and rotate it clockwise.
2 Pull the transducer connector away from the system.
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.
8
System controls
1 14
2
15
Getting Started
3
4 16
5
17
18
6 19
20
8 9 10 11 12 13
Near Adjusts the gain applied to the near field of the image.
Far Adjusts the gain applied to the far field of the image.
Gain/ In live imaging, adjusts the overall gain applied to the entire
Cine Buffer image. On a frozen image, moves the cine buffer.
15 Forms
REVIEW Accesses the patient list, saved images, and archiving functions.
10
16 EXAM Opens exam menu.
17 Shortcut keys Keys that you can program to perform common tasks.
SELECT Used with the touchpad to select items on-screen. Also switches
between Color and Doppler options, calipers for measurement,
pictograph-marker position and angle, frozen images in duplex
and dual screens, and arrow position and orientation.
Getting Started
SAVE CALC Saves calculations and their measurements to the patient report.
19 UPDATE Toggles between dual and duplex screens and imaging modes
in M Mode and Doppler (for example, between D-line and
Doppler spectral trace).
20 Imaging Modes
M MODE Turns M Mode on, toggles between M-line and M Mode trace.
DOPPLER Turns Doppler on, toggles between D-line and Doppler trace.
2D Turns 2D on.
11
7
8
1 Mode Data Area Current imaging mode information (for example, Gen, Res, THI,
and PW).
12
9 Patient Header Includes current patient name, patient ID number, institution,
user, and date/time.
Getting Started
General interaction
Touchpad and cursor
Use the touchpad to adjust and move objects on‐screen. The touchpad controls caliper position,
CPD or Color box position and size, the cursor, and more. The arrow keys control much of the
same functionality as the touchpad.
The cursor appears in the setup pages, the patient information form, and patient report. You
control the cursor through the touchpad. For example, in the patient information form, place
the cursor over the last name field and press the SELECT key to activate that field. Additionally,
you can use the cursor to select check boxes and items in lists.
On-screen options
The on‐screen options let you make adjustments and select settings. The options available
depend on context.
Each option is controlled by the pair of keys below it. Depending on the option, the control keys
function in one of four ways:
Cycle Moves through a list of settings continuously. The upper control key cycles upward. The
lower control key cycles downward.
Up-Down Moves through a list of settings, stopping at the top or bottom. The upper control key
moves upward. The lower control key moves downward. By default, a beep sounds when you
reach either end of the range. (See “To change audio and battery settings” on page 23.)
On-Off Turns a feature on or off. You can press either control key. In forms, you can instead
select the option by using the touchpad and the SELECT key.
Action Performs an action. You can press either control key. Or you can instead select the option
by using the touchpad and the SELECT key.
10
1
2 11
3
4
5 6 7 8 9
1 TAB Moves cursor among fields in the forms, and tabs between text
position in dual screens.
6 ARROW Displays an arrow graphic that can be moved and rotated within
the image area.
7 SPACEBAR Turns the keyboard on for text entry. In text entry, adds a space.
8 DELETE Removes all text from the screen during text entry and when not
measuring.
9 Arrow Keys Move highlighted selection in calculations menu, move cursor one
space when entering text, move caliper position, move cine buffer
forward and backward, and move among pages in image review
and reports.
14
Symbols
You can enter symbols and special characters in select fields and forms. The symbols and
special characters available depend on context.
Patient information form: Last, First, Middle, Patient ID, Accession, Indications, Procedure ID,
User, Reading Dr., Referring Dr., and Institution fields
DICOM or SiteLink configuration page: Alias and AE Title fields
A & B Key, Footswitch setup page: Text field
Getting Started
Text mode (imaging): Annotation field
Caution: To avoid damage to the transducer, use only gels recommended by SonoSite.
Using gels other than the one recommended by SonoSite can damage the
transducer and void the warranty. If you have questions about gel compatibility,
contact SonoSite or your local representative.
SonoSite recommends that you clean transducers after each use. See “Cleaning
and disinfecting transducers” on page 99.
Acoustic coupling gel must be used during exams. Although most gels provide suitable
acoustic coupling, some gels are incompatible with some transducer materials. SonoSite
recommends Aquasonic® gel and provides a sample with the system.
For general use, apply a liberal amount of gel between the transducer and the body. For
invasive or surgical use, install a transducer sheath.
WARNING: To prevent contamination, the use of sterile transducer sheaths and sterile
coupling gel is recommended for clinical applications of an invasive or surgical
nature. Do not apply the transducer sheath and gel until you are ready to
perform the procedure.
16
Chapter 2: System Setup
The system setup pages let you customize the system and set preferences.
System Setup
To program the shortcut keys and footswitch
1 Press the SETUP key.
2 Select A & B Key, Footswitch.
3 Select from the lists:
A Key, B Key The function of the shortcut keys. By default, the A shortcut key is set to
Print and the B shortcut key is set to Record. The shortcut keys are below the
alphanumeric keypad.
Footswitch (L), Footswitch (R) The function of the left and right footswitches: Save Clip,
Record, Freeze, Save Image, or Print. See also “To connect the footswitch” on page 17
WARNING: To avoid contamination, do not use the footswitch in a sterile environment. The
footswitch is not sterilized.
Security settings
WARNING: Health care providers who maintain or transmit health information are required by
the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the
European Union Data Protection Directive (95/46/EC) to implement appropriate
procedures: to ensure the integrity and confidentiality of information; to protect
against any reasonably anticipated threats or hazards to the security or integrity of
the information or unauthorized uses or disclosures of the information.
Security settings on the system allow you to meet the applicable security requirements
listed in the HIPAA standard. Users are ultimately responsible for ensuring the security
and protection of all electronic protected health information collected, stored, reviewed,
and transmitted on the system.
To log in as Administrator
1 Press the SETUP key.
2 Select Administration.
3 Type Administrator in the Name box.
4 Type the administrator password in the Password box.
If you don’t have the administrator password, contact SonoSite. (See “SonoSite Technical
Support” on page viii.)
5 Select Login.
18
To change the administrator password or let users change passwords
1 Log in as Administrator.
2 Under User List, select Administrator.
3 Do any of the following:
• Change the administrator password: Under User Information, type the new
password in the Password box and Confirm box. (See “Choosing a secure password”
on page 21.)
• Let users change their passwords: Select the Password changes check box.
4 Select Save.
User setup
To add a new user
1 Log in as Administrator.
System Setup
2 Select New.
3 Under User Information, fill in the Name, Password, and Confirm boxes. (See “Choosing
a secure password” on page 21.)
4 (Optional) In the Sonographer box, type the user’s initials to display them in the patient
header and the User field in the patient information form.
5 (Optional) Select the Administration Access check box to allow access to all
administration privileges.
6 Select Save.
To delete a user
1 Log in as Administrator.
2 Under User List, select the user.
3 Select Delete.
4 Select Yes.
20
To export the Event log
The Event log and the DICOM network log have the same file name (log.txt). Exporting
either one to a USB storage device overwrites any existing log.txt file.
1 Insert a USB storage device.
2 Select Log and then select Export on‐screen.
A list of USB devices appears.
3 Select the USB storage device, and select Export.
The Event log is a text file that you can open in a text‐editing application (for example,
Microsoft Word or Notepad).
System Setup
3 Select Yes.
Logging in as user
If user login is required, the User Login screen appears when you turn on the system. (See
“To require user login” on page 18.)
To log in as user
1 Turn on the system.
2 In the User Login screen, type your name and password, and select OK.
To log in as guest
Guests can scan but can’t access system setup and patient information.
1 Turn on the system.
2 In the User Login screen, select Guest.
22
4 Select Export. A list of USB devices appears.
5 Select the USB storage device, and select Export.
A copy of all predefined label groups for all exams saves to the USB storage device.
System Setup
Audio, Battery setup
On the Audio, Battery setup page, you can specify sounds and the length of time for Sleep
Delay and Power Delay.
Connectivity setup
On the Connectivity setup page, you specify options for using devices and for alerts when
internal storage is full. You also specify settings (including Transfer Mode and Location)
for SiteLink and DICOM, which are optional features. Refer to the SiteLink and DICOM
documentation.
To configure the system for a DVD recorder, PC, or bar code scanner
1 Press the SETUP key.
2 Select Connectivity.
3 (DVD recorder) In the Video Mode list, select the video standard: NTSC or PAL.
4 In the Serial Port list, select the peripheral.
Note: Because these peripherals use the same RS‐232 connector on the mini‐dock, you can
connect only one of them at a time.
Computer (PC) allows report data to be sent as ASCII text from the system to a PC. The
PC must have third‐party software to acquire, view, or format the data into a report.
Check the compatibility of your software with SonoSite Technical Support. (See also
“Sending reports and viewing EMED worksheets” on page 94.)
5 Select Yes to restart the system.
6 Attach a serial cable (RS‐232) from the serial port on the mini‐dock or docking system to
the peripheral.
24
3 Select Internal Storage Capacity Alert.
The system displays a message if internal storage is near capacity when you end an
exam. The system then deletes archived patient exams if specified in DICOM.
System Setup
4 In the Time box, type the current time in 24 hour format (hours and minutes).
OB Calculations setup
On the OB Calculations setup page, you select authors for OB calculation tables. You can
also import or export additional OB calculation tables.
See also “OB calculations” on page 83.
26
To specify gestational age and growth analysis
1 Press the SETUP key.
2 Select OB Calculations.
3 In the measurement lists under Gestational Age and Growth Analysis, select the desired
OB authors, or select None.
Selecting an author places the associated measurement on the calculations menu.
4 (Optional) Select More to display the list of user‐defined custom measurements and to
associate a custom table for the custom measurement.
This option is available only when a user‐defined custom table has been created for the
custom measurement.
System Setup
3 Select OB Calculations.
4 Select Export. A list of USB devices appears.
5 Select the USB storage device, and select Export.
All user‐defined tables and measurements are copied to the USB storage device.
WARNING: Prior to use, verify that custom table data entries are correct. The system does not
confirm the accuracy of the custom table data entered by the user.
To view OB tables
1 Press the SETUP key.
2 Select OB Custom Meas. or OB Calculations.
3 Select Tables on‐screen.
4 Select the desired table and measurement/author.
28
To create a new OB custom table
You can create two custom tables for each OB measurement. Growth analysis tables cannot
be created for custom OB measurements.
1 Press the SETUP key.
2 Select OB Custom Meas. or OB Calculations.
3 Select Tables on‐screen.
4 Select the desired table (Gestational Age or Growth Analysis).
5 In the Measurement list, select the measurement for the custom table.
6 Select New on‐screen.
7 In the Author box, type a unique name.
8 Enter the data.
9 Select Save on‐screen.
System Setup
To display the measurement for the custom table in the calculations menu, see “To specify
gestational age and growth analysis” on page 27.
Presets setup
The Presets setup page has settings for general preferences.
To set presets
1 Press the SETUP key.
2 Select Presets.
3 Select from the lists:
Doppler Scale Select cm/s or kHz.
Duplex The layout for displaying M Mode trace and Doppler spectral trace:1/3 2D, 2/3
Trace; 1/2 2D, 1/2 Trace; or Full 2D, Full Trace.
30
• SiteLink organizes files in a SiteLink‐style folder structure. Clips export in H.264
video saved as MP4 files. To view them, SonoSite recommends QuickTime 7.0 or
later.
• DICOM creates files readable by a DICOM server. DICOM is an optional feature.
5 Select an image format for your export type. For JPEG image format, also select a JPEG
compression.
A high compression has a smaller file size but less detail.
For SiteLink export type, the image format affects only still images. For DICOM export
type, the image format affects both still images and clips.
6 For SiteLink export type, select a sort order under Sort By.
To return to the previous screen, select Devices.
System Setup
To restore default settings for a setup page
On the setup page, select Reset on‐screen.
Imaging modes
The system has a high‐performance LCD and advanced image‐optimization technology that
greatly simplifies user controls. Imaging modes available depend on the transducer and exam
type. See “Imaging modes and exams available by transducer” on page 42.
To adjust gain
Do one of the following:
• To adjust gain automatically, press the AUTO GAIN key. The gain adjusts each time you
Imaging
press this key.
• To adjust gain manually, turn the NEAR , FAR , and GAIN knobs. These knobs
increase or decrease the amount of gain applied to the near field, far field, or the overall
image. (Near and far correspond to the time gain compensation [TGC] controls on other
ultrasound systems.)
• In PW and CW Doppler imaging, the GAIN knob affects Doppler gain.
• In CPD or Color imaging, the GAIN knob affects the color gain applied to the region of
interest (ROI) box. The NEAR and FAR knobs affect only the 2D image.
Chapter 3: Imaging 33
To move forward or backward in the cine buffer
Freeze the image, and do one of the following:
To zoom in on an image
You can zoom in 2D and Color imaging. You can freeze or unfreeze the image or change the
imaging mode at any time while zooming.
1 Press the ZOOM key. A ROI box appears.
2 Using the touchpad, position the ROI box as desired.
3 Press the ZOOM key again.
The image in the ROI box is magnified by 100%.
4 (Optional) If the image is frozen, use the touchpad or arrow keys to pan the image up, down,
left, and right. (You cannot pan in Dual.)
To exit zoom, press the ZOOM key again.
2D imaging
2D is the systemʹs default imaging mode. The system displays echoes in two dimensions by
assigning a brightness level based on the echo signal amplitude. To achieve the best possible
image quality, properly adjust the display brightness, gain, depth settings, viewing angle, and
exam type. Also, select an optimization setting that best matches your needs.
34
To display the 2D image
1 Do any of the following:
• Turn on the system.
• Press the 2D key.
2 Set options as desired. See “2D options.”
2D options
In 2D imaging, you can select the following on‐screen options.
2D options
Imaging
the negative range decreases the number of grays displayed.
Dual Displays side-by-side 2D images.
Select Dual, and then press the UPDATE key to display the second
screen and to toggle between the screens. With both images
frozen, press the UPDATE key to toggle between the images.
To return to full-screen 2D imaging, select Dual or press the 2D
key.
LVO On, LVO On turns on Left Ventricular Opacification. LVO Off turns off
LVO Off this option.
Use LVO for cardiac exams in 2D imaging mode when using an
imaging contrast agent. LVO lowers the mechanical index (MI) of
the system to enhance visualization of the contrast agent and
endocardial border.
This option depends on transducer and exam type.
Orientation Select from four image orientations: U/R (Up/Right), U/L (Up/Left),
D/L (Down/Left), D/R (Down/Right).
Chapter 3: Imaging 35
2D options (Continued)
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.
36
2 Use the touchpad to position the M‐line where desired.
3 Set options as desired.
Many optimization and depth options available in 2D imaging are also available in M Mode
imaging. See “2D options” on page 35.
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.
Chapter 3: Imaging 37
CPD and Color options
In CPD or Color imaging, you can set the following on‐screen options.
CPD and Color options
Color Shows or hides color information. You can select Show or Hide while in
Suppress live or frozen imaging. The setting shown on-screen is the current
selection.
Flow The current setting appears on-screen.
Sensitivity • Low optimizes the system for low flow states.
• Med optimizes the system for medium flow states.
• High optimizes the system for high flow states.
PRF Scale Select the desired pulse repetition frequency (PRF) setting by pressing
the control keys.
There is a wide range of PRF settings for each Flow Sensitivity setting
(Low, Med, and High).
Available on select transducers.
Wall Filter Settings include Low, Med, and High.
Available on select transducers.
Steering Select the steering angle setting of the color ROI box (-15, +0, or +15).
If adding PW Doppler, see “PW Doppler options” on page 40.
Available on select transducers.
Variance Turns variance on and off.
Available only for cardiac exam.
Page x/x Indicates which page of options is displayed. Select to display the next
page.
38
PW and CW Doppler imaging
Pulsed wave (PW) Doppler and continuous wave (CW) Doppler imaging modes are optional
features.
PW Doppler is a Doppler recording of blood flow velocities in a range specific area along the
length of the beam. CW Doppler is a Doppler recording of blood flow velocities along the
length of the beam.
You can use PW/CW Doppler and CPD/Color and simultaneously. If CPD/Color imaging is on,
the color ROI box is tied to the D‐line. The SELECT key cycles among color ROI box position,
color ROI box size, the D‐line, and (in PW Doppler) angle correction. The active selection is
green. Also, the indicator on the left‐hand screen shows which touchpad function is active.
Imaging
again to set the desired angle.
The SELECT key toggles between the D‐line and angle correction.
Chapter 3: Imaging 39
PW Doppler options
In PW Doppler imaging, you can set the following on‐screen options.
PW Doppler options
TDI On, Select TDI On to turn on tissue Doppler imaging. When on, TDI appears
TDI Off in the upper left-hand screen. The default is TDI off.
Available only in cardiac exams.
Steering Select the desired steering angle setting. The PW Doppler angle
correction automatically changes to the optimum setting.
• -15 has an angle correction of -60°.
• +0 has an angle correction of 0°.
• +15 has an angle correction of +60°.
You can manually correct the angle after selecting a steering angle
setting. (See “To display the D-line” on page 39.)
Available on select transducers.
Page x/x Indicates which page of options is displayed. Select to display the next
page.
40
Spectral trace options
In spectral trace imaging, you can set the following on‐screen options.
Spectral trace options
Scale Select the desired scale (pulse repetition frequency [PRF]) setting.
(To change the Doppler scale to cm/s or kHz, see “Presets setup” on
page 29.)
Line Sets the baseline position.
(On a frozen trace, the baseline can be adjusted if Live Trace is off.)
Imaging
Live Trace Displays a live trace of the peak or mean. (See “Presets setup” on
page 29 to specify peak or mean.)
Page x/x Indicates which page of options is displayed. Select to display the next
page.
Chapter 3: Imaging 41
Imaging modes and exams available by transducer
WARNING: To prevent misdiagnosis or harm to the patient, understand your system’s
capabilities prior to use. The diagnostic capability differs for each transducer,
exam type, and imaging mode. In addition, transducers have been developed to
specific criteria depending on their physical application. These criteria include
biocompatability requirements.
The transducer you use determines which exam types are available. In addition, the exam type
you select determines which imaging modes are available.
Imaging Mode
Exam 2D2 PW CW
Transducer CPD3 Color3
Type1 M Mode Doppler Doppler
C11x Abd X X X X —
Neo X X X X —
Nrv X X X X —
Vas X X X X —
C60x OB X X X X —
Gyn X X X X —
Abd X X X X —
Nrv X X X X —
HFL38x Bre X X X X —
SmP X X X X —
Vas X X X X —
Msk X X X X —
IMT X X X X —
Nrv X X X X —
Ven X X X X —
ICTx Gyn X X X X —
OB X X X X —
42
Imaging modes and exams available by transducer (Continued)
Imaging Mode
Exam 2D2 PW CW
Transducer CPD3 Color3
Type1 M Mode Doppler Doppler
L25x Msk X X X X —
Vas X X X X —
Nrv X X X X —
Sup X X X X —
Ven X X X X —
L38x Bre X X X X —
SmP X X X X —
Vas X X X X —
IMT X X X X —
Nrv X X X X —
Ven X X X X —
Imaging
P21x Abd X X X X —
OB X X X X —
Crd X — X X X
1. Exam type abbreviations are as follows: Abd = Abdomen, Bre = Breast, Crd = Cardiac, Gyn =
Gynecology, IMT = Intima Media Thickness, Msk = Muscle, Neo = Neonatal, Nrv = Nerve, OB =
Obstetrical, SmP = Small Parts, Sup = Superficial, Vas = Vascular, Ven = Venous
2. The optimization settings for 2D are Res, Gen, and Pen.
3. The optimization settings for CPD and Color are low, medium, and high (flow sensitivity) with a
range of PRF settings for Color depending on the setting selected.
Annotations
You can annotate live images as well as frozen images. (You cannot annotate a saved image.)
You can place text (including predefined labels), an arrow, or a pictograph. To set preferences
for annotations, see “Annotations setup” on page 22.
Chapter 3: Imaging 43
To place text on an image
You can place text in the following imaging layouts: full‐screen 2D, full‐screen trace, dual, or
duplex. You can place text manually or add a predefined label.
1 Press the TEXT key. A green cursor appears.
2 Move the cursor where desired:
• Use the touchpad or arrow keys.
• Select Home to move the cursor to the home position.
The default home position depends on the imaging screen layout. You can reset the home
position. See “To reset the home position” on page 44.
3 Using the keyboard, type text.
• The arrow keys move the cursor left, right, up, and down.
• The DELETE key deletes all text.
44
To place a pictograph on an image
The pictograph set available depends on transducer and exam type.
1 Press the PICTO key.
2 Select x/x to display the desired pictograph, and then press the SELECT key.
The first number shows which pictograph in the set has been selected. The second number
is the number of pictographs available.
3 Use the touchpad to position the pictograph marker.
4 (Optional) To rotate the pictograph marker, press the SELECT key and then use the
touchpad.
5 Select a screen location for the pictograph: U/L (Up/Left), D/L (Down/Left), D/R (Down/
Right), U/R (Up/Right).
In a duplex layout, the pictograph is restricted to upper left. In Dual, all four positions are
available.
To remove the pictograph, select Hide.
Imaging
the exam are linked to that patient. (See “Patient report” on page 92.)
2 Select New.
3 Fill in the form fields. See “Patient information form fields” on page 46.
4 Select Done.
Chapter 3: Imaging 45
3 Make changes as desired.
4 Select one of the following:
• Cancel to undo changes and return to imaging.
• Done to save changes and return to imaging.
• Select New to begin a new patient information form. (See “To create a new patient
information form” on page 45.)
Patient
46
Patient information form fields (Continued)
Exam
Twins (OB exam) Select the Twins check box to display Twin A and
Twin B measurements on the calculations menu and to have
Twin A and Twin B screens for previous exam data.
Previous (OB exam) Displays fields for five previous exams. The date for
Exams a previous exam must precede the current system date. For
button twins, select Twin A/B to toggle between Twin A and Twin B
screens. (If the Twin A/B option does not appear, select Back,
and make sure that the Twins check box is selected.)
Select Back to save changes and return to previous screen.
Imaging
BP (Cardiac, IMT, or Vascular exam)
Blood Pressure
HR (Heart (Cardiac or Vascular exam) Enter the beats per minute. Saving
Rate) the heart rate using a measurement overwrites this entry.
Chapter 3: Imaging 47
Patient information form fields (Continued)
Procedure
To save an image
Press the SAVE key.
The image saves to internal storage.
By default, the SAVE key saves only the image. As a shortcut during calculations, the SAVE key
can save both the image to internal storage and the calculation to the patient report. See “To set
presets” on page 29.
48
• Save to save the clip to internal storage
• Delete to delete the clip
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, PrevOn and PrevOff turn the preview feature on and off.
Preview Off • With Prev/On, the captured clip automatically plays on-screen.
The clip can be trimmed, saved, or deleted.
• With Prev/Off, the clip saves to internal storage, and the trim and
delete options are not available.
Imaging
Prospective, Pro and Retro determine how clips are captured:
Retrospective • With Pro, a clip is captured prospectively, after you press the CLIP
key.
• With Retro, a clip is captured retrospectively, from pre-saved data
before you press the CLIP key.
Chapter 3: Imaging 49
Patient list
WARNING: To avoid damaging the USB storage device and losing patient data from it,
observe the following:
• Do not remove the USB storage device or turn off the ultrasound system while
the system is exporting.
• Do not bump or otherwise apply pressure to the USB storage device while it is
in a USB port on the ultrasound system. The connector could break.
Caution: If the internal storage icon does not appear in the system status area, internal
storage may be defective. Contact SonoSite Technical Support. (See “SonoSite
Technical Support” on page viii.)
The patient list lets you organize saved images and clips from a central location. You can delete,
view, print, or archive them. You can also copy them to a USB storage device.
50
To sort the patient list
After the system starts, the patient list is arranged by date and time, with the most recent
patient file first. You can re‐sort the patient list as needed.
Select the column heading that you want to sort by. Select it again if sorting
in reverse order.
Note: The column heading is selectable.
Imaging
speed 1x, 1/2x, 1/4x.
5 Select x/x to cycle to the next image or clip you want to view.
To return to the patient list, select List. To return to imaging, select Done.
To print an image
1 Verify that a printer is selected. See “To configure the system for a printer” on page 24.
2 Do one of the following:
• In the patient list, review the patient’s images. Select Print when the image appears.
• With the image displayed, press the A shortcut key.
By default, the A shortcut key prints. To reprogram the A and B shortcut keys, see “To set
presets” on page 29.
Chapter 3: Imaging 51
• Print all images for multiple patients: Select one or more patients in the patient list. Then
select Print.
• Print all images for one patient: Highlight the patient in the patient list, and then select
Print.
Each image appears briefly on‐screen while printing.
ECG Monitoring
ECG Monitoring is an optional feature and requires a SonoSite ECG cable.
WARNING: To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms.
The SonoSite ECG option is a non-diagnostic feature.
To avoid electrical interference with aircraft systems, do not use the ECG cable
on aircraft. Such interference may have safety consequences.
52
Caution: Use only accessories recommended by SonoSite with the system. Your system
can be damaged by connecting an accessory not recommended by SonoSite.
To monitor ECG
1 Connect the ECG cable to the ECG connector on the ultrasound system, mini‐dock, or
docking system.
ECG Monitoring turns on automatically.
Note: An external ECG monitor may cause a lag in the timing of the ECG trace, corresponding with
the 2D image. Biopsy guidelines are not available when ECG is connected.
2 Select ECG on‐screen. (ECG may be on another page. It appears only if the ECG cable is
connected.)
3 Select options as desired.
Imaging
Position Sets the position of the ECG trace.
Sweep Speed Settings are Slow, Med, and Fast.
Delay Displays Line and Save for clip acquisition delay. (For instructions to
capture clips, see “To capture and save a clip” on page 48.)
Line The position of the delay line on the ECG trace. The delay line indicates
where the clip acquisition is triggered.
Save Saves the current position of the delay line on the ECG trace. (You can
change the position of the delay line temporarily. Starting a new
patient information form or cycling system power reverts the delay line
to the most recently saved position.)
Select Delay to display these options.
Chapter 3: Imaging 53
54
Chapter 4: Measurements and Calculations
You can measure for quick reference, or you can measure within a calculation. You can perform
general calculations as well as calculations specific to an exam type.
Measurements are performed on frozen images. For references used, see Chapter 7,
“References.”
Measurements
You can perform basic measurements in any imaging mode and can save the image with the
measurements displayed. (See “To save an image” on page 48.) Except for the M Mode HR
measurement, the results do not automatically save to a calculation and the patient report. If
you prefer, you can first begin a calculation and then measure. See “Performing and saving
measurements in calculations” on page 62.
Some options may not apply to your system. Options available depend on your configuration,
transducer, and exam type.
and Calculations
Measurements
When measuring, you work with calipers, often in pairs. Results based on the calipers’ position
appear at the bottom of the screen. The results update as you reposition the calipers by using
the touchpad. In trace measurements, the results appear after you complete the trace.
Outside a calculation, you can add calipers by pressing the CALIPER key. You can have
multiple sets of calipers and can switch from one set to another, repositioning them as needed.
Each set shows the measurement result. The active calipers and measurement result are
highlighted green. A measurement is complete when you finish moving its calipers.
Within a calculation, calipers appear when you select from the calculations menu. (See “To
select from the calculations menu” on page 61.)
For an accurate measurement, accurate placement of calipers is essential.
2D measurements
The basic measurements that you can perform in 2D imaging are as follows:
• Distance in cm
• Area in cm2
• Circumference in cm
You can also measure area or circumference by manually tracing.
You can perform a combination of distance, area, circumference, and manual trace
measurements at one time. The total number possible depends on their order and type.
56
Figure 1 2D image with two distance and one circumference measurement
and Calculations
Measurements
If you move the calipers close together, they shrink and the dotted line disappears.
See “To save a measurement to a calculation and patient report” on page 55.
M Mode measurements
The basic measurements that you can perform in M Mode imaging are as follows:
• Distance in cm/Time in seconds
• Heart Rate (HR) in beats per minute (bpm)
The time scale above the trace has small marks at 200 ms intervals and large marks at
one‐second intervals.
58
See “To save a measurement to a calculation and patient report” on page 55. Saving the heart
rate measurement to the patient report overwrites any heart rate entered on the patient
information form.
See also “To measure fetal heart rate (M Mode)” on page 88.
Doppler measurements
The basic measurements that you can perform in Doppler imaging are Velocity (cm/s), Pressure
Gradient, Elapsed Time, +/x Ratio, Resistive Index (RI), and Acceleration. You can also trace
manually or automatically.
For Doppler measurements, the Doppler scale must be set to cm/s. See “Presets setup” on
page 29.
To measure Velocities, Elapsed Time, +/x Ratio, Resistive Index (RI), and Acceleration
(Doppler)
1 On a frozen Doppler spectral trace, press the CALIPER key.
A single caliper appears.
2 Using the touchpad, position the caliper to a peak systolic waveform.
3 Press the SELECT key.
A second caliper appears.
and Calculations
Measurements
4 Using the touchpad, position the second caliper at the end diastole on the waveform.
See “To save a measurement to a calculation and patient report” on page 55.
Exam Type
60
Automatic Trace Measurement Results for Exam Type (Doppler) (Continued)
Exam Type
Gate Depth — — X — —
* The automatic trace tool must be used to calculate the TAM.
General calculations
Within calculations, you can save measurement results to the patient report. You can view,
repeat, and delete measurements from a calculation. Some measurements can be deleted
directly from the patient report pages. See “Patient report” on page 92.
Calculation packages depend on exam type and transducer.
and Calculations
Measurements
Calculations menu
The calculations menu contains measurements available for the imaging mode and exam type.
After you perform and save a measurement, the result saves to the patient report. (See “Patient
report” on page 92.) Also, a check mark appears next to the measurement name in the
calculations menu. If you highlight the checked measurement name, the results appear below
the menu. If you repeat the measurement, the results below the menu reflect either the last
measurement or the average, depending on the measurement.
Menu items followed by ellipses (. . .) have subentries.
To save a calculation
Do one of the following:
• Save the calculation only: Press the SAVE CALC key, or select Save on‐screen.
The calculation saves to the patient report. To save the image with the measurements
displayed, see “To save an image” on page 48.
• Save both the image and calculation: Press the SAVE key if the SAVE key functionality is
set to Image/Calcs. (See “To set presets” on page 29.)
The calculation saves to the patient report, and the image saves to internal storage with
the measurements displayed.
62
3 Perform the measurement again.
The new results appear on‐screen in the measurement and calculations data area. (See
“Screen layout” on page 12.) You can compare them to the saved results below the menu.
4 To save the new measurement, press the SAVE CALC key.
The new measurement saves to the patient report and overwrites the previously saved
measurement.
and Calculations
Measurements
Transducer Exam Types
C11x Abdomen
C60x Abdomen
P21x Abdomen
64
c Save the calculation. See “To save a calculation” on page 62.
The percent diameter reduction result appears in the measurement and calculation data area
and in the patient report.
Volume calculations
WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See“To create a new patient information form” on page 45
ICTx Gyn
P21x Abdomen
and Calculations
Measurements
To calculate volume
The volume calculation involves three 2D distance measurements: D1, D2, and D3. After all
measurements are saved, the result appears on‐screen and in the patient report.
Do the following for each image you need to measure:
a On the frozen 2D image, press the CALCS key.
b Do the following for each measurement you need to take:
i From the calculations menu, select the measurement name under Volume.
ii Position the calipers. (See “Working with calipers” on page 55.)
iii Save the measurement. See “To save a calculation” on page 62.
C11x Abdomen
C60x Abdomen
HFL38x Vascular
L25x Vascular
L38x Vascular
P21x Abdomen
The following table shows the measurements required to complete the volume flow
calculation. For definitions of acronyms, see “Glossary” on page 179.
Volume Flow Calculation
Both a 2D and a Doppler measurement are required for the volume flow calculation. The
Doppler sample volume should completely insonate the vessel.
Consider the following factors when performing volume flow measurements:
• Users should follow current medical practice for volume flow calculation applications.
• The accuracy of the volume flow calculation largely depends on the user.
• The factors identified in the literature that affect the accuracy are as follows:
• Using the diameter method for 2D area
66
• Difficulty ensuring uniform insonation of the vessel.
The system is limited to the following sample volume sizes:
• C11x transducer: 1, 2, 3 Gate Size (mm)
• C60x transducer: 2, 3, 5, 7, 10, 12 Gate Size (mm)
• HFL38x, L25x, and L38x transducers: 1, 3, 5, 7, 10, 12 Gate Size (mm)
• P21x transducer: 2, 3, 5, 7, 11.5, 14 Gate Size (mm)
• Precision in placing the caliper
• Accuracy in angle correction
The considerations and degree of accuracy for volume flow measurements and calculations are
discussed in the following reference:
Allan, Paul L. et al. Clinical Doppler Ultrasound, 4th Ed., Harcourt Publishers Limited, (2000)
36‐38.
and Calculations
Measurements
d Using the touchpad, position the vertical caliper at the beginning of the waveform.
If calipers are not positioned correctly, the calculation result is inaccurate.
e Press the SELECT key to display a second vertical caliper.
f Using the touchpad, position the second vertical caliper at the end of the waveform.
g Press the SET key to complete the trace and to display the results.
h Save the calculation. See “To save a calculation” on page 62.
To view the volume flow calculation, see “Patient report” on page 92.
Cardiac calculations
WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.
P21x Cardiac
The following table shows the measurements required to complete different cardiac
calculations. For definitions of acronyms, see “Glossary” on page 179.
Cardiac Calculations
LVD (2D) CI
LVPW (2D) SI
68
Cardiac Calculations (Continued)
LV Ao (2D or M Mode) Ao
LA/Ao
LA (2D or M Mode) LA
LA/Ao
and Calculations
Measurements
LVD (M Mode)
LVPW (M Mode) SI
LV Mass
HR HRa
MV (2D) MV Area
70
Cardiac Calculations (Continued)
MV E (Doppler) E
A (Doppler) E PG
A
A PG
E:A
and Calculations
Measurements
Vmean
PGmean
LV LVOT D (2D)
AV VTI (Doppler) SV
LV LVOT D (2D)
AV VTI (Doppler) CO
LV LVOT D (2D)
HR HRa
RA pressurec RVSP
72
3 Position the active (green) caliper at the starting point. (See “Working with calipers” on
page 55.)
4 Press the SELECT key, and position the second caliper.
5 Press the SELECT key.
Another caliper appears, and the calculations menu highlights the next measurement name.
6 Position the caliper, and press the SELECT key. Repeat for each measurement name in the
calculation group.
Each time you press the SELECT key, another caliper appears, and the calculations menu
highlights the next measurement name.
7 Save the calculation. (See “To save a calculation” on page 62.)
and Calculations
Measurements
d Complete the trace, and press the SET key.
e Save the calculation. (See “To save a calculation” on page 62.)
To calculate MV or AV area
1 On a frozen 2D image, press the CALCS key.
2 In the calculations menu, locate Area, and then select MV or AV.
3 Position the caliper where you want to begin the trace, and press the SELECT key.
4 Using the touchpad, trace the desired area.
To make a correction, select Undo on‐screen or press the BACKSPACE key.
5 Complete the trace, and press the SET key.
6 Save the calculation. (See “To save a calculation” on page 62.)
74
4 Using the touchpad, trace the waveform.
To make a correction, select Undo on‐screen, backtrack with the touchpad, or press the
BACKSPACE key.
5 Press the SET key to complete the trace.
6 Save the calculation. (See “To save a calculation” on page 62.)
For information on the automatic trace tool, see “To trace automatically (Doppler)” on page 60.
and Calculations
5 Save the calculation. (See “To save a calculation” on page 62.)
Measurements
To calculate Proximal Isovelocity Surface Area (PISA)
The PISA calculation requires a measurement in 2D, a measurement in Color, and two
measurements in Doppler spectral trace. After all measurements are saved, the result appears
in the patient report.
1 Measure from Ann D (2D):
a On a frozen 2D image, press the CALCS key.
b From the calculations menu, locate PISA, and then select Ann D.
c Position the calipers. (See “Working with calipers” on page 55.)
d Save the calculation. (See “To save a calculation” on page 62.).
76
4 Press the SELECT key.
A second horizontal dotted line with an active caliper appears at 300 cm/s.
5 Position the second caliper along the waveform at 300 cm/s.
6 Save the calculation. (See “To save a calculation” on page 62.)
To calculate Qp/Qs
The Qp/Qs calculation requires two measurements in 2D and two measurements in Doppler.
After the measurements are saved, the result appears in the patient report.
1 On a frozen 2D image, press the CALCS key.
2 Do the following to measure from LVOT D and again to measure from RVOT D:
and Calculations
a From the calculations menu, locate Qp/Qs and then select LVOT D or RVOT D.
Measurements
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)
3 On a frozen Doppler spectral trace, press the CALCS key.
4 Do the following to measure from LVOT VTI and again to measure from RVOT VTI:
a From the calculations menu, select Qp/Qs and then select LVOT VTI or RVOT VTI.
b Press the SELECT key to start the trace.
c Using the touchpad, trace the waveform.
To make a correction, select Undo on‐screen, backtrack with the touchpad, or press the
BACKSPACE key.
d Press the SET key to complete the trace.
78
1 (CI Only) Fill in the Height and Weight fields on the patient information form. The BSA is
calculated automatically. (See “To edit a patient information form” on page 45.)
2 Calculate SV. See “To calculate Stroke Volume (SV) or Stroke Index (SI)” on page 78.
3 Calculate HR. See “To calculate Heart Rate (HR)” on page 78.
WARNING: To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.
and Calculations
Measurements
Transducer Exam Type
C60x Gyn
ICTx Gyn
To measure follicles
You can save up to six follicular measurements, one distance measurement for each of up to six
follicles.
1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Follicle.
3 Do the following for each follicle you want to measure:
a From the calculations menu, select the measurement name under Right Fol or Left Fol.
b Position the calipers. (See “Working with calipers” on page 55.)
c Save the calculation. (See “To save a calculation” on page 62.)
IMT calculations
WARNING: To ensure high quality images, all patient images must be obtained by qualified and
trained individuals.
To avoid patient injury, IMT results should not be used as a sole diagnostic tool. All
IMT results should be interpreted in conjunction with other clinical information or
risk factors.
To avoid measurement errors, all measurements must be of the common carotid
artery (CCA). This tool is not intended for measuring the bulb or the internal carotid
artery (ICA).
To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.
L38x IMT
HFL38x IMT
80
The following table shows available measurements for IMT calculations. The IMT
measurement names are specified on the IMT setup page. See “IMT Calculations setup” on
page 25.
IMT Calculations (2D)
Plaque Plaq 1
Plaq 2
and Calculations
Measurements
2 From the calculations menu, select the measurement.
3 Using the touchpad or arrow keys, position the IMT tool over the area of interest until the
measurement results appear.
4 Adjust the tool, and edit as needed. See “IMT tool options” on page 82.
5 Save the calculation. (See “To save a calculation” on page 62.)
Width Adjusts the tool width by 1 mm. The upper key increases
the width, and the lower key decreases the width.
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.
82
To make a correction, select Undo on‐screen or press the BACKSPACE key to delete the
last segment.
c Press the SET key to complete the trace line.
5 Save the calculation. (See “To save a calculation” on page 62.)
To sketch IMT
The IMT sketch measurement involves two user‐defined sketch lines that you can adjust
manually.
1 On a frozen 2D image, press the CALCS key
2 From the calculations menu, select a measurement name.
3 Select Edit on‐screen, and then select Manual.
A single caliper appears on‐screen, and Sketch appears next to the measurement.
4 Do the following for the desired adventitia‐media boundary and then for the lumen‐intima
boundary:
a Position the caliper at the beginning of the boundary and press the SELECT key.
b Using the touchpad, mark points by moving the caliper to the next desired point and
pressing the SELECT key.
To make a correction, select Undo on‐screen or press the BACKSPACE key to delete the
last segment.
c Press the SET key to complete the trace line.
d If necessary, adjust or edit the measurement. See “IMT tool options” on page 82.
e Save the calculation. (See “To save a calculation” on page 62.)
OB calculations
and Calculations
EFW is calculated only after appropriate measurements are completed. If any one of these
Measurements
parameters results in an EDD greater than what the OB tables provide, the EFW is not
displayed.
WARNING: Make sure that you have selected the OB exam type and the OB calculations author
for the OB table you intend to use. See “System-Defined OB Calculations and Table
Authors” on page 86.
To avoid incorrect obstetrics calculations, verify with a local clock and calendar that
the system’s date and time settings are correct before each use of the system. The
system does not automatically adjust for daylight savings time changes.
C60x OB
ICTx OB
P21x OB
Term
Acronym
Definition
84
OB Calculation Terms in Patient Report and Patient Information Form (Continued)
Term
Acronym
Definition
UA Ultrasound Age
Calculated on the mean measurements taken for a particular fetal
biometry.
If you change the calculation author during the exam, the common measurements are retained.
and Calculations
Measurements
Gestational OB
Calculation Result Table Authors
Measurements
OFD Hansmann
FTA Osaka
AC, FL Hadlock 3
BPD, AC Shepard
86
System-Defined OB Calculations and Table Authors (Continued)
Gestational OB
Calculation Result Table Authors
Measurements
FL/AC Hadlock
FL/BPD Hohler
FL/HC Hadlock
HC/AC Campbell
a. The Gestational Age is automatically calculated and displayed next to the OB measurement you selected.
The average of the results is the AUA.
b. For Toyko U., APTD and TTD are used only to calculate EFW. No age or growth tables are associated with
these measurements.
c. The Estimated Fetal Weight calculation uses an equation that consists of one or more fetal biometry
measurements. The author for the OB tables, which you choose on a system setup page, determines the
measurements you must perform to obtain an EFW calculation. (See “OB Calculations setup” on page 26.)
Individual selections for Hadlock’s EFW equations 1, 2, and 3 are not determined by the user. The selected
and Calculations
equation is determined by the measurements that have been saved to the report with priority given to the
Measurements
order listed above.
d. The Growth Analysis tables are used by the Report Graphs feature. Three growth curves are drawn using
the table data for the selected growth parameter and published author. Growth tables are only available
with a user-entered LMP or Estab. DD.
88
To calculate MCA or Umba (Doppler)
Note: The system does not provide an MCA/UmbA ratio from the PI (Pulsatility Index).
1 Select OB exam type, and select LMP or Estab.DD in the patient information form.
2 On a frozen Doppler spectral trace, press the CALCS key.
3 Do the following for each measurement you need to take:
a From the calculations menu, select the measurement name under MCA (Middle Cerebral
Artery) or UmbA (Umbilical Artery).
b Position the calipers:
• For S/D, RI, position the first caliper at the peak systolic waveform. Press the SELECT
key, and position the second caliper at the end diastole on the waveform.
• For S/D, RI, PI, position the caliper at the beginning of the desired waveform, and press
the SELECT key. Use the touchpad to manually trace the desired area. Press the SET
key.
If calipers are not positioned correctly, the calculation result is inaccurate.
c Save the calculation. (See “To save a calculation” on page 62.)
Only one calculation (S/D, RI or S/D, RI, PI) can be saved.
and Calculations
L38x Small Parts
Measurements
To calculate hip angle
1 On a frozen 2D image, press the CALCS key.
2 From the calculations menu, select Right or Left.
3 Select Baseline under Hip Angle.
A baseline appears on‐screen.
4 Position the baseline, and press the SET key. (See “Working with calipers” on page 55.)
Line A (alpha line) appears on‐screen, and Line A is selected in the calculations menu.
5 Position Line A, and save the measurement. (See “To save a calculation” on page 62.)
Line B (beta line) appears on‐screen, and Line B is selected in the calculations menu.
Vascular calculations
WARNING: To avoid misdiagnosis or harming the patient outcome, start a new patient
information form before starting a new patient exam and performing calculations.
Starting a new patient information form clears the previous patient’s data. The
previous patient’s data will be combined with the current patient if the form is not
first cleared. See “To create a new patient information form” on page 45.
To avoid incorrect calculations, verify that the patient information, date, and time
settings are accurate.
HFL38x Vascular
L25x Vascular
L38x Vascular
P10x Vascular
90
The vascular measurements that you can save to the patient report are listed in the following
table. For definitions of acronyms, see “Glossary” on page 179.
Vascular Calculations
and Calculations
Measurements
3 Do the following for each measurement you want to take:
a From the calculations menu, select the measurement name.
b Using the touchpad, position the caliper at the peak systolic waveform.
c Press the SELECT key.
A second caliper appears.
d Using the touchpad, position the second caliper at the end diastole on the waveform.
e Save the calculation. (See “To save a calculation” on page 62.)
OB reports
The OB report pages have a signature space for signing printed reports.
To view the OB Twins report (individual)
1 After or during the OB exam, press the REPORT key.
2 Select Twin A/B on‐screen to view individual twin reports.
92
To view the OB Twins report (combined)
1 After or during the OB exam, press the REPORT key.
2 Select Compare on‐screen to view both twins in a single report.
To delete an OB measurement
1 After or during the OB exam, press the REPORT key.
2 Using the touchpad, select the desired OB measurement.
The selected measurement is highlighted green.
3 Select Delete on‐screen.
To delete all measurements, select the measurement label and press the SELECT key and
then select Delete on‐screen.
and Calculations
Measurements
Figure 3 OB Anatomy Checklist Page
To view OB graphs
OB Graphs may be viewed if LMP or Estab. DD is entered in the patient information form.
1 After or during the OB exam, press the REPORT key.
2 Select Graphs on‐screen.
3 In the Graphs list, select the desired measurement/author.
The graph for the selected measurement appears. You can select another
measurement/author or select 1/x on‐screen.
For twins, both measurement sets are plotted on the same graph.
4 (Optional) Press the SAVE key to save the current graph page.
5 Select one of the following on‐screen:
• Report to return to the previous report page
• Done to return to live imaging.
94
Chapter 5: Troubleshooting and Maintenance
This chapter contains information to help correct problems with system operation, to enter a
software license, and to take proper care of the system, transducer, and accessories.
Troubleshooting
If you encounter difficulty with the system, use the following table to help troubleshoot the
problem. If the problem persists, contact SonoSite Technical Support. (See “SonoSite Technical
Support” on page viii.)
Troubleshooting
Symptom Solution
System image quality is poor. Adjust the LCD screen to improve viewing angle.
Adjust the brightness.
Adjust the gain.
Print does not work. Select the printer on the Connectivity setup page. See “To
configure the system for a printer” on page 24.
Check the printer connections.
Ensure that the printer is turned on and set up properly. See
the printer manufacturer’s instructions, if necessary.
DVD recorder does not record. Check the DVD recorder connections.
Troubleshooting
Symptom Solution
System does not recognize the Disconnect and reconnect the transducer.
transducer.
Software licensing
SonoSite software is controlled by a license key. After you install new software, the system
prompts you for a license key. You must obtain one key for each system or transducer that uses
the software.
The software will operate for a short time (the “grace period”) without a license key. During the
grace period, all system functions are available. After the grace period, the system is not usable
until you enter a valid license key. Grace period time is not used while the system is off or
asleep. Grace period time remaining appears on the license update screen.
Caution: After the grace period expires, all system functions except licensing are unavailable
until a valid license key is entered.
To obtain a license key for your software, contact SonoSite Technical Support. (See “SonoSite
Technical Support” on page viii.) You need to provide the following information. (See “System
Information setup” on page 30.)
Software License Key Information
Name of person installing the upgrade Name of person installing the upgrade
After you obtain a license key, you must enter it into the system.
96
To enter a license key
1 Turn on the system.
The license update screen appears.
2 Enter the license key in the Enter license number field.
3 Select Done on‐screen.
If you entered a valid license key but the license update screen appears, verify that you
entered the license key correctly. If the license update screen still appears, contact SonoSite
Technical Support. (See “SonoSite Technical Support” on page viii.)
Maintenance
Use the recommendations in this section when cleaning or disinfecting your ultrasound
system, transducer, and accessories. Use the cleaning recommendations in the peripheral
manufacturer’s instructions when cleaning or disinfecting your peripherals.
No periodic or preventive maintenance is required for the system, transducer, or accessories
other than cleaning and disinfecting the transducer after every use. (See “Cleaning and
disinfecting transducers” on page 99.) There are no internal components that require periodic
testing or calibration. All maintenance requirements are described in this chapter and in the
ultrasound system service manual. Performing maintenance procedures not described in the
user guide or service manual may void the product warranty.
Contact SonoSite Technical Support for any maintenance questions. (See “SonoSite Technical
Support” on page viii.)
WARNING: Disinfectants and cleaning methods listed are recommended by SonoSite for
compatibility with product materials, not for biological effectiveness. Refer to the
disinfectant label instructions for guidance on disinfection efficacy and appropriate
clinical uses.
The level of disinfection required for a device is dictated by the type of tissue it will
contact during use. To avoid infection, ensure that the disinfectant type is
appropriate for the equipment. For information, see the disinfectant label
instructions and the recommendations of the Association for Professionals in
Infection Control and Epidemiology (APIC) and the U.S. Food and Drug
Administration (FDA).
To prevent contamination, the use of sterile transducer sheaths and sterile coupling
Troubleshooting
Caution: Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
WARNING: To avoid electrical shock, before cleaning, disconnect the system from the power
supply or remove from the mini-dock or docking system.
To avoid infection always use protective eyewear and gloves when performing
cleaning and disinfecting procedures.
To avoid infection, ensure that the solution expiration date has not passed.
To avoid infection, the level of disinfection required for a product is dictated by the
type of tissue it contacts during use. Ensure that the solution strength and duration
of contact are appropriate for the equipment. For information, see the disinfectant
label instructions and the recommendations of the Association for Professionals in
Infection Control and Epidemiology (APIC) and FDA.
Caution: Do not spray cleaners or disinfectant directly on the system surfaces. Doing so may
cause solution to leak into the system, damaging the system and voiding the
warranty.
Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since
these will damage the exterior surfaces.
Use only recommended cleaners or disinfectants on system surfaces.
Immersion-type disinfectants are not approved for use on system surfaces.
When you clean the system, ensure that the solution does not get inside the system
controls or the battery compartment.
Do not scratch the LCD screen.
98
4 Mix the disinfectant solution compatible with the system, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
5 Wipe surfaces with the disinfectant solution.
6 Air dry or towel dry with a clean cloth.
WARNING: To avoid electrical shock, before cleaning, disconnect the transducer from the
system.
To avoid injury, always use protective eyewear and gloves when performing
cleaning and disinfecting procedures.
To avoid infection, ensure that the solution expiration date has not passed.
To avoid infection, the level of disinfection required for a transducer is dictated by
the type of tissue it contacts during use. Ensure that the solution strength and
duration of contact are appropriate for the equipment. SonoSite tests products for
compatibility of materials only. SonoSite does not test for biological effectiveness.
For information, see the disinfectant label instructions and the recommendations of
the Association for Professionals in Infection Control and Epidemiology (APIC) and
FDA.
Caution: Transducers must be cleaned after every use. Cleaning transducers is necessary prior
to effective disinfection. Ensure that you follow the manufacturer's instructions
when using disinfectants.
Do not use a surgeon's brush when cleaning transducers. Even the use of soft
brushes can damage a transducer. Use a soft cloth.
Using a non-recommended cleaning or disinfection solution, incorrect solution
strength, or immersing a transducer deeper or for a longer period of time than
recommended can damage or discolor the transducer and void the transducer
warranty.
Do not allow cleaning solution or disinfectant into the transducer connector.
Troubleshooting
Do not allow disinfectant to contact metal surfaces. Use a soft cloth lightly
dampened in a mild soap or compatible cleaning solution to remove any
disinfectant that remains on metal surfaces.
Attempting to disinfect a transducer or transducer cable using a method other than
the one included here can damage the transducer and void the warranty.
100
Cleaning and disinfecting transducer cables
The transducer cable can be disinfected using a recommended wipe or immersion disinfectant.
Before disinfecting, orient the cable to ensure that the transducer and system do not get
immersed.
WARNING: To avoid infection, ensure that the solution expiration date has not passed.
Caution: Attempting to disinfect a transducer cable using a method other than the one
included here can damage the transducer and void the warranty.
5 Mix the disinfectant solution compatible with the transducer cable, following disinfectant
label instructions for solution strengths and disinfectant contact duration.
6 Immerse the transducer cable into the disinfection solution.
Follow the instructions on the disinfectant label for the duration of the transducer cable
immersion.
102
2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning
solution.
Apply the solution to the cloth rather than the surface.
3 Wipe the surfaces with any of the following products:
• Bleach (sodium hypochlorite)
• Cidex disinfectants
• Green soap
• Theracide
4 Air dry or towel dry with a clean cloth.
Troubleshooting
See www.sonosite.com for updated cleaning and disinfectant information. Click Quick Link, and then click
Documentation.
105
Troubleshooting
Table 1: Disinfectants Compatible with System and Transducers (Continued)
106
Disinfection and Country C60x/ICTx/ C11x/ System
Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces
107
Troubleshooting
Table 1: Disinfectants Compatible with System and Transducers (Continued)
108
Disinfection and Country C60x/ICTx/ C11x/ System
Type Active Ingredient HFL38x
Cleaning Solutions of Origin L38x/P21x L25x Surfaces
Safety
This chapter contains information required by regulatory agencies, including information
about the ALARA (as low as reasonably achievable) principle, the output display standard,
acoustic power and intensity tables, and other safety information. The information applies to
the ultrasound system, transducer, accessories, and peripherals.
Ergonomic safety
These healthy scanning guidelines are intended to assist you in the comfort and effective use
of your ultrasound system.
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.
Position yourself
Support your back during an exam
• Use a chair that has support for your lower back, that adjusts to your work surface height,
that promotes a natural body posture, and that allows for quick height adjustments.
• Always sit or stand in an upright manner. Avoid bending or stooping.
112
Promote comfortable hand, wrist, and finger postures
• Hold the transducer lightly in your fingers.
Safety
• Minimize the pressure applied on the patient.
• Keep your wrist in a straight position.
Internally powered equipment Ultrasound system not connected to the power supply
(battery only)
Electrical safety
This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type
BF isolated patient‐applied parts safety requirements.
WARNING: To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the
patient.
Under certain circumstances, the transducer connector and back of the display
enclosure can reach temperatures that exceed EN60601-1 limits for patient contact,
therefore only the operator shall handle the system. This does not include the
transducer face.
To avoid discomfort or minor risk of operator injury when handling the transducer
connector, the system should not be operated for more than 60 minutes
continuously in a live-scan mode (as opposed to freeze or sleep modes).
To avoid the risk of electrical shock or injury, do not open the system enclosures. All
internal adjustments and replacements, except battery replacement, must be made
by a qualified technician.
To avoid the risk of injury, do not operate the system in the presence of flammable
gasses or anesthetics. Explosion can result.
To avoid the risk of electrical shock, use only properly grounded equipment. Shock
hazards exist if the power supply is not properly grounded. Grounding reliability can
only be achieved when equipment is connected to a receptacle marked “Hospital
Only” or “Hospital Grade” or the equivalent. The grounding wire must not be
removed or defeated.
To avoid the risk of electrical shock, when using the system in an environment where
the integrity of the protective earth conductor arrangement is in doubt, operate the
system on battery power only without using the power supply.
To avoid the risk of electrical shock, do not connect the system’s power supply or a
docking system to an MPSO or extension cord.
To avoid the risk of electrical shock, before using the transducer, inspect the
transducer face, housing, and cable. Do not use the transducer if the transducer or
cable is damaged.
To avoid the risk of electrical shock, always disconnect the power supply from the
system before cleaning the system.
To avoid the risk of electrical shock, do not use any transducer that has been
immersed beyond the specified cleaning or disinfection level. See Chapter 5,
“Troubleshooting and Maintenance.”
To avoid the risk of electrical shock and fire hazard, inspect the power supply, AC
power cord, and plug on a regular basis. Ensure they are not damaged.
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To avoid the risk of electrical shock and fire hazard, the power cord set that connects
the power supply of the ultrasound system or MDS to mains power must only be
used with the power supply or MDS, and cannot be used to connect other devices to
Safety
mains power.
To avoid the risk of electrical shock, use only accessories and peripherals
recommended by SonoSite, including the power supply. Connection of accessories
and peripherals not recommended by SonoSite could result in electrical shock.
Contact SonoSite or your local representative for a list of accessories and peripherals
available from or recommend by SonoSite.
To avoid the risk of electrical shock, use commercial grade peripherals
recommended by SonoSite on battery power only. Do not connect these products
to AC mains power when using the system to scan or diagnose a patient/subject.
Contact SonoSite or your local representative for a list of the commercial grade
peripherals available from or recommended by SonoSite.
To avoid the risk of electrical shock, inspect cables and power cords used within the
system on a regular basis for damage.
To avoid the risk of electrical shock to the patient/subject, do not touch the system
battery contacts while simultaneously touching a patient/subject.
To prevent injury to the operator/bystander, the transducer must be removed from
patient contact before the application of a high-voltage defibrillation pulse.
To avoid possible electrical shock or electromagnetic interference, verify proper
operation and compliance with relevant safety standards for all equipment before
clinical use. Connecting additional equipment to the ultrasound system constitutes
configuring a medical system. SonoSite recommends verifying that the system, all
combinations of equipment, and accessories connected to the ultrasound system
comply with JACHO installation requirements and/or safety standards such as
AAMI-ES1, NFPA 99 OR IEC Standard 60601-1-1 and electromagnetic compatibility
standard IEC 60601-1-2 (Electromagnetic compatibility), and are certified according
to IEC Standard 60950 (Information Technology Equipment (ITE)).
Caution: Do not use the system if an error message appears on the image display: note the
error code; call SonoSite or your local representative; turn off the system by pressing
and holding the power key until the system powers down.
To avoid increasing the system and transducer connector temperature, do not block
the airflow to the ventilation holes on the side of the system.
Caution: Excessive bending or twisting of cables can cause a failure or intermittent operation.
Improper cleaning or disinfecting of any part of the system can cause permanent
damage. For cleaning and disinfecting instructions, see Chapter 5, “Troubleshooting
and Maintenance.”
Do not submerge the transducer connector in solution. The cable is not liquid-tight
beyond the transducer connector/cable interface.
Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of
the system.
Remove the battery from the system if the system is not likely to be used for some
time.
Do not spill liquid on the system.
Battery safety
To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury
or equipment damage, observe the following precautions.
WARNING: The battery has a safety device. Do not disassemble or alter the battery.
Charge the batteries only when the ambient temperature is between 0° and 40°C
(32° and 104°F).
Do not short-circuit the battery by directly connecting the positive and negative
terminals with metal objects.
Do not heat the battery or discard it in a fire.
Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire
and other heat sources.
Do not charge the battery near a heat source, such as a fire or heater.
Do not leave the battery in direct sunlight.
Do not pierce the battery with a sharp object, hit it, or step on it.
Do not use a damaged battery.
Do not solder a battery.
The polarity of the battery terminals are fixed and cannot be switched or reversed.
Do not force the battery into the system.
Do not connect the battery to an electrical power outlet.
116
WARNING: Do not continue recharging the battery if it does not recharge after two successive
six hour charging cycles.
Safety
If the battery leaks or emits an odor, remove it from all possible flammable sources.
Caution: To avoid the battery bursting, igniting, or emitting fumes from the battery and
causing equipment damage, observe the following precautions:
Do not immerse the battery in water or allow it to get wet.
Do not put the battery into a microwave oven or pressurized container.
If the battery emits an odor or heat, is deformed or discolored, or in any way appears
abnormal during use, recharging or storage, immediately remove it and stop using
it. If you have any questions about the battery, consult SonoSite or your local
representative.
Store the battery between -20°C (-4°F) and 60°C (140°F).
Use only SonoSite batteries.
Do not use or charge the battery with non-SonoSite equipment. Only charge the
battery with the system.
Biological safety
Observe the following precautions related to biological safety.
WARNING: To avoid device damage or patient injury, do not use the P10/P17 needle guide
bracket on patients with pacemakers or medical electronic implants. The needle
guide bracket for the P10 and P17 transducers contains a magnet that is used to
ensure the bracket is correctly oriented on the transducer. The magnetic field in
direct proximity to the pacemaker or medical electronic implant may have an
adverse effect.
Non-medical (commercial) grade peripheral monitors have not been verified or
validated by SonoSite as being suitable for diagnosis.
To avoid the risk of a burn hazard, do not use the transducer with high frequency
surgical equipment. Such a hazard may occur in the event of a defect in the high
frequency surgical neutral electrode connection.
Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in
the scanning sequence are indicative of a hardware failure that must be corrected
before use.
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
Electromagnetic compatibility
The ultrasound system has been tested and found to comply with the electromagnetic
compatibility (EMC) limits for medical devices to IEC 60601‐1‐2:2001. These limits are designed
to provide reasonable protection against harmful interference in a typical medical installation.
Caution: Medical electrical equipment requires special precautions regarding EMC and must
be installed and operated according to these instructions. It is possible that high
levels of radiated or conducted radio-frequency electromagnetic interference (EMI)
from portable and mobile RF communications equipment or other strong or nearby
radio-frequency sources, could result in performance disruption of the ultrasound
system. Evidence of disruption may include image degradation or distortion, erratic
readings, equipment ceasing to operate, or other incorrect functioning. If this occurs,
survey the site to determine the source of disruption, and take the following actions
to eliminate the source(s).
• Turn equipment in the vicinity off and on to isolate disruptive equipment.
• Relocate or re-orient interfering equipment.
• Increase distance between interfering equipment and your ultrasound system.
• Manage use of frequencies close to ultrasound system frequencies.
• Remove devices that are highly susceptible to EMI.
• Lower power from internal sources within facility control (such as paging
systems).
• Label devices susceptible to EMI.
• Educate clinical staff to recognize potential EMI-related problems.
• Eliminate or reduce EMI with technical solutions (such as shielding).
• Restrict use of personal communicators (cell phones, computers) in areas with
devices susceptible to EMI.
• Share relevant EMI information with others, particularly when evaluating new
equipment purchases which may generate EMI.
• Purchase medical devices that comply with IEC 60601-1-2 EMC Standards.
118
Caution: To avoid the risk of increased electromagnetic emissions or decreased immunity, use
only accessories and peripherals recommended by SonoSite. Connection of
accessories and peripherals not recommended by SonoSite could result in
Safety
malfunctioning of your ultrasound system or other medical electrical devices in the
area. Contact SonoSite or your local representative for a list of accessories and
peripherals available from or recommended by SonoSite. See the SonoSite
accessories user guide.
Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon.
ESD is common in conditions of low humidity, which can be caused by heating or air
conditioning. Static shock is a discharge of the electrical energy from a charged
body to a lesser or non-charged body. The degree of discharge can be significant
enough to cause damage to a transducer or an ultrasound system. The following
precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on
linoleum, and anti-static mats.
Manufacturer’s declaration
Table 1 and Table 2 document the intended use environment and EMC compliance levels of the
system. For maximum performance, ensure that the system is used in the environments
described in this table.
The system is intended for use in the electromagnetic environment specified below.
Table 1: Manufacturer’s Declaration - Electromagnetic Emissions
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment
Electrostatic 2.0KV, 4.0KV, 6.0KV 2.0KV, 4.0KV, 6.0KV Floors should be wood,
Discharge (ESD) contact contact concrete or ceramic tile. If
IEC 61000-4-2 2.0KV, 4.0KV, 8.0KV air 2.0KV, 4.0KV, 8.0KV floors are covered with
air synthetic material, the relative
humidity should be at least
30%.
Electrical fast 2KV on the mains 2KV on the mains Mains power quality should
Transient burst 1KV on signal lines 1KV on signal lines be that of a typical
commercial or hospital
IEC 61000-4-4
environment.
Surge 0.5KV, 1.0KV, 2.0KV on 0.5KV, 1.0KV, 2.0KV Mains power quality should
IEC 61000-4-5 AC power lines to on AC power lines be that of a typical
ground to ground commercial or hospital
0.5KV, 1.0KV on AC 0.5KV, 1.0KV on AC environment.
power lines to lines power lines to
lines
120
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Safety
Environment
Recommended Separation
Distance
d = 1.2 P
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment
a.Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite
ultrasound system should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system.
b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
ALARA principle
ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other
qualified ultrasound users, using good judgment and insight, determine the exposure that is
“as low as reasonably achievable.” There are no set rules to determine the correct exposure for
every situation. The qualified ultrasound user determines the most appropriate way to keep
exposure low and bioeffects to a minimum, while obtaining a diagnostic examination.
A thorough knowledge of the imaging modes, transducer capability, system setup and
scanning technique is necessary. The imaging mode determines the nature of the ultrasound
beam. A stationary beam results in a more concentrated exposure than a scanned beam, which
spreads that exposure over that area. The transducer capability depends upon the frequency,
122
penetration, resolution, and field of view. The default system presets are reset at the start of
each new patient. It is the scanning technique of the qualified ultrasound user along with
patient variability that determines the system settings throughout the exam.
Safety
The variables which affect the way the qualified ultrasound user implements the ALARA
principle include: patient body size, location of the bone relative to the focal point, attenuation
in the body, and ultrasound exposure time. Exposure time is an especially useful variable,
because the qualified ultrasound user can control it. The ability to limit the exposure over time
supports the ALARA principle.
Applying ALARA
The system imaging mode selected by the qualified ultrasound user is determined by the
diagnostic information required. 2D imaging provides anatomical information; CPD imaging
provides information about the energy or amplitude strength of the Doppler signal over time
at a given anatomical location and is used for detecting the presence of blood flow; Color
imaging provides information about the energy or amplitude strength of the Doppler signal
over time at a given anatomical location and is used for detecting the presence, velocity, and
direction of blood flow; Tissue Harmonic Imaging uses higher received frequencies to reduce
clutter, artifact, and improve resolution on the 2D image. Understanding the nature of the
imaging mode used allows the qualified ultrasound user to apply the ALARA principle.
Prudent use of ultrasound requires that patient exposure to ultrasound be limited to the lowest
ultrasound output for the shortest time necessary to achieve acceptable diagnostic results.
Decisions that support prudent use are based on the type of patient, exam type, patient history,
ease or difficulty of obtaining diagnostically useful information, and potential localized
heating of the patient due to transducer surface temperature.
The system has been designed to ensure that temperature at the face of the transducer will not
exceed the limits established in Section 42 of EN 60601‐2‐37: Particular requirement for the
safety of ultrasound medical diagnostic and monitoring equipment. See “Transducer surface
temperature rise” on page 128. In the event of a device malfunction, there are redundant
controls that limit transducer power. This is accomplished by an electrical design that limits
both power supply current and voltage to the transducer.
The sonographer uses the system controls to adjust image quality and limit ultrasound output.
The system controls are divided into three categories relative to output: controls that directly
affect output, controls that indirectly affect output, and receiver controls.
Direct controls
The system does not exceed a spatial peak temporal average intensity (ISPTA) of 720 mW/cm2
for all imaging modes. (For opthalmic use the Orb exam mode is limited to the following
values: ISPTA does not exceed 50 mW/cm2; TI does not exceed 1.0, and MI does not exceed
0.23.) The mechanical index (MI) and thermal index (TI) may exceed values greater than 1.0 on
some transducers in some imaging modes. One may monitor the MI and TI values and adjust
the controls to reduce these values. See “Guidelines for reducing MI and TI” on page 124.
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).
124
“↑” means to raise or increase setting of parameter to reduce MI or TI
Table 3: MI
Safety
Transducer Depth
C11x ↑
C60x ↑
HFL38x ↑
ICTx ↑
L25x ↑
L38x ↑
P21x ↑
C11x ↑ ↓ ↑ ↓ (Depth)
C60x ↓ ↑ ↓ ↑ ↓ (PRF)
HFL38x ↑ ↑ ↑ ↓ (Depth)
ICTx Exam
↑ ↑ ↓ ↓ (PRF)
Gyn
L25x ↓ ↑ ↓ (PRF)
L38x ↓ ↓ (Depth)
P21x ↓ ↓ ↑ ↓ (PRF)
2D/ CPD/ PW CW
Transducer Model Index
M Mode Color Doppler Doppler
C11x/8-5 MI No No No —
C60x/5-2 MI Yes No No —
HFL38x/13-6 MI No Yes No —
ICTx/8-5 MI No No No —
L25x/13-6 MI No No No —
Even when MI is less than 1.0, the system provides a continuous real‐time display of MI
whenever a transducer is operated in a 2D imaging mode. The index is displayed in increments
of 0.1.
The system meets the output display standard for TI. A continuous real‐time display of TI is
provided for the operator whenever a transducer is operated in a CPD, Color, M Mode, or PW
Doppler imaging mode. The index is displayed in increments of 0.1.
The thermal index consists of three user selectable indices, and only one of these is displayed
at any one time. In order to display properly and meet the ALARA principle, the user selects
an appropriate TI based on the specific exam being performed. SonoSite provides the AIUM
Medical Ultrasound Safety reference which contains guidance on how to determine which TI
is appropriate (see second reference listed in “Related guidance documents” on page 127).
126
Mechanical and thermal indices output display accuracy
The accuracy result for the mechanical index (MI) is stated statistically. With 90% confidence,
90% of the measured MI values will be within +16% to –31% of the displayed MI value, or +0.2
Safety
of the displayed value, whichever value is larger.
The accuracy result for the thermal index (TI) is stated statistically. With 90% confidence, 90%
of the measured TI values will be within +26% to –50% of the displayed TI value, or +0.2 of the
displayed value, whichever value is larger. The values equate to +1dB to –3dB.
A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than
0.05.
Test ICTx
3 5.5°C
2 12.0°C
128
Acoustic output measurement
Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)
Safety
from ultrasound exposure have been studied by various scientific and medical institutions. In
October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report
prepared by its Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic
Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as
the Stowe Report, which reviewed available data on possible effects of ultrasound exposure.
Another report “Bioeffects and Safety of Diagnostic Ultrasound,” dated January 28, 1993
provides more current information.
The acoustic output for this ultrasound system has been measured and calculated in
accordance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment” (NEMA UD2‐2004), and the “Standard for Real‐Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA
UDe3‐2004).
130
• Computed estimates of upper limits to temperature elevations during transabdominal scans
were obtained in a survey of 1988 and 1990 pulsed Doppler equipment. The vast majority of
models yielded upper limits less than 1° and 4°C (1.8° and 7.2°F) for exposures of
Safety
first‐trimester fetal tissue and second‐trimester fetal bone, respectively. The largest values
obtained were approximately 1.5°C (2.7°F) for first‐trimester fetal tissue and 7°C (12.6°F) for
second‐trimester fetal bone. Estimated maximum temperature elevations given here are for
a “fixed path” tissue model and are for devices having ISPTA values greater than 500 mW/
cm2. The temperature elevations for fetal bone and tissue were computed based on
calculation procedures given in Sections 4.3.2.1‐4.3.2.6 in “Bioeffects and Safety of Diagnostic
Ultrasound” (AIUM, 1993).
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) (a) — — — 1.2
pr.3 (MPa) #
W0 (mW) # — — 40.50
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) # —
deq(zsp) (cm) —
fc (MHz) # # — — — 4.38
Dim of Aaprt X (cm) # — — — 0.36
Y (cm) # — — — 0.5
PD (μsec) #
PRF (Hz) #
Other Information
pr@PIImax (MPa) #
deq@Pllmax (cm) —
Focal Length FLx (cm) # — — 1.56
FLy (cm) # — — 2.5
IPA.3@MImax (W/cm2) #
Control 1: Mode CPD
Conditions
Operating
Control
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
132
Table 9: Transducer Model: C11x/8-5 Operating Mode: PW Doppler
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.8 1.7
pr.3 (MPa) #
W0 (mW) — # 26.29 24.65
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) # 1.1
deq(zsp) (cm) 0.236
fc (MHz) # — # — 4.36 4.36
Dim of Aaprt X (cm) — # — 0.28 0.2
Y (cm) — # — 0.5 0.5
PD (μsec) #
PRF (Hz) #
Other Information
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.226
Focal Length FLx (cm) — # — 0.77
FLy (cm) — # — 2.5
IPA.3@MImax (W/cm2) #
Control 1: Exam Type Any Any
Conditions
Operating
Control
(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.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.0 (a) — — — (b)
pr.3 (MPa) 1.59
W0 (mW) # — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 5.3 —
deq(zsp) (cm) —
fc (MHz) 2.86 # — — — #
Dim of Aaprt X (cm) # — — — #
Y (cm) # — — — #
PD (μsec) 0.579
PRF (Hz) 7923
Other Information
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
134
Table 11: Transducer Model: C60x/5-2 Operating Mode: M Mode
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.0 — (a) — (a) (b)
pr.3 (MPa) 1.62
W0 (mW) — # # #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 4.7 #
deq(zsp) (cm) #
fc (MHz) 2.85 — # — # #
Dim of Aaprt X (cm) — # — # #
Y (cm) — # — # #
PD (μsec) 0.577
PRF (Hz) 800
Other Information
(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.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 3.1 (b)
pr.3 (MPa) #
W0 (mW) — # 85.64 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) # 1.255
deq(zsp) (cm) 0.51
fc (MHz) # — # — 2.233 #
Dim of Aaprt X (cm) — # — 0.6552 #
Y (cm) — # — 1.3 #
PD (μsec) #
PRF (Hz) #
Other Information
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.415
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm ) 2
#
Control 1: Exam Type Abd
Conditions
Operating
Control
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
136
Table 13: Transducer Model: HFL38x/13-6 Operating Mode: CPD/Color
TIS TIB
Safety
Index Label M.I. Non-scan Non- TIC
Scan
Aaprt≤1 Aaprt>1 scan
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 1.2 —
deq(zsp) (cm) —
fc (MHz) 5.328 5.324 — — — #
Dim of Aaprt X (cm) 0.44 — — — #
Y (cm) 0.4 — — — #
PD (μsec) 0.525
PRF (Hz) 2597
Other Information
Low/3.3 cm/
2.7 cm/
393
1938
Control 4: Color Box Position/Size Top/
Any
Short
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — 1.2 — 2.2 (b)
pr.3 (MPa) #
W0 (mW) — 46.55 46.55 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) # 1.1
deq(zsp) (cm) 0.33
fc (MHz) # — 5.33 — 5.33 #
Dim of Aaprt X (cm) — 1.04 — 1.04 #
Y (cm) — 0.4 — 0.4 #
PD (μsec) #
PRF (Hz) #
Other Information
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.46
Focal Length FLx (cm) — 3.72 — #
FLy (cm) — 2.5 — #
IPA.3@MImax (W/cm2) #
Control 1: Exam Type Vas/Ven/ Vas/Ven/
Conditions
Operating
IMT IMT
Control
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
138
Table 15: Transducer Model: ICTx/8-5 Operating Mode: PW Doppler
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.2 (a)
pr.3 (MPa) #
W0 (mW) — # 16.348 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) # 1.6
deq(zsp) (cm) 0.192
fc (MHz) # — # — 4.36 #
Dim of Aaprt X (cm) — # — 0.6 #
Y (cm) — # — 0.5 #
PD (μsec) #
PRF (Hz) #
Other Information
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.187
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm ) 2
#
Control 1: Exam Type Any
Conditions
Operating
Control
(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.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — (a) — 1.6 (b)
pr.3 (MPa) #
W0 (mW) — # 14.02 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) # 0.6
deq(zsp) (cm) 0.155
fc (MHz) # — # — 6.00 #
Dim of Aaprt X (cm) — # — 0.16 #
Y (cm) — # — 0.3 #
PD (μsec) #
PRF (Hz) #
Other Information
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.1549
Focal Length FLx (cm) — # — #
FLy (cm) — # — #
IPA.3@MImax (W/cm ) 2
#
Control 1: Exam Type Vas/Nrv/
Conditions
Operating
Ven
Control
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
140
Table 17: Transducer Model: L38x/10-5 Operating Mode: CPD/Color
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.3 1.0 — — — (b)
pr.3 (MPa) 2.89
W0 (mW) 64.88 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 1.1 —
deq(zsp) (cm) —
fc (MHz) 4.91 4.91 — — — #
Dim of Aaprt X (cm) 0.54 — — — #
Y (cm) 0.4 — — — #
PD (μsec) 0.529
PRF (Hz) 9547
Other Information
(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.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.04 — 2.0 — 2.6 (b)
pr.3 (MPa) 2.345
W0 (mW) — 84.94 84.94 #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 0.8 1.3
deq(zsp) (cm) 0.4685
fc (MHz) 5.01 — 5.05 — 5.05 #
Dim of Aaprt X (cm) — 1.80 — 1.80 #
Y (cm) — 0.4 — 0.4 #
PD (μsec) 1.29
PRF (Hz) 1008
Other Information
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
142
Table 19: Transducer Model: P21x/5-1 Operating Mode: 2D
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.3 1.1 — — — (b)
pr.3 (MPa) 1.83
W0 (mW) 122.87 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 5.1 —
deq(zsp) (cm) —
fc (MHz) 1.84 1.88 — — — #
Dim of Aaprt X (cm) 0.590 — — — #
Y (cm) 1.3 — — — #
PD (μsec) 0.963
PRF (Hz) 4421
Other Information
Any
Control
Gen
Control 3: Depth 4.7/7.6
4.7
cm
Control 4: THI On On
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.5 — (a) — (a) (a)
pr.3 (MPa) 2.10
W0 (mW) — # # #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 3.645 #
deq(zsp) (cm) #
fc (MHz) 1.93 — # — # #
Dim of Aaprt X (cm) — # — # #
Y (cm) — # — # #
PD (μsec) 0.904
PRF (Hz) 800
Other Information
OB
Control
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
144
Table 21: Transducer Model: P21x/5-1 Operating Mode: CPD/Color
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.5 1.3 — — — (b)
pr.3 (MPa) 2.19
W0 (mW) 136.91 — — #
min of [W.3(z1),ITA.3(z1)] (mW) —
Associated Acoustic
z1 (cm) —
Parameter
zbp (cm) —
zsp (cm) 4.5 —
deq(zsp) (cm) —
fc (MHz) 2.15 2.16 — — — #
Dim of Aaprt X (cm) 0.918 — — — #
Y (cm) 1.3 — — — #
PD (μsec) 1.20
PRF (Hz) 1063
Other Information
OB
Control
OB
Control 3: PRF/Depth 300/10 850/7.5
Control 4: Color Optimization Any Med
Control 5: THI On Off
Control 6: Color Box Size Short and
Any
Narrow
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
TIS TIB
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value 1.2 — — 1.3 3.9 (b)
pr.3 (MPa) 1.844
W0 (mW) — — 93.28 #
min of [W.3(z1),ITA.3(z1)] (mW) 120.13
Associated Acoustic
z1 (cm) 3.1
Parameter
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
146
Table 23: Transducer Model: P21x/5-1 Operating Mode: CW Doppler
TIS TIB
Safety
Index Label M.I. Non-scan TIC
Scan Non-scan
Aaprt≤1 Aaprt>1
Global Maximum Index Value (a) — — 1.0 3.4 (b)
pr.3 (MPa) #
W0 (mW) — — 88.30 #
min of [W.3(z1),ITA.3(z1)] (mW) 102.54
Associated Acoustic
z1 (cm) 1.386
Parameter
pr@PIImax (MPa) #
deq@Pllmax (cm) 0.45
Focal Length FLx (cm) — — 13.84 #
FLy (cm) — — 5.5 #
IPA.3@MImax (W/cm2) #
Control 1: Exam Type Card Card
Conditions
Operating
Control
Control 2: Zone
Zone 4 Zone 1
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
Term Definition
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.
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.
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.
148
Table 24: Acoustic Output Terms and Definitions (Continued)
Term Definition
Safety
deq(z) Equivalent beam diameter as a function of axial distance z, and is equal to
( 4 ⁄ ( π ) ) ( ( Wo ) ⁄ ( I TA ( z ) ) ) , where ITA(z) is the temporal-average intensity as a
function of z in centimeters.
Dim. of Aaprt Active aperture dimensions for the azimuthal (x) and elevational (y) planes in
centimeters.
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.
Precision Uncertainty
Quantity
(% of standard deviation) (95% confidence)
Pr 1.9% +11.2%
Wo 3.4% +10%
fc 0.1% +4.7%
Precision Uncertainty
Quantity
(% of standard deviation) (95% confidence)
Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 26: Labeling Symbols
Symbol Definition
Alternating Current (AC)
Canadian Standards Association. The “C” and “US” indicators next to this mark
signify that the product has been evaluated to the applicable CSA and ANSI/UL
Standards, for use in Canada and the US, respectively.
150
Table 26: Labeling Symbols (Continued)
Symbol Definition
Safety
REF Catalog number
Corrugated recycle
Dangerous voltage
Date of manufacture
Symbol Definition
Fragile
Hot
Non-ionizing radiation
Paper recycle
Disinfect transducer.
152
Table 26: Labeling Symbols (Continued)
Symbol Definition
Safety
Type BF patient applied part
(B = body, F = floating applied part)
Pollution Control Logo. (Applies to all parts/products listed in the China RoHS
disclosure table. May not appear on the exterior of some parts/products
because of space limitations.)
China Compulsory Certificate mark (“CCC Mark”). A compulsory safety mark for
compliance to Chinese national standards for many products sold in the
People’s Republic of China.
Contains mercury. (Applies to the LCD and may apply to other components in
the ultrasound system.)
WARNING: WARNING: Connect Only
Connect Only
Accessories and Accessories and Peripherals
Peripherals
Recommended by Recommended by SonoSite
SonoSite
Measurement accuracy
The measurements provided by the system do not define a specific physiological or anatomical
parameter. Rather, the measurements are of a physical property such as distance for evaluation
by the clinician. The accuracy values require that you can place the calipers over one pixel. The
values do not include acoustic anomalies of the body.
References
The 2D linear distance measurement results are displayed in centimeters with one place past
the decimal point, if the measurement is ten or greater; two places past the decimal point, if the
measurement is less than ten.
The linear distance measurement components have the accuracy and range shown in the
following tables.
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%.
Heart Rate < +/- 2% plus (Full Acquisition Phantomd 5-923 bpm
Scalec * Heart
Rate/100) %
a.Full scale for distance implies the maximum depth of the image.
b.An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used.
c.Full scale for time implies the total time displayed on the scrolling graphic image.
d.SonoSite special test equipment was used.
Doppler Mode
System Accuracy Test
Measurement Accuracy Range
Tolerance By Methoda
and Range
156
Sources of measurement errors
In general, two types of errors can be introduced into the measurement:
Acquisition Error Includes errors introduced by the ultrasound system electronics relating to
signal acquisition, signal conversion, and signal processing for display. Additionally,
computational and display errors are introduced by the generation of the pixel scale factor,
application of that factor to the caliper positions on the screen, and the measurement display.
Algorithmic Error The error introduced by measurements, which are input to higher order
calculations. This error is associated with floating‐point versus integer‐type math, which is
References
subject to errors introduced by rounding versus truncating results for display of a given level
of significant digit in the calculation.
Cardiac references
Acceleration (ACC) in cm/s2
Zwiebel, W.J. Introduction to Vascular Ultrasonography. 4th ed., W.B. Saunders Company, (2000),
52.
ACC = abs (delta velocity/delta time)
158
E:A Ratio in cm/sec
E:A = velocity E/velocity A
E/Ea Ratio
Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 225.
E Velocity/Ea velocity
where: E velocity = Mitral Valve E velocity
References
Ea = annular E velocity, also known as: E prime
where: V = Volume in ml
a = Diameter
b = Diameter
160
n = Number of segments (n=20)
L = Length
i = Segment
References
π 2 ⎛ L⎞
V = ⎛ ---⎞ ∑ ai ---
⎝ 4⎠ ⎝ n⎠
i=1
where: V = Volume
a = Diameter
n = Number of segments (n=20)
L = Length
i = Segment
where: 2 π = 6.28
r = aliasing radius
162
Qp/Qs
Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound,
Arizona Heart Institute, (2000), 400.
Qp/Qs = SV Qp site/SV Qs site
SV sites will vary depending upon the location of the shunt.
References
125.
RF = RV/ MV SV
where: RV = Regurgitant Volume
MV SV = Mitral Stroke Volume
Obstetrical references
Amniotic Fluid Index (AFI)
Jeng, C. J., et al. “Amniotic Fluid Index Measurement with the Four Quadrant Technique
During Pregnancy.” The Journal of Reproductive Medicine, 35:7 (July 1990), 674‐677.
164
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 103‐105.
Shepard M.J., V. A. Richards, R. L. Berkowitz, et al. “An Evaluation of Two Equations for
Predicting Fetal Weight by Ultrasound.” American Journal of Obstetrics and Gynecology, 142:1
(January 1, 1982), 47‐54.
University of Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal
Biometry.” Japanese Journal of Medical Ultrasonics, 23:12 (1996), 880, Equation 1.
References
Results are displayed in weeks and days, and is calculated as follows:
GA(LMP) = System date – LMP date
Gestational Age (GA) by Last Menstrual Period (LMPd) Derived from Established Due Date
(Estab. DD)
Same as GA by Estab. DD.
The gestational age derived from the system derived LMP using the Established Due Date
entered on the patient information form.
Results are displayed in weeks and days, and is calculated as follows:
GA(LMPd) = System Date – LMPd
Last Menstrual Period Derived (LMPd) by Established Due Date (Estab. DD)
Results are displayed as month/day/year.
LMPd(Estab. DD) = Estab. DD – 280 days
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.
166
Gestational Sac (GS)
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York:
Springer‐Verlag, (1986).
Nyberg, D.A., et al. “Transvaginal Ultrasound.” Mosby Yearbook, (1992), 76.
Gestational sac measurements provide a fetal age based on the mean of one, two, or three
distance measurements; however, Nyberg’s gestational age equation requires all three
distance measurements for an accurate estimate.
Tokyo University. “Gestational Weeks and Computation Methods.” Ultrasound Imaging
References
Diagnostics, 12:1 (1982‐1).
168
Head Circumference (HC)/Abdominal Circumference (AC)
Campbell S., Thoms Alison. “Ultrasound Measurements of the Fetal Head to Abdomen
Circumference Ratio in the Assessment of Growth Retardation,” British Journal of Obstetrics and
Gynaecology, 84: (March 1977), 165‐174.
Ratio calculations
FL/AC Ratio
Hadlock F.P., R. L. Deter, R. B. Harrist, E. Roecker, and S.K. Park. “A Date Independent
References
Predictor of Intrauterine Growth Retardation: Femur Length/Abdominal Circumference
Ratio,” American Journal of Roentgenology, 141: (November 1983), 979‐984.
FL/BPD Ratio
Hohler, C.W., and T.A. Quetel. “Comparison of Ultrasound Femur Length and Biparietal
Diameter in Late Pregnancy,” American Journal of Obstetrics and Gynecology, 141:7 (Dec. 1 1981),
759‐762.
FL/HC Ratio
Hadlock F.P., R. B. Harrist, Y. Shah, and S. K. Park. “The Femur Length/Head Circumference
Relation in Obstetric Sonography.” Journal of Ultrasound in Medicine, 3: (October 1984), 439‐442.
HC/AC Ratio
Campbell S., Thoms Alison. “Ultrasound Measurements of the Fetal Head to Abdomen
Circumference Ratio in the Assessment of Growth Retardation,” British Journal of Obstetrics and
Gynaecology, 84: (March 1977), 165‐174.
General references
+/x or S/D Ratio
+/x = abs (Velocity A/Velocity B)
where A = velocity cursor +
B = velocity cursor x
170
E PG = 4 * PE2
Peak A Pressure Gradient (A PG)
A PG = 4 * PA2
Peak Pressure Gradient (PGmax)
PGmax = 4 * PV2
Mean Pressure Gradient (PGmean)
PGmean = 4 * Vmax2
References
Pulsatility Index (PI)
Kurtz, A.B., W.D. Middleton. Ultrasound‐the Requisites. Mosby Year Book, Inc., (1996), 469.
PI = (PSV – EDV)/V
where PSV = peak systolic velocity
EDV = end diastolic velocity
V = mean flow velocity throughout the entire cardiac cycle
Volume (Vol)
Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987), 131.
This chapter contains system and accessory specifications and standards. The
specifications for recommended peripherals are in the manufacturers’ instructions.
Dimensions
System Display
Length: 11.8 in. (29.97 cm) Length: 8.4 in. (21.34 cm)
Width: 10.8 in. (27.43 cm) Height: 6.3 in. (16 cm)
Height: 3.1 in. (7.87 cm) Diagonal: 10.4 in. (26.4 cm)
Weight: 8.5 lbs. (3.9 kg) with the C60x
Specifications
transducer and battery installed
Supported transducers
• C11x/8‐5 MHz (6 ft/1.8 m) • L25x/13‐6 MHz (7.5 ft/2.3 m)
• C60x/5‐2 MHz (5.5 ft/1.7 m) • L38x/10‐5 MHz (5.5 ft/1.7 m)
• HFL38x/13‐6 MHz (5.6 ft/1.7 m) • P21x/5‐1 MHz(6 ft/1.8 m)
• ICTx/8‐5 MHz (5.5 ft/1.7 m)
Imaging modes
• 2D (256 gray shades) • Pulsed wave (PW) Doppler
• Color power Doppler (CPD) (256 • Continuous wave (CW) Doppler
colors)
• Tissue Doppler Imaging (TDI)
• Color Doppler (Color) (256 colors)
• Tissue Harmonic Imaging (THI)
• M Mode
Accessories
The following items are either included with or available for use on the ultrasound system.
• Battery
• Biopsy Guide
• Carry case
• ECG cable (6 ft/1.8 m)
• External display
• Footswitch
• Mini‐Dock
• Mobile Docking System M Series (MDSm)
• Mobile Docking System Lite II (MDS Lite II)
• Needle Guide
• Power supply
• SiteLink Image Manager
• SonoCalc IMT
• System AC power cord (10 ft/3.1 m)
• Triple Transducer Connect
Peripherals
See the manufacturer’s specifications for the following peripherals.
174
Non-medical Kensington Security Cable
grade
Operating limits
Specifications
1.05 ATM) 1.05 ATM)
System without
Battery Transducer
Battery
Electrical
Power Supply Input 100‐240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC
Battery
The battery comprises six lithium‐ion cells plus electronics, a temperature sensor, and
battery contacts.
Run time is up to two hours, depending on imaging mode and display brightness.
DICOM standard
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)‐Part 15:
Security Profiles.
176
HIPAA standard
The Health Insurance and Portability and Accountability Act, Pub.L. No. 104‐191 (1996).
45 CFR 160, General Administrative Requirements.
45 CFR 164, Security and Privacy.
Specifications
Terms
For ultrasound terms not included in this glossary, refer to Recommended Ultrasound
Terminology, Second Edition, published in 1997 by the American Institute of Ultrasound in
Medicine (AIUM).
as low as reasonably The guiding principle of ultrasound use, which states that you should
achievable (ALARA) keep patient exposure to ultrasound energy as low as reasonably
achievable for diagnostic results.
curved array Identified by the letter C (curved or curvilinear) and a number (60). The
transducer number corresponds to the radius of curvature of the array expressed
in millimeters. The transducer elements are electrically configured to
control the characteristics and direction of the acoustic beam. For
example, C15, C60e.
Glossary
linear array Identified by the letter L (linear) and a number (38). The number
transducer corresponds to the radius of width of the array expressed in
millimeters. The transducer elements are electrically configured to
control the characteristics and direction of the acoustic beam. For
example, L38.
PAL Phase Alternating Line. A video format setting. See also NTSC.
phased array A transducer designed primarily for cardiac scanning. Forms a sector
image by electronically steering the beam direction and focus.
Glossary 179
skinline A depth on the display that corresponds to the skin/transducer
interface.
Tissue Doppler A pulsed wave Doppler technique used to detect myocardial motion.
Imaging (TDI)
thermal index (TI) The ratio of total acoustic power to the acoustic power required to raise
tissue temperature by 1°C under defined assumptions. See Chapter 6,
“Safety,” for a more complete description of TI.
TIB (bone thermal A thermal index for applications in which the ultrasound beam passes
index) through soft tissue and a focal region is in the immediate vicinity of
bone.
TIC (cranial bone A thermal index for applications in which the ultrasound beam passes
thermal index) through bone near the beam entrance into the body.
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.
180
Abbreviations
Abbreviations in User Interface
Abbreviation Definition
Abd Abdomen
AC Abdominal Circumference
Glossary
ACC Acceleration Index
AI Aortic Insufficiency
AL Atlas Loop
Ao Aorta
Glossary 181
Abbreviations in User Interface (Continued)
Abbreviation Definition
AV Aortic Valve
BA Basilar Artery
Bifur Bifurcation
BP Blood Pressure
Bre Breast
CI Cardiac Index
CO Cardiac Output
Crd Cardiac
D Diameter
182
Abbreviations in User Interface (Continued)
Abbreviation Definition
Dist Distal
ECG Electrocardiogram
Glossary
EDD by LMP Estimated Date of Delivery by Last Menstrual Period
EF Ejection Fraction
Endo Endocardial
Epi Epicardial
ET Elapsed Time
FH Femoral Head
Glossary 183
Abbreviations in User Interface (Continued)
Abbreviation Definition
FL Femur Length
GA Gestational Age
GS Gestational Sac
Gyn Gynecology
HC Head Circumference
HR Heart Rate
LA Left Atrium
LV Left Ventricular
184
Abbreviations in User Interface (Continued)
Abbreviation Definition
Glossary
LVOT Area Left Ventricular Outflow Tract Area
MB SonoMB
Glossary 185
Abbreviations in User Interface (Continued)
Abbreviation Definition
MI Mechanical Index
Mid Middle
MM M Mode
Msk Muscle
MV Mitral Valve
Neo Neonatal
Nrv Nerve
OA Ophthalmic Artery
OB Obstetrical
Orb Orbital
186
Abbreviations in User Interface (Continued)
Abbreviation Definition
PI Pulsatility Index
Plaq Plaque
Glossary
PRF Pulse Repetition Frequency
Prox Proximal
PV Pulmonic Valve
RI Resistive Index
Glossary 187
Abbreviations in User Interface (Continued)
Abbreviation Definition
S SonoHD
SI Stroke Index
SM Submandibular
SO Suboccipital
Sup Superficial
SV Stroke Volume
TI Thermal Index
TO Transorbital
TT Transtemporal
188
Abbreviations in User Interface (Continued)
Abbreviation Definition
TV Tricuspid Valve
UA Ultrasound Age
VA Vertebral Artery
Vas Vascular
Ven Venous
VF Volume Flow
Vol Volume
Glossary
Glossary 189
190
Index
Index
volume 65
setup 22 volume flow 66
aorta (Ao) 73 calipers 55
aortic valve area (AVA) 77 cardiac calculations
arrow graphic 44 AAo 73
ascending aorta (AAo) 73 Ao 73
audio 23 AVA 77
CI 78
CO 78
B dP:dT 76
baseline 41 HR 78
battery IVRT 71
clean 102 LA 73
safety 116 LV volume (Simpson’s Rule) 73
setup 23
Index 191
LVd 72 default settings 31
LVOT D 73 delta pressure:delta time (dP:dT) 76
LVs 72 depth
MV/AV area 73 adjust 33
overview 68 definition 179
PHT 75 keys 9
PISA 70 marker 13
Qp/Qs 70 DICOM standard 176
RVSP 75 dimensions, system and display 173
setup 23 disinfect
SV 78 battery 102
TDI 79 ECG cable 102
VTI 74 system 98
cardiac index (CI) 78 transducer cables 101
cardiac output (CO) 78 transducers 99
cardiac references 157 disinfectants, compatibility 104
cardiac, intended uses 2 display setup 25
cautions, definition vii distance measurements
cine buffer 10, 34 2D 57
clean M mode 58
battery 102 D-line 39
ECG cable 102 Doppler
footswitch 102 measurements 59
LCD screen 98 scale setup 29
system 98 dual images 35
transducer cables 101 duplex 29
transducers 99 DVD recorder 24, 95
clip acquisition delay 53 Dynamic Range 30
clips
See also images and clips
options 36, 49 E
color Doppler (Color) imaging 37 ECG
color power Doppler (CPD) imaging 37 Monitoring 36, 52
color scheme, background 30 options 53
color suppress 38 elapsed time (ET) measurement 59
Color. See color Doppler (Color) imaging electrical
connectivity setup 24 safety 113
continuous wave (CW) Doppler imaging 39, 40 specifications 175
controls electromagnetic compatibility 118
direct 123 electromechanical safety standards 176
indirect 124 EMC classification standards 176
receiver 124 EMED worksheets 94
CPD. See color power Doppler (CPD) imaging equipment safety 116
customer assistance vii error message 115
CW Doppler. See continuous wave (CW) Doppler errors
imaging acquisition 157
algorithmic 157
measurement 157
D estimated date of delivery (EDD) 164
date 25 estimated fetal weight (EFW) 164
192 Index
Event log 20 I
exam
image quality, poor 95
change type 34
images and clips
end 46
archive 52
type and transducer 42
delete 52
export and import
export to USB 52
OB calculation tables 27
review 51
predefined label groups 22
imaging modes
user accounts 20
list of 173
transducer 42
F import. See export and import
IMT. See Intima Media Thickness (IMT)
far 10
in situ, definition 179
fetal heart rate (FHR) 88
infertility, intended uses 3
flow sensitivity 38
intended uses 2–4
focal zones, optimize 35
intensity
footswitch setup 17
derated 129
forms 10
in situ 129
freeze 33
water-value 129
interventional, intended uses 3
G Intima Media Thickness (IMT)
calculations 25, 80
gain sketch 83
adjust 33 trace 83
ECG 53 intraoperative, intended uses 3
knob 10 invert
gate size 40 Color 38
gestational age spectral trace 41
setup 27 iso volumic relaxation time (IVRT) 71
tables, references 165
gestational growth, measure 87
grace period 96 K
grayscale 35
keys 9
growth analysis
knobs 9
setup 27
tables, references 167
Index
guidance documents, related 127 L
guideline 36
labeling symbols 150
gynecology, intended uses 3
language 30
layout 29
H LCD screen
clean 98
heart rate 47
output 127
heart rate (HR) 58, 78, 88
left atrium (LA) 73
HIPAA standard 177
left ventricular diastolic (LVd) 72
home position 44
left ventricular outflow tract diameter (LVOT D) 73
humidity limits 175
left ventricular systolic (LVs) 72
left ventricular volume (LV volume) 73
license key 96
live trace 30, 41
Index 193
login O
Administrator 18
OB
user 18
calculations 26, 83
LVO (Left Ventricular Opacification) 35
custom measurements setup 27
custom tables setup 28
M graphs 94
intended uses 3
M Mode imaging 36
references 164
maintenance 97
tables setup 28
measurements
on-screen controls 10
See also calculations
optimize 35
+/x Ratio, Doppler 59
orientation
2D 56
marker 12
about 55
option 35
Acceleration, Doppler 59
output display 127
accuracy 55, 155
area, 2D 57
automatic trace, Doppler 60 P
circumference, 2D 57
PAL
delete 56
definition 179
distance, 2D 57
option 24
distance, M Mode 58
password 19, 20, 21
Doppler 59
patient header 13, 25
edit 56
patient information form 45
Elapsed Time, Doppler 59
patient list 50
errors 157
patient report
fetal heart rate 88
about 92
heart rate 58, 88
cardiac 92
M Mode 58
general 92
manual trace 58, 59
OB 92
Pressure Gradient, Doppler 59
save measurement to 55
publications 157
vascular 92
Resistive Index, Doppler 59
PC 24
save to calculation and report 55
pediatric, intended uses 3
terminology 157
percent reduction calculation 63
vascular 90
peripherals 174
Velocities, Doppler 59
pictographs
mechanical index (MI) 127, 179
PICTO key 12
mitral valve/aortic valve (MV/AV) 73
placing 45
M-line 36
power delay 23
mode data 12, 25
power key 9
modes, keys 11
precision, acoustic measurement 149
preferences 29
N presets 29
pressure half time (PHT) 75
near 10
pressure limits 175
network 26
PRF 38, 41
NTSC
print 51
definition 179
printer
option 24
problem 95
194 Index
setup 24 software license 96
probe. See transducer SonoHD 36, 180
prostate, intended uses 4 SonoMB 36, 180
proximal isovelocity surface area (PISA) 70 specifications 173
pulsed wave (PW) Doppler imaging 39 spectral trace 39
PW Doppler. See pulsed wave (PW) Doppler imaging standards
airborne equipment 176
DICOM 176
Q electromechanical 176
Qp/Qs 70 EMC classification 176
HIPAA 177
steering
R CPD 38
recording problem 95 Doppler 40
references storage specifications
cardiac 157 equipment 175
general 169 images 174
gestational age tables 165 stroke volume (SV) 78
growth analysis tables 167 superficial, intended uses 4
obstetrical 164 sweep speed
ratio calculations 169 Doppler 41
report, patient 92 ECG 53
resistive index (RI) measurement 59 M Mode 37
right ventricular systolic pressure (RVSP) 75 symbols, labeling 150
system
clean and disinfect 98
S controls 9
safety software 2
battery 116 status 13, 25
biological 117 wake up 6
electrical 113
electromagnetic compatibility 118
equipment 116
T
save Technical Support viii
calculations 62 temperature limits 175
image 10 text 44
Index
measurements 55 text description 12
SAVE key 30 thermal index (TI) 30, 127, 180
scale 41 THI 36
scanhead. See transducer time setup 25
screen layout 12 tissue Doppler imaging (TDI) 40, 79
security 18 tissue models 130
serial port 24 touchpad 10, 13
setup pages 17 transducer
shipping specifications 175 cables, clean and disinfect 101
shortcut keys 17 clean and disinfect 99
Simpson’s Rule 73 curved array 179
skin line, definition 180 definition 180
sleep delay 23 disinfect 99
small parts calculations 89 exam type 42
Index 195
general use 16
imaging modes 42
invasive or surgical use 16
linear array 179
preparation 16
problems 96
specifications 173
troubleshoot 95
U
ultrasound terminology 179
unfreeze text 22
USB storage device, export to 52
user account 20
user guide, conventions used vii
user setup 19
uses, intended 2–4
V
variance 38
vascular
calculations 90
intended uses 4
velocity measurement 59
velocity time integral (VTI) 74
volume
calculation 65
Doppler, adjust 41
volume flow 66
W
wall filter 38, 41
warnings, definition vii
worksheets, EMED 94
Z
zoom 34
196 Index
P07662-01
*P07662-01*