J Three Holding BU2073J Bluetooth Adaptor User Manual

J-Three International Holding Co., Ltd Bluetooth Adaptor Users Manual

User Manual S Series

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Document ID1089451
Application IDMM+ifrywJIMO7Tfk3/0dyQ==
Document DescriptionUser Manual S Series
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeUser Manual
Display FormatAdobe Acrobat PDF - pdf
Filesize101.56kB (1269466 bits)
Date Submitted2009-04-01 00:00:00
Date Available2009-04-01 00:00:00
Creation Date2007-11-16 13:55:38
Producing SoftwareAcrobat Distiller 7.0 (Windows)
Document Lastmod2007-11-16 14:24:12
Document TitleUsers Manual
Document CreatorFrameMaker 7.0
Document Author: SonoSite

S Series
Ultrasound System
User Guide
S Series
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.
S-Cath, S-FAST, S-ICU, S-Nerve, SiteLink, SonoHD, SonoMB, and SonoSite are registered trademarks or trademarks of SonoSite, Inc.
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. Patents pending
P07525‐01 11/2007
Copyright 2007 by SonoSite, Inc.
All rights reserved.
ii
Contents
Introduction
Conventions .................................................................................................................. vii
Customer comments .................................................................................................. vii
Chapter 1: Getting Started
About the system .......................................................................................................... 1
Preparing the system ................................................................................................... 1
Compartments and connectors ...................................................................... 1
Installing or removing the battery ................................................................. 3
Using AC power and charging the battery ................................................. 3
Turning the system on or off ............................................................................ 4
Connecting transducers .................................................................................... 5
Inserting and removing USB storage devices ............................................ 6
System controls .............................................................................................................. 7
Screen layout .................................................................................................................. 8
General interaction ....................................................................................................... 9
Touchpad ................................................................................................................ 9
Control keys ............................................................................................................ 9
Entering text .......................................................................................................... 9
Preparing transducers ...............................................................................................10
Intended uses ...............................................................................................................11
Chapter 2: System Setup
Displaying the setup pages .....................................................................................13
Restoring default settings ........................................................................................13
Administration setup .................................................................................................14
Security settings .................................................................................................14
User setup .............................................................................................................15
Exporting or importing user accounts .......................................................16
Exporting and clearing the Event log .........................................................16
Logging in as user ..............................................................................................17
Choosing a secure password .........................................................................17
Audio, Battery setup ...................................................................................................18
Connectivity setup ......................................................................................................18
Date and Time setup ..................................................................................................19
Display Information setup ........................................................................................19
Presets setup ................................................................................................................. 19
System Information setup ........................................................................................20
USB Devices setup .......................................................................................................20
iii
Chapter 3: Imaging
Imaging modes ............................................................................................................ 21
2D imaging ........................................................................................................... 21
CPD and color Doppler imaging ................................................................... 22
Adjusting depth and gain ........................................................................................ 23
Freezing, viewing frames, and zooming ............................................................. 23
Turning guidelines on and off ................................................................................ 24
Imaging modes and exams available by transducer ...................................... 24
Patient information form .......................................................................................... 27
Images and clips .......................................................................................................... 28
Saving images and clips .................................................................................. 28
Reviewing images and clips ........................................................................... 28
Printing, exporting, and deleting images and clips ............................... 30
Chapter 4: Measurements
Working with calipers ................................................................................................ 33
Distance measurements ........................................................................................... 34
Area and circumference measurements ............................................................. 35
Measurement accuracy ............................................................................................. 35
Sources of measurement errors ............................................................................. 36
Chapter 5: Troubleshooting and Maintenance
Troubleshooting .......................................................................................................... 37
Software licensing ....................................................................................................... 38
Maintenance ................................................................................................................. 39
Cleaning and disinfecting the ultrasound system ................................. 40
Cleaning and disinfecting transducers ...................................................... 41
Cleaning and disinfecting the battery ....................................................... 43
Chapter 6: Safety
Ergonomic safety ......................................................................................................... 51
Position the system ........................................................................................... 52
Position yourself ................................................................................................. 52
Take breaks, exercise, and vary activities ................................................... 53
Electrical safety classification .................................................................................. 53
Electrical safety ............................................................................................................ 53
Equipment safety ........................................................................................................ 56
Battery safety ................................................................................................................ 56
Clinical safety ................................................................................................................ 57
Electromagnetic compatibility ............................................................................... 58
Manufacturer’s declaration ............................................................................. 59
ALARA principle ........................................................................................................... 62
Applying ALARA ................................................................................................. 63
iv
Direct controls .....................................................................................................63
Indirect controls ..................................................................................................64
Receiver controls ................................................................................................64
Acoustic artifacts .........................................................................................................64
Guidelines for reducing MI and TI .........................................................................64
Output display ..............................................................................................................66
Mechanical and thermal indices output display accuracy ..................67
Factors that contribute to display uncertainty ........................................67
Related guidance documents ........................................................................67
Transducer surface temperature rise ...................................................................68
Acoustic output measurement ...............................................................................69
In Situ, derated, and water value intensities .............................................69
Tissue models and equipment survey ........................................................70
Acoustic output tables ..............................................................................................71
Terms used in the acoustic output tables .................................................78
Acoustic measurement precision and uncertainty ................................79
Labeling symbols .........................................................................................................80
Chapter 7: Specifications
Supported transducers .............................................................................................85
Imaging modes ............................................................................................................85
Images and clips storage ..........................................................................................85
Accessories .....................................................................................................................85
Peripherals .....................................................................................................................86
Temperature and humidity limits ..........................................................................86
Electrical ..........................................................................................................................87
Battery .............................................................................................................................87
Electromechanical safety standards .....................................................................87
EMC standards classification ...................................................................................87
Airborne equipment standards ..............................................................................88
HIPAA standard ............................................................................................................88
Glossary
Terms ................................................................................................................................89
Abbreviations ................................................................................................................91
Index ..............................................................................................................................93
vi
Introduction
The user guide is for a reader familiar with ultrasound techniques. It does not provide training
in sonography or clinical practices. Before using the system, you must have ultrasound
training.
See the applicable SonoSite accessory user guide for information on using accessories and
peripherals. See the manufacturer’s instructions for specific information about peripherals.
Conventions
The user guide follows these conventions:
• A WARNING describes precautions necessary to prevent injury or loss of life.
• A Caution describes precautions necessary to protect the products.
• Numbered steps must be performed in a specific order.
• Bulleted lists present information in list format but do not imply a sequence.
Symbols and terms used on the system and transducer are explained in Chapter 1, Chapter 6,
and Glossary.
Customer comments
Questions and comments are encouraged. SonoSite is interested in your feedback regarding the
system and the user guide. Please call SonoSite at 888‐482‐9449 in the US. Outside the US, call
the nearest SonoSite representative. You can also e‐mail SonoSite at comments@sonosite.com.
Introduction
vii
Introduction
This S Series Ultrasound System User Guide provides information on preparing and using the
S Series ultrasound system and on cleaning and disinfecting the system and transducers. It also
provides system specifications, and safety and acoustic output information.
For technical support, please contact SonoSite as follows:
SonoSite Technical Support
Phone (US or Canada):
877-657-8118
Phone (Outside US
and Canada):
425-951-1330
Or call your local representative.
Fax:
425-951-6700
E-mail:
service@sonosite.com
Web site:
www.sonosite.com. Click Support & Service.
Europe Service Center:
+44-(0)1462-444-800
e-mail: uk.service@sonosite.com
viii
Chapter 1: Getting Started
About the system
The system has multiple configurations and feature sets used to acquire and display
high‐resolution, real‐time ultrasound images. Features available on your system depend on
system configuration, transducer, and exam type.
A license key is required to activate the software. See “Software licensing” on page 38. On
occasion, a software upgrade may be required. SonoSite provides a USB device containing the
software. One USB device can upgrade multiple systems.
To use the ultrasound system
1 Turn the system on. (For power switch location, see “System controls” on page 7.)
2 Attach a transducer.
3 Press Patient, and complete the patient information form.
4 Press an imaging‐mode control key: 2D or Color.
Preparing the system
Compartments and connectors
The back of the system has compartments for the battery and transducer as well as connectors
for USB devices, power cords, cables, and more. The side has additional connectors.
Chapter 1: Getting Started
Getting Started
The SonoSite S Series ultrasound system is a portable, software‐controlled device using
all‐digital architecture. The S Series includes the S‐Cath™ ultrasound system, S‐FAST™
ultrasound system, S‐ICU™ ultrasound system, and the S‐Nerve™ ultrasound system.
1
Figure 1.1 System Back (Left) and Side (Right):
Handle
Transducer
Connectors
(See the table “Connectivity Symbols on Back and Side of System”)
Battery compartment
Each connector on the back and side of the system has a symbol that describes its use.
Connectivity Symbols on Back and Side of System
Symbol
Definition
Symbol
Definition
S-video out
Print control
S-video in
USB
DVI video out
Ethernet*
Composite video out
RS-232 (DVD recorder
or bar code scanner)
Audio out
Getting Started
DC input
* Not currently supported
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.
To install the battery
1 Disconnect the power supply from the ultrasound system.
2 Slide the two prongs at the bottom of the battery into the battery compartment on the back
of the system.
3 Lower the battery into the compartment.
4 Push down on the locking lever at the top of the battery to secure the battery.
To remove the battery
1 Disconnect the power supply from the ultrasound system.
2 Push down on the locking lever at the top of the battery, and lift the battery up.
Using AC power and charging the battery
The battery charges when the system is connected to the AC power supply. A fully discharged
battery recharges in less than five hours.
The system can run on AC power and charge the battery if AC power is connected to the
system.
Chapter 1: Getting Started
The system can run on battery power for up to two hours, depending on the imaging mode and
the display brightness.
WARNING:
The equipment shall be connected to a center-tapped single phase supply circuit
when users in the United States connect the equipment to a 240V supply system.
Caution:
Verify that the hospital supply voltage corresponds to the power supply voltage
range. See “Electrical” on page 87.
To operate the system using AC power
1 Connect the DC power cable from the power supply to the connector on the system. See
Figure 1.1 on page 2.
2 Connect the AC power cord to the power supply and to a hospital‐grade electrical outlet.
Turning the system on or off
Caution:
Do not use the system if an error message appears on the display. Note the error
code and turn off the system. Call SonoSite or your local representative.
To turn the system on or off
™ Press the power switch. (See “System controls” on page 7.)
To wake up the system
To conserve battery life while the system is on, the system goes into sleep mode if untouched
for a preset time. To adjust the time for sleep delay, see “Audio, Battery setup” on page 18.
™ Press a key, or touch the touchpad.
Connecting transducers
WARNING:
To avoid injury to the patient, do not place the connector on the patient. Operate
the ultrasound system in the S Stand or on a convenient 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 1.2 Connect the Transducer
To connect a transducer
1 Pull the transducer latch up, and rotate it clockwise.
2 Align the transducer connector with the connector on the back of the system.
3 Insert the transducer connector into the system connector.
4 Turn the latch counterclockwise.
5 Press the latch down, securing the transducer connector to the system.
To remove a transducer
1 Pull the transducer latch up, and rotate it clockwise.
2 Pull the transducer connector away from the system.
Chapter 1: Getting Started
Inserting and removing USB storage devices
Images and clips are saved to internal storage and are organized in a sortable patient list. You
can archive the images and clips from the ultrasound system to a PC using a USB storage
device. Although the images and clips cannot be viewed from a USB storage device on the
ultrasound system, you can remove the device and view them on your PC.
You can also import and export user accounts and the event log using a USB storage device.
There are three USB ports on the system: two on the back, and one on the side. For additional
USB ports, you can connect a USB hub into any USB port.
WARNING:
To avoid damaging the USB storage device and losing patient data from it, observe
the following:
• Do not remove the USB storage device or turn off the ultrasound system while the
system is exporting.
• Do not bump or otherwise apply pressure to the USB storage device while it is in a
USB port on the ultrasound system. The connector could break.
Caution:
If the USB icon does not appear in the system status area on-screen, the USB storage
device may be defective or password-protected. Turn the system off and replace the
device.
To insert a USB storage device
™ Insert the USB storage device into a USB port on the system. See Figure 1.1 on page 2.
The USB storage device is ready when the USB icon appears.
To view information about the device, see “USB Devices setup” on page 20.
To remove a USB storage device
Removing the USB storage device while the system is exporting may cause the exported files
to be corrupted or incomplete.
1 Wait five seconds after the USB animation stops.
2 Remove the USB storage device from the port.
System controls
Getting Started
Figure 1.3 System Controls:
Power switch
Turns the system on and off.
Control keys
Perform an action or make a selection based on context.
Current names appear on-screen adjacent to the keys.
Control knobs
Adjust gain, depth, cine buffer, ROI box, and brightness.
Sometimes perform an action. Are turned or pressed.
Touchpad
Moves the pointer and other items.
Touchpad key
Works in conjunction with the touchpad. Is pressed to
activate an item on-screen.
Chapter 1: Getting Started
Screen layout
Figure 1.4 Screen Layout
Mode Data Area
Current imaging mode information (for example, Gen, S, THI). S
and THI are on when available on the transducer and are not
user-controlled. For definitions, see “Glossary.”
Orientation Marker
Provides indication for image orientation.
Image
Ultrasound image.
Measurement Data
Area
Current data on measurements.
Patient Header
Includes current patient name, patient ID number, institution,
user, and date/time.
System Status
Information on system status (for example, exam type,
transducer, AC connected, battery charging, and USB).
Depth Marker
Marks in .5 cm, 1 cm, and 5 cm increments depending on depth.
To specify style, see “Presets setup” on page 19.
Exam label
Preset exam label from patient information form.
Control keys
Controls available in the current context. (See also “Control keys”
on page 9.)
General interaction
Touchpad
In forms and the setup pages, the touchpad is similar to a mouse on portable PCs. Using the
touchpad, you move the pointer to an item and then click (press the key below the touchpad)
to activate that item.
Control keys
The control keys display forms, adjust settings, and perform actions such as freezing and
zooming.The functionality depends on context. The current name appears on‐screen next to the
key. Control keys are usually pressed, but in forms you can also click them. The Page x/x
control key displays additional control keys.
A control key functions in one of the following ways:
Cycle Moves through a list of settings.
On-Off Turns a feature on or off.
Action Performs an action such as saving a clip.
Figure 1.5 Control key names, lower screen (Color imaging shown)
Entering text
In forms, you can enter text in text fields using either the on‐screen keyboard or an external USB
keyboard connected to a USB port on the system.
To enter text in text fields
1 Click a text field.
The on‐screen keyboard appears with the text field at the top.
2 Click each character you want to enter. If an external keyboard is connected, you can enter
characters by typing.
• The Äñ key displays and hides international characters.
• The SYMBOLS key displays symbols and punctuation.
• The CAPS LOCK key
• The SHIFT key
turns capital letters on and off.
turns capital letters on or off for the next letter entered.
Chapter 1: Getting Started
Getting Started
In other contexts, the touchpad adjusts and moves items on‐screen: calipers, region of interest
(ROI) box, and more.
• The DELETE key deletes the character right of the pointer.
3 (Optional) Navigate among text fields:
• Click Next to advance to the next field.
• Click Prev to return to the previous field.
4 To exit the keyboard, click one of the following:
• OK to save changes.
• 2D to save changes and display 2D imaging.
Preparing transducers
WARNING:
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
Some gels and sterilants can cause an allergic reaction on some individuals.
Caution:
To avoid damage to the transducer, use only gels recommended by SonoSite.
Using gels other than the one recommended by SonoSite can damage the
transducer and void the warranty. If you have questions about gel compatibility,
contact SonoSite or your local representative.
SonoSite recommends that you clean transducers after each use. See “Cleaning
and disinfecting transducers” on page 41.
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:
10
To prevent contamination, the use of sterile transducer sheaths and sterile
coupling gel is recommended for clinical applications of an invasive or surgical
nature. Do not apply the transducer sheath and gel until you are ready to
perform the procedure.
To install a transducer sheath
SonoSite recommends the use of market‐cleared, transducer sheaths for intracavitary or
surgical applications.To lessen the risk of contamination, install the sheath only when you are
ready to perform the procedure.
1 Place gel inside the sheath.
2 Insert the transducer into the sheath.
3 Pull the sheath over the transducer and cable until the sheath is fully extended.
5 Check for and eliminate bubbles between the face of the transducer and the sheath.
Bubbles between the face of the transducer and the sheath may affect the ultrasound image.
6 Inspect the sheath to ensure that there are no holes or tears.
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 24.
Abdominal Imaging Applications This system transmits ultrasound energy into the abdomen
of patients using 2D, SonoMB™ technology, color Doppler (Color), color power Doppler
(CPD), and Tissue Harmonic Imaging (THI) 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, SonoMB technology, color Doppler (Color), and Tissue Harmonic Imaging
(THI), 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.
Gynecology and Infertility Imaging Applications This system transmits ultrasound energy in
the pelvis and lower abdomen using 2D, SonoMB technology, color power Doppler (CPD), and
color Doppler (Color) 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, SonoMB technology, color Doppler (Color), color power Doppler
(CPD), and Tissue Harmonic Imaging (THI) 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, amniocentesis and other obstetrical procedures, and provide assistance during
abdominal, breast, and neurological surgery.
Chapter 1: Getting Started
11
Getting Started
4 Secure the sheath using the bands supplied with the sheath.
Obstetrical Imaging Applications This system transmits ultrasound energy into the pelvis of
pregnant women using 2D, SonoMB technology, color Doppler (Color), and color power
Doppler (CPD) to obtain ultrasound images. The fetal anatomy, amniotic fluid, and
surrounding anatomical structures can be assessed for the presence or absence of pathology
transvaginally. CPD and color Doppler (Color) imaging is intended for high‐risk pregnant
women.
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, SonoMB multi‐beam technology, color Doppler (Color), and color power
Doppler (CPD) to obtain ultrasound images. The pediatric abdominal and pelvic anatomy,
pediatric hips, and surrounding anatomical structures can be assessed for the presence or
absence of pathology.
Superficial Imaging Applications This system transmits ultrasound energy into various parts
of the body using 2D, SonoMB multi‐beam technology, color Doppler (Color), and color power
Doppler (CPD) to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias,
musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can
be assessed for the presence or absence of pathology. This system can be used to provide
ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral
nerve blocks, and spinal nerve blocks and taps.
Vascular Imaging Applications This system transmits ultrasound energy into the various parts
of the body using 2D, SonoMB, color Doppler (Color), and color power Doppler (CPD) to
obtain ultrasound images. The carotid arteries, deep veins, and arteries in the arms and legs,
superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels
feeding organs can be assessed for the presence or absence of pathology.
12
Chapter 2: System Setup
The setup pages let you customize the system and set preferences.
Displaying the setup pages
To display a setup page
1 In 2D imaging mode, do one of the following:
• Press Patient, and then press Setup on the horizontal row of control keys.
• Press Setup on the vertical row of control keys.
2 Click the setup page under Setup Pages.
System Setup
To return to imaging from a setup page, press Done.
Restoring default settings
To restore default settings for a setup page
™ On the setup page, press Reset.
To restore all default settings
1 Turn the system off.
2 Connect the system to AC power. (See “To operate the system using AC power” on
page 4.)
3 Simultaneously press the power key and the control key below it (the upper‐left control
key).
The system beeps several times.
Chapter 2: System Setup
13
Administration setup
On the Administration setup page, you can configure the system to require users to log in
and enter passwords. Required login helps protect patient data. You can also add and
delete users, change passwords, import and export user accounts, and view the event log.
Security settings
WARNING:
Health care providers who maintain or transmit health information are required
by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and
the European Union Data Protection Directive (95/46/EC) to implement
appropriate procedures: to ensure the integrity and confidentiality of
information; to protect against any reasonably anticipated threats or hazards to
the security or integrity of the information or unauthorized uses or disclosures
of the information.
Security settings on the system allow you to meet the applicable security requirements
listed in the HIPAA standard. Users are ultimately responsible for ensuring the security
and protection of all electronic protected health information collected, stored, reviewed,
and transmitted on the system.
To log in as Administrator
1 On the Administration setup page, type Administrator in the Name box. (See “Entering
text” on page 9.)
2 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.)
3 Click Login.
To log out as Administrator
™ Turn off or restart the system.
To require user login
You can set the system to display the User Login screen at startup.
1 Log in as Administrator.
2 In the User Login list, click On.
• On requires a user name and password at startup.
• Off allows access to the system without a user name and password.
14
To change the administrator password or let users change passwords
1 Log in as Administrator.
2 Under User List, click 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 17.)
• Let users change their passwords: Select the Password changes check box.
4 Click Save.
User setup
To add a new user
2 Click New.
3 Under User Information, fill in the Name, Password, and Confirm boxes. (See “Choosing
a secure password” on page 17.)
4 (Optional) In the User box, type the user’s initials to display them in the patient header
and the User box in the patient information form.
5 (Optional) Select the Administration Access check box to allow access to all
administration privileges.
6 Click Save.
To modify user information
1 Log in as Administrator.
2 Under User List, click the user.
3 Under User Information, make changes as desired.
4 Click Save.
Any change to the user name replaces the previous name.
To delete a user
1 Log in as Administrator.
2 Under User List, click the user.
3 Click Delete.
4 Click Yes.
Chapter 2: System Setup
15
System Setup
1 Log in as Administrator.
To change a user password
1 Log in as Administrator.
2 In the User List, click the user.
3 Type the new password in the Password box and Confirm box.
4 Click Save.
Exporting or importing user accounts
The export and import commands let you configure multiple systems and back up user
account information.
To export user accounts
1 Insert a USB storage device.
2 Log in as Administrator.
3 Press Export. A list of USB devices appears.
4 Click the USB storage device, and click Export.
All user names and passwords are copied to the USB storage device.
To import user accounts
1 Insert the USB storage device that contains the accounts.
2 Log in as Administrator.
3 Press Import.
4 Click the USB storage device, and click Import.
5 Click Done in the dialog box that appears.
The system restarts. All user names and passwords on the system are replaced with the
imported data.
Exporting and clearing the Event log
The Event log collects errors and events and can be exported to a USB storage device and
read on a PC.
To view the Event log
1 Log in as Administrator.
2 Press Log.
The Event log appears.
To return to the previous screen, press Back.
16
To export the Event log
The Event log has the file name (log.txt). Exporting the Event log to a USB storage device
overwrites any existing log.txt file.
1 Insert a USB storage device.
2 Press Log and then press Export.
A list of USB devices appears.
3 Click the USB storage device, and click Export.
The Event log is a text file that you can open in a text‐editing application (for example,
Microsoft Word or Notepad).
To clear the Event log
1 View the Event log.
2 Press Clear.
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 14.)
To log in as user
1 Turn on the system.
2 In the User Login screen, type your name and password, and click 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, click Guest.
To change your password
1 Turn on the system.
2 In the User Login screen, click Password.
3 Type your old and new passwords, confirm the new password, and then click OK.
Choosing a secure password
To ensure security, choose a password that contains uppercase characters (A‐Z), lowercase
characters (a‐z), and numbers (0‐9). Passwords are case‐sensitive.
Chapter 2: System Setup
17
System Setup
3 Click Yes.
Audio, Battery setup
On the Audio, Battery setup page, you can select options from the following lists:
Key click: Click On or Off for keys to make a clicking sound when pressed.
Beep alert: Click On or Off for the system to beep when saving, warning, starting, or
shutting down.
Sleep delay: Click Off, or 5 or 10 minutes to specify the period of inactivity before the
system goes into sleep mode.
Power delay: Click Off, or 15 or 30 minutes to specify the period of inactivity before the
system automatically turns off.
Connectivity setup
On the Connectivity setup page, you select options for using devices and for alerts when
internal storage is full.
To configure the system for a printer
1 Set up the printer hardware. (See instructions included with the printer or S Series
stand.)
2 On the Connectivity setup page, click the printer in the Printer list.
To configure the system for a DVD recorder or bar code scanner
1 On the Connectivity setup page, do the following:
• (DVD recorder) In the Video Mode list, click the video standard: NTSC or PAL.
• In the Serial Port list, click the peripheral.
2 Click Yes to restart the system.
3 Attach a serial cable (RS‐232) from the serial port on the back of the system to the
peripheral.
To receive storage alerts
™ On the Connectivity setup page, select Internal Storage Capacity Alert.
The system displays a message if internal storage is near capacity when you end an
exam.
18
Date and Time setup
To set the date and time
™ On the Date and Time setup page, do the following:
• In the Date box, type the current date. (See “Entering text” on page 9.)
• In the Time box, type the current time in 24 hour format (hours and minutes).
Display Information setup
On the Display Information setup page, you can specify which details appear on‐screen
during imaging. You can select check boxes in the following sections:
Patient Header: Information from the patient information form. (See “Patient
information form” on page 27.)
System Setup
Mode Data: Imaging information.
System Status: Power, battery, printer, and similar information.
Presets setup
The Presets setup page has settings for general preferences. You can select from the
following lists:
Depth Markers: Type 1 displays unnumbered markers, with the maximum depth
number in the lower right screen. Type 2 displays markers with numbers.
Thermal Index: You can select TIS, TIB, or TIC. The default setting is based on exam type:
OB is TIB, TCD is TIC, and all others are TIS.
Clip Length: Clip length in seconds.
Language: The system language. Changing the language requires restarting the system.
Display Brightness: High displays brighter key names and icons and is suitable for a
bright environment, such as daylight. Low displays dimmer key names and icons and is
suitable for a dark environment.
Auto save Pat. Form: Automatically saves the patient information form as an image in
the patient’s file.
Chapter 2: System Setup
19
System Information setup
The System Information setup page displays system hardware and software versions, and
license information.
See also “To enter a license key” on page 38.
USB Devices setup
On the USB Devices setup page, you can view information about connected USB devices,
including space availability. You can also specify a file format for images you export to a
USB storage device.
To specify a file format for exported images
The image format you specify affects only still images. Clips export in H.264 video saved
as MP4 files. To view them, SonoSite recommends QuickTime 7.0 or later.
1 On the USB Devices setup page, click Export.
2 Under SiteLink, select an image format. For JPEG image format, also select a JPEG
compression.
A high compression has a smaller file size but less detail.
3 Click a sort order under Sort By.
The sort order specifies how exported files are organized.
To return to the previous screen, click Devices.
20
Chapter 3: Imaging
Imaging modes
The system has a high‐performance LCD and advanced image‐optimization technology that
greatly simplifies user controls. Imaging modes available depend on the transducer and exam
type. See “Imaging modes and exams available by transducer” on page 24.
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, use an optimization setting that best matches your needs.
To display the 2D image
1 Do any of the following:
• Turn on the system.
• Press 2D.
2 Adjust settings. See “2D settings.”
2D settings
2D settings
Control key
Icon
Description
Auto Gain
The gain adjusts each time you press the key. To adjust gain
manually, see “Adjusting depth and gain” on page 23.
Brightness
Adjusts the display brightness. Press Bright and then turn the
left-hand knob. Settings range from 1 to 10. (You can also adjust
the brightness of only the key names and icons. See “Presets
setup” on page 19.)
The display brightness affects battery life. To conserve battery life,
adjust brightness to a lower setting.
Chapter 3: Imaging
21
Imaging
In 2D imaging, the following control keys adjust settings. See also “Adjusting depth and gain”
on page 23.
2D settings (Continued)
Control key
Optimize
Icon
Description
Settings are as follows:
• Res provides the best possible resolution.
• Gen provides a balance between resolution and penetration.
• Pen provides the best possible penetration.
Some of the parameters optimized to provide the best image
include focal zones, aperture size, frequency (center and
bandwidth), and waveform. They cannot be adjusted by the user.
Orientation
Select from four image orientations: U/R (Up/Right), U/L (Up/Left),
D/L (Down/Left), D/R (Down/Right).
SonoMB (MB)
MB On and MB Off turn SonoMB technology on and off. When
SonoMB is on, MB appears in the upper left-hand screen.
SonoMB depends on transducer and exam type.
Page x/x
Indicates which page of options is displayed. Press to display the
next page.
CPD and color Doppler imaging
Color power Doppler (CPD) and color Doppler (Color) are optional features.
CPD is used to visualize the presence of detectable blood flow. Color is used to visualize the
presence, velocity, and direction of blood flow in a wide range of flow states.
To display the CPD or Color image
1 Press Color.
A ROI box appears in the center of the 2D image.
2 Press CPD or Color on the left.
In Color imaging, the Color indicator bar on the upper left‐hand screen displays velocity in
cm/s.
3 Using the touchpad, position the ROI box as needed.
A green outline shows the change.
22
Adjusting depth and gain
To adjust depth
You can adjust the depth in all imaging modes. The vertical depth scale is marked in 0.5 cm,
1 cm, and 5 cm increments, depending on the depth. To change the style of depth markers, see
“Presets setup” on page 19.
™ Turn the Depth knob:
• Right increases the displayed depth.
• Left decreases the displayed depth.
To adjust gain manually
To adjust gain automatically in 2D, see “2D settings” on page 21.
1 Press the left‐hand knob to select a setting:
• Near
• Far
adjusts the gain applied to the near field of the image.
adjusts the gain applied to the far field of the image.
• Gain
adjusts the overall gain applied to the entire image.
2 Turn the knob.
Freezing, viewing frames, and zooming
To freeze or unfreeze an image
™ Press Freeze.
On a frozen image, the cine icon and frame number appear in the system status area.
To move forward or backward in the cine buffer
™ On a frozen image, turn the cine knob
The total number of frames appears next to the cine icon. The number changes to the current
frame number as you move forward or backward.
Chapter 3: Imaging
23
Imaging
In CPD or Color imaging, the Overall setting affects the color gain applied to the region of
interest (ROI) box. The Near and Far settings affect only the 2D image. (Near and far
correspond to the time gain compensation [TGC] controls on other ultrasound systems.)
To zoom in on an image
You can freeze or unfreeze the image or change the imaging mode at any time while zooming.
1 Press Zoom. A ROI box appears.
2 Using the touchpad, position the ROI box as desired.
3 Press Zoom again.
The image in the ROI box is magnified by 100%.
4 (Optional) If the image is frozen, use the touchpad to pan the image up, down, left, and right.
To exit zoom, press Zoom again.
Turning guidelines on and off
Guidelines are for needle guidance and are an optional feature.
To turn guidelines on or off
™ On a 2D image, press one of the following control keys:
• Biopsy
: This feature depends on transducer type. For more information, see SonoSite
Biopsy User Guide.
• Guide: This feature depends on transducer and exam type. For more information, see
SonoSite Bracket and Needle Guide User Guide.
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.
To change the exam type
™ Do one of the following:
• In 2D imaging, press Exam, and then click the exam type in the menu.
• On the patient information form, click the exam type in the Exam list. (See “Patient
information form” on page 27.)
24
Imaging modes and exams available by transducer
Imaging Mode
Exam
Type1
S Series
System
2D2
CPD
Color
C11x
Nrv
S-Nerve
Vas
S-Nerve
Abd
S-Cath
S-FAST
S-ICU
Nrv
S-Nerve
Bre
S-Cath
Nrv
S-Nerve
SmP
S-Cath
S-FAST
S-ICU
Vas
S-Cath
S-FAST
S-ICU
S-Nerve
Ven
S-Cath
S-FAST
S-ICU
Gyn
S-FAST
OB
S-FAST
C60x
HFL38x
ICTx
Imaging
Transducer
Chapter 3: Imaging
25
Imaging modes and exams available by transducer (Continued)
Imaging Mode
Transducer
Exam
Type1
S Series
System
2D2
CPD
Color
L25x
Nrv
S-Nerve
Sup
S-Cath
Vas
S-Cath
S-ICU
S-Nerve
Ven
S-Cath
S-ICU
Bre
S-Cath
Nrv
S-Nerve
SmP
S-Cath
S-FAST
S-ICU
Vas
S-Cath
S-FAST
S-ICU
S-Nerve
Ven
S-Cath
S-FAST
S-ICU
Abd
S-Cath
S-FAST
S-ICU
Crd
S-FAST
S-ICU
—
L38x
P21x
1. Exam type abbreviations are as follows: Abd = Abdomen, Bre = Breast,
Crd = Cardiac, Nrv = Nerve, OB = Obstetrical, SmP = Small Parts, Sup =
Superficial, Vas = Vascular, Ven = Venous.
2. The optimization settings for 2D are Res, Gen, and Pen.
26
Patient information form
The patient information form lets you enter patient identification, exam, and clinical
information for the patient exam.
When you create a new patient information form, all images and other data you save during
the exam are linked to that patient. (See “Saving images and clips” on page 28.)
To create a new patient information form
1 In 2D, press Patient.
2 Press
New.
3 Fill in the form fields. See “Patient information form fields” on page 28 and “Entering text”
on page 9.
4 Press Done.
To edit a patient information form
You can edit patient information during the exam. However, if you change the patient name or
ID after saving an image, a new patient information form is created.
1 In 2D, press Patient.
2 If you need to change the patient name or ID, save any data you want to keep.
3 Make changes as desired.
Imaging
4 Press one of the following:
• Cancel to undo changes and return to imaging.
• Done to save changes and return to imaging.
To end the exam
1 Make sure that you have saved images and other data you want to keep. (See “Images and
clips” on page 28.)
2 In 2D, press Patient.
3 Do one of the following:
• Press End Exam.
• Press
New to begin a new patient information form. (See “To create a new patient
information form” on page 27.)
Chapter 3: Imaging
27
Patient information form fields
Field
Description
Last
First
Patient name
ID
Patient identification number
Exam
Exam type
Exam label
Exam-specific label that appears in the lower-right screen
User
User initials, up to 3 characters. Appears in the patient list and
image header.
Institution
Institution name. Appears in the image header.
Images and clips
Saving images and clips
When you save an image or clip, it saves to internal storage. The system beeps afterward if Beep
Alert is on, and the percentage icon flashes. (See “Audio, Battery setup” on page 18.)
The percentage icon shows the percentage of space used in internal storage. To receive alerts
when storage is near capacity, see “To receive storage alerts” on page 18.
To access saved images and clips, open the patient list. See “Reviewing images and clips.”
To save an image
™ Press Save.
To save a clip
™ Press Clip.
To specify clip length, see “Presets setup” on page 19.
Reviewing images and clips
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.
28
Figure 3.1 Patient List
To open the patient list
1 In 2D, press Patient.
Imaging
2 Press Review
3 If there is a current patient, press List.
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.
™ Click the column heading that you want to sort by. Click it again if sorting
in reverse order.
Note: The selection column
is sortable.
To select patients in the patient list
™ Select the check box for one or more patients.
Clicking Select All selects all patients.
To deselect patients, clear checked boxes or click Clear All.
Chapter 3: Imaging
29
To review images and clips
You can review only one patient’s images and clips at a time.
1 In the patient list, click the patient whose images and clips you want to review.
The patient row is highlighted.
2 Press the Review knob.
The icon on the knob changes to two numbers: the file displayed and the total files saved.
3 Turn the knob to cycle to the image or clip you want to review
4 (Clip Only) Press the Play key.
The clip plays automatically after loading. The load time depends on clip length.
You can press the Pause key to freeze the clip and can turn the right‐hand knob
playback speed.
5 Turn the left‐hand knob
for a
x/x to cycle to the next image or clip you want to view.
To return to the patient list, press List. To return to imaging, press Done.
Printing, exporting, and deleting images and clips
WARNING:
To avoid damaging the USB storage device and losing patient data from it,
observe the following:
• Do not remove the USB storage device or turn off the ultrasound system while
the system is exporting.
• Do not bump or otherwise apply pressure to the USB storage device while it is
in a USB port on the ultrasound system. The connector could break.
To print an image
1 Verify that a printer is selected. See “To configure the system for a printer” on page 18.
2 Do one of the following:
• In the patient list, review the patient’s images. Press Print when the image appears.
• Freeze the image, and press Print.
To print multiple images
1 Verify that a printer is selected. See “To configure the system for a printer” on page 18.
2 Do one of the following:
• Print all images for multiple patients: Select one or more patients in the patient list. Then
press Print.
• Print all images for one patient: Highlight the patient in the patient list, and press Print.
Each image appears briefly on‐screen while printing.
30
To export images and clips to a USB storage device
A USB storage device is for temporary storage of images and clips. Patient exams should be
archived regularly. To specify file format, see “USB Devices setup” on page 20. A patient exam
must be ended before you can export its images and clips. See “To end the exam.”
1 Insert the USB storage device. (See “Inserting and removing USB storage devices” on
page 6.)
2 In the patient list, select the patients whose images and clips you want to export.
3 Select Exp. USB on‐screen. A list of USB devices appears.
4 Select the USB storage device, and select Export.
Only available USB devices (for example, not password‐protected) are selectable.
The files are finished exporting approximately five seconds after the USB animation stops.
Removing the USB storage device or turning off the system while exporting may cause
exported files to be corrupted or incomplete. To stop in‐progress exporting, select
Cancel Export.
To delete images and clips
1 Select one or more patients in the patient list.
2 Select Delete to delete the selected patients. A confirmation screen appears.
Imaging
Chapter 3: Imaging
31
32
Chapter 4: Measurements
You can perform distance, area, and circumference measurements in any imaging mode.
Measurements are performed on frozen images.
You can perform multiple measurements at one time: up to eight distance measurements or
four area/circumference measurements or a combination; for example, six distance
measurements and one area/circumference measurement.
Measurements
Figure 4.1 2D image with one distance and one circumference measurement
Working with calipers
When measuring, you work with calipers. 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.
You can add calipers by pressing the Calipers 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.
For an accurate measurement, accurate placement of calipers is essential.
Chapter 4: Measurements
33
To switch the active calipers
™ Do one of the following:
• To switch the active caliper within a set, click.
• To switch the active set, press Switch.
To delete or edit a measurement
™ With the measurement active (highlighted), do one of the following:
• To delete, press the Delete knob.
• To edit, use the touchpad to move the calipers.
To improve precision of caliper placement
™ Do any of the following:
• Adjust the display for maximum sharpness.
• Use leading edges (closest to the transducer) or borders for starting and stopping points.
• Maintain a consistent transducer orientation for each type of measurement.
• Make sure that the area of interest fills as much of the screen as possible.
• Minimize the depth, or zoom.
Distance measurements
Distance is measured in cm.
To measure distance
1 On a frozen image, press Calipers.
A pair of calipers appears, connected by a dotted line.
2 Using the touchpad, position the first caliper, and then click.
The other caliper becomes active.
3 Using the touchpad, position the other caliper.
If you move the calipers close together, they shrink and the dotted line disappears.
To save the image with the measurements displayed, see “To save an image” on page 28.
34
Area and circumference measurements
Area and circumference measurements use an ellipse with calipers. You can measure the
following:
• Area in cm2
• Circumference in cm
To measure area or circumference
1 On a frozen image, press Calipers.
2 Press Ellipse.
Note: If you exceed the allowed number of measurements, Ellipse is not available.
3 Use the touchpad to adjust the size and position of the ellipse. Clicking toggles between
position and size.
To save the image with the measurements displayed, see “To save an image” on page 28.
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.
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.
Measurements
Chapter 4: Measurements
35
Table 1: 2D Measurement Accuracy and Range
2D Measure Accuracy
and Range
System
Tolerancea
Accuracy
By
Test
Methodb
Range (cm)
Axial Distance
< ±2% plus 1% of
full scale
Acquisition
Phantom
0-26 cm
Lateral Distance
< ±2% plus 1% of
full scale
Acquisition
Phantom
0-35 cm
Diagonal Distance
< ±2% plus 1% of
full scale
Acquisition
Phantom
0-44 cm
Areac
< ±4% plus (2% of Acquisition
full scale/smallest
dimension) * 100
plus 0.5%
Phantom
0.01-720 cm2
Circumferenced
< ±3% plus (1.4%
of full scale/
smallest
dimension) * 100
plus 0.5%
Acquisition
Phantom
0.01-96 cm
a.Full scale for distance implies the maximum depth of the image.
b.An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used.
c.The area accuracy is defined using the following equation:
% tolerance = ((1 + lateral error) * (1 + axial error) – 1) * 100 + 0.5%.
d.The circumference accuracy is defined as the greater of the lateral or axial accuracy and by the following
equation:
% tolerance = ( 2 (maximum of 2 errors) * 100) + 0.5%.
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
subject to errors introduced by rounding versus truncating results for display of a given level
of significant digit in the calculation.
36
Chapter 5: Troubleshooting and Maintenance
This chapter contains information to help correct problems with system operation, to enter a
software license, and to take proper care of the system, transducer, and accessories.
Troubleshooting
If you encounter difficulty with the system, use the following table to help troubleshoot the
problem. If the problem persists, contact SonoSite Technical Support. (See “SonoSite Technical
Support” on page viii.)
Troubleshooting
Symptom
Solution
System does not turn on.
Check all power connections.
Remove the DC input connector and battery, wait 10 seconds,
and then reinstall them.
Ensure that the battery is charged.
System image quality is poor.
Adjust the LCD screen to improve viewing angle.
Adjust the brightness.
Adjust the gain.
No CPD image.
Adjust the gain.
No Color image.
Adjust the gain or the scale.
Print does not work.
Select the printer on the Connectivity setup page. See “To
configure the system for a printer” on page 18.
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.
System does not recognize the
transducer.
A maintenance icon
appears on the system screen.
Disconnect and reconnect the transducer.
System maintenance may be required. Record the number in
parentheses on the C: line and contact SonoSite or your
SonoSite representative.
Chapter 5: Troubleshooting and Maintenance
37
Troubleshooting
Ensure that the DVD recorder is turned on and set up properly.
See the applicable SonoSite accessory user guide and the
manufacturers’ instructions.
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 20.)
Software License Key Information
System Software
Transducer Software
Name of institution installing the upgrade
Name of institution installing the upgrade
Serial number (on bottom of system)
Transducer serial number
ARM version
Transducer part number (REF)
or model number (for example, C60x)
PCBA serial number
Transducer bundle version
After you obtain a license key, you must enter it into the system.
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.)
38
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 41.) 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
gel is recommended for clinical applications of an invasive or surgical nature. Do not
apply the transducer sheath and gel until you are ready to perform the procedure.
Caution:
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
Troubleshooting
Chapter 5: Troubleshooting and Maintenance
39
Cleaning and disinfecting the ultrasound system
The exterior surface of the ultrasound system and the accessories can be cleaned and
disinfected using a recommended cleaner or disinfectant. See Table 1, “Disinfectants
Compatible with System and Transducers” on page 44.
WARNING:
To avoid electrical shock, before cleaning, disconnect the system from the power
supply or remove it from the stand.
To avoid infection always use protective eyewear and gloves when performing
cleaning and disinfecting procedures.
To avoid infection, ensure that the solution expiration date has not passed.
To avoid infection, the level of disinfection required for a product is dictated by the
type of tissue it contacts during use. Ensure that the solution strength and duration
of contact are appropriate for the equipment. For information, see the disinfectant
label instructions and the recommendations of the Association for Professionals in
Infection Control and Epidemiology (APIC) and FDA.
Caution:
Do not spray cleaners or disinfectant directly on the system surfaces. Doing so may
cause solution to leak into the system, damaging the system and voiding the
warranty.
Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since
these will damage the exterior surfaces.
Use only recommended cleaners or disinfectants on system surfaces.
Immersion-type disinfectants are not approved for use on system surfaces.
When you clean the system, ensure that the solution does not get inside the system
controls or the battery compartment.
Do not scratch the LCD screen.
To clean the LCD screen
™ Dampen a clean, non‐abrasive, cotton cloth with an ethanolic‐based liquid cleaner, and wipe
the screen clean.
Apply the cleaner to the cloth rather than the surface of the screen.
To clean and disinfect system surfaces
1 Turn off the system.
2 Disconnect the system from the power supply, or remove it from the stand.
3 Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent
cleaning solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
40
4 Mix the disinfectant solution compatible with the system, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
5 Wipe surfaces with the disinfectant solution.
6 Air dry or towel dry with a clean cloth.
Cleaning and disinfecting transducers
To disinfect the transducer and its cable, use the immersion method or the wipe method.
Immersible transducers can be disinfected only if the product labeling indicates they can be
used with an immersion method.
See Table 1, “Disinfectants Compatible with System and Transducers” on page 44.
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 disinfectant to contact metal surfaces. Use a soft cloth lightly
dampened in a mild soap or compatible cleaning solution to remove any
disinfectant that remains on metal surfaces.
Attempting to disinfect a transducer or transducer cable using a method other than
the one included here can damage the transducer and void the warranty.
Chapter 5: Troubleshooting and Maintenance
41
Troubleshooting
Do not allow cleaning solution or disinfectant into the transducer connector.
To clean and disinfect a transducer (wipe method)
1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning
solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Rinse with water or wipe with water‐dampened cloth, then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
6 Wipe surfaces with the disinfectant solution.
7 Air dry or towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local
representative.
To clean and disinfect a transducer (immersion method)
1 Disconnect the transducer from the system.
2 Remove any transducer sheath.
3 Clean the surface using a soft cloth lightly dampened in a mild soap or compatible cleaning
solution to remove any particulate matter or body fluids.
Apply the solution to the cloth rather than the surface.
4 Rinse with water or a wipe with water‐dampened cloth, and then wipe with a dry cloth.
5 Mix the disinfectant solution compatible with the transducer, following disinfectant label
instructions for solution strengths and disinfectant contact duration.
6 Immerse the transducer into the disinfection solution not more than 12‐18 inches (31‐46 cm)
from the point where the cable enters the connector.
Follow the instructions on the disinfectant label for the duration of the transducer
immersion.
7 Using the instructions on the disinfectant label, rinse to the point of the previous immersion,
and then air dry or towel dry with a clean cloth.
8 Examine the transducer and cable for damage such as cracks, splitting, or fluid leaks.
If damage is evident, discontinue use of the transducer, and contact SonoSite or your local
representative.
42
Cleaning and disinfecting the battery
Caution:
To avoid damaging the battery, do not allow cleaning solution or disinfectant to
come in contact with the battery terminals.
To clean and disinfect a battery (wipe method)
1 Remove the battery from the system.
2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning
solution.
Apply the solution to the cloth rather than the surface.
3 Wipe the surfaces with the disinfection solution. Theracide disinfectant is recommended.
4 Air dry or towel dry with a clean cloth.
Troubleshooting
Chapter 5: Troubleshooting and Maintenance
43
44
Table 1 does not have the following regulatory information for disinfectants:
• EPA Registration
• FDA 510(k) clearance (liquid sterilant, high level disinfectant)
• CE approval
Prior to use, confirm that the regulatory status of the disinfectant is appropriate for
your jurisdiction and use.
See www.sonosite.com for updated cleaning and disinfectant information. Click Quick Link, and then click
Documentation.
Table 1: Disinfectants Compatible with System and Transducers
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
C60x/ICTx/
L38x/P21x
HFL38x
C11x/
L25x
System
Surfaces
AbcoCide 14
USA
Liquid
Gluteraldehyde
Accel Wipes
CAN
Wipe
Hydrogen Peroxide
Accel Plus
CAN
Wipe
Hydrogen Peroxide
Accel TB
CAN
Wipe
Hydrogen Peroxide
Aidal Plus
AUS
Liquid
Gluteraldehyde
Alkacide
FRA
Liquid
Gluteraldehyde
Alkazyme
FRA
Liquid
Quat. Ammonia
Anioxy-Twin
FRA
Liquid
Peracetic Acid
Aquatabs (1000)
IRL
Tablet
Sodium
Dichloroisocyanurate
Aquatabs (2000)
IRL
Tablet
Sodium
Dichloroisocyanurate
Table 1: Disinfectants Compatible with System and Transducers (Continued)
Chapter 5: Troubleshooting and Maintenance
C60x/ICTx/
L38x/P21x
HFL38x
C11x/
L25x
System
Surfaces
Sodium
Dichloroisocyanurate
Liquid
Peracetic Acid
USA
Liquid
Quat Ammonia
Asepti-HB
USA
Liquid
Quat Ammonia
Asepti-Steryl
USA
Spray
Ethanol
Asepti-Wipes
USA
Wipe
Propanol (Isopropyl
Alcohol
Bacillocid rasant
DEU
Liquid
Glut./Quat. Ammonia
Banicide
USA
Liquid
Gluteraldehyde
Bleach
USA
Liquid
NaCl Hypochlorite
Cavicide
USA
Liquid
Isopropyl
Caviwipes
USA
Wipes
Isopropanol
Chlor-Clean
GBR
Liquid
Sodium
Dichloroisocyanurate
Cidalkan Lingettes
FRA
Wipes
Ethyl Alcohol
Cidex
USA
Liquid
Gluteraldehyde
Cidex OPA
USA
Liquid
Ortho-phthaldehyde
Cidex Plus
USA
Liquid
Gluteraldehyde
Cleanisept
DEU
Wipes
Quat Ammonia
Clorox Wipes
USA
Wipes
Isopropanol
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Aquatabs (5000)
IRL
Tablet
Anioxyde 1000
FRA
Ascend
45
Troubleshooting
46
Table 1: Disinfectants Compatible with System and Transducers (Continued)
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
C60x/ICTx/
L38x/P21x
HFL38x
C11x/
L25x
System
Surfaces
Control III
USA
Liquid
Quat. Ammonia
Coverage Spray
USA
Spray
Quat. Ammonia
DentaSept
FRA
Liquid
Quat. Ammonia
Denatured Alcohol USA
Liquid
Ethanol
DisCide Wipes
USA
Wipes
Isopropyl Alcohol
DisOPA
JPN
Liquid
Ortho-phthaldehyde
Dispatch
USA
Spray
NaCl Hypochlorite
Dynacide PA
FRA
Liquid
Peracetic Acid
End-Bac II
USA
Liquid
Quat. Ammonia
Endozime AW Plus
FRA
Liquid
Propanol
Envirocide
USA
Liquid
Isopropyl
Enzol
USA
Cleaner
Ethylene Glycol
Expose
USA
Liquid
Isopropyl
Gigasept AF
DEU
Liquid
Quat. Ammonia
Gigasept FF
DEU
Liquid
Bersteinsaure
Gluteraldehyde SDS USA
Liquid
Gluteraldehyde
Hexanios
FRA
Liquid
Polyhexanide/Quat.
Ammonia
Hi Tor Plus
USA
Liquid
Chloride
Hibiclens
USA
Cleaner
Chlorhexidine
Table 1: Disinfectants Compatible with System and Transducers (Continued)
C60x/ICTx/
L38x/P21x
HFL38x
C11x/
L25x
System
Surfaces
Hydrogen Peroxide
Liquid
Alcohol
DEU
Liquid
Propanol
Kohrsolin ff
DEU
Liquid
Gluteraldehyde
Korsolex basic
DEU
Liquid
Gluteraldehyde
Korsolex extra
DEU
Liquid
Ethanol/Propanol
Lem-O-Quat
USA
Liquid
Alkyl/Chloride
LpHse
USA
Liquid
O-phenylphenol
Lysol
USA
Spray
Ethanol
Lysol IC
USA
Liquid
O-phenylphenol
Madacide 1
USA
Liquid
Isopropanol
Matar
USA
Liquid
O-phenylphenol
MetriCide 14
USA
Liquid
Gluteraldehyde
MetriCide 28
USA
Liquid
Gluteraldehyde
MetriZyme
USA
Cleaner
Propylene Glycol
Mikrobak forte
DEU
Liquid
Ammonium Chloride
Mikrozid Wipes
DEU
Wipe
Ethanol/Propanol
Nuclean
FRA
Spray
Alcohol/Biguanide
Precise
USA
Spray
O-phenylphenol
Prevention
CAN
Liquid
Hydrogen Peroxide
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Hydrogen Peroxide USA
Liquid
Isopropanol Alcohol ALL
Kodan Tücher
47
Troubleshooting
Chapter 5: Troubleshooting and Maintenance
48
Table 1: Disinfectants Compatible with System and Transducers (Continued)
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
C60x/ICTx/
L38x/P21x
HFL38x
C11x/
L25x
System
Surfaces
Ruthless
USA
Spray
Quat. Ammonia
Sagrosept Wipe
DEU
Wipe
Propanol
Salvanios pH 7
FRA
Liquid
Quat. Ammonia
Sani-Cloth HB
USA
Wipe
Quat. Ammonia
Sani-Cloth Plus
USA
Wipe
Quat. Ammonia
Sekusept
DEU
Liquid
Gluteraldehyde
Sklar
USA
Liquid
Isopropanol
Sporicidin
USA
Liquid
Phenol
Sporicidin Wipes
USA
Wipe
Phenol
Staphene
USA
Spray
Ethanol
Steranios
FRA
Liquid
Gluteraldehyde
Super Sani-Cloth
USA
Wipe
Isopropyl Alcohol
T-Spray
USA
Spray
Quat. Ammonia
T-Spray II
USA
Spray
Alkyl/Chloride
TASK 105
USA
Spray
Quat. Ammonia
TBQ
USA
Liquid
Quat. Ammonia
Theracide Plus
USA
Liquid
Quat. Ammonia
Theracide Plus
Wipes
USA
Wipe
Quat. Ammonia
Tor
USA
Liquid
Quat. Ammonia
Table 1: Disinfectants Compatible with System and Transducers (Continued)
Chapter 5: Troubleshooting and Maintenance
C60x/ICTx/
L38x/P21x
HFL38x
C11x/
L25x
System
Surfaces
Alcohol
Liquid
Chlorine Dioxide
GBR
Wipe
Chlorine Dioxide
Vesphene II
USA
Liquid
Sodium/
o-Phenylphenate
Virex II 256
USA
Liquid
Ammonium Chloride
Virex TB
USA
Liquid
Quat. Ammonia
Virox 5
CAN
Wipe
Hydrogen Peroxide
Virufen
FRA
Liquid
Alkyl Ammonium
Chloride
Wavicide -01
USA
Liquid
Gluteraldehyde
Wavicide -06
USA
Liquid
Gluteraldehyde
Wex-Cide
USA
Liquid
O-phenylphenol
Disinfection and
Cleaning Solutions
Country
of Origin
Type
Active Ingredient
Transeptic
USA
Cleaner
Tristel
GBR
Tristel Wipes
A = Acceptable
N = Not acceptable (Do not use)
U = Untested (Do not use)
49
Troubleshooting
50
Chapter 6: Safety
Ergonomic safety
These healthy scanning guidelines are intended to assist you in the comfort and effective use
of your ultrasound system.
WARNING:
To prevent musculoskeletal disorders, follow the guidelines in this section.
Use of an ultrasound system may be linked to musculoskeletal disordersa,b,c.
Use of an ultrasound system is defined as the physical interaction among the
operator, the ultrasound system, and the transducer.
When using an ultrasound system, as with many similar physical activities, you may
experience occasional discomfort in your hands, fingers, arms, shoulders, eyes, back,
or other parts of your body. However, if you experience symptoms such as constant
or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning
sensation, or stiffness, do not ignore these warning signs. Promptly see a qualified
health professional. Symptoms such as these can be linked with musculoskeletal
disorders (MSDs). MSDs can be painful and may result in potentially disabling
injuries to the nerves, muscles, tendons, or other parts of the body. Examples of
MSDs include carpal tunnel syndrome and tendonitis.
While researchers are not able to definitively answer many questions about MSDs,
there is a general agreement that certain factors are associated with their
occurrence including: preexisting medical and physical conditions, overall health,
equipment and body position while doing work, frequency of work, duration of
work, and other physical activities that may facilitate the onset of MSDsd. This
chapter provides guidelines that may help you work more comfortably and may
reduce your risk of MSDse,f.
a.Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. “Work-related Musculoskeletal Complaints
in Sonologists.” Occupational Environmental Medicine. 41:11 (1999), 981-988.
b.Craig, M. “Sonography: An Occupational Hazard?” Journal of Diagnostic Medical Sonography. 3 (1985),
121-125.
c.Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. “Musculoskeletal Pain in Cardiac Ultrasonographers:
Results of a Random Survey.” Journal of American Society of Echocardiography. (May1997), 357-362.
d.Wihlidal, L.M. and S. Kumar. “An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta.”
International Journal of Industrial Ergonomics. 19 (1997), 205-216.
Chapter 6: Safety
51
Safety
This chapter contains information required by regulatory agencies, including information
about the ALARA (as low as reasonably achievable) principle, the output display standard,
acoustic power and intensity tables, and other safety information. The information applies to
the ultrasound system, transducer, accessories, and peripherals.
e.Habes, D.J. and S. Baron. “Health Hazard Report 99-0093-2749.” University of Medicine and Dentistry of New
Jersey. (1999).
f.Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. “Prevalence of Carpal Tunnel Syndrome and Other
Work-related Musculoskeletal Problems in Cardiac Sonographers.” Journal of Medicine. 35:6 (1993), 605-610.
Position the system
Promote comfortable shoulder, arm, and hand postures
Use a stand to support the weight of the ultrasound system.
Minimize eye and neck strain
• When the exam or procedure allows, position the system within reach.
• Adjust the angle of the system and display to minimize glare from overhead or outside
lighting.
• If using a stand, adjust its height so that the display is at or slightly below eye level.
Position yourself
Support your back during an exam
• Use a chair that has support for your lower back, that adjusts to your work surface height,
that promotes a natural body posture, and that allows for quick height adjustments.
• Always sit or stand in an upright manner. Avoid bending or stooping.
Minimize reaching and twisting
• Use a bed that is height adjustable.
• Position the patient as close to you as possible.
• Face forward. Avoid twisting your head or body.
• Move your entire body front to back, and position your scanning arm next to or slightly in
front of you.
• Stand for difficult exams to minimize reaching.
Promote comfortable shoulder and arm postures
• Keep your elbow close to your side.
• Relax your shoulders in a level position.
• Support your arm using a support cushion or pillow, or rest it on the bed.
Minimize neck bending and twisting
Position the ultrasound system directly in front of you.
52
Promote comfortable hand, wrist, and finger postures
• Hold the transducer lightly in your fingers.
Safety
• Minimize the pressure applied on the patient.
• Keep your wrist in a straight position.
Take breaks, exercise, and vary activities
• Minimizing scanning time and taking breaks can effectively allow your body to recover from
physical activity and help you avoid MSDs. Some ultrasound tasks may require longer or
more frequent breaks. One way of taking a break is to stop and relax. However, simply
changing tasks can help some muscle groups relax while others remain or become active.
• Work efficiently by using the software and hardware features correctly.
• Keep moving. Avoid sustaining the same posture by varying your head, neck, body, arm,
and leg positions.
• Targeted exercises can strengthen muscle groups, which may help you avoid MSDs. Contact
a qualified health professional to determine stretches and exercises that are right for you.
Electrical safety classification
Class I equipment
Ultrasound system powered from power supply or part
of the S Series stand.
Internally powered equipment
Ultrasound system not connected to the power supply
(battery only)
Type BF applied parts
Ultrasound transducers
IPX-7 (watertight equipment)
Ultrasound transducers
Non AP/APG
Ultrasound system power supply, S Series stand, and
peripherals. Equipment is not suitable for use in the
presence of flammable anaesthetics.
Electrical safety
This system meets EN60601‐1, Class I/internally‐powered equipment requirements and Type
BF isolated patient‐applied parts safety requirements.
This system complies with the applicable medical equipment requirements published in the
Canadian Standards Association (CSA), European Norm Harmonized Standards, and
Underwriters Laboratories (UL) safety standards. See Chapter 7, “Specifications.”
Chapter 6: Safety
53
For maximum safety observe the following warnings and cautions.
WARNING:
To avoid discomfort or minor risk of patient injury, keep hot surfaces away from the
patient.
Under certain circumstances, the transducer connector and back of the display
enclosure can reach temperatures that exceed EN60601-1 limits for patient contact,
therefore only the operator shall handle the system. This does not include the
transducer face.
To avoid discomfort or minor risk of operator injury when handling the transducer
connector, the system should not be operated for more than 60 minutes
continuously in a live-scan mode (as opposed to freeze or sleep modes).
To avoid the risk of electrical shock or injury, do not open the system enclosures. All
internal adjustments and replacements, except battery replacement, must be made
by a qualified technician.
To avoid the risk of injury, do not operate the system in the presence of flammable
gasses or anesthetics. Explosion can result.
To avoid the risk of electrical shock, use only properly grounded equipment. Shock
hazards exist if the power supply is not properly grounded. Grounding reliability can
only be achieved when equipment is connected to a receptacle marked “Hospital
Only” or “Hospital Grade” or the equivalent. The grounding wire must not be
removed or defeated.
To avoid the risk of electrical shock, when using the system in an environment where
the integrity of the protective earth conductor arrangement is in doubt, operate the
system on battery power only without using the power supply.
To avoid the risk of electrical shock, do not connect the system’s power supply or the
S Stand’s auxiliary mains outlet receptacles 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.
To avoid the risk of electrical shock and fire hazard, the power cord set that connects
the power supply of the ultrasound system or S Series stand to mains power must
only be used with the power supply or S Series stand, and cannot be used to
connect other devices to mains power.
54
WARNING:
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 back of the system.
Chapter 6: Safety
55
Safety
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.
Equipment safety
To protect your ultrasound system, transducer, and accessories, follow these precautions.
Caution:
Excessive bending or twisting of cables can cause a failure or intermittent operation.
Improper cleaning or disinfecting of any part of the system can cause permanent
damage. For cleaning and disinfecting instructions, see Chapter 5, “Troubleshooting
and Maintenance.”
Do not submerge the transducer connector in solution. The cable is not liquid-tight
beyond the transducer connector/cable interface.
Do not use solvents such as thinner or benzene, or abrasive cleaners on any part of
the system.
Remove the battery from the system if the system is not likely to be used for some
time.
Do not spill liquid on the system.
Battery safety
To prevent the battery from bursting, igniting, or emitting fumes and causing personal injury
or equipment damage, observe the following precautions.
WARNING:
The battery has a safety device. Do not disassemble or alter the battery.
Charge the batteries only when the ambient temperature is between 0° and 40°C
(32° and 104°F).
Do not short-circuit the battery by directly connecting the positive and negative
terminals with metal objects.
Do not heat the battery or discard it in a fire.
Do not expose the battery to temperatures over 60°C (140°F). Keep it away from fire
and other heat sources.
Do not charge the battery near a heat source, such as a fire or heater.
Do not leave the battery in direct sunlight.
Do not pierce the battery with a sharp object, hit it, or step on it.
Do not use a damaged battery.
Do not solder a battery.
The polarity of the battery terminals are fixed and cannot be switched or reversed.
Do not force the battery into the system.
Do not connect the battery to an electrical power outlet.
56
WARNING:
Do not continue recharging the battery if it does not recharge after two successive
six hour charging cycles.
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.
Clinical safety
Observe the following precautions related to clinical safety.
WARNING:
Non-medical (commercial) grade peripheral monitors have not been verified or
validated by SonoSite as being suitable for diagnosis.
To avoid the risk of a burn hazard, do not use the transducer with high frequency
surgical equipment. Such a hazard may occur in the event of a defect in the high
frequency surgical neutral electrode connection.
Do not use the system if it exhibits erratic or inconsistent behavior. Discontinuities in
the scanning sequence are indicative of a hardware failure that must be corrected
before use.
Some transducer sheaths contain natural rubber latex and talc, which can cause
allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for
devices that contain natural rubber.
Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably
achievable) principle and follow the prudent use information concerning MI and TI.
Chapter 6: Safety
57
Safety
If the battery leaks or emits an odor, remove it from all possible flammable sources.
WARNING:
SonoSite does not currently recommend a specific brand of acoustic standoff. If an
acoustic standoff is used, it must have a minimum attentuation of .3dB/cm/MHz.
Some SonoSite transducers are approved for intraoperative applications if a
market-cleared sheath is used.
Electromagnetic compatibility
The ultrasound system has been tested and found to comply with the electromagnetic
compatibility (EMC) limits for medical devices to IEC 60601‐1‐2:2001. These limits are designed
to provide reasonable protection against harmful interference in a typical medical installation.
Caution:
Medical electrical equipment requires special precautions regarding EMC and must
be installed and operated according to these instructions. It is possible that high
levels of radiated or conducted radio-frequency electromagnetic interference (EMI)
from portable and mobile RF communications equipment or other strong or nearby
radio-frequency sources, could result in performance disruption of the ultrasound
system. Evidence of disruption may include image degradation or distortion, erratic
readings, equipment ceasing to operate, or other incorrect functioning. If this occurs,
survey the site to determine the source of disruption, and take the following actions
to eliminate the source(s).
•
•
•
•
•
•
•
•
•
•
•
•
58
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.
Caution:
Electrostatic discharge (ESD), or static shock, is a naturally occurring phenomenon.
ESD is common in conditions of low humidity, which can be caused by heating or air
conditioning. Static shock is a discharge of the electrical energy from a charged
body to a lesser or non-charged body. The degree of discharge can be significant
enough to cause damage to a transducer or an ultrasound system. The following
precautions can help reduce ESD: anti-static spray on carpets, anti-static spray on
linoleum, and anti-static mats.
Manufacturer’s declaration
Table 1 and Table 2 document the intended use environment and EMC compliance levels of the
system. For maximum performance, ensure that the system is used in the environments
described in this table.
The system is intended for use in the electromagnetic environment specified below.
Table 1: Manufacturer’s Declaration - Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment
RF emissions
Group 1
The SonoSite ultrasound system uses RF energy only
for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
Class A
The SonoSite ultrasound system is suitable for use in
all establishments other than domestic and those
directly connected to the public low-voltage power
supply network which supplies buildings used for
domestic purposes.
ClSPR 11
RF emissions
ClSPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Complies
IEC 61000-3-3
Chapter 6: Safety
59
Safety
To avoid the risk of increased electromagnetic emissions or decreased immunity, use
only accessories and peripherals recommended by SonoSite. Connection of
accessories and peripherals not recommended by SonoSite could result in
malfunctioning of your ultrasound system or other medical electrical devices in the
area. Contact SonoSite or your local representative for a list of accessories and
peripherals available from or recommended by SonoSite. See the SonoSite
accessories user guide.
The system is intended for use in the electromagnetic environment specified below.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electrostatic
Discharge (ESD)
2.0KV, 4.0KV, 6.0KV
contact
2.0KV, 4.0KV, 6.0KV
contact
IEC 61000-4-2
2.0KV, 4.0KV, 8.0KV air
2.0KV, 4.0KV, 8.0KV
air
Electrical fast
2KV on the mains
2KV on the mains
Transient burst
1KV on signal lines
1KV on signal lines
0.5KV, 1.0KV, 2.0KV on
AC power lines to
ground
0.5KV, 1.0KV, 2.0KV
on AC power lines
to ground
0.5KV, 1.0KV on AC
power lines to lines
0.5KV, 1.0KV on AC
power lines to
lines
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
>5% UT
>5% UT
(>95% dip in UT ) for
0.5 cycle
(>95% dip in UT )
for 0.5 cycle
40% UT
40% UT
(60% dip in UT ) for 5
cycles
(60% dip in UT ) for
5 cycles
IEC 61000-4-11
70% UT
70% UT
(30% dip in UT ) for 25
cycles
(30% dip in UT ) for
25 cycles
>5% UT
>5% UT
(>95% dip in UT ) for 5s
(>95% dip in UT )
for 5s
IEC 61000-4-4
Surge
IEC 61000-4-5
60
Electromagnetic
Environment
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of the
SonoSite ultrasound system
requires continued operation
during power mains
interruptions, it is
recommended that the
SonoSite ultrasound system
be powered from an
uninterruptible power supply
or a battery.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
IEC 60601 Test Level
Compliance Level
Power
Frequency
Magnetic Field
3 A/m
3 A/m
If image distortion occurs, it
may be necessary to position
the SonoSite ultrasound
system further from sources of
power frequency magnetic
fields or to install magnetic
shielding. The power
frequency magnetic field
should be measured in the
Intended installation location
to assure that it is sufficiently
low.
Conducted RF
3 Vrms
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Portable and mobile RF
communications equipment
should be used no closer to
any part of the SonoSite
ultrasound system including
cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
IEC 61000-4-8
Safety
Electromagnetic
Environment
Immunity Test
Recommended Separation
Distance
d = 1.2 P
Radiated RF
3 Vim
IEC 61000-4-3
80 MHz to 2.5 GHz
3 V/m
d = 1.2 P
80 MHz to 800 MHz
d = 2.3 P
800 MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Chapter 6: Safety
61
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity (Continued)
Immunity Test
Radiated RF
IEC 61000-4-3
(continued)
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic Site
surveya, should be less than
the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
(IEC 60417 No. 417-IEC-5140:
“Source of non-ionizing
radiation”)
Note: UT is the AC mains voltage prior to application of the test level.
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a.Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the SonoSite
ultrasound system should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the SonoSite ultrasound system.
b.Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
ALARA principle
ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other
qualified ultrasound users, using good judgment and insight, determine the exposure that is
“as low as reasonably achievable.” There are no set rules to determine the correct exposure for
every situation. The qualified ultrasound user determines the most appropriate way to keep
exposure low and bioeffects to a minimum, while obtaining a diagnostic examination.
A thorough knowledge of the imaging modes, transducer capability, system setup and
scanning technique is necessary. The imaging mode determines the nature of the ultrasound
beam. A stationary beam results in a more concentrated exposure than a scanned beam, which
spreads that exposure over that area. The transducer capability depends upon the frequency,
62
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 68. 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. 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 64. Additionally, one means for meeting the ALARA principle is to set the MI or TI
values to a low index value and then modifying this level until a satisfactory image or Doppler
mode is obtained. For more information on MI and TI, see BS EN 60601‐2‐37:2001: Annex HH.
Chapter 6: Safety
63
Safety
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.
Indirect controls
The controls that indirectly affect output are controls affecting imaging mode, freeze, and
depth. The imaging mode determines the nature of the ultrasound beam. Tissue attenuation is
directly related to transducer frequency. The higher the PRF (pulse repetition frequency), the
more output pulses occur over a period of time.
Receiver controls
The receiver controls are the gain controls. Receiver controls do not affect output. They should
be used, if possible, to improve image quality before using controls that directly or indirectly
affect output.
Acoustic artifacts
An acoustic artifact is information, present or absent in an image, that does not properly
indicate the structure or flow being imaged. There are helpful artifacts that aid in diagnosis and
those that hinder proper interpretation. Examples of artifacts include:
• Shadowing
• Through transmission
• Aliasing
• Reverberations
• Comet tails
For more information on detecting and interpreting acoustic artifacts, see the following
reference:
Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B.
Saunders Company, (Oct. 17, 2005).
Guidelines for reducing MI and TI
The following are general guidelines for reducing MI or TI. If multiple parameters are given,
then the best results may be achieved by minimizing these parameters simultaneously. In some
modes changing these parameters will not affect MI or TI. Changes to other parameters may
also result in MI and TI reductions. Please note the ‘MI’ or ‘TI’ read out on the right side of the
LCD screen.
64
“↓” means to decrease or lower setting of parameter to reduce MI or TI.
“↑” means to raise or increase setting of parameter to reduce MI or TI
Safety
Table 3: MI
Transducer
Depth
C11x
↑
C60x
↑
HFL38x
↑
ICTx
↑
L25x
↑
L38x
↑
P21x
↑
Table 4: TI (TIS, TIC, TIB)
Color Power Doppler Settings
Transducer
Box
Width
Box
Height
C11x
C60x
↓
HFL38x
ICTx
L25x
↑
PRF
Depth
↑
↓
↑
↑
↓
↑
↑
↑
↑
↑
↓
↓
Optimize
Exam
Gyn
↑
↓
L38x
P21x
Box
Depth
↓
↓
↑
Chapter 6: Safety
65
Output display
The system meets the AIUM output display standard for MI and TI (see last reference listed in
“Related guidance documents” below). Table 5 indicates for each transducer and operating
mode when either the TI or MI is greater than or equal to a value of 1.0, thus requiring display.
Table 5: Cases Where Either a Thermal or Mechanical Index is ≥ 1.0
Transducer Model
Index
2D
CPD/
Color
C11x/8-5
MI
No
No
TIC,TIB, or TIS
No
Yes
MI
Yes
No
TIC, TIB, or TIS
No
No
MI
No
Yes
TIC, TIB, or TIS
No
Yes
MI
No
No
TIC, TIB, or TIS
No
No
MI
No
No
TIC,TIB, or TIS
No
No
MI
No
Yes
TIC, TIB, or TIS
No
Yes
MI
Yes
Yes
TIC, TIB, or TIS
Yes
Yes
C60x/5-2
HFL38x/13-6
ICTx/8-5
L25x/13-6
L38x/10-5
P21x/5-1
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 or Color 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 67).
66
Mechanical and thermal indices output display accuracy
The accuracy result for the thermal index (TI) is stated statistically. With 90% confidence, 90%
of the measured TI values will be within +26% to –50% of the displayed TI value, or +0.2 of the
displayed value, whichever value is larger. The values equate to +1dB to –3dB.
A displayed value of 0.0 for MI or TI means that the calculated estimate for the index is less than
0.05.
Factors that contribute to display uncertainty
The net uncertainty of the displayed indices is derived by combining the quantified uncertainty
from three sources; measurement uncertainty, system and transducer variability, and
engineering assumptions and approximations made when calculating the display values.
Measurement errors of the acoustic parameters when taking the reference data are the major
source of error that contributes to the display uncertainty. The measurement error is described
in “Acoustic measurement precision and uncertainty” on page 79.
The displayed MI and TI values are based on calculations that use a set of acoustic output
measurements that were made using a single reference ultrasound system with a single
reference transducer that is representative of the population of transducers of that type. The
reference system and transducer are chosen from a sample population of systems and
transducers taken from early production units, and they are selected based on having an
acoustic output that is representative of the nominal expected acoustic output for all
transducer/system combinations that might occur. Of course every transducer/system
combination has its own unique characteristic acoustic output, and will not match the nominal
output on which the display estimates are based. This variability between systems and
transducers introduces an error into displayed value. By doing acoustic output sampling
testing during production, the amount of error introduced by the variability is bounded. The
sampling testing ensures that the acoustic output of transducers and systems being
manufactured stays within a specified range of the nominal acoustic output.
Another source of error arises from the assumptions and approximations that are made when
deriving the estimates for the display indices. Chief among these assumptions is that the
acoustic output, and thus the derived display indices, are linearly correlated with the transmit
drive voltage of the transducer. Generally, this assumption is very good, but it is not exact, and
thus some error in the display can be attributed to the assumption of voltage linearity.
Related guidance documents
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers, FDA, 1997.
• Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. (A
copy is included with each system.)
Chapter 6: Safety
67
Safety
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
of the displayed value, whichever value is larger.
• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA
UD2‐2004.
• Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound
Equipment, American Institute of Ultrasound in Medicine, 1993.
• Standard for Real‐Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, NEMA UD3‐2004.
• Guidance on the interpretation of TI and MI to be used to inform the operator, Annex HH,
BS EN 60601‐2‐37 reprinted at P05699.
Transducer surface temperature rise
Table 6 and Table 7 list the measured surface temperature rise from ambient* of transducers
used on the ultrasound system. The temperatures were measured in accordance with EN
60601‐2‐37 section 42 where controls and settings were positioned to give maximum
temperatures
Test 1: The transducer surface temperature test on tissue mimicking material (TMM) is based
on the following standard: 42.3(a) 1, Test Method B (IEC 60601‐2‐37, Amendment 1). The limit
is a 10°C rise from ambient, as measured on the TMM.
Test 2: The transducer surface temperature test in air is based on the following standard:
42.3(a) 2 (IEC 60601‐2‐37, Amendment 1). The limit is a 27°C rise from ambient.
Test 3: The transducer surface temperature test on TMM is based on the following standard:
42.3(a) 1, Test Method B (IEC 60601‐2‐37, Amendment 1). The limit is a 6°C rise from ambient,
as measured on the TMM.
*The ambient temperature shall be 23°C ± 3°C.
Table 6: Transducer Surface Temperature Rise EN 60601-2-37 (External Use)
Test
C11x
C60x
HFL38x
L25x
L38x
P21x
9.2°C
9.0°C
9.5°C
9.5°C
9.6°C
9.0°C
19.0°C
18.0°C
19.0°C
18.2°C
20.0°C
20.0°C
Table 7: Transducer Surface Temperature Rise IEC 60601-2-37 (Internal Use)
68
Test
ICTx
5.5°C
12.0°C
Acoustic output measurement
The acoustic output for this ultrasound system has been measured and calculated in
accordance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment” (NEMA UD2‐2004), and the “Standard for Real‐Time Display of Thermal and
Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment” (NEMA
UDe3‐2004).
In Situ, derated, and water value intensities
All intensity parameters are measured in water. Since water does not absorb acoustic energy,
these water measurements represent a worst case value. Biological tissue does absorb acoustic
energy. The true value of the intensity at any point depends on the amount, type of tissue, and
the frequency of the ultrasound passing through the tissue. The intensity value in the tissue,
In Situ, has been estimated by using the following formula:
In Situ= Water [e‐(0.23alf)]
where:
In Situ = In Situ intensity value
Water = Water intensity value
e = 2.7183
a = attenuation factor (dB/cm MHz)
Attenuation factor (a) for various tissue types are given below:
brain = 0.53
heart = 0.66
kidney = 0.79
liver = 0.43
muscle = 0.55
l = skinline to measurement depth in cm
f = center frequency of the transducer/system/mode combination in MHz
Chapter 6: Safety
69
Safety
Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects)
from ultrasound exposure have been studied by various scientific and medical institutions. In
October 1987, the American Institute of Ultrasound in Medicine (AIUM) ratified a report
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.
Since the ultrasonic path during the exam is likely to pass through varying lengths and types
of tissue, it is difficult to estimate the true In Situ intensity. An attenuation factor of 0.3 is used
for general reporting purposes; therefore, the In Situ value commonly reported uses the
formula:
In Situ (derated) = Water [e ‐(0.069lf)]
Since this value is not the true In Situ intensity, the term “derated” is used to qualify it.
The maximum derated and the maximum water values do not always occur at the same
operating conditions; therefore, the reported maximum water and derated values may not be
related by the In Situ (derated) formula. For example: a multi‐zone array transducer that has
maximum water value intensities in its deepest zone, but also has the smallest derating factor
in that zone. The same transducer may have its largest derated intensity in one of its shallowest
focal zones.
Tissue models and equipment survey
Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from
measurements of acoustic output made in water. Currently, available models may be limited in
their accuracy because of varying tissue paths during diagnostic ultrasound exposures and
uncertainties in the acoustic properties of soft tissues. No single tissue model is adequate for
predicting exposures in all situations from measurements made in water, and continued
improvement and verification of these models is necessary for making exposure assessments
for specific exam types.
A homogeneous tissue model with attenuation coefficient of 0.3 dB/cm MHz throughout the
beam path is commonly used when estimating exposure levels. The model is conservative in
that it overestimates the In Situ acoustic exposure when the path between the transducer and
site of interest is composed entirely of soft tissue. When the path contains significant amounts
of fluid, as in many first and second‐trimester pregnancies scanned transabdominally, this
model may underestimate the In Situ acoustic exposure. The amount of underestimation
depends upon each specific situation.
Fixed‐path tissue models, in which soft tissue thickness is held constant, sometimes are used to
estimate In Situ acoustic exposures when the beam path is longer than 3 cm and consists largely
of fluid. When this model is used to estimate maximum exposure to the fetus during
transabdominal scans, a value of 1 dB/cm MHz may be used during all trimesters.
Existing tissue models that are based on linear propagation may underestimate acoustic
exposures when significant saturation due to non‐linear distortion of beams in water is present
during the output measurement.
The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad
range of values:
• A survey of 1990‐equipment models yielded MI values between 0.1 and 1.0 at their highest
output settings. Maximum MI values of approximately 2.0 are known to occur for currently
available equipment. Maximum MI values are similar for real‐time 2D and M Mode imaging.
70
Acoustic output tables
Table 8 through Table 13 indicate the acoustic output for the system and transducer
combinations with a thermal index or mechanical index equal to or greater than one. These
tables are organized by transducer model and imaging mode. For a definition of terms used in
the tables, see “Terms used in the acoustic output tables” on page 78.
Chapter 6: Safety
71
Safety
• Computed estimates of upper limits to temperature elevations during transabdominal scans
were obtained in a survey of 1988 and 1990 pulsed Doppler equipment. The vast majority of
models yielded upper limits less than 1° and 4°C (1.8° and 7.2°F) for exposures of
first‐trimester fetal tissue and second‐trimester fetal bone, respectively. The largest values
obtained were approximately 1.5°C (2.7°F) for first‐trimester fetal tissue and 7°C (12.6°F) for
second‐trimester fetal bone. Estimated maximum temperature elevations given here are for
a “fixed path” tissue model and are for devices having ISPTA values greater than 500 mW/
cm2. The temperature elevations for fetal bone and tissue were computed based on
calculation procedures given in Sections 4.3.2.1‐4.3.2.6 in “Bioeffects and Safety of Diagnostic
Ultrasound” (AIUM, 1993).
Table 8: Transducer Model: C11x/8-5
Operating Mode: CPD/Color
TIS
Index Label
M.I.
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
(MPa)
(a)
TIB
Non-scan
TIC
—
1.2
—
40.50
—
—
—
—
—
—
—
—
—
—
—
4.38
0.36
0.5
(cm)
—
FLx (cm)
—
—
1.56
FLy (cm)
—
—
2.5
(W/cm2)
Control 1: Mode
Control 2: Exam Type
Control 3: PRF
Control 4: Optimization/Depth
Control 5: Color Box
Position/ Size
CPD
Vas
2841
Med/2.0
Top/
Short
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
72
Table 9: Transducer Model: C60x/5-2
Operating Mode: 2D
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.0
1.59
Non-scan
Scan
Aaprt≤1
Aaprt>1
(a)
—
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
Non-scan
TIC
—
(b)
—
—
5.3
—
(MHz)
deq@Pllmax
2.86
X (cm)
Y (cm)
(μsec) 0.579
(Hz) 7923
(MPa) 2.679
(cm)
Focal Length
FLx (cm)
—
—
FLy (cm)
—
—
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
Control 1: Exam Type
Control 2: Optimization
Control 3: Depth
Control 4: THI
Safety
TIS
—
—
—
—
—
—
—
—
—
—
(W/cm ) 197.7
Any
Pen
6.6 cm
On
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
Chapter 6: Safety
73
Table 10: Transducer Model: HFL38x/13-6
Operating Mode: CPD/Color
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.1
2.556
Non-scan
Aaprt≤1
Aaprt>1
1.0
—
—
—
(b)
53.49
—
—
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
TIC
Nonscan
Scan
W0
Dim of Aaprt
Operating
Control
Conditions
M.I.
TIB
—
1.2
—
5.328
5.324
0.44
0.4
—
—
—
—
—
—
—
—
—
0.525
2597
3.187
(cm)
—
FLx (cm)
1.32
—
—
FLy (cm)
2.5
—
—
(W/cm2)
Control 1: Mode
Control 2: Exam Type
Control 3: Optimization/Depth/PRF
Control 4: Color Box Position/Size
325.5
Color
Any
Low/3.3 cm/
393
Any
Color
Any
Med/
2.7 cm/
1938
Top/
Short
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
74
Table 11: Transducer Model: L38x/10-5
Operating Mode: CPD/Color
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.3
2.89
TIB
Non-scan
Scan
Aaprt≤1 Aaprt>1
1.0
—
64.88
—
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Dim of Aaprt
PD
PRF
pr@PIImax
deq@Pllmax
Focal Length
IPA.3@MImax
Operating
Control
Conditions
M.I.
X (cm)
Y (cm)
(μsec)
(Hz)
(MPa)
Safety
TIS
Non-scan
TIC
—
(b)
—
—
1.1
—
4.91
4.91
0.54
0.4
—
—
—
—
—
—
—
—
—
0.529
9547
3.48
(cm)
—
FLx (cm)
1.5
—
—
FLy (cm)
2.5
—
—
(W/cm )
Control 1: Mode
Control 2: Exam Type
Control 3: PRF
Control 4: Optimization/Depth
Control 5: Color Box Position/Size
439.3
Color
Any
331
Any/3.1
Any
CPD
Bre
2137
Med/3.1
Def/
Def/Def
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
Chapter 6: Safety
75
Table 12: Transducer Model: P21x/5-1
Operating Mode: 2D
TIS
Index Label
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
(MPa)
1.3
1.83
Non-scan
Scan
Aaprt≤1
Aaprt>1
1.1
—
—
122.87
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
Non-scan
TIC
—
(b)
—
—
5.1
—
1.84
1.88
0.590
1.3
—
—
—
—
—
—
—
—
—
deq@Pllmax
X (cm)
Y (cm)
(μsec) 0.963
(Hz) 4421
(MPa) 2.574
(cm)
Focal Length
FLx (cm)
1.55
—
—
FLy (cm)
5.5
—
—
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
M.I.
TIB
Control 1: Exam Type
Control 2: Optimization
Control 3: Depth
Control 4: THI
—
(W/cm2) 209.0
Card Abd/OB
Pen/
Any
Gen
4.7/7.6
4.7
cm
On
On
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
76
Table 13: Transducer Model: P21x/5-1
Operating Mode: CPD/Color
Index Label
M.I.
Associated Acoustic
Parameter
Global Maximum Index Value
pr.3
Other Information
Non-scan
Scan
Aaprt≤1
Aaprt>1
1.3
—
—
136.91
—
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
—
z1
(cm)
—
zbp
(cm)
—
zsp
(cm)
deq(zsp)
(cm)
fc
Non-scan
TIC
—
(b)
—
—
4.5
—
(MHz)
2.16
0.918
1.3
deq@Pllmax
2.15
X (cm)
Y (cm)
(μsec) 1.20
(Hz) 1063
(MPa) 2.574
(cm)
Focal Length
FLx (cm)
3.68
—
—
FLy (cm)
5.5
—
—
Dim of Aaprt
PD
PRF
pr@PIImax
IPA.3@MImax
Operating
Control
Conditions
(MPa)
1.5
2.19
TIB
—
—
—
—
—
—
—
—
—
—
(W/cm ) 330.4
Control 1: Mode
Control 2: Exam Type
Control 3: PRF/Depth
Control 4: Color Optimization
Control 5: THI
Control 6: Color Box Size
Color
Abd/
OB
300/10
Any
On
Any
CPD
OB
850/7.5
Med
Off
Short and
Narrow
(a) This index is not required for this operating mode; value is <1.
(b) This transducer is not intended for transcranial or neonatal cephalic uses.
#No data are reported for this operating condition since the global maximum index value is not reported for
the reason listed. (Reference Global Maximum Index Value line.)
— Data are not applicable for this transducer/mode.
Chapter 6: Safety
77
Safety
TIS
Terms used in the acoustic output tables
Table 14: Acoustic Output Terms and Definitions
78
Term
Definition
ISPTA.3
Derated spatial peak, temporal average intensity in units of milliwatts/cm2.
TI type
Applicable thermal index for the transducer, imaging mode, and exam type.
TI value
Thermal index value for the transducer, imaging mode, and exam type.
MI
Mechanical index.
Ipa.3@MImax
Derated pulse average intensity at the maximum MI in units of W/cm2.
TIS
(Soft tissue thermal index) is a thermal index related to soft tissues. TIS scan is
the soft tissue thermal index in an auto-scanning mode. TIS non-scan is the
soft tissue thermal index in the non-autoscanning mode.
TIB
(Bone thermal index) is a thermal index for applications in which the
ultrasound beam passes through soft tissue and a focal region is in the
immediate vicinity of bone. TIB non-scan is the bone thermal index in the
non-autoscanning mode.
TIC
(Cranial bone thermal index) is the thermal index for applications in which
the ultrasound beam passes through bone near the beam entrance into the
body.
Aaprt
Area of the active aperture measured in cm2.
Pr.3
Derated peak rarefactional pressure associated with the transmit pattern
giving rise to the value reported under MI (Megapascals).
Wo
Ultrasonic power, except for TISscan, in which case it is the ultrasonic power
passing through a one centimeter window in units of milliwatts.
W.3(z1)
Derated ultrasonic power at axial distance z1 in units of milliwatts.
ISPTA.3(z1)
Derated spatial-peak temporal-average intensity at axial distance z1
(milliwatts per square centimeter).
z1
Axial distance corresponding to the location of maximum [min(W.3(z), ITA.3(z)
x 1 cm2)], where z > zbp in centimeters.
zbp
1.69
zsp
For MI, the axial distance at which pr.3 is measured. For TIB, the axial distance
at which TIB is a global maximum (for example, zsp = zb.3) in centimeters.
( A a p r t ) in centimeters.
Table 14: Acoustic Output Terms and Definitions (Continued)
Definition
deq(z)
Equivalent beam diameter as a function of axial distance z, and is equal to
Safety
Term
( 4 ⁄ ( π ) ) ( ( Wo ) ⁄ ( I TA ( z ) ) ) , where ITA(z) is the temporal-average intensity as a
function of z in centimeters.
fc
Center frequency in MHz.
Dim. of Aaprt
Active aperture dimensions for the azimuthal (x) and elevational (y) planes in
centimeters.
PD
Pulse duration (microseconds) associated with the transmit pattern giving
rise to the reported value of MI.
PRF
Pulse repetition frequency associated with the transmit pattern giving rise to
the reported value of MI in Hertz.
pr@PIImax
Peak rarefactional pressure at the point where the free-field, spatial-peak
pulse intensity integral is a maximum in Megapascals.
deq@PIImax
Equivalent beam diameter at the point where the free-field, spatial-peak
pulse intensity integral is a maximum in centimeters.
FL
Focal length, or azimuthal (x) and elevational (y) lengths, if different
measured in centimeters.
Acoustic measurement precision and uncertainty
All table entries have been obtained at the same operating conditions that give rise to the
maximum index value in the first column of the table. Measurement precision and uncertainty
for power, pressure, intensity, and other quantities that are used to derive the values in the
acoustic output table are shown in the table below. In accordance with Section 6.4 of the Output
Display Standard, the following measurement precision and uncertainty values are
determined by making repeat measurements and stating the standard deviation as a
percentage.
Table 15: Acoustic Measurement Precision and Uncertainty
Precision
(% of standard deviation)
Uncertainty
(95% confidence)
Pr
1.9%
+11.2%
Pr.3
1.9%
+12.2%
Wo
3.4%
+10%
fc
0.1%
+4.7%
Quantity
Chapter 6: Safety
79
Table 15: Acoustic Measurement Precision and Uncertainty (Continued)
Precision
(% of standard deviation)
Uncertainty
(95% confidence)
PII
3.2%
+12.5 to -16.8%
PII.3
3.2%
+13.47 to -17.5%
Quantity
Labeling symbols
The following symbols are used on the products, packaging, and containers.
Table 16: Labeling Symbols
Symbol
Definition
Alternating Current (AC)
Class 1 device indicating manufacturer’s declaration of conformance with
Annex VII of 93/42/EEC
Class 1 device requiring verification by the Notified Body of sterilization or
measurement features, or to a Class IIa, IIb, or III device requiring verification or
auditing by the Notified Body to applicable Annex(es) of 93/42/EEC
Attention, see the user guide
Device complies with relevant Australian regulations for electronic devices.
LOT
Batch code, date code, or lot code type of control number
Biological risk
Device complies with relevant Brazilian regulations for electro-medical devices.
Canadian Standards Association. The “C” and “US” indicators next to this mark
signify that the product has been evaluated to the applicable CSA and ANSI/UL
Standards, for use in Canada and the US, respectively.
80
Table 16: Labeling Symbols (Continued)
Definition
REF
Catalog number
Safety
Symbol
Collect separately from other household waste (see European Commission
Directive 93/86/EEC). Refer to local regulations for disposal.
STERILE EO
Contents sterilized using ethylene oxide process.
Corrugated recycle
Dangerous voltage
Date of manufacture
Direct Current (DC)
Do not get wet.
Do not stack over 2 high.
Do not stack over 5 high.
Do not stack over 10 high.
Electrostatic sensitive devices
Device complies with relevant FCC regulations for electronic devices.
Chapter 6: Safety
81
Table 16: Labeling Symbols (Continued)
Symbol
Definition
Fragile
GEL STERILE R
Gel sterilized by radiation.
Hot
Indoor use only
Device emits a static (DC) magnetic field.
Non-ionizing radiation
Paper recycle
SN
Serial number type of control number
Storage temperature conditions
Submersible. Protected against the effects of temporary immersion.
Water-Tight Equipment. Protected against the effects of extended immersion.
Handle transducer with care.
Type BF patient applied part
(B = body, F = floating applied part)
Underwriter’s Laboratories labeling
82
Table 16: Labeling Symbols (Continued)
Symbol
Definition
Safety
Pollution Control Logo. (Applies to all parts/products listed in the China RoHS
disclosure table. May not appear on the exterior of some parts/products
because of space limitations.)
China Compulsory Certificate mark (“CCC Mark”). A compulsory safety mark for
compliance to Chinese national standards for many products sold in the
People’s Republic of China.
Contains mercury. (Applies to the LCD and may apply to other components in
the ultrasound system.)
WARNING:
Connect Only
Accessories and
Peripherals
Recommended by
SonoSite
WARNING: Connect Only
Accessories and Peripherals
Recommended by SonoSite
Chapter 6: Safety
83
84
Chapter 7: Specifications
This chapter contains system and accessory specifications and standards. The
specifications for recommended peripherals are in the manufacturers’ instructions.
Supported transducers
• 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)
Specifications
• C11x/8‐5 MHz (6 ft/1.8 m)
• ICTx/8‐5 MHz (5.5 ft/1.7 m)/
Imaging modes
• 2D (256 gray shades)
• Color Doppler (Color) (256 colors)
• Color power Doppler (CPD) (256
colors)
Images and clips storage
Internal storage: The number of images and clips you can save depends on imaging mode
and file format.
Accessories
The following items are either included with or available for use on the ultrasound system.
• Battery
• Biopsy Guide
• Needle Guide
• Power supply
• System AC power cord (10 ft/3.1 m)
• S Series stand
Chapter 7: Specifications
85
Peripherals
Peripherals include medical grade (conforming to EN60601‐1 requirements) and
non‐medical grade (commercial) products. Manufacturer’s instructions accompany each
peripheral.
Medical
grade
• Black-and-white printer
Recommended sources for printer paper: Contact Sony at 800-686-7669
or www.sony.com/professional to order supplies or to find the local
distributor.
• DVD recorder
Non-medical
grade
• Kensington Security Cable
• USB keyboard
Temperature and humidity limits
Note: The temperature, pressure, and humidity limits apply only to the ultrasound system,
transducers, and battery.
Table 1: Operating Limits
System
Battery
Transducer
10–40°C (50–104°F),
15–95% R.H.
10–40°C (50–104°F),
15–95% R.H.
10–40°C (50–104°F),
15–95% R.H.
700 to 1060hPa (0.7 to
1.05 ATM)
700 to 1060hPa (0.7 to
1.05 ATM)
Table 2: Shipping and Storage Limits
System without
Battery
Battery
Transducer
-35–65°C (-31–149°F),
15–95% R.H.
-20–60°C (-4–140°F),
15–95% R.H.*
-35–65°C (-31–149°F),
15–95% R.H.
500 to 1060hPa (0.5 to
1.05 ATM)
500 to 1060hPa (0.5 to
1.05 ATM)
* For storage longer than 30 days, store at or below room temperature.
86
Electrical
Power Supply Input
100‐240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC
Power Supply Output #1
15 VDC, 5.0 A Max
Power Supply Output #2
12 VDC, 2.3 A Max
Specifications
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.
Electromechanical safety standards
EN 60601‐1:1997, European Norm, Medical Electrical Equipment–Part 1. General
Requirements for Safety.
EN 60601‐1‐1:2001, European Norm, Medical Electrical Equipment–Part 1. General
Requirements for Safety–Section 1‐1. Collateral Standard. Safety Requirements for Medical
Electrical Systems.
EN 60601‐2‐37:2001 + Amendment A1:2005, European Norm, Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment.
CAN/CSA C22.2, No. 601.1‐M90, Canadian Standards Association, Medical Electrical
Equipment–Part 1. General Requirements for Safety (including CSA 601.1 Supplement
1:1994 and CSA 601.1 Amendment 2:1998).
CEI/IEC 61157:1992, International Electrotechnical Commission, Requirements for the
Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment.
UL 60601‐1 (1st Edition), Underwriters Laboratories, Medical Electrical Equipment‐Part 1:
General Requirements for Safety.
EMC standards classification
EN 60601‐1‐2:2001, European Norm, Medical Electrical Equipment. General Requirements
for Safety‐Collateral Standard. Electromagnetic Compatibility. Requirements and Tests.
CISPR11:2004, International Electrotechnical Commission, International Special
Committee on Radio Interference. Industrial, Scientific, and Medical (ISM)
Radio‐Frequency Equipment Electromagnetic Disturbance Characteristics‐Limits and
Methods of Measurement.
Chapter 7: Specifications
87
The Classification for the ultrasound system, stand, accessories, and peripherals when
configured together is: Group 1, Class A.
Airborne equipment standards
RTCA/DO‐160E:2004, Radio Technical Commission for Aeronautics, Environmental
Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio
Frequency Energy, Category B.
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.
88
Glossary
Terms
For ultrasound terms not included in this glossary, refer to Recommended Ultrasound
Terminology, Second Edition, published in 1997 by the American Institute of Ultrasound in
Medicine (AIUM).
The guiding principle of ultrasound use, which states that you should
keep patient exposure to ultrasound energy as low as reasonably
achievable for diagnostic results.
curved array
transducer
Identified by the letter C (curved or curvilinear) and a number (60). The
number corresponds to the radius of curvature of the array expressed
in millimeters. The transducer elements are electrically configured to
control the characteristics and direction of the acoustic beam. For
example, C15, C60e.
depth
Refers to the depth of the display. A constant speed of sound of
1538.5 meters/second is assumed in the calculation of echo position in
the image.
in situ
In the natural or original position.
LCD
liquid crystal display
linear array
transducer
Identified by the letter L (linear) and a number (38). The number
corresponds to the radius of width of the array expressed in
millimeters. The transducer elements are electrically configured to
control the characteristics and direction of the acoustic beam. For
example, L38.
mechanical index
(MI)
An indication of the likelihood of mechanical bioeffects occurring: the
higher the MI, the greater the likelihood of mechanical bioeffects. See
Chapter 6, “Safety,” for a more complete description of MI.
MI/TI
See mechanical index (MI) and thermal index (TI).
NTSC
National Television Standards Committee. A video format setting. See
also PAL.
PAL
Phase Alternating Line. A video format setting. See also NTSC.
phased array
A transducer designed primarily for cardiac scanning. Forms a sector
image by electronically steering the beam direction and focus.
Glossary
89
Glossary
as low as reasonably
achievable (ALARA)
90
skinline
A depth on the display that corresponds to the skin/transducer
interface.
SonoHD™ imaging
technology
A subset of the 2D imaging mode in which the 2D image is enhanced
by reducing speckle noise artifact at tissue margins and improving
contrast resolution by reducing artifacts and improving visualization of
texture patterns within the image.
SonoMB technology
A subset of the 2D imaging mode in which the 2D image is enhanced
by looking at a target from three angles and then merging or averaging
the scanned data together to improve overall image quality and, in
parallel, reducing noise and artifacts.
thermal index (TI)
The ratio of total acoustic power to the acoustic power required to raise
tissue temperature by 1°C under defined assumptions. See Chapter 6,
“Safety,” for a more complete description of TI.
TIB (bone thermal
index)
A thermal index for applications in which the ultrasound beam passes
through soft tissue and a focal region is in the immediate vicinity of
bone.
TIC (cranial bone
thermal index)
A thermal index for applications in which the ultrasound beam passes
through bone near the beam entrance into the body.
TIS (soft tissue
thermal index)
A thermal index related to soft tissues.
Tissue Harmonic
Imaging
Transmits at one frequency and receives at a higher harmonic
frequency to reduce noise and clutter and improve resolution.
transducer
A device that transforms one form of energy into another form of
energy. Ultrasound transducers contain piezoelectric elements, which
when excited electrically, emit acoustic energy. When the acoustic
energy is transmitted into the body, it travels until it encounters an
interface, or change in tissue properties. At the interface, an echo is
formed that returns to the transducer, where this acoustic energy is
transformed into electrical energy, processed, and displayed as
anatomical information.
Abbreviations
Abbreviations in User Interface
Definition
Abd
Abdomen
Bre
Breast
CPD
Color Power Doppler
Crd
Cardiac
MB
SonoMB
MI
Mechanical Index
Msk
Musculoskeletal
Nrv
Nerve
NTSC
National Television Standards Committee
OB
Obstetrical
SonoHD imaging technology
SmP
Small Parts
THI
Tissue Harmonic Imaging
TI
Thermal Index
Vas
Vascular
Ven
Venous
Glossary
Abbreviation
Glossary
91
92
Index
Numerics
2D imaging 21
abbreviations 91
abdominal, intended uses 11
accessories list 85
acoustic measurement precision 79
acoustic output
measurement 69
tables 71
terms in tables 78
acquisition error 36
add new user 15
Administrator 14
airborne equipment standards 88
ALARA principle 62, 63, 89
alphanumeric keys 7
audio 3, 18
click 9
clips
length 19
See also images and clips
color Doppler (Color) imaging 22
color power Doppler (CPD) imaging 22
Color. See color Doppler (Color) imaging
connectivity
setup 18
symbols 3
control keys 8, 9
controls
direct 63
indirect 64
receiver 64
CPD. See color power Doppler (CPD) imaging
customer assistance vii
cables, connect power 4
calipers 33
cardiac, intended uses 11
cautions, definition vii
cine buffer 23
clean
battery 43
LCD screen 40
system 40
transducers 41
electrical
safety 53
specifications 87
electromagnetic compatibility 58
electromechanical safety standards 87
Ellipse 35
EMC classification standards 87
equipment safety 56
error message 55
Index
battery
charge 3
clean 43
install or remove 3
safety 56
setup 18
specifications 87
biological safety 57
Biopsy 24
brightness 21
date 19
default settings 13
depth
adjust 23
definition 89
marker 8, 19
disinfect
battery 43
system 40
transducers 41
disinfectants, compatibility 44
display brightness 19
distance measurements 34
DVD recorder 18, 37
Index
93
errors
acquisition 36
algorithmic 36
measurement 36
Event log 16
exam
end 27
type and transducer 25
type, change 24
export
Event log 16
images and clips 31
USB Devices setup 20
user accounts 16
intended uses 11
intensity
derated 69
in situ 69
water-value 69
interventional, intended uses 11
labeling symbols 80
language 19
LCD screen
clean 40
output 67
license key 38
login
Administrator 14
user 14
focal zones, optimize 22
freeze 23
gain
adjust 23
Auto Gain 21
grace period 38
guidance documents, related 67
Guide 24
guidelines 24
gynecology, intended uses 11
HIPAA standard 88
humidity limits 86
image quality, poor 37
images and clips
delete 31
export to USB 31
review 30
save 28
imaging modes
list of 85
transducer 25
import user accounts 16
in situ, definition 89
infertility, intended uses 11
94
Index
keyboard, on-line 9
keys 7
knobs 7
maintenance 39
measurements
accuracy 33, 35
area, 2D 35
circumference, 2D 35
delete 34
distance 34
edit 34
errors 36
mechanical index (MI) 67, 89
mode data 8, 19
needle guide 24
NTSC
definition 89
option 18
OB, intended uses 12
optimize 22
orientation
marker 8
option 22
output display 67
PAL
definition 89
option 18
password 15, 16, 17
patient header 8, 19
patient information form 27
patient list 28
PC 18
pediatric, intended uses 12
peripherals 86
power delay 18
power key 7
precision, acoustic measurement 79
preferences 19
presets 19
pressure limits 86
print 30
print control 3
printer
problem 37
setup 18
probe. See transducer
recording problem 37
safety
battery 56
clinical 57
electrical 53
electromagnetic compatibility 58
equipment 56
save 28
scanhead. See transducer
screen layout 8
security 14
serial port 18
setup pages 13
shipping specifications 86
skin line, definition 90
Technical Support viii
temperature limits 86
text, enter 9
thermal index (TI) 19, 67, 90
time setup 19
tissue models 70
touchpad 9
transducer
clean and disinfect 41
connect 5
curved array 89
definition 90
disinfect 41
exam type 25
general use 10
imaging modes 25
invasive or surgical use 10
linear array 89
preparation 10
problems 37
sheath 10
specifications 85
troubleshoot 37
Index
sleep delay 18
software license 38
SonoHD 90
SonoMB 22, 90
specifications 85
standards
airborne equipment 88
electromechanical 87
EMC classification 87
HIPAA 88
storage specifications
equipment 86
images 85
superficial, intended uses 12
symbols
connectivity 3
labeling 80
system
clean and disinfect 40
controls 7
software 1
status 8
wake up 4
Index
95
U
ultrasound terminology 89
USB
export 20, 31
insert or remove device 6
port 3
user accounts 16
user guide, conventions used vii
user setup 15
uses, intended 11
vascular, intended uses 12
video 3
warnings, definition vii
zoom 24
96
Index
P07525-01
*P07525-01*
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PDF Version                     : 1.6
Linearized                      : No
Encryption                      : Standard V2.3 (128-bit)
User Access                     : Print, Extract, Print high-res
Page Mode                       : UseOutlines
XMP Toolkit                     : 3.1-701
Producer                        : Acrobat Distiller 7.0 (Windows)
Create Date                     : 2007:11:16 13:55:38Z
Creator Tool                    : FrameMaker 7.0
Modify Date                     : 2007:11:16 14:24:12-08:00
Metadata Date                   : 2007:11:16 14:24:12-08:00
Format                          : application/pdf
Title                           : S Series Ultrasound System User Guide
Creator                         : SonoSite
Document ID                     : uuid:43541713-5464-4511-a26b-664cbf21b80b
Instance ID                     : uuid:efdd26d5-b3f8-4747-b89f-183852728b94
Page Count                      : 108
Author                          : SonoSite
EXIF Metadata provided by EXIF.tools
FCC ID Filing: QQGBU2073J

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