SonoSite Titan User manual
Ultrasound System
Service Manual
Manufactured by
SonoSite, Inc.
21919 30th Drive SE
Bothell, WA 98021-3904
USA
Telephone: 1-888-482-9449 or 1-425-951-1200
Fax: 1-425-951-1201
SonoSite Ltd
Alexander House
40A Wilbury Way
Hitchin, Herts
SG4 OAP UK
T: +44-1462-444800
F: +44-1462-444801
Caution: United States federal law restricts this device to sale by or on the order of a physician.
“TITAN” and “SonoSite TITAN” are trademarks of SonoSite, Inc.
Kensington is a registered trademark of Kensington Technology Group.
Non-SonoSite product names may be trademarks or registered trademarks of their respective owners.
SonoSite products may be covered by one or more of the following U.S. patents: 4454884, 4462408, 4469106, 4474184, 4475376, 4515017, 4534357,
4542653, 4543960, 4552607, 4561807, 4566035, 4567895, 4581636, 4591355, 4603702, (4607642), 4644795, 4670339, 4773140, 4817618, 4883059,
4887306, 5016641, 5050610, 5095910, 5099847, 5123415, 5158088, 5197477, 5207225, 5215094, 5226420, 5226422, 5233994, 5255682, (5275167),
5287753, 5305756, 5353354, 5365929, 5381795, 5386830, 5390674, 5402793, (5,423,220), 5438994, 5450851, 5456257, 5471989, 5471990, 5474073,
5476097, 5479930, 5482045, 5482047, 5485842, 5492134, 5517994, 5529070, 5546946, 5555887, 5603323, 5606972, 5617863, (5634465), 5634466,
5636631, 5645066, 5648942, 5669385, (5706819), 5715823, 5718229, 5720291, 5722412, 5752517, 5762067, 5782769, 5800356, 5817024, 5833613,
5846200, 5860924, 5893363, 5916168, 5951478, 6036643, 6102863, 6104126, 6113547, 6117085, 6142946, 6203498 B1, 6371918, 6135961, D0280762,
D0285484, D0286325, D0300241, D0306343, D0328095, D0369307, D0379231. Other patents pending.
P03309-02 01/2004
Copyright 2004 by SonoSite, Inc.
All rights reserved. Printed in the USA.
ii
Contents
Chapter 1: Introduction
1.1 Audience ..............................................................................................1
1.2 Conventions Used in This Service Manual ....................................1
1.3 Product Upgrades and Updates ......................................................1
1.4 Customer Comments .........................................................................1
1.5 About the System ...............................................................................2
1.6 About the System Software ..............................................................4
1.7 Software Licensing .............................................................................4
Chapter 2: Safety
2.1 Electrical Safety ..................................................................................5
2.2 Equipment Safety ...............................................................................6
2.3 Battery Safety ......................................................................................6
2.4 Biological Safety .................................................................................7
2.5 Labeling Symbols ...............................................................................7
Chapter 3: System Overview
3.1 System Overview ...............................................................................9
3.2 Theory of Operation ..........................................................................9
3.2.1 Transducer ..............................................................................10
3.2.2 Front End Subsystem ............................................................10
3.2.3 Digital Signal Processing Subsystem ..................................12
3.2.4 Backend Subsystem ...............................................................12
3.2.5 Control Subsystem ................................................................14
3.2.6 Power Supply and Control Subsystem ..............................15
3.3 System Specifications ......................................................................16
3.3.1 System Dimensions ...............................................................16
3.3.2 Display Dimensions ..............................................................16
3.3.3 Transducers ............................................................................16
3.3.4 Imaging Modes ......................................................................16
3.3.5 Applications ...........................................................................16
3.3.6 Image Storage .........................................................................17
3.3.7 Accessories .............................................................................17
3.3.8 Peripherals ..............................................................................17
3.3.9 Temperature, Pressure, and Humidity Limits ..................18
3.3.10 Electrical ................................................................................18
3.3.11 Electromechanical Safety Standards .................................18
3.3.12 EMC Standards Classification ...........................................18
3.3.13 Airborne Equipment Standards ........................................19
3.3.14 ECG Standard ......................................................................19
3.3.15 DICOM Standard .................................................................19
Chapter 4: Setup and Operation
4.1 System Controls ................................................................................21
4.2 System Components ........................................................................22
4.3 Setup ..................................................................................................23
4.4 Touchpad ...........................................................................................24
4.5 Accessories ........................................................................................24
4.6 Preparing the System for Operation ..............................................25
4.6.1 Installing and Removing the Battery ..................................25
4.6.2 Using AC Power/Charging Battery ...................................26
4.6.3 Connecting to AC Power ......................................................27
4.6.4 Connecting and Removing Transducers ............................28
4.6.5 Turning the System On and Off ..........................................28
iii
4.7 Upgrading the System Software ....................................................29
4.7.1 Obtaining a License Key .......................................................34
4.7.2 Installing a License Key ........................................................34
4.7.3 To Display the System Information Screen .......................35
4.7.4 To Display the License Update Screen ...............................35
Chapter 5: Cleaning and Disinfecting
5.1 Universal Precautions ......................................................................37
5.2 Receipt of Suspected Contaminated Materials ............................37
5.3 Recommended Disinfectants ..........................................................37
Chapter 6: Troubleshooting
6.1 Basic Troubleshooting .....................................................................39
6.2 Periodic Maintenance ......................................................................40
6.3 System and Subsystem Diagnosis .................................................40
6.4 System Repair ...................................................................................41
6.5 Test Equipment ................................................................................41
6.6 Failure Modes ...................................................................................41
6.6.1 Display ....................................................................................41
6.6.2 Control Panel ..........................................................................41
6.6.3 System/Main PCBA ..............................................................41
6.6.4 Battery .....................................................................................42
6.6.5 Mini-Dock/Mobile Docking System ..................................42
6.6.6 DICOM ....................................................................................42
6.7 Troubleshooting Flow Diagrams ...................................................43
6.7.1 Display ....................................................................................43
6.7.2 Control Panel ..........................................................................44
6.7.3 System .....................................................................................45
6.7.4 Battery .....................................................................................46
6.7.5 Mini-Dock/Mobile Docking System ..................................47
6.7.6 Triple Transducer Connect ..................................................49
Chapter 7: Replacement Procedures
7.1 Display Replacement .......................................................................51
7.1.1 Required Parts ........................................................................51
7.1.2 Required Tools .......................................................................51
7.1.3 Display Removal ....................................................................51
7.1.4 Display Replacement ............................................................53
7.1.5 Test the Display .....................................................................54
7.2 Control Panel Subassembly Replacement ....................................54
7.2.1 Required Parts ........................................................................54
7.2.2 Required Tools .......................................................................54
7.2.3 Control Panel Removal .........................................................54
7.2.4 Control Panel Replacement ..................................................54
7.3 Main System Disassembly for Repair and/or Replacement .....55
7.3.1 Required Parts ........................................................................55
7.3.2 Required Tools .......................................................................55
7.3.3 Main PCBA Removal ............................................................55
Chapter 8: Performance Testing
8.1 Overview ...........................................................................................61
8.2 Test Equipment ................................................................................61
8.3 Setting Up Performance Tests ........................................................61
8.3.1 Scan Reference Orientation ..................................................61
iv
8.4 Testing 2D Performance ..................................................................62
8.4.1 2D Image Quality ..................................................................62
8.4.2 Axial Measurement Accuracy .............................................62
8.4.3 Lateral Measurement Accuracy ...........................................63
8.4.4 Penetration ..............................................................................63
8.5 Additional Performance Tests ........................................................64
8.5.1 CPD ..........................................................................................64
8.5.2 Directional Color Power Doppler (DCPD) ........................64
8.5.3 M Mode Imaging ...................................................................65
8.5.4 Tissue Harmonic Imaging ....................................................65
8.5.5 Pulsed Wave (PW) Doppler Imaging .................................65
8.5.6 Image Quality Verification Test/Livescan ........................65
8.5.7 Image Review .........................................................................65
8.5.8 Printer ......................................................................................66
8.5.9 Battery Charging ....................................................................66
8.5.10 Video Output .......................................................................66
8.6 Returning Products to SonoSite .....................................................67
8.6.1 Contacting SonoSite Technical Support .............................67
8.6.2 Shipping Instructions ............................................................67
Chapter 9: Accessory Service
9.1 Mobile Docking System ..................................................................69
9.2 Mini-Dock ..........................................................................................71
9.3 Connectivity ......................................................................................71
9.3.1 Connection Panel ...................................................................71
9.3.2 Docking System/Mini-Dock Connections .........................72
9.4 Block Diagrams and Schematics ....................................................72
9.5 Theory of Operation ........................................................................80
9.5.1 Video .......................................................................................80
9.5.2 Power Distribution ................................................................80
9.6 Replacement Procedures .................................................................81
9.6.1 Required Tools .......................................................................81
9.6.2 Cup Surround ........................................................................81
9.6.3 Casters .....................................................................................81
9.6.4 Power Supply .........................................................................82
9.6.5 Locking Handle .....................................................................84
9.6.6 Deflector ..................................................................................84
9.6.7 Mini-Dock ...............................................................................84
9.6.8 Triple Transducer Connect ..................................................86
Appendix A: Parts List
A.1 Replacement Parts List ...................................................................89
A.1.1 Display ...................................................................................89
A.1.2 Control Panel ........................................................................90
A.1.3 Replacement Parts, System .................................................91
A.1.4 Transducer Nest Frame Assembly .....................................96
A.1.5 AC Adapter ...........................................................................97
A.1.6 Mini-Dock ..............................................................................98
A.1.7 Mobile Docking System .......................................................99
A.1.8 Triple Transducer Connect ...............................................102
A.2 Ordering Replacement Parts .......................................................103
Appendix B: Service Event Report
Index .................................................................................................107
v
vi
Chapter 1: Introduction
Before servicing the TITANTM high-resolution ultrasound system, please read the information in this manual. This
text applies only to the SonoSite TITAN ultrasound system product manufactured after June 19, 2003. Please find
service information about products manufactured before June 17, 2003 in C1.51 Ultrasound System Service Manual
(P00715), C1.75 Ultrasound System Service Manual (P01118), C1.9 PLUS Ultrasound System Service Manual (P02287),
and C1.99 PLUS and ELITE Ultrasound System Service Manual (P02913).
1.1 Audience
The intended audience of this manual is properly trained field and in-house service personnel.
1.2 Conventions Used in This Service Manual
These conventions are used in this service manual:
Warning describes precautions necessary to prevent injury or loss of life.
• A
• A
Caution describes precautions necessary to protect the products.
• When the steps in the operating instructions must be performed in a specific order, the steps are numbered.
• Bulleted lists present information in list format, but they do not imply a sequence.
• The system handle is on the front of the system, and the battery compartment is on the back of the system.
1.3 Product Upgrades and Updates
SonoSite may offer software upgrades and new features that may improve system performance. Service manual
updates, explaining the effects of upgrades and new features on system performance, will accompany the
upgrades.
1.4 Customer Comments
Questions and comments are encouraged. SonoSite is interested in your feedback regarding the service manual.
Please call SonoSite at 1-877-657-8118. If you are outside the USA, call the nearest SonoSite representative. You
can also send electronic mail (e-mail) to SonoSite at the following address:
service@sonosite.com
Chapter 1: Introduction 1
1.5 About the System
The ultrasound system has multiple configurations and feature sets. All are described in this service manual but
not every option may apply to your system. System features are dependent on your system configuration,
transducer, and exam type.
Figure 1.1 TITAN System Front View
Table 1.1: TITAN System Front Features
4
1
2
5
3
Number Feature
1 Control panel
2 Transducer connection
3Handle
4Display
5 CompactFlash™ slots (front for image storage, back for system and transducers updates and
import/export of DICOM configuration)
2 Chapter 1: Introduction
1
3 42
Figure 1.2 TITAN System Rear View
Table 1.2: TITAN System Rear Connectors
Number Feature
1 DC input connector
2 I/O connector
3Battery
4 ECG connector (available on future releases)
The TITAN system is a portable, software-controlled, ultrasound system using all-digital architecture. The
system is used to acquire and display high-resolution, real-time ultrasound images: 2D, color power Doppler
(CPD), directional color power Doppler (DCPD), Tissue Harmonic Imaging (THI), M Mode, and pulsed wave
(PW) Doppler. The system has cine buffer, image zoom, labeling, biopsy, measurements, calculations, a USB
connection for image transfer, image storage, image review, printing, recording, and the ability to archive
Doppler with audio output to a videotape.
Currently, the system supports the following broadband transducers:
• C8/8-5 MHz 8 mm microcurved array
• C11/8-5 MHz 11 mm microcurved array
• C15/4-2 MHz 15 mm microcurved array
• C60/5-2 MHz 60 mm curved array
• HST/10-5 MHz 25 mm linear array
• ICT/8-5 MHz 11 mm intracavitary array
• L38/10-5 MHz 38 mm linear array
System accessories include the TITAN mobile docking system, the TITAN mini-dock, a power supply, a battery,
video and printer cables, and SiteLink Image Manager 2.1 software.
System peripherals include medical grade (conforming to the requirements of EN60601-1) and non-medical
(commercial) grade products. System medical grade peripherals include a printer and VCR. System non-medical
grade peripherals include a CompactFlash card and a Kensington Security Cable. Use of peripherals is covered
in the manufacturers’ instructions, which accompany each peripheral.
Chapter 1: Introduction 3
1.6 About the System Software
The ultrasound system contains software that controls its operation. A software upgrade may be required.
SonoSite will provide you with a CompactFlash card containing the software. Typically new software provides
new capabilities. A single CompactFlash card can be used to update one or more systems. Software upgrades use
the back CompactFlash slot on the right hand side of the system. CompactFlash cards installed in the front
CompactFlash slot do not upgrade the system.
1.7 Software Licensing
SonoSite software is controlled by a license key, which is obtained from SonoSite or from its authorized
representatives. You must obtain one key for each system or transducer that will use the new software. See
“Obtaining a License Key” on page 34.
The software may be installed and will operate for a short period of time without requiring a valid license key.
We refer to this period of time as the “grace period.” The grace period is variable.
When you first install your software, your SonoSite system prompts you for a license key. If you have not yet
obtained a valid license key, you can elect to use the software as long as the grace period time has not been fully
consumed.
When a system is running in the grace period, all system functions are available. As you use the system, the grace
period is slowly consumed. When the grace period has expired, the system will not be usable until a valid license
key has been entered. Grace period time is not consumed while the system is powered off or when it is in “sleep”
mode. Whenever a system is running in the grace period, the grace period time remaining is available on the
license update screen.
Caution: When the grace period expires, all system functions except for licensing are unavailable until a
valid license key is entered into the system.
4 Chapter 1: Introduction
Chapter 2: Safety
Read this information before using the ultrasound system. The information in this manual applies to the
ultrasound system, transducer, accessories, and peripherals. This chapter contains safety information.
A Warnin g describes precautions necessary to prevent injury or loss of life.
A Caution describes precautions necessary to protect the products.
2.1 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.
For maximum safety observe the following warnings and cautions:
Warnin g: 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, 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, “Cleaning and Disinfecting.”
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, 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 recommended by
SonoSite.
To avoid the risk of electrical shock, use commercial grade peripherals recommended by
SonoSite on battery power only. Do not connect these products to AC mains power when using
the system to scan or diagnose a patient/subject. Contact SonoSite or your local representative
for a list of the commercial grade peripherals available from or recommended by SonoSite.
To avoid the risk of electrical shock, inspect the interconnect cables 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.
Chapter 2: Safety 5
Caution: Although your system has been manufactured in compliance with existing EMC/EMI
requirements (EN60601-1-2), use of the system in the presence of an electromagnetic field can
cause degradation of the ultrasound image. If this occurs often, SonoSite suggests a review of
the system environment. Identify and remove the possible sources of the emissions or move
your system.
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.
Do not use the system if an error message appears on the display: note the error code; call
SonoSite or your local representative; turn off the system by pressing and holding the power key
until the system powers down.
To avoid increasing the system and transducer connector temperature, do not block the airflow
to the ventilation holes on the side of the system.
2.2 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.
To avoid damaging the power supply, verify the power supply input is within the correct
voltage range. See “Electrical” on page 18 in Chapter 3.
Improper cleaning or disinfecting of any part of the system can cause permanent damage. For
cleaning and disinfecting instructions, see Chapter 5, “Cleaning and Disinfecting.”
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.
2.3 Battery Safety
To prevent the battery from bursting, igniting, or emitting fumes and causing equipment damage, observe the
following precautions.
Warnin g: 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 45°C (32° and 113°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 storage 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.
6 Chapter 2: Safety
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.
Warnin g: The polarity of the battery terminals is 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.
Do not continue recharging the battery if it does not recharge after two successive six hour
charging cycles.
Caution: To prevent the battery from bursting, igniting, or emitting fumes 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 leaks or emits an odor, remove it from all possible flammable sources.
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
TITAN system.
2.4 Biological Safety
Observe the following precautions related to biological safety.
Warnin g: Non-medical (commercial) grade peripheral monitors have not been verified or validated by
SonoSite as being suitable for diagnosis.
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.
Do not use the system if it exhibits artifacts on the LCD screen, either within the clinical image or
in the area outside of the clinical image. Artifacts are indicative of hardware and/or software
errors 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.
SonoSite does not currently recommend a specific brand of acoustic standoff.
2.5 Labeling Symbols
Labeling symbols for SonoSite products can be found in the user guide for each product.
Chapter 2: Safety 7
8 Chapter 2: Safety
Chapter 3: System Overview
3.1 System Overview
The system houses the system electronics, display, control panel, and the system batteries. It provides basic
connections for external power, and the transducer connector and a general purpose docking connector for all
other interfaces. The system operates with external transducers and optional peripheral equipment. The types of
external devices that may be used are:
• Transducer(s)
• AC Power Supply/Charger
• Mobile Docking System/Mini-dock
• External Peripherals
The transducer connects to the main unit through the scanhead connector. The transducer contains data, which
the system uses to drive the transducer in the scanhead, process the data received back and format and display
the data for the user. The interface is backward compatible to previous systems and scanheads.
The AC power supply not only provides power from the AC mains for operating the system, it also contains the
charger for charging the internal system battery. This may be used if a mobile docking system or mini-dock is not
desired or available.
The mobile docking system provides power to run the system, contains the charger to charge the internal system
battery and provides fixed external power, video, RS-232, and USB connections. The docking system may also
provide additional control surfaces and monitors. The unit interfaces to the docking system through connections
on the back of the unit. It provides a convenient place for the unit to be operated and stored under certain usage
scenarios.
The mini-dock provides the breakout for all the connectors from the docking connector for remote use where a
docking system may not be available and the external connections are desired. The use of a mini-dock allows the
main unit to be more portable when the connections are not required.
External OEM peripherals are items such as monitor, printers, and VCRs. These can be connected to the mobile
system or directly to the system with the use of the mini-dock using the video and/or printer control
input/outputs.
3.2 Theory of Operation
The system has six major functional groups: the transducer, the frontend subsystem, the digital signal processing
subsystem, the backend subsystem, the control subsystem, and the power supply and control subsystem.
Figure 3.1 shows how these functions interact.
Chapter 3: System Overview 9
Figure 3.1 TITAN Block Diagram
3.2.1 Transducer
The transducer elements convert the pulser voltage to acoustic energy during the “transmit” portion of the
ultrasound acquisition cycle. Also, the transducer elements convert the acoustic echo to voltage in the “receive”
portion of the acquisition cycle. The system transducers have 64 to 128 elements. The front end subsystem senses
the voltage developed on the transducer elements.
3.2.2 Front End Subsystem
The Front End is designed to support various imaging modalities such as 2D, spectral Doppler and color
Doppler. From the Front End's perspective all modes can be grouped into a few basic types: single mode,
simultaneous modes and triggered modes. All these modes are built from similar, basic transmit and receive
sequences controlled within the Front End. A generic top level block diagram of a typical Front End is in the
following figure.
10 Chapter 3: System Overview
Figure 3.2 Front End Subsystem
The transmit section consists of a waveform generator, delay block, and high power high voltage driver to excite
the transducer element. Multiple elements are driven with delays determined by the time of flight in the medium
from the elements to the point in space where the beam is to be focused. The longer the time of flight is to the
focal point the smaller the delay is for a given transmit element to allow all to arrive at the focal point at the same
time. The number of elements driven is determined by element sensitivity off axis and depth of field
considerations. The waveform is selected to drive the transducer at a certain center frequency, bandwidth, and
power and is optimized for the given mode.
The receive section consists of a transmit/receive switch to protect the receiver from the transmit voltage, a
variable gain receiver to amplify and condition the return echoes, an A/D to digitize the data, a delay block to
focus the return signals and a weight block to scale the return echoes for each channel. All the signals are then
summed together to generate the beamformed receive data. The analog gain varies with depth to compensate for
signal attenuation through the medium. The delays and weights are independent for each channel. The delay and
weight for the receive channel can typically be changed dynamically to keep the receive beam in continuous
focus. The delay is simply set by the time of flight in the medium from the point of interest to the element, which
starts at skinline and proceeds to the deepest depth of interest.
The control section drives the data to the various data path elements on a line by line basis, controls the timing
for the transmit and receive sections, and controls the tagged information and timing of the data to the rest of the
system.
Unique transmit and receive sequences, lines or PRIs, are arranged into repeated groups or frames. The simplest
frame is for a single mode where the line does not change, for example M Mode or PW Doppler. Here the same
line characteristics; aperture size, delay, weights, and waveform information, are continually repeated. A
scanned single mode, such as 2D, keeps the same transmit aperture size but the delays and receive weights
change due to the aperture translation or steering changes with each line acquired. Simultaneous modes may also
change the transmit waveform and aperture size and the delays and receive weights. Downstream processing
also changes, due to the unique processing requirements for the different types of data. Triggered modes are the
same as the previous modes except that the frames are started and stopped on user or external inputs.
Chapter 3: System Overview 11
3.2.3 Digital Signal Processing Subsystem
The DSP subsystem receives data from the front end chip sets, performs processing to enhance the signal-to-noise
ratio of signal features of interest, and prepares data for raster scan conversion and display.
Figure 3.3 Digital Signal Processing Subsystem
3.2.4 Backend Subsystem
The Backend subsystem is responsible for the conversion of raw acquisition data into a raster image ready for
display. This includes the acquisition data path with flash suppression and temporal filtering, and the display
data path with scan conversion into raster space. The Backend subsystem also contains the video data path that
supports generation of video comprising of the ultrasound image as well as graphics annotation. Video
generation of both standard composite interlaced video and progressive scan video is supported. Most
functionality is within the ASIC. However, the memory resources for acquisition memory, and display memory
are found in external memory components. The conversion from PC type video to TV type video is also
performed externally.
Control is received initially from the CPU to setup each functional block and afterward the hardware is
completely data driven. This control takes the form of programming setup registers inside the blocks and setting
up scan conversion tables. Each block provides temporary storage as required to buffer data and keep their
respective processing pipeline full and operating. Also note that the block diagrams show only the data path, but
each block is responsible for generating any necessary memory addresses for their respective input data stream.
12 Chapter 3: System Overview
The BackEnd subsystem is shown in the figure below.
Figure 3.4 BackEnd Subsystem Block Diagram
The backend subsystem performs processing encompassing three main data domains, acquisition data, raster
data, and video data.
Support for acquisition data includes the input buffer, flash suppression, frame average, and external ACQ
memory. Cine buffer management is performed by the acquisition controller.
Conversion from acquisition data to raster data is performed by the graphics overlay, scan conversion engine,
sweeping engine, and 3D engine. Raster data is stored in an external DISPLAY memory. Also supporting raster
operations is the graphics support block that provides acceleration hardware for pixel operations from the CPU
and graphics overlay engine.
Video data is processed as progressive scan (60 Hz) and supplied externally on a digital bus. In addition,
interlaced (30 Hz) video is supplied in both composite and S-video formats. The progressive video path includes
buffers, priority logic, and LUTs. External video in signals are input and multiplexed onto the external video out
path to allow for external sources to display information on connected displays, VCRs, or printers.
Chapter 3: System Overview 13
3.2.5 Control Subsystem
The control subsystem is shown in the figure below.
Figure 3.5 Control Subsystem
The core control subsystem contains the processor, the system bus, the system memory resources of FLASH and
RAM, the interrupt logic, system timers, a DMA engine, and a floating point unit.
Support for the ultrasound subsystem consists of a scanhead interface, scanhead mux control, a portion of the
system FLASH for storage of saved images, and a control path to program the ultrasound datapath.
Communication interfaces consist of an Ethernet interface, USB port, two general purpose serial bus interfaces,
and the I2C bus.
14 Chapter 3: System Overview
3.2.6 Power Supply and Control Subsystem
A
V
V
V
V
V
A
A
V
V
V
The system Power Supply and Control System consists of an easily replaced rechargeable battery pack; an
On/Off Key; a standby power regulator; digital, analog, display and transducer power supplies; a power monitor
and a power control system. Operating current is drawn from the battery or an external AC/DC Adapter, which
also contains circuitry for charging the battery.
The Power Supply and Control Subsystem are in the figure below.
EXT
VBAT
Battery
Pack
Power
Select
BDATA
Fan
EXTS
Power
Switch
Standby Power
Regulator
PWR
Digital
Power
Supplies
nalog
Power
Supplies
Display
Power
Supplies
STBY
EXTS
BATS
PWR_Enable
VCC1_Good
DPS_Enables
+HVB
+HV
+6V
-6V
PS_Enable
PS_Sense
Fan_Enable
BL_PWR
LCD(n)
LCD_Control
LCD_Enable
HV_ADJ
On/Off
Latch
Power
Monitor
and
Control
Off
RSTN
PS_Bus
On/Off Key
CC(n)
CC1
CPU
Temp
Sense
Transducer
Power
Supplies
SH_5V
SH_3.3V
SH_VPP
SH_Enable
Figure 3.6 Power Supply and Control System Block Diagram
Chapter 3: System Overview 15
3.3 System Specifications
This section contains system and accessory specifications and agency approvals. The specifications for
recommended peripherals can be found in the manufacturers’ instructions.
3.3.1 System Dimensions
Length: 11.8 in. (29.97 cm)
Width: 10.9 in. (27.69 cm)
Depth: 3.0 in. (7.62 cm)
Weight: 8.3 lbs. (3.76 kg) with the C60 transducer and battery installed
3.3.2 Display Dimensions
Length: 5.1875 in. (13.18 cm)
Width: 6.75 in. (17.15 cm)
Diagonal: 8.5 in. (21.59 cm)
3.3.3 Transducers
• C8/8-5 MHz 8 mm curved array (5 ft./1.5 m)
• C11/8-5 MHz 11 mm microcurved array (5 ft./1.5 m)
• C15/4-2 MHz 15 mm microcurved array (5.5 ft./1.7 m)
• C60/5-2 MHz 60 mm curved array (5 ft./1.5 m)
• HST/10-5 MHz 25 mm linear array (8 ft./2.1 m)
• ICT/8-5 MHz 11 mm intracavitary array (5 ft./1.5 m)
• L38/10-5 MHz 38 mm linear array (5.5 ft./1.7 m)
3.3.4 Imaging Modes
2D (256 gray shades)
Color power Doppler (CPD) (256 colors)
Directional color power Doppler (DCPD) (256 colors)
MMode
Pulsed wave (PW) Doppler
Tissue Harmonic Imaging
3.3.5 Applications
Abdominal Imaging
Cardiac Imaging
Gynecology and Fertility Imaging
Interventional and Intraoperative Imaging Applications
Obstetrical Imaging
Pediatric and Neonatal Imaging
Prostate Imaging
Superficial Imaging
Vascular Imaging
16 Chapter 3: System Overview
3.3.6 Image Storage
The number images saved to the CompactFlash card vary depending on the card storage capacity.
Cine buffer
3.3.7 Accessories
3.3.7.1 Hardware, Software, and Documentation
AIUM Ultrasound Medical Safety Guidance Document
Battery
Biopsy Guide
Carry case
External display
Mobile Docking System
Mini-Dock
Power supply
Quick Reference Guide
SiteLink Image Manager 2.1
System User Guide
Triple Transducer Connect
Ultrasound gel
3.3.7.2 Cables
Ethernet cable (10 ft./3 m)
Ethernet interface cable (7 in./18 cm)
External display power cord (6 ft./1.8 m)
External display VGA cable (3 ft./0.9 m)
Print control cable (10 ft./3.1 m)
Printer AC power cord (1 ft./30.5 cm)
VCR AC power cord (1.5 ft./45.7 cm)
VCR (control/audio) cable (6 ft./1.8 m)
Video cable (RCA/RCA) (10 ft./3.1 m)
Video cable (RCA/BNC) (10 ft./3.1 m)
S-video (6 ft./1.8 m)
System AC power cord (10 ft./3.1 m)
USB cable for SiteLink (10 ft./3.1 m)
3.3.8 Peripherals
See the manufacturer’s specifications for the following peripherals.
3.3.8.1 Medical Grade
Black-and-white printer
Recommended sources for printer paper: Contact Sony at 1-800-686-7669 or www.sony.com/professional
to order supplies or to obtain the name and number of the local distributor.
Color printer
Video cassette recorder
3.3.8.2 Non-Medical Grade
Kensington Security Cable
Chapter 3: System Overview 17
3.3.9 Temperature, Pressure, and Humidity Limits
The temperature, pressure, and humidity limits apply only to the ultrasound system and transducers.
Operating Limits: System
• 10–40°C (50–104°F), 15–95% R.H.
• 700 to 1060hPa (0.7 to 1.05 ATM)
Shipping/Storage Limits: System without Battery
• -35–65°C (-31–149°F), 15–95% R.H.
• 500 to 1060hPa (0.5 to 1.05 ATM)
Operating Limits: Battery
• 10–40°C (50–104°F), 15–95% R.H.
Shipping/Storage Limits: Battery
• -20–60°C (-4–140°F), 0–95% R.H.*
• 500 to 1060hPa (0.5 to 1.05 ATM)
* For storage longer than 30 days, store at or below room temperature.
Operating Limits: Transducer
• 10–40°C (50–104°F), 15–95% R.H.
Shipping/Storage Limits: Transducer
• -35–65°C (-31–149°F), 15–95% R.H.
3.3.10 Electrical
Power Supply Input: 100-240 VAC, 50/60 Hz, 1.2 A Max @ 100 VAC.
Power Supply Output (system on): (1) 15 VDC, 2.7A Max (system)
(2) 12.6 VDC, 0.8A Max (battery charging)
Power Supply Output (system off): (1) 15 VDC, 2.0A Max (system)
(2) 12.6 VDC, 1.8A Max (battery charging)
Combined output not exceeding 52W.
Battery
• 6-cell, 11.25 VDC, 4.4 amp-hours, rechargeable lithium ion battery pack.
• Run time is 2 hours or more, depending on imaging mode and display brightness.
3.3.11 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.
C22.2, No. 601.1:1990, Canadian Standards Association, Medical Electrical Equipment–Part 1. General
Requirements for Safety.
CEI/IEC 61157:1992, International Electrotechnical Commission, Requirements for the Declaration of the
Acoustic Output of Medical Diagnostic Ultrasonic Equipment.
UL 2601-1:1997, Second Edition, Underwriters Laboratories, Medical Electrical Equipment-Part 1: General
Requirements for Safety.
3.3.12 EMC Standards Classification
EN 60601-1-2:2001, European Norm, Medical Electrical Equipment. General Requirements for Safety-Collateral
Standard. Electromagnetic Compatibility. Requirements and Tests.
CISPR11:97, International Electrotechnical Commission, International Special Committee on Radio Interference.
Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment Electromagnetic Disturbance
Characteristics-Limits and Methods of Measurement.
The Classification for the SonoSite system, SiteStand, accessories, and peripherals when configured together is:
Group 1, Class A.
18 Chapter 3: System Overview
3.3.13 Airborne Equipment Standards
RTCA/DO160D:1997, Radio Technical Commission for Aeronautics, Environmental Conditions and Test
Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B.
3.3.14 ECG Standard
ANSI/AAMI EC53-1995, Association for the Advancement of Medical Instrumentation, ECG Cables, and Lead
Wires.
The SonoSite ultrasound system meets the requirements of this standard except Section 4.4.1 (Exposure to
ethylene oxide (EO) sterilization) and Section 4.5.9 (Connector retention force). The requirement in Section 4.5.9
does not apply, because the product weighs less than 8. 4 pounds.
3.3.15 DICOM Standard
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15: Security Profiles.
Chapter 3: System Overview 19
20 Chapter 3: System Overview
Chapter 4: Setup and Operation
4.1 System Controls
1
2
3
4
5
6
7
Figure 4.1 System Controls
8 9 11 12 13
10
14
15
16
17
18
19
20
Table 4.1: System Controls
Number System Control Description
1 Power Turns system on and off.
2 Alphanumeric Use to enter text and numbers.
3 Annotation Text Turns the keyboard on and off for text entry.
Picto Turns the pictographs/pictograph marker on and off.
Arrow Displays an arrow that can be moved and rotated within the
image area.
4 THI Turns Tissue Harmonic Imaging on and off.
5 Depth Depth Adjusts the imaging depth for 2D.
Depth Up Decreases imaging depth.
Depth Down Increases imaging depth.
6 Zoom Magnifies image 2x.
7 Gain Near Adjusts the gain applied to the near field of the image.
Far Adjusts the gain applied to the far field of the image.
Gain Adjusts the overall gain applied to the entire image.
8 AC power
indicator
A steady green light indicates AC power is connected. A flashing green light
indicates the system is in sleep mode.
Chapter 4: Setup and Operation 21
Table 4.1: System Controls (Continued)
Number System Control Description
9 Caliper/Calcs Caliper activates a measurement caliper on the screen.
Calcs turns the calculation menu on and off.
10 Touchpad Use to select, adjust, and move objects on the screen.
11 Select Use to switch among touchpad control for line position (2D), text position
(text), calipers for measurement (calipers), pictograph marker position/angle
(picto), arrow position/orientation (arrow).
12 Print Prints the active image to the printer.
13 Save Saves an image to the CompactFlash card.
14 Remappable
controls
15 Forms Setup Access to the system settings.
16 (Delta key) Use as a shortcut to existing functionality in the system.
17 Video recording Record Turns VCR record on and off.
18 Freeze Freeze Stops the live imaging and displays a frozen image.
19 Update Toggles between image modes in M Mode and Doppler, e.g., between Doppler
20 Modes M Mode Turns M Mode on and off.
Controls features on the context menu which are adjusted based on the system
state.
Report Access to the patient report.
Review Access to the patient list and saved patient images.
Patient Access to patient information.
Save Clip (Available on future releases.)
Cine Review images stored in the cine buffer; (back/forward)
back/forward through last-in, first-out sequence.
All mode images can be stored and reviewed in
the cine buffer.
sample line and Doppler spectral trace.
Doppler Turns Doppler on and off.
Color Turns CPD/DCPD on and off.
2D Turns 2D on and off.
4.2 System Components
The SonoSite system components are identified in “About the System” on page 2.
22 Chapter 4: Setup and Operation
4.3 Setup
Key click
Beep alert
Sleep delay
Power delay
OB Authors
Date
Time
1 Press the Setup key.
2 Select Audio, Battery from the on-screen menu.
3 In the Key click list, select On or Off.
1 Press the Setup key.
2 Select Audio, Battery from the on-screen menu.
3 In the Beep alert list, select On or Off.
1 Press the Setup key.
2 Select Audio, Battery from the on-screen menu.
3 In the Sleep delay list, select Off, 5, or 10 minutes.
1 Press the Setup key.
2 Select Audio, Battery, from the on-screen menu.
3 In the Power delay list, select Off, 15, or 30 minutes.
1 Press the Setup key.
2 Select Calculations from the on-screen menu.
3 In OB Authors list, select the desired OB authors.
1 Press the Setup key.
2 Select Date and Time, Presets from the on-screen menu.
3 In the Date field, enter the current date (year, month, and day).
1 Press the Setup key.
2 Select Date and Time, Presets from the on-screen menu.
3 In the Time field, enter the current time in 24 hour format (hours and
minutes).
Delta Key
F Keys
Patient Header
Mode Data
System Status
Doppler Scale
1 Press the Setup key.
2 Select Delta Key, F Keys from the on-screen menu.
3 Select desired functionality for the Delta key.
The Delta key will now control this function.
1 Press the Setup key.
2 Select Delta Key, F Keys from the on-screen menu.
3 Type in desired text. Use the Backspace key or Delete key to correct
mistakes.
1 Press the Setup key.
2 Select Display Information from the on-screen menu.
3 Select the desired check boxes to display desired information in the patient
header.
1 Press the Setup key.
2 Select Display Information from the on-screen menu.
3 Select the desired check boxes to display imaging information on the screen.
1 Press the Setup key.
2 Select Display Information from the on-screen menu.
3 Select the desired check boxes to display the system status on the screen.
1 Press the Setup key.
2 Select Date and Time, Presets from the on-screen menu.
3 In the Doppler Scale list, select cm/s or kHz.
Chapter 4: Setup and Operation 23
Duplex
1 Press the Setup key.
2 Select Presets from the on-screen menu.
3 In the Duplex list, select desired image display.
• Full 2D, Full Trace
• 1/3 2D, 2/3 Trace
• 1/2 2D, 1/2 Trace
Printer
Thermal Index
Video mode
Connectivity
System Information
Reset
1 Press the Setup key.
2 Select Date and Time, Presets from the on-screen menu.
3 In the Printer list, select the desired printer from the list of recommended
printers.
1 Press the Setup key.
2 Select Date and Time, Presets from the on-screen menu.
3 In the Thermal Index list, select TIS, TIB, or TIC.
1 Press the Setup key.
2 Select Date and Time, Presets from the on-screen menu.
3 In the Video mode list, select NTSC or PAL.
1 Press the Setup key.
2 Select Presets from the on-screen menu.
3 In the Connectivity mode list, select SiteLink or DICOM.
After changing connectivity, a dialog box is displayed to restart the system.
Note: SiteLink and DICOM are optional features.
1 Press the Setup key.
2 Select System Information from the on-screen menu.
Note: To install a license key see “Installing a License Key” on page 34.
To return settings for this setup page to factory default, select Reset from the
on-screen menu.
Press the Setup key to exit.
4.4 Touchpad
The touchpad is used to select, adjust, and move objects on the screen. For example, it controls the caliper
position, CPD/DCPD box position, floating cursor, and more.
Note: The arrow keys control much of the same functionality as the touchpad.
4.5 Accessories
For information about accessories and other SonoSite products, refer to the user guide for each product.
24 Chapter 4: Setup and Operation
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