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).
1.1Audience
The intended audience of this manual is properly trained field and in-house service personnel.
1.2Conventions Used in This Service Manual
These conventions are used in this service manual:
•A Warning describes precautions necessary to prevent injury or loss of life.
•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.
1.3Product 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.
1.4Customer 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: Introduction1
1.5About 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
NumberFeature
1Control panel
2Transducer connection
3Handle
4Display
5CompactFlash™ slots (front for image storage, back for system updates)
2Chapter 1: Introduction
1
342
Figure 1.2 TITAN System Rear View
Table 1.2: TITAN System Rear Connectors
NumberFeature
1DC input connector
2I/O connector
3Battery
4ECG 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:
•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 2.0 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: Introduction3
1.6About 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.
1.7Software Licensing
Use of the software that you receive from SonoSite is controlled by a license key. A license key is a
number sequence containing exactly 12 decimal digits.
License keys are obtained from SonoSite or from its authorized representatives. You must obtain one
key for each system that will use the new software. See “Obtaining a License Key” on page 32 for
information on obtaining a license key.
Software that you receive from SonoSite 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.
4Chapter 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 Warning describes precautions necessary to prevent injury or loss of life.
A Caution describes precautions necessary to protect the products.
2.1Electrical 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:
Warning: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.
Chapter 2: Safety5
Warning: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.
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.
2.2Equipment 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.
6Chapter 2: Safety
2.3Battery Safety
To prevent the battery from bursting, igniting, or emitting fumes and causing 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 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.
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 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.
Chapter 2: Safety7
2.4Biological Safety
Observe the following precautions related to biological safety.
Warning: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.
2.5Labeling Symbols
Labeling symbols for SonoSite products can be found in the user guide for each product.
8Chapter 2: Safety
Chapter 3: System Overview
3.1System 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.
3.2Theory 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 Overview9
Figure 3.1 TITAN Block Diagram
3.2.1Transducer
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.
3.2.2Front 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.
10Chapter 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
Chapter 3: System Overview11
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.
3.2.3Digital 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
3.2.4Backend 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.
12Chapter 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 Overview13
3.2.5Control 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.
14Chapter 3: System Overview
3.2.6Power 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 Overview15
3.3System Specifications
This section contains system and accessory specifications and agency approvals. The specifications for
recommended peripherals can be found in the manufacturers’ instructions.
3.3.1System 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
3.3.2Display Dimensions
Length: 5.1875 in. (13.18 cm)
Width: 6.75 in. (17.15 cm)
Diagonal: 8.5 in. (21.59 cm)
3.3.3Transducers
•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)
3.3.4Imaging 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
3.3.5Applications
Abdominal Imaging
Cardiac Imaging
Cephalic Imaging
Gynecology Imaging
Interventional and Intraoperative Imaging Applications
Obstetrical Imaging
Pediatric and Neonatal Imaging
Superficial Imaging
Vascular Imaging
16Chapter 3: System Overview
3.3.6Image Storage
The number images saved to the CompactFlash card vary depending on the card storage capacity.
Cine buffer
3.3.7Accessories
3.3.7.1 Hardware, Software, and Documentation
AIUM Ultrasound Medical Safety Guidance Document
Battery
Biopsy Guide
Mobile Docking System
Mini-Dock
Power supply
Quick Reference Guide
SiteLink Image Manager 2.0
SiteLink DICOM 2.0
SonoKnowledge education package
System User Guide
Ultrasound gel
3.3.7.2 Cables
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)
3.3.8Peripherals
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
distributor.
Color printer
Video cassette recorder
to order supplies or to obtain the name and number of the local
3.3.8.2 Non-Medical Grade
Kensington Security Cable
Chapter 3: System Overview17
3.3.9Temperature, 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.
18Chapter 3: System Overview
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.
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 Overview19
20Chapter 3: System Overview
Chapter 4: Setup and Operation
4.1System Controls
1
2
3
4
5
6
7
Figure 4.1 System Controls
891112 13
10
14
15
16
17
18
19
20
Table 4.1: System Controls
NumberSystem ControlDescription
1PowerTurns system on and off.
2AlphanumericUse to enter text and numbers.
3AnnotationTextTurns the keyboard on and off for text entry.
PictoTurns the pictographs/pictograph marker on and off.
ArrowDisplays an arrow that can be moved and rotated within the