Scanning Systems, Ultrasonic, General-Purpose

Scope of this Product Comparison

This Product Comparison covers general-purpose ultrasonic scanning systems intended
primarily for abdominal, obstetric/gynecologic (OB/GYN), small-parts, and vascular
imaging. Portable, dedicated cardiac, and dedicated intravascular ultrasonic scanning
systems are excluded from this report.

These devices are also called: abdominal ultrasound scanners, arteriographic

ultrasonic units, dedicated linear-array ultrasonic scanners, gynecologic ultrasonic
scanners, obstetric ultrasonic scanners, renal ultrasonic scanners, small-parts scanners,
small-parts ultrasonic scanners, thyroid ultrasonic scanners, urologic ultrasonic
scanners, vascular scanners.

Purpose
General-purpose ultrasonic scanning systems provide two-dimensional (2-D) images of
most soft tissues without subjecting patients to ionizing radiation. They are typically used
in the hospital's radiology department and in other hospital departments as well as free-
standing imaging centers and private physician offices primarily for vascular and
OB/GYN applications. Some systems include additional transducers to facilitate more
specialized diagnostic procedures, such as cardiac, vascular, endovaginal, endorectal,
or small-parts (e.g., thyroid, breast, scrotum, prostate) scanning.

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Principles of Operation
Ultrasound refers to sound waves emitted at frequencies above the range of human
hearing. For diagnostic imaging, frequencies ranging from 2 to 15 megahertz (MHz) are
typically used. Ultrasound waves are mechanical (acoustic) vibrations that require a
medium for transmission; because they exhibit the normal wave properties of reflection,
refraction, and diffraction, they can be predictably aimed, focused, and reflected.

A typical ultrasonic scanning system consists of a beamformer, a central processing unit,

a user interface (e.g., keyboard, control panel, trackball), several probes (transducers or
scanheads), one or more video displays, some type of recording device, and a power
system.
 To perform ultrasonic imaging, a probe
is either placed on the skin (after an acoustic coupling gel is applied) or inserted into a
body cavity. Ultrasonic probes contain one or more elements made of piezoelectric
materials (materials that convert electrical energy into acoustic energy and vice versa).
When the ultrasonic energy emitted from the probe is reflected from the tissue, the
transducer receives some of these reflections (echoes) and reconverts them into
electrical signals. These signals are processed and converted into an image (sonogram).
Lower sound frequencies provide decreased resolution but greater tissue penetration,
while higher frequencies improve resolution when deep penetration is not necessary
(e.g., in pediatric or small-parts studies).

Multifrequency (broadband) transducers have broad frequency ranges and can enhance
the overall quality of the images produced. Many suppliers offer multifrequency probes
that allow switching among two or more frequencies—for example, among 2.5, 3.5, and
5 MHz.

Various modes are available for displaying the returning echoes. B-mode (brightness-
modulated mode) is the scanning system's basic imaging mode. B-mode produces a
real-time, 2-D image that represents a cross-sectional slice of the area under study. The
image is created as the transducer sweeps the pulsed ultrasound beam through the
image plane either mechanically or electronically. The image is updated multiple times to
produce a real-time image; the sweep (or frame) rate determines how often the image
updating occurs. M-mode (motion mode) uses a fixed-position pulsed beam to produce a
moving display of a single scan line over an interval of time. Used almost exclusively in
cardiac applications, M-mode produces a graphical display of a moving structure (e.g.,
the cardiac valve over several heartbeats). Simultaneous display of M- and B-modes is
particularly useful when examining dynamic structures, such as the heart.

Transducers most commonly generate two differently shaped patterns: rectangular

(linear) images and wedge-shaped (sector) images. Linear images are produced by flat,
linear array transducers, which contain a series of piezoelectric elements arranged in a
single line with available array lengths of 4 to 15 cm. The elements are pulsed
sequentially in groups, advancing from one end of the array to the other while the
system switches between transmit and receive modes. This produces a number of
parallel acoustic beams across the length of the array during a single sweep to image a
rectangular region directly in front of the elements. (Figure 1 illustrates the basic types of
transducers and the ultrasonic wave patterns they generate.) As with other real-time
scanners, each linear sweep updates the display with a new cross-sectional image.
Various methods are used to improve image resolution, such as special transmit and
receive phase-delay techniques that significantly improve beam focusing and image
quality. Because the entire length of the array is placed on the patient's skin, a large
field-of-view (FOV) displays structures close to the transducer. Therefore, a flat linear
array (often called just "linear array") system is ideal for those obstetric examinations in
which the placenta or fetal skull might be positioned close to the transducer. Because of
their less sophisticated electronic circuitry, scanners utilizing only linear array
transducers are generally less expensive than many other real-time ultrasonic scanning
devices, but there are disadvantages. For instance, maintaining complete skin contact
with the large surface of the array is sometimes difficult.
Two basic transducer configurations are currently used for sector scanning: mechanical
and electronic (nonmechanical). Mechanical-sector transducers contain one or more
piezoelectric elements in a sealed fluid path. A motor-driven system moves the element
rapidly through an arc that establishes the sector, while the transducer switches between
transmit mode and receive mode. Although mechanical transducers commonly use a
single element, some use an annular array: multiple concentric, ring-shaped elements
that produce a cylindrical, more uniform, and better-focused beam in both the horizontal
and elevational (vertical) planes. This 2-D focusing reduces slice thickness for improved
image quality. Activating the elements at different delays allows the beam produced by
these arrays to be focused at different depths depending on the region of interest.

Electronic-sector scanning uses array transducers, which consist of a series of linear

piezoelectric elements. A curvilinear-array (convex array) probe operates similarly to the
flat linear probe, but its convex shape allows a larger field of view (FOV) than a flat linear
array transducer with the same contact area and a better depiction of the anatomy.

Electronically steered scanning uses phased-array transducers, which consist of a series

of individual piezoelectric elements operating as a unit. Phased arrays are the same as
linear arrays except that they have smaller skin contact areas and electronic timing
circuits that allow them to fire groups of elements in a variety of sequences. This permits
each burst of ultrasonic energy to leave the transducer at a slightly different angle.
Transmitting and receiving ultrasonic energy through different angles within the scan
plane forms a sector image. Phased-array transducers are generally smaller and easier
to handle than most linear array transducers. However, they require more sophisticated
electronic timing systems. Although they provide a limited FOV for superficial structures,
their smaller scanning surfaces (often as small as 6 mm) permit imaging of structures in
tight areas or behind obstructions (e.g., areas between or behind ribs). Some systems
combine linear- and phased-array techniques to provide a trapezoidal (often termed
"vector") imaging format. This is accomplished by adding pie-shaped sectors to both
sides of a rectangular linear image. The transducer's scanning surface is slightly larger
than that of a normal phased-array transducer, and the sector image that is produced
has a wider FOV in the near field.

Electronic transducers provide a greater number of imaging capabilities, such as

simultaneous 2-D and Doppler imaging. And, because they have no moving parts, they
also are more reliable. But, in the typical linear element configuration, with rows of
elements arranged horizontally, electronic focusing is possible only in the 2-D
(horizontal) scan plane; therefore, there is no focusing of the transducer's elevational
plane to reduce slice thickness.

Multidimensional arrays have the normal row of elements arranged horizontally, but they
also have a few (five to seven) vertical rows of elements. These vertical rows allow the
arrays to be focused in the elevational plane, thus creating a tighter focal area. However,
the elevational focus cannot always be adjusted, nor can the beams be steered
vertically. Nevertheless, these arrays (often referred to as 1.5-dimensional arrays)
typically have a thinner slice thickness so they provide somewhat better vertical
resolution than standard linear arrays.
 In both mechanical and electronic
systems, each sweep produces a new cross-sectional image (frame) that is used to
update the display. Generally, high frame rates are useful for imaging rapidly moving
structures (e.g., the valves of the heart), while lower frame rates provide improved image
quality by increasing the density of the acoustic lines that make up the image.
Depending on the system, frame rates can be fixed, selected by the operator, or varied
automatically based on the FOV and other variables chosen by the operator. Some
scanning systems permit the user to change the FOV by varying the sector angle.

A scan converter system displays the image on a high-resolution video monitor. During
scanning, the converter assigns discrete shades of gray (grayscale) to the returning
echo amplitude levels; the number of shades depends on how many bits of information
can be stored for each point of image memory. Some scanners offer user-selectable
preprocessing and postprocessing features that permit the user to optimize the image
quality by altering the texture and grayscale emphasis within the image. The scan
converter also permits freeze-frame, which captures a single frame for display,
documentation, and analysis.
Some scanning systems are capable of performing real-time three-dimensional (3-D)
ultrasound, which involves volume-per-second acquisition and display for volume
measurements, improved image presentation, and volume-of-interest studies. 3-D
images can be produced by direct online acquisition of a volume of data instead of a
slice of the tissue. Another method is the reconstruction of previously acquired 2-D
cross-sections or tomograms using offline hardware and software. 3-D ultrasound
images have been found to be clinically useful for cardiac, blood-flow, ophthalmic, brain,
prostate, renal, and fetal imaging, as well as for surgical planning. So-called "real-time 3-
D" (4-D) is typically available only on high-end scanners. Currently, 4-D scanners do not
provide true real-time frame rates because the acquisition of multiple 2-D slices and
reconstruction of the data requires more time than conventional 2-D imaging. Instead,
the image is updated approximately 3–10 times per second.

On some systems, the operator can magnify (zoom) the display for further examination
and can also store images or transfer them via networks for storage on picture archiving
and communication systems (PACS). (For more information, see the Product
Comparison titled Picture Archiving and Communication Systems (PACS), Radiology.)

Many ultrasonic scanning system suppliers incorporate the National Electrical

Manufacturers Association Digital Imaging and Communications in Medicine (DICOM
3.0) Standard on their scanning systems. The purpose of this standard is to allow digital
images produced by any medical device to be stored and transferred through PACS or
other means, regardless of the device supplier.

Scanned structures can be measured using digital calipers—cursors electronically

superimposed over the acquired image that calculate the size of the scanned structure.
The caliper system can also be used to plot and measure the area, circumference, or
volume of a structure. In obstetric applications, gestational-age programs use
measurements of various fetal body parts (e.g., the femur and head circumference) to
calculate an estimated age of the fetus.

A data-entry keyboard permits information such as patient name, medical record

number, and type of study to be entered and displayed along with the scanned image.
Other user-adjustable controls permit manipulation of the transmitted acoustic signal or
the received echoes to allow the user to optimize the image quality.

Doppler Imaging
Many scanners now include Doppler capability to determine the direction and speed of
blood flow. Most scanners include spectral Doppler, either continuous-wave (CW) or
pulsed-wave (PW). CW Doppler, the simplest spectral Doppler mode, is commonly used
for blood-flow analysis in which vessel-depth information is not important; it receives
information from all the moving reflectors in the path of the beam. CW Doppler is able to
provide accurate measurements of blood velocity through the sampled area. PW
Doppler is used when depth selectivity is required, but it cannot be used for higher
velocities because of the problem of frequency aliasing; when the pulse-repetition
frequency (PRF) is too low to adequately sample the Doppler frequency shift. To resolve
the problem of aliasing, the PRF can be increased or a lower-frequency transducer can
be used. Some scanners allow the use of a high pulse-repetition frequency (HPRF)
Doppler mode—a function that corrects for aliasing by increasing the PRF for a sample
volume depth. PW Doppler allows the operator to select the area of interest for flow
analysis using cursors superimposed on the 2-D image. PW depth-selective information
is obtained by acoustic pulses emitted from the transducer, allowing analysis of blood
flow data from a precise location depicted on a 2-D B-mode reference image.

Spectral Doppler includes a spectrum analyzer to display frequency shifts plotted against
time, with grayscale intensity varying with the received signal's strength or amplitude.
The spectrum analyzer may also employ fast Fourier transform (FFT), a high-rate
sampling method that analyzes the Doppler-shift signals and allows the user to perform
complex calculations on them. FFT analyzers typically produce peak and mean displays.
The peak display provides a linear-time waveform that represents the maximum
instantaneous velocity present. The mean display provides a linear-time waveform that
represents the statistical mean velocity of all velocities present at a given point in time.

Some units provide a simultaneous display of real-time and 2-D imaging and Doppler.
Other units freeze the 2-D image when Doppler is engaged; if the transducer or patient
moves, however, it can be difficult to determine the precise anatomic location from which
blood flow data is being acquired. Thus, some units update the 2-D image at adjustable
intervals, although the Doppler shuts off during the 2-D update. True simultaneous
(duplex) scanners allow the 2-D image to remain in real time (although at a lower frame
rate) while the Doppler beam is used to acquire blood flow information.

Color Doppler imaging (CDI) displays the relative Doppler frequency shifts in color
superimposed on a 2-D B-mode image. The real-time B-mode image is used to display
the anatomic features, while CDI provides a depiction of hemodynamic data. CDI is most
commonly used to determine presence, direction, and relative velocity of blood flow at
multiple points along multiple beam paths within an area of interest. The use of CDI
complements and enhances the diagnostic value of conventional 2-D real-time
ultrasound imaging by providing information about normal and abnormal blood-flow.

Like color television, CDI uses combinations of primary colors. Typically, red and blue
hues are used to indicate blood flow directed towards and away from the transducer,
respectively. Lighter shades of red or blue indicate higher velocities, such as those
caused by stenotic valves or narrowed vessels. In addition to blood-flow direction, mean
flow rate and degree of variance can also be depicted by CDI. Manufacturers provide a
wide range of user-selectable color maps. A commonly used color map is a rainbow map
that uses shades of red to yellow and and blue to green to demonstrate blood flow
directed towards and away from the transducer, respectively.

Many scanning systems are capable of power Doppler imaging (PDI), which can be
used as an adjunct to CFMCDI. Power Doppler imaging displays the integrated power of
the reflected signal arising from moving tissue (e.g., blood) in the conventional color-flow
Doppler technique. PDI typically has higher sensitivity than CDI and provides good blood
flow data even when the direction of blood flow is at poor Doppler angles (which often
cannot be visualized well with CDI). This technology can produce images of structures
not normally seen sonographically. However, power Doppler provides no quantitative
data, such as flow rate or direction. PDI typically has low frame rates and is subject to
motion artifacts, both of which make it unsuitable for assessments of rapidly moving
structures such as the heart.

Some systems offer a triplex mode, which simultaneously acquires and displays 2-D B-
mode, spectral Doppler, and color-flow data. Triplex mode can be useful for assessment
of blood flow and flow anomalies in small vessels.

Harmonic Imaging (HI)

HI is a version of B-mode that, in many cases, improves image quality over that provided
by conventional B-mode imaging. Harmonics are frequencies that occur at multiples of
the fundamental, or transmitted, ultrasound frequency. In HI mode, ultrasound is
transmitted at one frequency and received at twice the transmitted frequency (e.g.,
transmit 2 MHz and only use echoes at 4 MHz to form the image). The returning high-
frequency signal can be isolated from the fundamental signal by use of a filter or other
sophisticated signal transmission and processing techniques.

Generating 2-D images from harmonic frequencies enhances image quality by improving
resolution and reducing artifacts in the harmonic signal in order to improve the signal-to-
noise ratio. There are two basic types of HI: HI used with ultrasound contrast agents
(contrast HI [CHI]) and HI used to image tissue (tissue HI [THI]).

Reported Problems
Diagnostic ultrasound imaging appears to be risk-free when used properly. However, its
accuracy depends on the skill of the operator, who must continuously and carefully
adjust transducer direction and instrument controls to avoid artifacts in ultrasound
images, which can significantly degrade image quality and possibly lead to an
incomplete or incorrect diagnosis. In addition to routine quality assurance procedures,
the scanner must be maintained properly in accordance with its manufacturer's technical
support service.

Ultrasound transducers should be handled carefully to avoid damage. A quality control

program should include frequent testing of transducers and system performance with
standard ultrasound phantoms to evaluate lateral and axial resolution, distance
accuracy, sensitivity, uniformity, and hard-copy appearance. Electromechanical
problems, such as cracks in piezoelectric elements, can alter beam width and/or spatial
pulse length, thereby affecting lateral and axial resolution.

Errors in distance measurements can cause incorrect calculations. An error margin of

2% or less measured over 10 cm is considered acceptable for most ultrasound systems.
The appearance of the hard-copy image should be the same as that of the image on the
monitor. Most manufacturers can supply a test pattern on software to evaluate the
performance of the recording device.

Purchase Considerations
Included in the accompanying comparison chart are ECRI Institute's recommendations
for minimum performance requirements for general-purpose ultrasound scanners;
recommended specifications have been categorized into four groups (cardiac, OB/GYN,
vascular, and small parts) based on specific clinical applications (other than abdominal)
where general-purpose scanners may be used. General-purpose scanners are routinely
used for imaging abdominal organs (e.g., the liver and kidneys) and vessels including
the aorta and inferior vena cava. Diagnostic ultrasound examinations are performed for a
wide range of indications including the assessment of organs for diffuse disease as well
as benign and malignant tumors, fluid collections, obstruction of the kidneys, and gall
stones. Doppler ultrasound modes permit evaluations of blood flow in vessels as well as
organs and tumors thus enhancing the overall diagnostic potential of the modality.

General-purpose scanners with OB/GYN capabilities are used to investigate a variety of

gynecologic abnormalities, including ovarian or uterine masses; to detect the presence
and condition of a fetus; to evaluate the blood supply to the fetus; and to monitor fetal
growth throughout pregnancy. Ultrasonography is also used to guide amniocenteses, for
oocyte retrieval on patients undergoing in vitro fertilization, and other invasive
procedures. Obstetric analysis packages provide the ability to calculate valuable
information, including gestational age, fetal weight, and fetal growth over time. Most
scanners can include the calculations in a detailed and customizable report to facilitate
documentation of the examination findings. Endocavity transducers are used extensively
for OB/GYN applications. Comprehensive OB/GYN studies require a full-featured
system, which is used in a hospital's radiology department, OB/GYN department,
imaging center or in private OB/GYN offices.

General-purpose scanners can be equipped with a wide variety of transducers. High-

frequency small-parts linear array probes are commonly used for examinations of the
thyroid, breast, scrotum, and musculoskeletal system. Microconvex linear array probes
are used for neonatal brain and other pediatric examinations while endocavity
transducers are designed for prostate imaging and to guide prostate biopsies. General-
purpose abdomen and small-parts studies require a full-featured system, which is
typically used in a hospital's radiology department or in a free-standing imaging center.

General-purpose scanners with vascular capabilities are used to evaluate blood vessels
throughout the body, enabling clinicians to diagnose arterial and venous abnormalities
and their causes. Doppler ultrasound modes are required for thorough assessments of
vascular structures to detect and characterize blood flow in organs and tumors as well
as the extremities. Spectral Doppler analysis packages can perform calculations
automatically. A comprehensive vascular study requires a full-featured system, which is
used in a hospital's radiology department, cardiology department, noninvasive vascular
lab or in a private vascular surgeon's office. Common vascular examinations include
evaluation of the extracranial arteries, peripheral arterial and venous studies and for
routine screening for aortic aneurysms.

Other Considerations
When purchasing an ultrasonic scanning system, facilities need to consider six basic
issues: functions and features, cost, ease of use, upgradeability, image storage, and
customer support. Some suppliers now provide remote diagnostics whereby the scanner
can be monitored from a remote location through a modem.

Ultrasound Accreditation
Within the last several years, the American College of Radiology, the American Institute
of Ultrasound in Medicine, the Intersocietal Commission for the Accreditation of Vascular
Laboratories, and the Intersocietal Commission for the Accreditation of
Echocardiography Laboratories introduced accreditation programs for hospital- and
office-based ultrasound practices. These voluntary accreditation programs were created
to ensure the quality of ultrasonic imaging because significant variations in the quality of
care have been found among healthcare facilities. In the United States, healthcare
payers and managed care providers can insist on ultrasound accreditation as a condition
for reimbursement.
Environmental Considerations
As a result of increasing concerns over the environment and the conservation of
resources, many manufacturers have adopted green shipping and production methods,
as well as features that improve the energy efficiency of their products or make them
more recyclable. In addition, healthcare facilities and device manufacturers have begun
to adopt green initiatives that promote building designs and work practices that reduce
waste and encourage the use of recycled materials.

Ultrasound systems have high energy requirements, so some systems have

implemented energy-saving features, such as standby mode and battery back-up.
Batteries should be rechargeable and contain no mercury or cadmium. Facilities may
also want to consider how fast the system starts up and powers down, which will impact
the time required to perform portable studies (e.g., studies performed at the patient's
bedside, in the emergency department, or in the operating room).

End-of-life costs should also be taken into account, such as how much of the device can
be recycled. Facilities should look for systems that minimize the use of polyvinyl chloride
and brominated and chlorinated fire retardants. Some manufacturers provide take-back
programs on system components, so the facility will not incur the cost of removal.

Cost Containment
Since ultrasound systems require ongoing maintenance and operational costs, the initial
acquisition cost does not accurately reflect the total cost of ownership. In today's
competitive ultrasound market there are, in general, few significant technical differences
between high-end ultrasound scanners manufactured by the market leaders. Therefore,
a purchase decision should be based on issues such as life-cycle cost (LCC), local
service support, discount rates and non-price-related benefits offered by the supplier.
For example, consideration should be given to the experience of the end-users; their
learning curve may be shortened by purchasing equipment from the same manufacturer
of a facility's existing equipment (i.e., purchasing all ultrasound scanners from one
supplier).

Hospitals can purchase service contracts or service on a time-and-materials basis from

the supplier. Service may also be available from a third-party organization or by the
facility's biomedical engineering department. The decision to purchase a service contract
should be carefully considered. Because ultrasound systems tend to be highly reliable
(many suppliers have a 99% to 100% uptime guarantee), the financial risk associated
with not purchasing a service contract may be minimal. However, the decision to
purchase a service contract can be justified for several reasons. Most suppliers provide
routine software updates that enhance the scanner's performance, at no charge to
service contract customers. Furthermore, software updates are often cumulative; that is,
previous software revisions may be required in order to install and operate a new
performance feature. Purchasing a service contract also ensures that preventive
maintenance will be performed at regular intervals, thereby eliminating the possibility of
unexpected maintenance costs. Also, many suppliers do not extend system performance
and uptime guarantees beyond the length of the warranty unless the system is covered
by a service contract. Because transducers and hard-copy imaging devices are the
components of the system most prone to failure or damage, they should be included in
the service contract.

ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate

pricing for service contracts before the system is purchased. As a guideline, full-service
contracts typically cost approximately 6% to 8% of the ultrasound system's purchase
price. Additional service contract discounts may be negotiable for multiple-year
agreements or for service contracts that are bundled with contracts on other scanners in
the department or hospital. Buyers should also negotiate for a nonobsolescence clause
stating that the supplier agrees not to introduce a replacement system within one or two
years and that if a replacement system is introduced during this time period, 100% of the
purchase price can be applied to the purchase of the new system.

In addition, given the current highly competitive market for ultrasound systems, hospitals
should negotiate for a significant discount on the capital purchase—many suppliers
discount new, fully configured systems from 15% to 60%. The actual discount received
will depend on the hospital's negotiating skills, the system configuration and model to be
purchased, previous experience with the supplier, and the extent of concessions granted
by the supplier, such as extended warranties, fixed prices for annual service contracts,
and guaranteed on-site service response. Buyers should make sure that applications
training is included in the purchase price of the system. Some suppliers offer more
extensive on-site or off-site training programs for an additional cost.

ECRI Institute recommends that buyers consider the number and types of ultrasound
studies performed at their institution before deciding on a specific system configuration.
Also, if multiple scanners are necessary to handle the patient volume, hospitals should
determine the types of scanners and capabilities required in order to avoid paying for
unnecessary analysis packages and scanning features. For instance, a hospital may
want to purchase three scanners: one dedicated to OB/GYN, one to general radiology,
and one for cardiac scanning. In this case, purchasing all three scanners from one
supplier could result in a significant discount. Standardization of equipment can make
staff training easier, simplify servicing and parts acquisition, and provide greater
bargaining leverage when negotiating the purchase of new equipment and/or service
contract costs.

Given their relatively low capital cost compared to other imaging equipment, ultrasonic
scanners are typically purchased outright; however, leasing more expensive, high-
performance systems is becoming more common. In general, renting is not a cost-
effective alternative.

Stage of Development
General-purpose ultrasonic scanners have been commercially available for more than
30 years. Most have a modular design that can be easily upgraded to include
specialized functions, such as cardiac scanning and/or spectral Doppler and CDI,
permitting users to keep pace with the rapidly changing technology of the modality.

Given its low cost relative to other imaging technologies (approximately $20,000 to
$300,000, depending on system configuration), its noninvasiveness, the absence of
ionizing radiation, and recent improvements in image quality, ultrasound is now a widely
utilized medical imaging modality.

Current trends are directed toward increased use of digitization, smaller-sized units, new
transducer designs, and interconnectivity with information systems. This introduction
follows the larger trend toward the development of all-digital radiology departments. In
addition to the conventional applications of OB/GYN, abdominal, vascular, and
cardiology, ultrasound is recognized as a valuable diagnostic tool in the emergency
room, surgery, rhematology department and for musculoskeletal applications.
Additionally, ultrasound is now widely used to guide interventional procedures including
diagnostic biopsies and fluid drainages as well as for therapeutic applications such as
radio frequency ablations and cryoablations of tumors.
Sonography is recognized as a highly user-dependent modality. To address this issue,
ultrasound equipment manufacturers have begun to incorporate features to make their
systems easier to use. Another motivating factor for equipment manufacturers to
improve their scanners is the prevalence of work-related musculoskeletal disorders
(WRMSDs) among sonography professionals. The need to perform many repetitive
tasks during the course of an examination has been recognized as a major contributing
factor for sonographer WRMSDs and manufacturers have begun to address this issue
via increased utilization of automation (i.e., use hardware and/or software to accomplish
tasks that were previously performed manually).

Manufacturers have developed automatic image optimization features that fine-tune the
scanner's performance during the actual scanning examination of a given patient. There
are commercially available systems that have automated optimization features that work
on grayscale, CDI, and spectral Doppler modes. When the so-called "auto-op" control is
activated the system employs adaptive processing to analyze the returning echoes and
other acoustic data to automatically adjust parameters to optimize image quality or, in
the case of Doppler, to improve flow detection sensitivity and optimize the display of
blood flow data.

Another area of automation provided by some manufacturers is automated

measurement packages that streamline measurement processes. These can be
particularly useful in cases where multiple measurements and calculations are required
(e.g., obstetric and cerebrovascular exams). Automation has the potential to reduce
inter-operator variability, reduce WRMSD and improve workflows.

Breast sonography is a common application of ultrasound imaging. Breast sonography is

used to characterize breast masses, guide aspirations and core needle biopsies, as well
as for wire localizations. Ultrasound is well established as an complementary technique
to mammography for evaluating breast lesions. Because it is nonionizing, ultrasound is
particularly advantageous for evaluation of palpable masses in pediatric patients,
pregnant, or lactating women. Ultrasound examination can overcome much of the
decreased sensitivity of mammography in patients with radiographically dense breasts
that can make it difficult to distinguish cancer tissues from normal glandular tissue. It can
differentiate cysts from solid masses seen on mammograms or found on palpation.
Because taut compression is not required, it can be useful in evaluating a painful,
inflamed breast to determine if a focal, drainable abscess is the problem. It can also be
helpful when no mammographic abnormality is seen in a clinically suspicious area of the
breast. However, ultrasound cannot detect all solid masses, nor can it consistently show
microcalcifications which can be associated with malignancies. The American College of
Radiology (ACR) has established a standardized way to describe breast ultrasound
findings called the BI-RADS Breast Ultrasound Reporting System.

For these procedures to be performed safely, the shaft and tip of the needle must be
well visualized with ultrasound to allow for accurate needle placement. Transducer-
mounted needle guides, needles designed with central apertures, and complex
electronic guidance systems have been developed to facilitate accurate needle
placement and assist in these procedures. Electronic beam steering is also used to
improve needle visualization during ultrasound-assisted interventions. This technique
can considerably enhance the visibility of needles used in interventional procedures,
thus increasing the safety and time efficiency of procedures.

The use of commercially available ultrasound contrast agents for echocardiographic

examinations is gaining acceptance as a routine procedure. Several different contrast
agents are now available but their government approved indications in the United States
are limited. Although ultrasound contrast agents can be used to enhance Doppler
signals, they are more frequently used with ultrasound scanners that have contrast-
specific imaging modes such as CHI, which has been found to greatly improve the
diagnostic effectiveness of contrast-enhanced sonography.

Another development in ultrasound technology is known as elastography. Ultrasound

elastography (sonoelastography) is used to determine tissue stiffness which, when
combined with findings from B-mode and Doppler evaluations, can enhance the ability to
characterize tissue as benign or malignant. Ultrasound-based elastography is in a
relatively early stage of development but appears to have clinical value for a wide range
of indications. Currently, the most common applications of elastography are to identify
changes in liver stiffness that can result from a number of diseases (e.g., hepatitis C) as
well as to characterize focal breast and thyroid masses.

This Product Comparison covers general-purpose ultrasonic scanning systems intended

primarily for abdominal, obstetric/gynecologic (OB/GYN), small-parts, and vascular
imaging. Portable, dedicated cardiac, and dedicated intravascular ultrasonic scanning
systems are excluded from this report.

These devices are also called: abdominal ultrasound scanners, arteriographic

ultrasonic units, dedicated linear-array ultrasonic scanners, gynecologic ultrasonic
scanners, obstetric ultrasonic scanners, renal ultrasonic scanners, small-parts scanners,
small-parts ultrasonic scanners, thyroid ultrasonic scanners, urologic ultrasonic
scanners, vascular scanners.

Purpose
General-purpose ultrasonic scanning systems provide two-dimensional (2-D) images of
most soft tissues without subjecting patients to ionizing radiation. They are typically used
in the hospital's radiology department to complement other imaging modalities and in
other hospital departments and private physician offices primarily for abdominal and
OB/GYN scanning. Some systems include additional transducers to facilitate more
specialized diagnostic procedures, such as cardiac, vascular, endovaginal, endorectal,
or small-parts (e.g., thyroid, breast, scrotum, prostate) scanning.

Principles of Operation
Ultrasound refers to sound waves emitted at frequencies above the range of human
hearing. For diagnostic imaging, frequencies ranging from 2 to 15 megahertz (MHz) are
typically used. Ultrasound waves are mechanical (acoustic) vibrations that require a
medium for transmission; because they exhibit the normal wave properties of reflection,
refraction, and diffraction, they can be predictably aimed, focused, and reflected.

A typical ultrasonic scanning system consists of a beamformer, a central processing unit,

a user interface (e.g., keyboard, control panel, trackball), several probes (transducers or
scanheads), one or more video displays, some type of recording device, and a power
system.

To perform ultrasonic imaging, a probe is either

placed on the skin (after an acoustic coupling gel is applied) or inserted into a body
cavity. Ultrasonic probes contain one or more elements made of piezoelectric materials
(materials that convert electrical energy into acoustic energy and vice versa). When the
ultrasonic energy emitted from the probe is reflected from the tissue, the transducer
receives some of these reflections (echoes) and reconverts them into electrical signals.
These signals are processed and converted into an image (sonogram). Lower sound
frequencies provide decreased resolution but greater tissue penetration, while higher
frequencies improve resolution when deep penetration is not necessary (e.g., in pediatric
or small-parts studies).
Multifrequency (broadband) transducers have larger frequency ranges than traditional
transducers. Larger bandwidths allow the user to more easily select transducer
resolution and tissue penetration in different imaging procedures. Many suppliers offer
multifrequency probes that allow switching among two or more frequencies—for
example, among 2.5, 3.5, and 5 MHz.

Various modes are available for displaying the returning echoes. B-mode (brightness-
modulated mode) is the scanning system's basic imaging mode. B-mode produces a
real-time, 2-D image that represents a cross-sectional slice of the area under study. The
image is created as the transducer sweeps the pulsed ultrasound beam through the
image plane either mechanically or electronically. The image is updated multiple times to
produce a moving image, and the sweep (or frame) rate determines how often the image
updating occurs. M-mode (motion mode) uses a fixed-position pulsed beam to produce a
moving display of a single scan line over an interval of time. Used almost exclusively in
cardiac applications, M-mode produces a graphical display of a moving structure (e.g.,
the cardiac valve over several heartbeats). Simultaneous display of M- and B-modes is
particularly useful when examining dynamic structures, such as the heart.

Transducers most commonly generate two differently shaped patterns: rectangular

(linear) images and wedge-shaped (sector) images. Linear images are produced by flat,
linear array transducers, which contain a series of piezoelectric elements arranged in a
single line with available array lengths of 4 to 15 cm. The elements are pulsed
sequentially in groups, advancing from one end of the array to the other while the
system switches between transmit and receive modes. This produces a number of
parallel acoustic beams across the length of the array during a single sweep to image a
rectangular region directly in front of the elements. (Figure 1 illustrates the basic types of
transducers and the ultrasonic wave patterns they generate.) As with other real-time
scanners, each linear sweep updates the display with a new cross-sectional image.
Various methods are used to improve image resolution, such as special transmit and
receive phase-delay techniques that significantly improve beam focusing and image
quality. Because the entire length of the array is placed on the patient's skin, a large
field-of-view (FOV) displays structures close to the transducer. Therefore, a flat linear
array (often called just "linear array") system is ideal for obstetric examinations in which
the placenta or fetal skull might be positioned close to the transducer. Because of their
less sophisticated electronic circuitry, scanners utilizing only linear array transducers are
generally less expensive than many other real-time ultrasonic scanning devices, but
there are disadvantages. For instance, maintaining complete skin contact with the large
surface of the array is sometimes difficult.
Two basic transducer configurations are currently used for sector scanning: mechanical
and nonmechanical (electronic). Mechanical-sector transducers contain one or more
piezoelectric elements in a sealed fluid path. A motor-driven system moves the element
rapidly through an arc that establishes the sector, while the transducer switches between
transmit mode and receive mode. Although mechanical transducers commonly use a
single element, some use an annular array: multiple concentric, ring-shaped elements
that produce a cylindrical, more uniform, and better-focused beam in both the horizontal
and elevational (vertical) planes. This 2-D focusing reduces slice thickness for improved
image clarity. Activating the elements at different delays allows the beam produced by
these arrays to be focused at several different depths.

Electronic-sector scanning uses array transducers, which consist of a series of linear

piezoelectric elements. A curvilinear-array (convex array) probe operates similarly to the
flat linear probe, but its convex shape allows a larger field of view (FOV) than a flat linear
array transducer with the same contact area so that images of deep structures can be
more easily obtained.

Electronically steered scanning uses phased-array transducers, which consist of a series

of individual piezoelectric elements operating as a unit. Phased arrays are the same as
linear arrays except that they have smaller contact areas and electronic timing circuits
that allow them to fire groups of elements in a variety of sequences. This permits each
burst of ultrasonic energy to leave the transducer at a slightly different angle.
Transmitting and receiving ultrasonic energy through different angles within the scan
plane forms a sector image. Phased-array transducers are generally smaller and easier
to handle than most other transducers. However, they require more sophisticated
electronic timing systems. Although they provide a limited FOV for nearby structures,
their smaller scanning surfaces (often as small as 6 mm) permit imaging of structures in
tight areas or behind obstructions (e.g., areas between or behind ribs). Some systems
combine linear- and phased-array techniques to provide a trapezoidal (often termed
"vector") imaging format. This is accomplished by adding pie-shaped sectors to both
sides of a rectangular linear image. The transducer's scanning surface is slightly larger
than that of a normal phased-array transducer, and the sector image that is produced
has a wider FOV in the near field.

Electronic transducers provide a greater number of imaging capabilities, such as

simultaneous 2-D and Doppler imaging. And, because they have no moving parts, they
also appear to be more reliable. But, in the typical linear element configuration, with rows
of elements arranged horizontally, electronic focusing is possible only in the 2-D
(horizontal) scan plane; therefore, there is no focusing action along the transducer's
elevational plane to reduce slice thickness.
Multidimensional arrays have the normal row of elements arranged horizontally, but they
also have a few (five to seven) vertical rows of elements. These vertical rows allow the
arrays to be focused in the elevational plane as well, creating a tighter focal area.
However, the elevational focus cannot always be adjusted, nor can the beams be
steered vertically. Nevertheless, these arrays (often referred to as 1.5-dimensional
arrays) provide somewhat better vertical resolution than standard linear arrays.

In both mechanical and electronic systems, each sweep produces a new cross-sectional
image (frame) that is used to update the display. Generally, high frame rates are useful
for imaging rapidly moving structures, while lower frame rates provide improved image
quality by increasing the density of the acoustic lines that make up the image.
Depending on the system, frame rates can be fixed, selected by the operator, or varied
automatically based on the FOV chosen by the operator. Some scanning systems permit
the user to change the FOV by varying the sector angle.

A scan converter system displays the image on a high-resolution video monitor. During
scanning, the converter assigns discrete shades of gray (grayscale) to the returning
echo amplitude levels; the number of shades depends on how many bits of information
can be stored for each point of image memory. Some scanners offer user-selectable
preprocessing and postprocessing features that permit the operator to optimize the
image quality by altering the texture and grayscale emphasis within the image. The scan
converter also permits freeze-frame, which captures a single real-time frame for display
and analysis.

Some scanning systems are capable of performing real-time three-dimensional (3-D)

ultrasound, which involves volume-per-second acquisition and display for volume
measurements, improved image presentation, and volume-of-interest studies. 3-D
images can be produced by direct online 3-D acquisition, with a transducer scanning a
volume instead of a slice of the tissue. Another method is the reconstruction of
previously acquired 2-D cross-sections or tomograms in an offline procedure. An
advantage of 3-D ultrasound is that it can simulate intraoperative visualization. 3-D
ultrasound images may be clinically useful for cardiac, blood-flow, ophthalmic, brain,
prostate, renal, and fetal imaging, as well as for surgical planning.

On some systems, the operator can magnify (zoom) the display for further examination
and can also store images or transfer them via networks for storage on picture archiving
and communication systems (PACS).

Many ultrasonic scanning system suppliers incorporate the National Electrical

Manufacturers Association Digital Imaging and Communications in Medicine (DICOM
3.0) Standard on their scanning systems. The purpose of this standard is to allow digital
images produced by any medical device to be stored and transferred through PACS or
other means, regardless of the device supplier.

The maximum display depth of a system indicates the depth for which space is provided
on the display, rather than the actual penetration by the ultrasound energy, which is
based on many factors, including transducer and signal-processing characteristics. The
display depth, the size or FOV of the displayed image, and the image focus are usually
operator selectable.

Scanned structures can be measured using digital calipers—cursors electronically

superimposed over the scanned cross-sectional image that calculate the size of the
scanned structure. The caliper system can also be used to plot and measure the area,
circumference, or volume of a structure. In obstetric applications, gestational-age
programs use digital caliper measurements to calculate the age of the fetus.

A data-entry keyboard permits information such as patient name, date, and type of study
to be entered and displayed along with the scanned image. In some systems, an
alphanumeric keyboard interacts with a computer to permit manipulation of the displayed
image or system operating parameters.

Doppler Imaging
Many scanners now include Doppler capability to determine the direction and speed of
blood flow. Most scanners include spectral Doppler, either continuous-wave (CW) or
pulsed-wave (PW). CW Doppler, the simplest spectral Doppler mode, is commonly used
for blood-flow analysis in which vessel-depth information is not important; it receives
information from all the moving reflectors in the path of the beam. CW Doppler is able to
provide accurate measurements of blood velocity through the sample area. PW Doppler
is used when depth selectivity is required, but it cannot be used for higher velocities
because of the problem of frequency aliasing; when the pulse-repetition frequency (PRF)
is too low to adequately sample the Doppler frequency shift, aliasing causes high-
velocity blood flow in one direction to be displayed as flow in the opposite direction. To
resolve the problem of aliasing, the PRF can be increased or a lower-frequency
transducer can be used. Some scanners allow the use of a high pulse-repetition
frequency (HPRF) Doppler mode—a function that corrects for aliasing by increasing the
PRF for a sample volume depth. PW Doppler allows the operator to select the area of
interest for flow analysis using cursors superimposed on the 2-D image. PW depth-
selective information is obtained by acoustic pulses emitted from the transducer,
allowing the precise location of the target area, as well as the flow, to be determined.
Spectral Doppler includes a spectrum analyzer to display frequency shifts plotted against
time, with grayscale intensity varying with the received signal's strength or amplitude.
The spectrum analyzer may also employ fast Fourier transform (FFT), a high-rate
sampling method that analyzes the Doppler-shift signals and performs complex
calculations on them. FFT analyzers typically produce peak and mean displays. The
peak display provides a linear-time waveform that represents the maximum
instantaneous velocity present. The mean display provides a linear-time waveform that
represents the statistical mean velocity of all velocities present.

Some units provide a simultaneous display of real-time and 2-D imaging and Doppler.
Other units freeze the 2-D image when Doppler is engaged; if the transducer or patient
moves, however, it can be difficult to determine the precise anatomic location of the
blood flow being measured. Thus, some units update the 2-D image at adjustable
intervals, although the Doppler shuts off during the 2-D update. True simultaneous
(duplex) scanners allow the 2-D image to remain in real time (although at a lower frame
rate) while the Doppler beam provides flow information.

Doppler color flow mapping (CFM) simultaneously assesses the direction and relative
velocity of blood flow at multiple points along multiple beam paths. The result is an
image of the hemodynamics of vessels. As conventional 2-D real-time techniques
display the anatomic features in black and white, color superimposed on this image
visually depicts the direction and average velocity of blood flow. CFM complements and
enhances the diagnostic value of conventional 2-D real-time images, as well as provides
more information about and enables better quantification of the direction and velocity of
blood-flow abnormalities.

Like color television, CFM uses combinations of primary colors. In cardiac and other
vascular studies, red and blue hues are commonly used. White shades are often added
to the colored background to indicate higher flows, such as those caused by stenotic
valves or narrowed vessels. In addition to blood-flow direction, mean flow rate and
degree of variance can also be depicted by CFM.

Many scanning systems are capable of power Doppler imaging, which can be used as
an adjunct to CFM. Power Doppler displays the integrated power of the reflected signal
in the conventional color-flow Doppler technique. It increases the flow sensitivity of color
Doppler imaging and provides good results even at angles perpendicular to the direction
of flow, which cannot be visualized at all with standard Doppler. This technology can
produce images of structures not normally seen sonographically. However, power
Doppler provides no quantitative data, such as flow rate or direction.

Some systems offer a triplex mode, which simultaneously acquires and displays 2-D
grayscale, spectral Doppler, and color-flow data. The triplex mode is used in the
quantification of blood flow and flow anomalies in small vessels to improve placement of
the Doppler sample volume.

Harmonic Imaging
Harmonic imaging (HI) is a sonographic technique that provides images of higher quality
than those provided by conventional techniques. Harmonics are frequencies that occur
at multiples of the fundamental or transmitted sonographic frequency. In HI sonography,
ultrasound is transmitted at one frequency and received at twice that frequency. This
technology was initially used in conjunction with contrast echocardiography to enhance
myocardial contrast visualization. The principle of the technique is based on the fact that
microbubbles resonate when they come in contact with ultrasonic frequencies. The
oscillation of the microbubbles triggers "backscatter," which is usually at a higher
frequency than the original ultrasound frequency. Since signals emanating from
microbubbles are much more likely to contain harmonics than signals returning from
tissue, most of the higher frequency sensed is due to echo contrast. The returning high-
frequency signal can be isolated from the fundamental signal by use of a filter or addition
of inverted fundamental pulses. This allows the image to be produced by the high-
frequency signal alone. Generating 2-D images from harmonic frequencies improves
image quality by improving resolution and reducing artifacts in the harmonic signal so
that the signal-to-noise ratio is improved. Studies have reported that the use of HI
without contrast agents also resulted in enhanced echocardial visualization (Caidahl et
al. 1998). This discovery aided the development of tissue harmonic imaging (THI)—
harmonic energy is generated as ultrasound passes through tissue. THI is commercially
available from several companies that produce ultrasonic scanning equipment.

Reported Problems
Ultrasound diagnostic imaging appears to be risk-free when used properly. However, its
accuracy depends on the skill of the operator, who must continuously and carefully
adjust transducer direction and instrument controls to avoid artifacts in ultrasound
images, which can significantly degrade image quality and possibly lead to an
incomplete or incorrect diagnosis. In addition to routine quality assurance procedures,
the scanner must be maintained properly in accordance with its manufacturer's technical
support service.

Ultrasound transducers should be handled carefully to avoid damage. A quality control

program should include frequent testing of transducers and system performance with
standard ultrasound phantoms to evaluate lateral and axial resolution, distance
accuracy, sensitivity, uniformity, and hard-copy appearance. Electromechanical
problems, such as cracks in piezoelectric elements, can alter beam width and/or spatial
pulse length, thereby affecting lateral and axial resolution.

Errors in distance measurements can cause incorrect calculations. An error margin of

2% or less measured over 10 cm is considered acceptable for most ultrasound systems.
The appearance of the hard-copy image should be the same as that of the image on the
monitor. Most manufacturers can supply a test pattern on software to evaluate the
performance of the recording device.

Purchase Considerations
Included in the accompanying comparison chart are ECRI Institute's recommendations
for minimum performance requirements for general-purpose ultrasound scanners;
recommended specifications have been categorized into three groups based on specific
clinical applications. General-purpose scanners are routinely used for imaging
abdominal organs. Diagnoses of disease, cysts, and tumors can be made from the
anatomic formation (e.g., size, texture, location) provided by ultrasound scans. Basic
Doppler capabilities enhance evaluations of abdominal organs, allowing further
diagnosis by providing information on blood flow.

General-purpose scanners with OB/GYN capabilities are used to investigate a variety of

gynecologic abnormalities, including infertility; to detect the presence and condition of a
fetus; to investigate the blood supply to the fetus; and to monitor fetal growth throughout
pregnancy. Ultrasonography is also useful in guiding amniocentesis and other invasive
procedures. Obstetric analysis packages provide valuable information, including
gestational age, fetal weight, and fetal growth calculation, and some are also capable of
report generation. Endocavity transducers are available for use with gynecologic
imaging. Comprehensive OB/GYN studies require a full-featured system, which is used
in a hospital's radiology department, OB/GYN department, or imaging center or in
OB/GYN offices in which comprehensive obstetric ultrasound examinations are
performed.

Some general-purpose scanners can be equipped with specialized high-frequency

small-parts probes for use in thyroid, breast, scrotum, neonatal brain, and
musculoskeletal evaluation. Endocavity transducers are available on some general-
purpose scanners for prostate screening. General-purpose abdomen and small-parts
studies require a full-featured system, which is typically used in a hospital's radiology
department or imaging center.

General-purpose scanners with vascular capabilities provide flow profiles of vessels

throughout the body, enabling clinicians to diagnose arterial and venous abnormalities
and their causes. Doppler further extends vascular techniques by providing flow
detection in vessels, such as those found in organs and tumors and in extremities.
Spectral Doppler analysis packages can perform calculations automatically. A
comprehensive vascular study requires a full-featured system, which is used in a
hospital's radiology department, cardiology department, or noninvasive vascular lab or in
a vascular surgeon's office. Examinations include comprehensive extracranial and
peripheral vascular studies.

Other Considerations
When purchasing an ultrasonic scanning system, facilities need to consider six basic
issues: functions and features, cost, ease of use, upgradeability, image storage, and
customer support. Some suppliers now provide remote diagnostics whereby scanning
system functions can be monitored at a remote location through a modem.

Ultrasound Accreditation
Within the last several years, the American College of Radiology, the American Institute
of Ultrasound in Medicine, the Intersocietal Commission for the Accreditation of Vascular
Laboratories, and the Intersocietal Commission for the Accreditation of
Echocardiography Laboratories introduced accreditation programs for hospital- and
office-based ultrasound practices. These voluntary accreditation programs were created
to ensure the quality of ultrasonic imaging because significant variations in image quality
have been found among hospitals and offices. In the United States, healthcare payers
and managed care providers can insist on ultrasound accreditation as a condition for
being a referral site or for reimbursement.

Environmental Considerations
As a result of increasing concerns over the environment and the conservation of
resources, many manufacturers have adopted green shipping and production methods,
as well as features that improve the energy efficiency of their products or make them
more recyclable. In addition, healthcare facilities and device manufacturers have begun
to adopt green initiatives that promote building designs and work practices that reduce
waste and encourage the use of recycled materials.

Ultrasound systems have high energy requirements, so some systems have

implemented energy-saving features, such as standby mode and battery back-up.
Batteries should be rechargeable and contain no mercury or cadmium. Facilities may
also want to consider how fast the system starts up and powers down.
End-of-life costs should also be taken into account, such as how much of the device can
be recycled. Facilities should look for systems that minimize the use of polyvinyl chloride
and brominated and chlorinated fire retardants. Some manufacturers provide take-back
programs on system components, so the facility will not incur the cost of removal.

Cost Containment
Since ultrasound systems entail ongoing maintenance and operational costs, the initial
acquisition cost does not accurately reflect the total cost of ownership. In today's
competitive ultrasound market there are, in general, few significant technical differences
between high-end ultrasound scanners manufactured by the market leaders. Therefore,
a purchase decision should be based on issues such as life-cycle cost (LCC), local
service support, discount rates and non-price-related benefits offered by the supplier,
and standardization with existing equipment in the department or hospital (i.e.,
purchasing all ultrasound scanners from one supplier).

Hospitals can purchase service contracts or service on a time-and-materials basis from

the supplier. Service may also be available from a third-party organization. The decision
to purchase a service contract should be carefully considered. Because ultrasound
systems tend to be highly reliable (many suppliers have a 99% to 100% uptime
guarantee), the financial risk associated with not purchasing a service contract may be
minimal. However, the decision to purchase a service contract can be justified for
several reasons. Most suppliers provide routine software updates, which enhance the
scanner's performance, at no charge to service contract customers. Furthermore,
software updates are often cumulative; that is, previous software revisions may be
required in order to install and operate a new performance feature. Purchasing a service
contract also ensures that preventive maintenance will be performed at regular intervals,
thereby eliminating the possibility of unexpected maintenance costs. Also, many
suppliers do not extend system performance and uptime guarantees beyond the length
of the warranty unless the system is covered by a service contract. Because transducers
and hard-copy imaging devices are the components of the system most prone to failure
or damage, they should be included in the service contract.

ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate

pricing for service contracts before the system is purchased. As a guideline, full-service
contracts typically cost approximately 6% to 8% of the ultrasound system's purchase
price. Additional service contract discounts may be negotiable for multiple-year
agreements or for service contracts that are bundled with contracts on other scanners in
the department or hospital. Buyers should also negotiate for a nonobsolescence clause
stating that the supplier agrees not to introduce a replacement system within one or two
years and that if a replacement system is introduced during this time period, 100% of the
purchase price can be applied to the purchase of the new system.

In addition, given the current highly competitive market for ultrasound systems, hospitals
should negotiate for a significant discount on the capital purchase—many suppliers
discount new, fully configured systems from 15% to 60%. The actual discount received
will depend on the hospital's negotiating skills, the system configuration and model to be
purchased, previous experience with the supplier, and the extent of concessions granted
by the supplier, such as extended warranties, fixed prices for annual service contracts,
and guaranteed on-site service response. Buyers should make sure that applications
training is included in the purchase price of the system. Some suppliers do offer more
extensive on-site or off-site training programs for an additional cost.

ECRI Institute recommends that buyers consider the number and types of ultrasound
studies performed at their institution before deciding on a specific system configuration.
Also, if multiple scanners are necessary to handle the patient volume, hospitals should
determine the types of scanners and capabilities required in order to avoid paying for
unnecessary analysis packages and scanning features. For instance, a hospital may
want to purchase three scanners: one dedicated to OB/GYN, one to general radiology,
and one to cardiac scanning. In this case, purchasing all three scanners from one
supplier could result in a significant discount. Standardization of equipment can make
staff training easier, simplify servicing and parts acquisition, and provide greater
bargaining leverage when negotiating the purchase of new equipment and/or service
contract costs.

Given their relatively low capital cost compared to other imaging equipment, ultrasonic
scanners are typically purchased outright; however, leasing more expensive, high-
performance systems is becoming more common. In general, renting is not a cost-
effective alternative.

Stage of Development
General-purpose ultrasonic scanners have been commercially available for many years.
Most have a modular design that can be easily upgraded to include specialized
functions, such as cardiac scanning and/or spectral Doppler and CFM, permitting users
to keep pace with the rapidly changing technology of ultrasonic imaging.

Given its low cost relative to other imaging technologies (approximately $20,000 to
$300,000, depending on system configuration), its noninvasiveness, the absence of
ionizing radiation, and recent improvements in image quality, ultrasound is now a
preferred medical imaging technique. Some suppliers can now provide remote
diagnostics that monitor device performance from remote locations to diagnose
problems before they become apparent to the user.

Current trends are directed toward the use of digital processors to provide image
enhancement, improved resolution, analysis of tissue characteristics, and new
transducer scanning techniques. This introduction follows the larger trend toward the
development of all-digital radiology departments. Applications have now expanded to
include intraoperative ultrasound (the use of ultrasonic imaging to aid in surgery),
harmonic imaging, ultrasonic breast imaging, intravascular ultrasound (the use of a
miniature high-frequency transducer in a catheter inserted into the blood vessels),
ultrasonic delivery of therapeutic agents, ultrasound tissue characterization, and
ultrasonic contrast agents.

Bladder ultrasounds are considered a safer, non-invasive alternative to catheterization in

diagnosing urinary retention. They can be used for acute care, rehabilitation, and long-
term care. Although there are no significant risks involved with this procedure, there can
be errors in the measurement of fluid depending upon patient position and condition.
Sutures, cysts, and tumors can also affect measurement.

Another ultrasound technology that is quickly gaining acceptance is breast sonography

for detecting cancer and directing aspirations, wire localizations, and core biopsies.
Ultrasound reflects the acoustic characteristics of breast tissue and is well established
as an ancillary technique for evaluating breast lesions. Because it is nonionizing,
ultrasound is particularly advantageous for evaluation of palpable masses in young,
pregnant, or lactating women. Ultrasound examination can overcome much of the
decreased sensitivity of mammography in patients with radiographically dense breasts
that can make it difficult to distinguish cancer tissues from normal glandular tissue. It can
differentiate cysts from solid masses seen on mammograms or found on palpation.
Because taut compression is not required, it can be useful in evaluating a painful,
inflamed breast to determine if a focal, drainable abscess is the problem. It can also be
helpful when no mammographic abnormality is seen in a clinically suspicious area of the
breast. However, ultrasound cannot detect all solid masses, nor can it consistently show
microcalcifications. Overall, sonography of the breast is an extremely useful
examination, particularly as an adjunct to mammography and physical examination.

In addition to examination of the breast, sonography is also being used to guide

procedures such as percutaneous cyst aspiration, hook-wire localization, fine-needle
aspiration, and large-needle core biopsy of the breast. For these procedures to be
performed safely, the shaft and tip of the needle must be well visualized to allow for
accurate needle placement. Transducer-mounted needle guides, needles designed with
central apertures, and complex electronic guidance systems have been developed to
facilitate accurate needle placement and assist in these procedures. Electronic beam
steering is also in development for use in sonographically guided needle interventions.
This technique can considerably enhance the visibility of needles used in interventional
procedures, thus increasing the safety and allowing more rapid performance of the
procedures.

During some endovascular procedures, ultrasound systems may be used as

navigational tools. A recent study used stent and graft materials in combination with an
ultrasound system to track an endovascular catheter. Although there was a reduction in
signal intensity through the stent materials, there was no reduction in the accuracy of the
ultrasound.

The use of contrast agents has recently been very successful. A number of different
contrast agents are now commercially available, and others are being developed and
tested as this technology continues to develop and improve. Ultrasound contrast agents
are used to enhance Doppler signals and in some cases, gray scale images.

Software packages that compensate for artifacts, such as those caused by microbubbles
in ultrasound contrast agents, are also available.

Another development in ultrasound technology is known as elastography, which uses

the deformability and the elastic and relative stiffness properties of tissues to determine
the likelihood of abnormality. Elastography-based palpation using the ultrasound
transducer is a real-time technique that improves the differentiation of benign and
malignant disease in a range of clinical applications.