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Key Considerations

for Transducer Repair


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Transducers are an integral component of the ultrasound Anatomy of the Ultrasound Transducer
system. Basic transducer technology is well understood
and is essentially the same across major manufacturers, Let’s review the components of an ultrasound transducer,
commonly referred to as Original Equipment Manufacturers its purpose and the consequence of improper repair.
or OEMs. However, the OEM’s on-going innovation in trans-
ducer design (unique lens development, complex match-
ing layers, piezoelectric design, etc.) increases the com- Lens
plexity of manufacturing and repairing an ultrasound
transducer. Matching Layer
The transducer represents a substantial investment in the Shield Layer
Piezoelectric
overall ultrasound solution. There are several points that
Crystal
should be considered to ensure continued image quality, Grounding Foil
patient safety, and diagnostic confidence when deciding
Backing
about a transducer repair strategy. Flex Circuit
Material
OEMs of ultrasound transducers follow a common design
principle found in the majority of today’s transducers (see Figure 1: Expanded View of an Ultrasound Transducer
Figure 1). While it may appear transducer construction is
a simple assembly of a few components, it is in fact inten-
sive, requiring significant investment in facilities and equip-
ment to maintain a high quality manufacturing process.
What is the purpose of each component of a transducer?
What are the consequences if these components are not
repaired correctly? This technical paper identifies the
questions that should be asked when considering a trans-
ducer repair strategy.
The Lens The Shield Layer
◾◾ Purpose: The lens acts as a non-electrical means of ◾◾ Purpose: The shield layer is intended to reduce
focusing sound waves in the elevation dimension of the interference (noise) from radio frequency (RF) sources,
ultrasound transducer. Each lens is specifically designed e.g., cell phones, elevators, or emergency room
for that particular transducer and the type of application equipment.
intended. It also acts as an electrical safety barrier.
◾◾ Consequence of Improper Repair: As with the lens,
◾◾ Consequence of Improper Repair: In general, repair this component must be replaced if damaged. Improperly
of the transducer lens is not possible. There are specific replacing this layer can allow outside sources of RF to
measures of ultrasound exposure that the FDA and interfere with the piezoelectric crystal and the flex circuit,
International Standards regulate. These consist of reducing image quality and introducing artifacts that
different measures of the strength of the transmitted result in inconsistent image quality, sensitivity degrada-
acoustic field. For example: tion and layer delamination.
– Mechanical Index (MI) measures the potential
for cavitation The Matching Layer
– Thermal Indices (TI) measure heat generation ◾◾ Purpose: The matching layer is designed to maximize
– Intensity Spatial Peak Temporal Average (ISPTA) the transmission of ultrasonic waves through the patient’s
evaluates energy flux skin and into the body. This layer also provides the
If attempted, an improper lens repair could lead to the frequency bandwidth necessary for imaging operation.
transducer exceeding FDA limits for MI, TI, and ISPTA. ◾◾ Consequence of Improper Repair: Variations or defects
Instead of repair, typically the lens is replaced with a new in the matching layer introduced during repair can result
lens. If the replacement lens is not installed properly in poor penetration and reduced image quality. It is nearly
and not made from the same material used by the OEM, impossible to repair or replace the matching layer without
beam forming properties may be affected. The result is altering the original acoustic design of the transducer.
disrupted focal zones and poor image quality.
Grounding Foil
The lens material touches the patient and acts as an
insulation layer against electrical signals. The lens ◾◾ Purpose: The grounding foil provides a pathway for
material must comply with regulatory requirements for RF signals to safely direct around the sensitive electrical
biocompatibility and safety. The OEM has the ability and components and route to the grounding wire. This is a
knowledge to make the repair with originally approved part of the transducer’s cir­cuitry. In addition to being a
material from the original specification. key component of the transducer’s receiver circuitry, the
grounding foil is the electrical pathway by which high-
voltage RF signals from the system’s transmitters return
safely to ground.
◾◾ Consequence of Improper Repair: Risk of electric shock,
poor transmission and reception of acoustic signal, and
vulnerability to RF signals can occur.

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The Piezoelectric Crystal The Backing Material
◾◾ Purpose: The piezoelectric crystal (PZT) is made from ◾◾ Purpose: Backing material is used to reduce the ‘ringing’
delicate ceramic and is responsible for generating sound of the piezoelectric material and improve axial resolu-
waves by converting electrical signals from the ultra- tion and sensitivity. During the excitation of the piezo-
sound system into sound waves transmitted into the body. electric crystal, the backing material reduces the noise
The PZT also converts reflected sound waves into elec- in transmission and allows for a “quiet“ listening period
trical signals that the ultrasound system then processes for receiving the reflected ultrasonic waves.
to generate the image displayed on the system.
◾◾ Consequence of Improper Repair: Improper repair
◾◾ Consequence of Improper Repair: Due to their or replacement with a material of different acoustic
delicate nature, repair of the existing crystal is not pos- properties compared to the original backing material
sible. If the crystal is damaged, the entire array must be can negatively affect transducer function and image
replaced. An Independent Service Organization (ISO) quality.
does not have access to original production arrays. This
can alter the most important transducer characteristic
leading to significant loss of image quality. In addition, Connector and Cable
improper PZT replacement could lead to the transducer ◾◾ Purpose: The main purpose of the connector and cable
exceeding FDA or European Medical Device Directive is to transmit electrical signals from the ultrasound sys-
limits. tem to the PZT elements to form an ultrasound beam.
Improper installation of the PZT can also result in poor Each individual PZT element requires two wires to apply
image quality as dead PZT elements reduce the trans- voltage. Therefore, a 128-element transducer has 256
ducer’s effectiveness. This can also alter frequency char- individual wires running through the cable carrying
acteristics and sensitivity. information.
◾◾ Consequence of Improper Repair: Repair of individual
The Flex Circuit wires is extremely difficult and risky, potentially causing
electrical shorts or individual PZT elements to misfire.
◾◾ Purpose: The flex circuit establishes the electrical con-
The most effective repair is to replace the entire cable
nection between the ultrasound system (through the
assembly.
transducer cable) and the piezoelectric crystal. This is
the primary pathway for information flow to and from
the ultrasound transducer. Due to the large number of
individual piezoelectric elements present in a modern
transducer, the element size is very small. This requires
electrical connections printed on a thin film of material
to deliver electrical pulses to each individual element
in the correct sequence to generate quality ultrasound
images.
◾◾ Consequence of Improper Repair: Any misalignment
between the flex circuit and the PZT can result in the
misfire of PZT elements and render the transducer
unusable.

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Options for a Damaged Transducer The tests are also designed based on how the ultrasound
system images with a particular transducer. Embedded
Over time transducers may fail or are subject to damage, within the ultrasound system’s imaging software is a set
resulting in the need for repair or replacement. Repair costs of imaging parameters for each transducer supported by
range from several hundred to several thousand US dollars, that system. These system parameter sets, which are
with full replacement being the only option in some cases. referred to as “imaging specs”, instruct the imaging sys-
When transducers are in need of repair or replacement the tem on how to image with each transducer. These include
options for service are: specifications of the acoustic pulse (pulse shape and fre-
quency), the focusing, scan rate, etc. In order to ensure
• Buy a brand new transducer from the OEM a standard of image quality, the pass/fail criteria of the
• Have the transducer repaired or replaced by the OEM transducer test must be designed with the imaging spec
• Have the transducer repaired or replaced by an ISO in mind. If the imaging spec of a particular probe includes
To minimize financial impact, customers often first con- imaging at 10 MHz, for example, then the acoustic test
sider repair or replacement by an ISO. It’s important to should be designed to ensure that the probe has adequate
keep in mind that reduced price options can result in acoustic response at 10 MHz. The OEM has access to
compromised quality. The OEM will ensure that image original transducer and system specifications required to
quality and diagnostic confidence will be maintained develop proper tests to ensure transducers will meet the
while maintaining compliance with regulatory guidelines. intended use.

The Importance of Transducer Specification Array Non-Uniformity: OEM Specifications


Development and Testing Protect Image Quality
Due to the physical nature of transducers, it is easy to see Poor transducer repair can cause element-to-element
them as existing separately from the ultrasound system. variation, which leads to off-axis “junk” in the point-
However, transducers are uniquely designed and matched spread function. Comparing element-to-element variation
to the specific ultrasound system and are rarely inter- is an example of why detailed modeling, required to
changeable without affecting performance. This is why, develop a robust specification, is important to preserving
when developing ultrasound system software and archi- image quality. While the elements of an ideal transducer all
tecture, considerable attention is given to the design and have identical properties (sensitivity, frequency response,
implementation of the transducers. etc.), repaired transducers often exhibit a substantial
degree of element-to-element variation in these properties.
The design of the test for each transducer involves deter-
mination of specific pass/fail criteria. The testing apparatus Figure 2 shows two point-spread functions (“imaging
measures various parameters such as response times, functions”), one of an ideal array (uniform array) and one
sensitivity levels and bandwidth. In order to determine the of a non-uniform array with element-to-element variations.
specific values for these parameters and ensure a level The off-axis “junk” seen in the non-uniform array causes
of image quality, detailed mathematical models are devel- degradation of imaging performance in the form of clutter.
oped. These models translate the various test parameters The OEM knows the tolerable degree of array non-con­
into measures of image quality, such as axial resolution, formity and will fail transducers that exhibit poor image
lateral resolution and penetration. The models take into quality.
account a variety of factors, including not only the geo-
metric, electrical, material and acoustic properties of the
transducer, but also the electrical properties of the ultra-
sound system itself. Any deviation or change to these
characteristics can have an immediate and significant impact
on overall ultrasound system image quality and diagnostic
confidence. The OEM has the detailed knowledge of these
properties, and is therefore uniquely able to effectively
design such tests.

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Transducer Safety Testing
Transducer safety testing is an extensive process involving
testing against the imaging spec, as described above, and
testing to meet electrical safety, thermal requirements
and physical integrity specification. In particular, electrical
safety testing is an important aspect to ensure that
repaired transducers meet international safety standards.
Unauthorized testing or repairs of transducers during the
warranty period may void a warranty claim with the OEM
in the event an ISO improperly treats the probe or causes
a failure.
Leakage current is the unwanted or unintended flow of
electrical current that presents an electrical hazard such as
shock or burn.

Testing and Repair with ISOs


Many service providers offer testing and repair services
for ultrasound transducers. In most cases these vendors,
who are not associated with OEM, can offer a low cost
solution due to lower overhead expenses. There are sig­
nificant differences between the quality of repair testing
and reliability available.
Performing regular diagnostic testing on transducers is a
good practice to determine if transducers are fully opera-
tional and to ensure the highest level of diagnostic confi-
dence. The repair process involves identifying weak or
dead transducer elements, detection of electrical safety
problems and assurance that the transducer is operating
within its specified frequency range. The OEM has knowl-
edge of transducer test specifications to determine if the
transducer is operating within the optimal performance
range and conforms to FDA and International Standards
limits.
Figure 2: Array Non-uniformity

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Case Study: ties of the transducer, causing poor image quality. As can
Transducer Lens Replacement be seen in Figure 3, the repaired transducer may appear to
be fully functional on first inspection.
An 18L6 HD transducer required service due to poor
image quality. An ISO performed a lens replacement using However, a more detailed inspection reveals more serious
a different core material than the original transducer. This problems with the transducer. Figure 4 shows tooling
resulted in changes to the acoustic and electrical proper- marks that are the result of a poor lens removal process.

New Transducer

Lens material was changed

ISO repaired
transducer

Figure 3: Visual inspection results for repaired 18L6 HD transducer

Figure 4: Closer inspection of repaired 18L6 HD transducer shows tooling marks

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From the same repaired transducer, Figure 5 shows a
phantom image revealing shadows in the image with
weak penetration depth.

Sensitivity Element Index

Figure 7: Post-repair Test on Repaired Transducer

Figure 5: Scanning results with 18L6 HD transducer Not using the original lens material affected the trans-
ducer focus because the replacement materials sound
speed does not match that of the original transducer. This
could result in imaging problems, causing the transducer
Sensitivity Measurements with 18L6 HD to exceed FDA thermal limits on the strength of the trans-
Transducer mitted ultrasound. The same is true if the acoustic loss
The transducer in this case study would not have passed in the new material is less than the original material. If
the acoustic requirements from an OEM transducer speci- the acoustic loss is more, the transducer could heat up
fication. Figure 6 shows the same transducer’s sensitivity and exceed FDA and International Standards limits on the
curve when it was new. Figure 7 shows the repaired trans- probe’s surface temperature.
ducer sensitivity after the ISO repair. Ultrasound transducers are a sandwich of many layers
of various materials, some conductive, some insulating,
some piezoelectric. The materials used in these layers are
chosen for their acoustic and electrical properties in addi-
tion to their adhesive properties and robustness. In order
to ensure good adhesion between layers, various surface
preparations are utilized. The OEM has the detailed knowl-
edge of the specific materials used in the production of
a particular probe, and the surface treatment required to
Sensitivity

ensure good adhesion. The OEM is therefore uniquely


suited to repair the transducer to ensure the probe retains
its intended acoustic properties and does not degrade due
to delamination or corrosion.
Finally, due to damage to the piezoelectric crystal at the
core of the transducer, the 18L6 HD transducer in this case
study should not have been a candidate for repair. Attempt-
ing to save costs with a simple repair of the lens material
Element Index instead of a complete transducer replacement is not
appropriate if the core of the transducer is not operating
Figure 6: Post-production Test on New Transducer correctly.

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Testing and Repair with the OEM
What is the best option for transducers in need of repair or
no longer functional? An ideal option is to repair or replace
the transducer with the OEM. This ensures replaced or
repaired transducers adhere to the following standards:
• Compatibility with OEM’s system imaging spec and
software
• Compliance with regulatory and safety requirements
• Use of consistent, compliant materials
• Compliance with electrical leakage testing standards

Proper Transducer Care & Maintenance


While not all transducer faults are avoidable, many trans-
ducer failures are caused by accidental damage, improper
storage, and failure to perform regular preventative main- Figure 8: Example of bite marks on a TEE transducer
tenance. Taking proper precautions in the use, storage,
and cleaning of ultrasound transducers will protect against Figure 8 shows an example of bite marks on the lens of a
unnecessary wear and keep them at the optimum perfor- transesophageal (TEE) transducer. Depending on the severity
mance level. In general, information on approved cleaning of the bite marks, the punctures to the lens diminish image
agents and proper storage can be found in the User Manual quality and expose patients to risk of electric shock. Using
for the ultrasound equipment. The OEM recommends reg- bite guards during TEE exams can greatly reduce the risk
ular preventive maintenance service by a qualified service to both the patient and the transducer.
engineer for the ultrasound system and transducers.
Shown in the following photos are examples of commonly
seen forms of transducer damage and tips to avoid costly
repairs and replacements, including examples of damaged
transducer cables which will affect image quality. Manag-
ing transducer cables can be difficult as they are designed
to allow a wide range of motion around the ultrasound
system. If clinical workflow calls for frequently changing
transducers, the cables can become tangled and drag on
the floor. Proper training, careful handling, and consistent
use of the cable hooks on the ultrasound system are effec-
tive ways to avoid this type of damage.
It should be noted that damage caused by mishandling or
neglect can void the OEM’s product warranty and require
costly replacement or repair.

Figure 9: Example of a gouged lens

Figure 9 shows a gouged lens due to improper storage


and handling. The damage to the lens will have a severe
impact on the transducer’s imaging capabilities. Ensuring
that transducers are properly stored in hard cases when
not in use and that all personnel are trained to handle
transducers cautiously can reduce the likelihood of this
type of damage.

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Figure 10: Example of a cut in a transducer’s cable jacket Figure 12: Example of broken transducer knob

Figure 10 shows a cut in the protective cable jacket. This Figure 12 shows a transducer connector that has had
can be caused by rolling over the cable with the ultrasound its locking knob broken off. A likely cause of this kind of
system wheels or pinching the cable between hard sur- damage is being hit by a heavy object while the trans-
faces. In many cases, extensive damage to the cable jacket ducer was locked into place.
indicates damage to the delicate wiring inside, causing
dead elements and poor image quality.

Figure 11: Example of damage to transducer cable insulation Figure 13: Example of connector pin bent or damaged

Figure 11 shows a transducer cable with damage that has Figure 13 shows a transducer connector with bent electri-
completely cut through the insulation. This is most likely cal contact pins. This kind of damage occurs when the
from having been crimped by something with a sharp edge transducer has been connected or disconnected forcefully.
like a storage cabinet door or by having been pulled into This can also be caused by dropping or banging the con-
the wheel housing of a cart. This level of damage to the nector with another object.
cable jacket also indicates probable damage to the delicate
wiring inside, causing dead elements and poor image
quality. This is another example of something that can be
avoided with proper training, careful handling and consis-
tent use of the cable hooks.

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Summary
Basic transducer technology is well understood. However,
on-going innovation in transducer design and manufac-
turing increases the complexity of performing quality trans-
ducer repair. Each component of an ultrasound transducer
contributes in a specific way towards the development
of a quality ultrasound image with unique consequences
resulting from improper repair. The OEM has the knowledge
of the carefully selected original materials used to manu-
facture the transducer. Even with a high quality repair pro-
cess, the use of the incorrect materials may degrade the
safety and diagnostic efficacy of an ultrasound transducer.
Having knowledge of the OEM test specifications or original
materials used allows determination if the transducer is
operating within an optimal performance range.
Figure 14: Modified transducer cable The transducer cannot be seen as a stand-alone diagnostic
tool. The transducer design process is closely tied to the
Figure 14 shows a damaged transducer cable that has had ultrasound system design. For this reason, the OEM is
a “quick fix” repair with the use of shrink-wrap material or best positioned to develop proper tests based on how an
tape. The repair material does not fit the cable snugly and ultrasound system images with a specific transducer. This
introduces the risk of spilled liquid coming in contact with assures the transducer will meet its intended use with
the electrical lines. This can cause further damage to the optimal image quality, patient safety and regulatory
transducer, potential system damage, or electrical shock. compliance.
Proper transducer care and preventative maintenance can
significantly reduce the need and severity of repairs. If the
transducer becomes damaged and malfunctions, the OEM
is the optimal partner to consult for repair or replacement
to assure the image quality meets original specifications.
Ultimately, the best image quality ensures the highest
level of diagnostic confidence.
For more information, please go to
www.siemens.com/ultrasound.

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Transducer Repair Frequently Asked
Questions
Below are key questions when considering a transducer Q. Can you be sure that the repaired/replaced trans-
repair decision. ducer is tested to OEM specifications in order to
function properly with ultrasound system’s advanced
Q. Are the materials used to replace/repair components imaging software and clinical applications?
the same as used by the OEM?
A. When developing the pass-fail criteria for a transducer,
A. The OEM can ensure that the transducer repair and the system specifications that direct how the system
components are at the same quality as used in the orig- drives the transducer (i.e. acoustic pulse shape and fre-
inal transducer production. Using certified materials quency, focusing, scan rate, etc.) should be considered.
can significantly effect both the diagnostic efficacy and The OEM has the detailed understanding of the original
the safety of the transducer. transducer and system specification required to develop
proper tests to ensure the trans­ducers will meet their
Q. D
 oes the thermal/power output of the repaired intended use.
transducer fall within the specifications of the
transducer design? In order to have confidence that repaired or replaced
transducers meet the stringent quality standards of the
A. Ultrasound transducers are a sandwich of many layers
original manufacturer, the OEM is an optimal partner to
of different materials carefully engineered for their elec-
consult for testing, repair or replacement of a damaged
trical, mechanical and acoustic properties. Additionally,
or malfunctioning transducer.
in order to ensure good adhesion between layers, vari-
ous sorts of surface preparation are utilized. The OEM
has the detailed knowledge of the specific materials
used in the production of a particular probe, and surface
treatments that must be used in order to ensure good
adhesion. If the acoustic properties of the material used
in the repair differ from the material used by the OEM,
there is risk that power output could exceed the design
specifications and/or FDA and International Standards
limits.
Q. H
 as the repair vendor tested the transducer
accounting for all frequencies and imaging modes
utilized by the ultrasound system to ensure the
transducer meets the tolerances for the imaging
specification and functions correctly with the ultra-
sound system’s advanced clinical applications?
A. The OEM has a detailed understanding of the original
transducer and system specification required to develop
proper tests to ensure the transducers will meet their
intended use.

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Siemens Healthcare Headquarters Legal Manufacturer
Siemens Healthcare GmbH Siemens Medical Solutions USA, Inc.
Henkestr. 127 Ultrasound
91052 Erlangen 685 E. Middlefield Road
Germany Mountain View, CA 94043
Phone: + 49 9131 84 - 0 USA
siemens.com/healthcare Phone: +1-888-826-9702
www.siemens.com/ultrasound

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