Innovatus Digital Supplement by MD Publishing

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Vol. 11

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

DIGITAL SUPPLEMENT

A LEGACY OF INNOVATION FOR DECADES

DIGITAL SUPPLEMENT FEATURED INSIDE

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Headquartered in Pittsburgh, Pennsylvania, Innovatus Imaging Centers of Excellence are located as follows: • MRI Coil Repair and Radiography Systems – Pittsburgh, PA • Ultrasound Probe Repair – Tulsa, OK • Engineering, Design and Manufacturing – Denver, CO The vision behind operating Centers of Excellence that go beyond traditional depot repair facilities, according to Innovatus Imaging CEO Dave Johnson, is to continue to improve upon the status quo to not just save lives through accurate diagnosis due to high-performing devices, but to also enable facilities to operate with greater efficiencies, less operating costs and thus be in a position to improve access and costs for patients. TECHNOLOGICAL AND COST ADVANTAGES Beyond passing on efficiencies to health care providers, Innovatus Imaging continuously explores new ideas and improves methodologies for repairing probes and coils to not only assure they perform as originally intended, but to also enable providers to extend the life of their equipment investments and lower overall operating cost. Innovation comes to life at Innovatus’ FDA-registered Center of Excellence for Design and Manufacturing, located in Denver, Colorado, and led by Innovatus co-founder and Chief Technology Officer Mike LaBree. At this FDA-registered facility, specialty probes are manufactured for sophisticated medical equipment, such as robotic and other surgical systems. Other devices, intended to help physicians and other clinicians diagnose and treat patients, are designed and manufactured as well. All facilities employ an ISO 13485:2016 certified quality management system. “Restoring both the functional performance and the physical condition of all SPONSORED BY INNOVATUS IMAGING

devices we service is needed to meet the requirements of our OEM customers and to meet the rigorous quality standards set by leadership at Innovatus Imaging,” Johnson says. Johnson, formerly CEO of Joerns Healthcare, Vice President of Healthcare for Resilience Capital, and a greenbelt in Six Sigma, brings a deep understanding of operational excellence to assure efficiency, performance and quality at all levels of the organization. His focus on research, testing and continual development of improving the company’s best practices already guiding the industry have helped strengthen Innovatus’ position as the leader for excellence in probe and coil repair, and for delivering value that impacts budgets and equipment ROI for customers of all sizes. Additionally, Johnson has streamlined the company’s operations to assure financial viability and stability. At a time when many providers are struggling to meet profitability goals, Innovatus Imaging has grown exponentially in recent months. “Medical device service is a life-saving business and practices need to be built upon the values of patient safety, performance standards, operational efficiencies and ROI for health care facilities, in that order,” says Johnson. “It is imperative to our mission that we continue to be the leading provider in all of these areas. This is what drives what we do every day and at every level, from repairs, research and development to customer service.” UNMATCHED VALUE FOR HEALTH CARE FACILITIES To comply with current regulatory standards and those imposed by Innovatus’ engineers and executive team, the company takes a holistic approach to product repair, which helps ensure a lower total cost of ownership over the entire product life cycle. Innovatus applies their manufacturing mindset to the repair model.

Integrated into each repair are foundations in research, material science, engineering and technological innovation. The high success rate for repairs allows Innovatus Imaging to offer the industry’s longest warranty periods. “Based on our unique approach to repair and the methods of applying our 13485:2016 certified quality management system, we had the data to support a 12-month warranty period on all standard probes. We are very happy to be able to offer it to our customers,” says Johnson. Whether developing new technology as part of device manufacturing or engineering repair solutions on the latest probe and coil models, Innovatus Imaging continually invests in and focuses on R&D. They offer some of the widest and deepest breadths of repair capabilities across their service offerings. Currently, over 100 probe models are considered fully repairable and the company boasts a 99.9% repair rate across all MRI coil models. Very significant repair capabilities exist on today’s most advanced probe models, such as those employing single-crystal design or matrix array technology (Philips X7-2t, X8-2t, X5-1 and GE 6VT-D). Repair solutions are available on over 700 models of MRI coils and over 400 models of ultrasound probes. At Innovatus, the mission is to be the innovative leader in providing superior service solutions for customers across a wide range of medical devices. They are committed to delivering best-in-class, compliant solutions while reducing customer downtime and operating costs.

FOR MORE INFORMATION, please visit www.innovatusimaging.com.

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6-CRITERIA FOR LIFE-EXTENDING PROBE REPAIR P

robe repairs should not just fix the issue at hand, they should actually extend the life of your device.

The key to getting more life out of each probe is understanding what goes into a sustainable, long-term repair vs. a short-term fix, and knowing the criteria you should be discussing with each provider to really understand what you’re getting and how they measure up to proven best practices for extending the life and lowering overall costs of ownership. Following are 6 questions to ask repair providers to really know what you’re getting. 1. What are your benchmarking standards? Providers should invest in researching and testing functions, components and outputs of new probes to fully characterize each model. Findings are used to identify the best processes for returning a probe back to the performance level it was originally intended to achieve, and ensure the device is safe and effective. There is a huge difference between getting a probe working again and getting it back to OEM form, fit and function. Innovatus Imaging collects data from their research and manufacturing processes upon which they base proprietary Gold Standard Testing which they apply to repairs. 2. How do you Assess Chemical Compatibility? OEM’s spend considerable time and money ensuring their materials can withstand exposure to 4

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harsh chemicals and environments with minimal deterioration and no irritation or negative effects to the patient. You should expect the same from materials and chemicals used during a repair. Ask repair providers how they assess chemical compatibility on the materials used in their repairs and if they are ISO-10993 compliant. 3. What is the source for your replacement parts? When harvested vs. new or specialty-built parts are used in a repair, you may end up with a short-term fix vs. a long-term solution. Many harvested parts, such as cables, have been repaired multiple times making them unstable. It’s important to ask providers where and how replacement parts are sourced and if they have procedures in-place to qualify them. 4. Do you conduct Holistic Testing as part of repair process? Testing all aspects of a probe during the repair process and assuring the probe is returned in top working order is critical to your device lifecycle and ROI. Failing to conduct holistic testing can often lead to latent, secondary failures as parts not inspected during the initial repair may fail. Skipping this step to get devices back to customers in record time, can often result in more downtime and higher operational costs down the road. 5. Do you have Manufacturing experience? Providers which are also device manufacturers have a strong foundation of research, technological innovations and proprietary processes

which are often applied to repairs. Applying a manufacturing mindset and process rigor to repairs often increases a probe’s sustainability and lifetime. 6. What is the depth of experience you bring to repair processes? Experience matters when it comes to repairing something as critical as diagnostic imaging devices. Ask providers about their length of time in the industry and quantity of repairs performed. Both matter. For example, the teams at Innovatus Imaging are applying learnings from 40 years of experience and 150,000 plus repairs to help predict failures, determine material durability and define best-in-class probe repair processes. Ultimately, providers should demonstrate a dedication to quality by having ISO 13485:2016 certifications, which are specific to medical devices. Asking providers about these 6 Criteria will help you get more out of your repairs, and all your ultrasound probe investments. Why this matters? Probe maintenance costs are no small hits to a facility’s bottom line. For example, TEE probes have the potential to fail within the first year of use due to repeated exposure to caustic chemicals, harsh environments and compromised handling. With a potential replacement cost of $22,000 vs. a typical repair cost of $5,000, or a preventative service cost of around $1,000, the savings of $17,000 – $21,000 are huge. If you have 10 TEE probes, just imagine what you can do with the potential savings.

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Our Repairs Are Priceless Too The process behind every repair is what ensures your probes will be reliable for your patients in critical moments. Our Denver facility is FDA-registered as an ultrasound probe manufacturer and we apply some of the same processes, technology and testing to our repairs as we do in manufacturing. With over 40 years of research & testing, 150,000+ completed repairs and some of the broadest probe repair capabilities on the market, you can trust your probe with us. www.innovatusimaging.com Call Us 1-844-687-5100 customercare@innovatusimaging.com PITTSBURGH | TULSA | DENVER | MAASTRICHT

20/20 VISION FOR SUSTAINABLE MRI REPAIRS E

ven perfect vision may not be enough to know if you are getting an MRI coil repair that will enable your MRI to perform as intended, and one that will produce long-lasting accuracy. Knowing which lens from which to view MRI coil repairs can make all the difference in sustainability and operational costs. Here’s some questions to ask providers so you can see what you’re really getting in a repair.

1. Are raw cables replaced or are they spliced? Replacing costs more, however; the longevity of the repair and life extension of the coil more than compensate for the extra money and help to lower the overall cost of ownership. Spliced cables can fail more often as they can separate over time, meaning more frequent repairs, more down time and potentially more performance issues. Sustainable processes replace all raw cable harnesses versus splicing and results in higher first-time fix rates. 2. What testing methods are used? Simplistic testing often fails to find additional issues affecting coil performance. Look for modular testing methods which break down the system and test each section to the component level assuring the whole system is functioning optimally. Ask too if they can find potential hidden electrical issues or perform predictive maintenance. 3. What is the source of mechanical parts used in the repair? Are they sourced from soft molding and machining or 3D printing? While 3D printing can increase speed and accessibility, this method may not always last as long as molding and machining. It’s critical to know how parts are sourced for your repairs as they can affect the longevity, cost of ownership and future downtime. 6

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4. What is the process for inspecting coil quality? You should know if the supplier tears apart the cable or uses a less or non-invasive method to inspect the quality and condition of each coil. Look for procedures such as those used at the Innovatus MRI Center of Excellence that provides the option to use an x-ray device to view cabling structures and avoid unnecessary disassembly of cables. Invasive procedures can increase the risk of other failures and extend the time for triage and repair. 5. What experience, research and processes are behind the repair? More important than price differential is the experience differential among providers. Low price, low experience is a sure combination for low quality. Ask how many years providers have been repairing the make and model you need repaired, and what depth of knowledge the team brings to the process vs. basic certifications and skill levels. Companies that continually research and test new methods and bring manufacturing mindsets to the process

are more likely to produce sustainable repairs which boost your operating ROI. With a core team that once manufactured MRI coils, and a major repair provider for all makes and models for more than 25 years, Innovatus Imaging has maintained one of the strongest records and reputations industry-wide for success and proven longevity for all types of repairs they complete. Why This Matters: MRI coil repair processes are not created equal. Because the barrier to enter the repair provider market is low, there are wide variances in quality produced by suppliers. A low-quality repair not only puts your coils back in the repair queue, they increase your down time, decrease patient access to diagnostic care, jeopardize customer relationships, and not least, elevate your operational costs. Entrusting repairs with proven providers that might be slightly higher in price or turn time usually pays off big dividends for patient care and ROI.

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3-WAYS THAT BIG DATA DRIVES SUSTAINABILITY AND DEVICE LONGEVITY

ata-driven protocols are to device repair what evidence-based medicine is to clinical care. The common denominator is better outcomes.

For treatment plans and repair processes, data-driven protocols enable clinicians and technicians to eliminate guess work and deliver results at higher confidence levels. Unlike the clinical world of healthcare which can follow data-driven guidelines provided by the NIH, there is no specific governing body to research best practices for imaging device repair, specifically ultrasound probes and MRI coils. Yet when providers base repair processes on scientifically valid research, they can increase repair sustainability and device longevity. The challenge is that new providers, in a price-driven market, do not typically have the resources to continually test and develop data-driven methodologies. Doing so requires high levels of clinical and technical expertise, valid evidence and an ability to execute efficiently and affordably. Having the above requires more than a typical depot repair shop with skilled technicians. It requires engineering depth, testing and research capabilities and leadership that understands what to test, and how to identify valid evidence around which to build best practices. Because of its original research, Design and Manufacturing Center of Excellence, SPECIAL ADVERTISING SECTION

and more than 40 years in the business, Innovatus Imaging is one of few providers that has the resources to apply big data and big amounts of data to every repair process they execute. Following are 3 of the many benefits data driven repair offers imaging facilities of all sizes: 1. Data-driven processes resolve problems accurately and efficiently: Repair providers that engage in multiple types and levels of testing are more prepared to solve problems right the first time and achieve optimum outcomes. Yet not all data is equal as all providers don’t have access to original data or data compiled by OEMs. It’s important to ask providers what data they use to define their processes and practices. Is the data backed by high level evidence from randomized controlled trials or observations from multiple time trial studies? Or low-level evidence such as personal experience and opinion? While low level evidence can be impactful, the best evidence for building best practices and optimum outcomes comes from controlled testing and trials. With more than 150,000 successful probe repairs and 30,000 plus MRI coil repairs completed and industry-leading warranty rates, Innovatus Imaging continues to collect and apply proprietary data for repair methodologies for ultrasound probe,

MRI Coil and Radiography device repairs. Ongoing testing programs help gather evidence and identify thresholds at which efficacy diminishes further impacting quality outcomes. 2. Advanced Testing Identifies Better Practices: Providers that engage in high level testing programs are those that are most often able to build proprietary methods that define new best practices. Hydrophone testing of new probes is a good example of current processes that allow engineers to document baseline acoustic performance and use the data to build an acoustic profile for a given probe model. As a result, big data can ensure repaired probes perform as originally intended. 3. Data Drives Accountability and Savings: With data, repair providers can document processes and validate them to understand precisely what they are getting from a repair and what customers can expect. It’s important to understand what research and testing repair providers conduct in order to know how current and accurate their processes are likely to be, and to project the likelihood of sustainable repairs that will increase your products’ lifecycles and optimize performance. When comparing providers, ask about testing, data used, and how they document procedures used against desired outcomes. INNOVATUS IMAGING | DIGITAL SUPPLEMENT

plan

workflow

Quality repair

webinars

design

management

Lifecycle end-user training

patients throughput

manufacturing

quality management

engineering consulting cost

technical field service

strategy support

innovate

service

reduction

Solutions

Could you improve service to your customers if.... • • • •

Your repair provider was also an FDA registered medical device manufacturer? They utilized the same expertise and methodologies in repair as they do in manufacturing? You had immediate access to complementary technical support when you needed it? Your customers could receive end-user training proven to reduce costs and frequency of equipment failures? At Innovatus Imaging, we call this Lifecycle Management and it’s what we do each and every day. Combining expertise in device manufacturing and data from over 200,000+ repairs performed with longevity and sustainability at the core, we’re able to offer up to a 1-year warranty.

Visit us at Booth 502 at MDExpo April 20-22 in Irvine, CA

customercare@innovatusimaging.com 844-687-5100 INnovatusimaging.com

Lifecycle management through Innovatus Imaging: Proven to help extend the life of your MRI coil, ultrasound probe or radiography device.

WHAT A CENTER OF EXCELLENCE FOR DEVICE REPAIR CAN MEAN FOR YOUR INVENTORY

tâ&#x20AC;&#x2122;s easy to think that a repair is a repair and so price matters most. Time to think again.

The success of a repair needs to be measured by the sustainability of the repair, the testing that proves its validity, and the documentation showing where

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the parts came from and the processes executed to get the device back to its original form, fit and function. Mike LaBree, CTO for Innovatus Imaging, and a seasoned imaging device engineer and manufacturer, explains what happens at a Center of Excellence for Ultrasound design and manufactur-

ing and why protocols and processes rooted in ISO 13485:2016 matter for imaging departments, large and small. Learn what a Center of Excellence for device repair can mean for your inventory by watching this brief 3-minute video. Link to video: https://youtu.be/zxi2KKlGJQU

INNOVATUS IMAGING | DIGITAL SUPPLEMENT

WHY ACCREDITATION FOR IMAGING DEPARTMENTS MATTERS A

ccreditation such as ISO 13485:2016 should not stop with engineering and operations. Quality assurance processes are important for all aspects of a facility.

The American College of Radiology (ACR), the American Institute of Ultrasound in Medicine (AIUM), and the Intersocietal Accreditation Commission (IAC) offer accreditation processes and certification for radiologists and cardiologists to help increase clinical knowledge, and quality outcomes. Accreditation for clinicians requires demonstrating adherence to established standards for image quality testing, equipment maintenance, quality systems, and showing that medical personnel meet standards for interpretation of diagnostic examinations. It also signifies that facilities have audited their strengths and weaknesses and have taken any needed corrective actions to streamline efficiencies and operations to better serve patients. Why this matters: Patients are highly informed consumers and review performance studies on hospitals and caregivers provided by reporting organizations such as Health Grades and other sites which allow consumers to compare hospitals on many factors such as patient experience, timely and effective care, overall value, AND the use of medical imaging. Hospitals that don’t follow best practices for imaging services could be flagged as conducting unnecessary services or missing vital diagnoses. 10

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Clinical engineers play a vital role in quality assurance and accountability for several processes and outcomes, including: • Providing full-service histories, repair documentation, and other activities associated with a device. • Performing frequent image quality assessments in much greater detail than the OEM • Assessing and documenting performance on accessory devices such as ultrasound probes, MRI coils and hard copy devices • Acquiring and assembling Quality Control data for the department applying for accreditation. Even if your imaging departments are not currently accredited, aligning your teams’ activities with accreditation requirements can help avoid costly mistakes, downtime and other issues that can impact clinicians, diagnostic efficiencies, and patient satisfaction, all of which can impact your hospital’s quality ratings and potential insurance reimbursements. An additional step you can take to protect your team and patients is to always work with repair providers that have proven their commitment to

quality by becoming and maintaining ISO 13485:2016 certification. Companies maintaining this level of certification provide many added values non-certified providers cannot such as: • Confidence that medical device repairs are being performed according to well-defined processes, that their partners and suppliers are routinely reviewed and qualified, that a system of continuous quality improvement based upon risk analysis is in-place and that the organization is open to external bodies assessing their entire operations. • Assurance that all aspects of the device are addressed during repair to ensure longevity and safe and effective performance. • Knowledge that short-cuts are not being taken during the repair process, which although may be cheaper, could lead to premature or latent failures or more importantly compromised safety or performance. For more information about certification from ACR, AIUM, IAC, and ISO, download our summary of various accreditation programs, a PDF of our Webinar Wednesday on this topic at www.innovatusimaging.com/resources. SPONSORED BY INNOVATUS IMAGING

KEEPING UP WITH TECHNICAL ADVANCEMENTS WITHIN ULTRASOUND TECHNOLOGY

ignificant advancements have occurred in transducer technology in the past few years, including single-crystal technology, CMUT, matrix array technology and wireless probes. Even though the causes of probe failure remain mostly unchanged, the components within probes and the methods to address the failures have become increasingly challenging. Healthcare organizations have been struggling to find true repair solutions for live 3D volumetric probes, such as the Philips X8-2t, X7-2t, X5-1,

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GE 6VT-D, and that most solutions result in replacement versus traditional repair.

Take a few minutes to learn how Innovatus focuses on new technology and how we can help to reduce your overall cost of ownership. Link to video: https://youtu.be/VR4NRLWjWWo

INNOVATUS IMAGING | DIGITAL SUPPLEMENT

3-STRATEGIES FOR ADDRESSING MRI FAILURES

o you know what's NOT covered under warranty and contract on your MRI? More importantly, do you know how you'll address it?

Warranties and service contracts provide us with a sense of security that sometimes can be misleading. It’s easy to think that because we have a warranty or contract in place, our MRI’s are covered no matter what happens, and we’ll be back up and running in short order. However, what many of us might not know is that warranties and contracts are very different from insurance. You’re only protected under certain circumstances and you’re not covered under others. Like with your car, warranties cover manufacturing defects or failures, not user error or slip ups. Scenarios involving user error or human slip ups occur every day in healthcare facilities. For instance, while prepping for an MRI, a technologist drops a large body coil. While performing a scan, the patient loses bladder control. The magnet is quenched because a ferrous object is 12

DIGITAL SUPPLEMENT | INNOVATUS IMAGING

pulled into the field. While lowering the patient table, an MRI coil's cable becomes trapped and is partially severed. Whether a new MRI, covered under warranty, or an older model, covered under OEM contract, addressing the failures described above are, most times, the responsibility of the facility. It's not new. Failures considered preventable, avoidable or attributed to trauma and/or misuse are often not covered by an OEM service contract. In the chance that a single, preventable, event IS covered, it most likely won't be a second time. Understanding how and why out-of-pocket expenses occur and developing contingency plans for when preventable failures occur can have a huge impact on service budgets. For example, MRI coils. With a core team that once manufactured MRI coils, and a major repair provider for all makes and models for more than 25 years, Innovatus Imaging has amassed a large amount of failure analysis data. Data shows that most MRI coil failures are a direct result of or related to mechanical damage or trauma. Over 35% of all

coils present with mechanical damage due to trauma and an additional 18% are RELATED to trauma and/or improper use. Typically, when a coil fails, the OEM sends a replacement next day. It may take days or weeks before an invoice is received highlighting preventable damage and the out-of-pocket expense. You may be surprised to learn that some OEM's install shock sensors within their coils to determine if the coil has been dropped or exposed to an unusual amount of force. So, even though there are no outward signs or trauma or mechanical damage, coverage may be denied. The tough reality we must face with most contracts we buy is that 50% of your coil failures may not be covered. Having to absorb an out-of-pocket expense of $35,000 - $100,000+ for a single coil failure can ruin any budget. At one point or another, we've all been asked, "Did you read the fine print?" Analyze your options when considering a service contract on your MRI. 1. Insure that, if you have a service contract, that ANY and ALL SPONSORED BY INNOVATUS IMAGING

failures are covered in the final cost. Costs will be high, but this option can ensure maximum uptime and continued workflow while eliminating out-of-pocket expenses. 2. If a standard OEM service contract is in-place, use an ISO 13485:2016 certified repair provider, such as Innovatus Imaging, to address any coil that shows evidence of preventable or avoidable damage. And, if there is ANY mechanical damage, do not assume that a replacement coil, through the OEM, will be covered. Address the failure via repair or non-OEM replacement using a qualified provider. 3. If magnets are not supported

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in-house, service contracts are a must to insure uptime and continued workflow. Knowing that over 50% of coil failures may not be covered provides some powerful information. Consider removing MRI coils from the service contract altogether. It is possible and there is a huge cost savings to be realized. Coil repairs start as low as $500 and some repair providers offer loaners and/or expedited repairs. Why this matters: The bottom line for any facility, large or small, is simple: When selecting a repair provider, be sure that repairs are performed with longevity in-mind. Ask about their

length of time in the industry and quantity of repairs performed. Both matters. For example, the team at Innovatus Imaging is applying experience from over 25 years and 30,000 plus repairs to define best-inclass coil repair processes and even help predict potential future failures. Ultimately, providers should demonstrate a dedication to quality by having ISO 13485:2016 certifications specific to the medical device(s) they support.

For more information on how Innovatus Imaging can help to reduce your service budget with quality, sustainable repairs for MRI coils and US probes, please contact info@innovatusimaging.com.

INNOVATUS IMAGING | DIGITAL SUPPLEMENT

by just 1 year? We've performed over 30,000 coil repairs across 800+ models. We've got the experience and expertise to keep you up and running.

Getting more life out of every MRI coil depends on Getting the most out of every coil repair. At Innovatus Imaging MRI Center of Excellence, we've taken 30 years of data from manufacturing, testing and repairing hundreds of coil models to develop proprietary processes and methodologies that result in sustainable repairs. Our work includes testing every repair for durability, qualifying the parts we use, and testing all elements of the coil to look for hidden issues that could cause another failure. We also have, and continue to invest in, one of the largest loaner inventories available, assuring we have what you need when you need it!

Jason Brownley MRI Coil Operations Manager Innovatus Imaging

To learn more about our proprietary repair processes that result in affordable and sustainable repairs, download our 5 Steps to Sustainable MRI Coil Repairs brief at www.innovatusimaging.com/resources.

Chat with our experts live at InnovatusImaging.com, email us at INFO@innovatusimaging.com or call us at

844-687-5100

Centers of Excellence for Ultrasound Probe Repair, MRI Coil Repair, Radiography, and Design and Manufacturing

Innovatus Digital Supplement

Articles inside

What is the process for inspecting coil

What testing methods are used? Simplis

quality? You should know if the supplier

Are raw cables replaced or are they