Testing Solutions from Bose

Enabling our customers to make better products and improve the quality of life About the ElectroForce Systems Group

The ElectroForce Systems Group of Bose Corporation is a leading supplier of materials testing and durability simulation instruments to research institutions and universities, as well as medical device, biotechnology, engineering, and manufacturing companies worldwide. Bose® test instruments help customers design better products and get them to market faster. Proprietary linear motor technology developed by Bose is the foundation for Bose test instruments, providing unique performance capabilities, “plug and play” simplicity, and exceptional energy-efficiency.

Bose test instruments provide exceptional dynamic performance and precision for a variety of testing applications, including characterization of engineered materials, soft tissues and biomaterials; fatigue testing of materials and components used in industrial and consumer applications; and durability simulation of medical devices, including stents, endovascular grafts, and orthopaedic implants.

We’ll work closely with you to understand your specific testing requirements, and then create a tailored system solution so you can reach your goals. It’s all part of what you expect from Bose; exceptional performance and support, time after time. Learn more about Bose ElectroForce system benefits for a variety of testing applications. Then, we invite you to put us to the test.

A History of Bose

Bose Corporation was founded in 1964 by Dr. Amar G. Bose, then Professor of Electrical Engineering at the Massachusetts Institute of Technology. As an MIT grad student in the 1950s, Dr. Bose decided to purchase a new stereo system. He was disappointed to find that speakers with impressive technical specifications failed to reproduce the realism of a live performance.

Extensive research in the fields of speaker design and psychoacoustics—the human perception of sound—led to the groundbreaking 901® Direct/Reflecting® speaker system in 1968. Its unprecedented approach to sound reproduction came much closer to the essence and emotional impact of live music, and won immediate acclaim. Today, Bose has over 9,000 employees, and operations in the United States, Europe, Canada, Mexico, Australia, Asia and South America.

Bose® Technologies – For Lifelike Sound and Beyond

Research fuels technology, and the Bose commitment to research has served us well. The list of major Bose innovations continues to grow. Fourteen years of research led to the development of acoustic waveguide speaker technology, found in our award-winning Wave® music system. Acoustimass® speaker technology reshaped conventional thinking about the relationship between speaker size and sound, enabling palm-sized speakers to produce audio quality previously thought impossible from speakers so small.

The Bose systems approach for design has paved the way for numerous innovative solutions, audio and beyond. Integrated systems account for the acclaimed performance of Bose automotive sound systems and Acoustic Noise Cancelling® headsets. Auditioner® audio demonstrator technology removed the guesswork from sound system design for arenas and other large venues. It allows architects to hear precisely what a Bose system will sound like in their building, even if the building only exists as a blueprint. The proprietary integrated system design found in Bose Lifestyle® systems delivers award-winning performance and elegance from elements specifically engineered to work together.

The innovative Bose Ride® system and the broad portfolio of Bose ElectroForce test instruments rely on proprietary Bose software and hardware working together in harmony. All feature technologies available only from Bose. Table of Contents

Bose® Technologies - Overview and Benefits The ElectroForce® Advantage...... 4 Bose Corporation - ElectroForce Systems Group...... 5-6 ElectroForce Linear Motion Systems...... 7-10 ElectroForce Test Instruments...... 11-14 ElectroForce Series 7 Software...... 15-18 Load Frame Products ElectroForce 3100 Test Instrument...... 19-20 ElectroForce 3200 Series II Test Instrument...... 21-24 ElectroForce 3330 Series II Test Instrument...... 25-28 ElectroForce Extended Stroke Test Instruments...... 29-30 ElectroForce 3510 Test Instrument...... 31-32 ElectroForce 3520 Test Instrument...... 33-34 ElectroForce 3550 Test Instrument...... 35-36 TestBench and Planar Biaxial Systems TestBench Instruments...... 37-38 ElectroForce Planar Biaxial TestBench Test Instrument...... 39-40 ElectroForce 3330 Dental Wear Simulator...... 41-42 ElectroForce Series II Multi-specimen Fatigue Test Instruments...... 43-44 Cardiovascular Instruments ElectroForce Stent/Graft Test Instruments for Pulsatile Distention...... 45-46 ElectroForce 9210 Drug-Eluting Stent Test Instrument...... 47-48 ElectroForce 9400 Multiaxial Peripheral Stent Test Instrument...... 49-50 ElectroForce 9500 Multiaxial Coronary Stent Test Instrument...... 51-52 BioDynamic® Instruments ElectroForce BioDynamic® Test Instruments...... 53-56 Multi-specimen BioDynamic Test Instruments...... 57-58 ElectroForce 5900 BioDynamic Test Instrument...... 59-60 Biomedical Application Briefs Mechanical Testing of Porcine Trachea...... 61-62 Degradation of PLGA Scaffolds Under Dynamic Loading...... 63-64 ElectroForce BioDynamic Instruments Drive Stem Cell Differentiation...... 65-66 Micromechanical Multicyclic Creep Tests of Human Cortical Bone...... 67-68 Test Research Leads to a Better Understanding of Tissue Engineered Cartilage...... 69 Dynamic Testing Characterizes the Viscoelastic Properties of Vocal Fold Tissue...... 70-72 Characterizing Mechanical Properties of Cartilage In Situ...... 73-74 Characterizing Heel Tissue to Develop a Dynamic Finite Element Model of the Foot...... 75 Tooth Fracture Studies Lead to Longer Lasting Teeth...... 76 Viscoelastic Characterization of Agarose Gel Scaffolds...... 77-78 Evaluation of Orally Disintegrating Tablets (ODTs) Using Precision Compressive Loading...... 79-80 Dynamic Testing Characterizes Frequency Dependence of Liver Tissue...... 81 Dynamic Mechanical Analysis of Hydrogel...... 82 Compressive Loading of Polyvinyl Alcohol Microbeads...... 83 Small Diameter Vascular Graft Elasticity Measurement in Response to Pulsatile Pressure...... 84 Testing to Improve the Durability of Artificial Heart Valves...... 85 Engineered Materials Application Briefs Dynamic Testing Brings Running Into the Laboratory...... 86 Dynamic Testing Leads to Improved Fibers...... 87 Dynamic Testing Predicts Success of Nanocomposites...... 88 Tire Cord Dynamic Properties Measured for FEA Model...... 89 Automotive Fatigue Life and Dynamic Mechanical Analysis of a Matrix Polymer...... 90 Generation of Master Curves for Cured Rubber...... 91 Dynamic Testing Uncovers Rheology of Rubber...... 92 Fatigue Testing of Thin Metallic Foils and Wires...... 93 The ElectroForce® Advantage

We start with your specific testing needs and combine unique Bose® ElectroForce® motor technologies with our test applications engineering expertise to create a tailored test solution that meets your testing objectives. After you buy a Bose product, you become a valued, lifelong customer. Providing exceptional, ongoing support is our commitment to you.

Technology - creating a new direction for mechanical testing

Bose has been committed to electromagnetic technology and research since its founding more than 40 years ago. This ongoing effort has resulted in the development of high-performance linear motors that feature essentially zero-friction moving-magnet designs. With over twenty years of electromagnetic system engineering and test experience, The Bose ElectroForce Systems Group has established itself as an industry leader in electrodynamic testing.

Applications - test applications expertise to deliver innovative products

Bose is continually developing new testing solutions that combine its test applications knowledge and engineering expertise with novel motor technologies to create high-performance test instruments. Bose proprietary motors are the cornerstone of the Bose ElectroForce test instrument portfolio and provide unique performance advantages in many testing applications.

Support - our commitment to lifetime customer service and support

The ElectroForce Systems Group is dedicated to providing exceptional customer service and support, following deeply-held traditions of Bose. Our mission is to provide highly-responsive technical support and value-added services throughout the life of the instruments we provide. We measure our success by the success of our customers.

Bose® Technology Benefits

In the audio field, it’s well known that reproducing sound with lifelike detail requires extraordinary control of a loudspeaker’s motion. During a research project on an experimental loudspeaker, Bose engineers developed a new kind of specialized electromagnetic linear motor with a patented, durable moving-magnet design. Additional research revealed that the technology in this new linear motor integrated with an advanced test control system could be used to create test instruments with exceptional fidelity and precision.

Motor Technology Benefits Software Technology Benefits -- Improving performance -- -- Improving productivity --

Patented ElectroForce linear motor provides Easy-to-use, intuitive software with exceptional dynamic performance advanced testing capabilities

Reliable High-fidelity Low-force 10-year Clean Energy-efficient Ease of Direct Control Real-time Security Testing Control Control Warranty Technology Technology Use Over Data Test Control and History Tracking 4 BoseBose CorporationCorporation ElectroForceElectroForce SystemsSystems GroupGroup

Setting a New Standard of Performance in Testing The ElectroForce Systems Group of Bose Corporation provides materials testing and durability simulation instruments to research institutions, universities, medical device companies and engineering companies worldwide. It is also a strategic venture for Bose that builds upon and transcends its forty year history of audio innovation. The History Well before this venture, Bose engineers had developed a proprietary linear motor for an experimental loudspeaker, recognizing its potential in non-audio settings. In 1999, Bose began supplying the linear motor and related components to EnduraTEC Systems Corporation, who saw how this technology could enhance their materials testing business. Five years later, Bose acquired company assets related to the development, manufacture and sales of materials testing equipment, and EnduraTEC became the ElectroForce Bose built its reputation creating high Systems Group. performing audio products. Now, we are growing our business beyond these The Technology boundaries, leveraging our intellectual The ElectroForce Systems Group is making its mark in test instruments, and the assets in much broader ways. Bose linear motor is helping them take their business to an entirely new level. The ElectroForce Systems Group is a By incorporating proprietary Bose technology, the ElectroForce® linear motor Bose business providing advanced provides exceptional fidelity and precision for a variety of testing mechanical testing instruments to applications. As a result, ElectroForce test instruments set a new standard for research and product development performance, simplicity and elegance in a single test system. organizations worldwide.

The Test Applications Typical test applications include: • Durability simulation of cardiovascular devices and orthopaedic implants; • Evaluation of soft tissues, biomaterials, and tissue-engineered constructs; • Characterization of engineered materials such as microelectronics, elastomers, components, fibers, foils and films.

The Bose® Commitment to Customer Satisfaction At Bose, an overriding goal is to create value for our customers by offering products and services that meet their needs. Our experienced sales and applications specialists strive to understand your specific testing needs, and then provide a solution for you. We put customers at the center of a dedicated focus on quality and service, and we measure success by the satisfaction of our customers. We are dedicated to bringing you products of superior quality and performance, and exceptional service so you can achieve your goals.

5 A History of Bose

In 1964, Dr. Amar G. Bose set out to deliver better sound through research

Bose Corporation was founded in 1964 by Dr. Amar Bose, then professor of electrical engineering at the Massachusetts Institute of Technology. While doing graduate work at MIT in the 1950s, Dr. Bose decided to purchase a high fidelity speaker system. He was disappointed to find that speakers with impressive technical specifications failed to reproduce the realism of a live performance. This led to extensive research in the fields of speaker design and psychoacoustics—the human perception of sound. Dr. Bose’s findings resulted in significantly new design concepts that help deliver the emotional impact of live music.

Bose Corporation established itself by introducing the 901® Direct/Reflecting® speaker system in 1968. With this introduction, Bose achieved international acclaim by setting a new standard for lifelike sound reproduction. The list of major technologies emerging from Bose continues to grow. Fourteen years of research led to the development of acoustic waveguide speaker technology, found in our award-winning Wave® radio, Wave® music system and Acoustic Wave® systems. The introduction of Acoustimass® speakers reshaped conventional thinking about the relationship between speaker size and sound. Speakers small enough to fit in the palm of your hand produce exceptional sound quality with an Acoustimass enclosure. The proprietary integrated system design found in Bose Lifestyle® systems has set new standards for home theater systems.

We’ve taken our commitment and our passion for innovation and applied them to developing unique sound solutions to meet virtually any audio challenge in any application, even the space program. While many of our products are designed for entertainment and home audio solutions, you’ll find Bose sound is prevalent in both the aviation and automotive industries, too. We’ve also designed professional sound systems for many applications, including stadiums and auditoriums, houses of worship, retail businesses, department stores and restaurants. In the home and on the road, you can hear the realism of the most respected name in sound—Bose.

Our Philosophy Since Bose Corporation was founded in 1964, the original philosophies and founding principles have not changed. Bose maintains an exceptionally strong commitment to research, for it is within the discipline of research that yesterday's fiction becomes tomorrow's reality. We strive to identify Research fuels technology, and superior things which, when made better, improve people's lives. technology leads to superior performance. At Bose, we support our research by reinvesting But it's more than just research. 100% of our profits back into the company. Our In everything we do, we aim for commitment to innovation has served us well. excellence, from the way we run our business to our Today, Bose has over 9,000 employees, and customer service. operations in the United States, Europe, Canada, Mexico, Australia, Asia and South America.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo and ElectroForce are registered trademarks of Bose Corporation. 022613 6 ElectroForceElectroForce®® LinearLinear MotionMotion SystemsSystems

In research and development centers throughout the world, scientists and engineers are working to create the next-generation of machines – machines that will do what today seems miraculous. Oftentimes, to realize these dreams, a technical team is asking for the essential force and motion components of their machines to operate with extraordinary precision and dynamic performance. These embedded motors and controls are often at the heart of these new, innovative products.

Customized Solutions from Bose If you have a challenging motion and force control requirement for your high-volume OEM application, consider a relationship with Bose to create a customized embedded solution for your new product. There are a number of important considerations when developing the appropriate solution for advanced linear motion control, so we invite you to contact us for a technical consultation. We can help you determine if an ElectroForce® moving magnet motor and Bose® controls package might be the proper answer for your OEM application.

The ElectroForce Moving Magnet Motor The ElectroForce linear motor provides an attractive alternative to traditional motion and force control because of its simple, durable, moving-magnet design. The proprietary motor uses a friction-free, flexure suspension in order to achieve exceptional fidelity and precision. As a result, ElectroForce linear motion systems have set a new standard of dynamic performance for a variety of motion and force control applications.

Bose - An Engineering Solutions Company Since its founding in 1964, Bose has always maintained a commitment to research, innovation, and excellence in everything we do. To this day, these principles are cultivated as core elements of the company’s culture. Although most of the world knows Bose for its speakers, we actually do a lot more than that - in fact several of our research projects have nothing at all to do with music or home theater systems - or even sound, for that matter.

The Bose ElectroForce Systems Group Throughout the 40-year history of Bose Corporation, the company has maintained expertise in certain technical disciplines, namely - power electronics, controls and linear electromagnetic actuators. The ElectroForce Systems Group leveraged this expertise to develop a variety of test instruments for medical device development and materials research. Through an OEM relationship, it is now possible to leverage the breadth of Bose controls expertise for your demanding applications requiring precise position and force control capabilities. We apply our systems expertise with select development partners to tailor system-level linear motion solutions for advanced OEM control applications that have significant business potential.

7 Motion and Force Control Systems Expertise Power Electronics ElectroForce® linear motion systems combines Bose’s deep expertise and research in the core disciplines, power electronics, controls, and Power Amplifier electromagnetic linear actuators, that are required to deliver precision Packaging Design motion and force control solutions.

Power Electronics Power electronics has been a technology cornerstone for Bose from the start. In fact, before we even got into high-fidelity audio, Bose’s co-founders established the company by working on government and Algorithm Electromagnetics defense contracts in power electronics by day, while designing speakers Development at night. Since those early days, Bose developed power electronics technologies that to this day are used onboard commercial aircraft to Digital Signal Actuator & regulate power. We manufacture electronics for controllers and switching Processing Transducer Design amplifiers in large annual quantities to stringent quality standards for our demanding automotive OEM partners and others. Controls Linear Actuators Combining Expertise in the Core Disciplines of Controls Power Electronics, Controls and Actuators Another area where Bose has developed significant expertise over the years relates to controls. One of the company’s first controls project led to an algorithm used to control fuel rods inside nuclear reactors. Today, Bose® QuietComfort® Acoustic Noise Cancelling® headphones utilize advanced controls technologies to actively monitor unwanted noise, and then create an electronically processed correction to negate the unwanted noise so it doesn’t reach your ears. For durability testing instruments, Bose has developed TuneIQ® control optimization software that can systematically characterize a motion system to provide more accurate controller tuning. A proprietary system stability test is utilized in the tuning sequence to ensure that the system is optimally tuned and stable. TuneIQ software supports a broad range of ElectroForce linear motion configurations and control modes to dramatically improve closed loop performance under a greater variety of real-life service conditions.

Electromagnetic Actuators A third area where Bose has developed strong competency over the years is in the development of electromagnetic linear actuators. Given the company’s focus on developing high-quality transducers for its speakers, Bose has built technical strengths in electromagnetics, materials science, motion control and other related disciplines in order to produce high-performance linear actuators. Over the years, Bose has developed several different linear actuator topologies. One of them is the ElectroForce moving-magnet linear motor, originally developed for an experimental loudspeaker. Bose obtained a U.S. patent on that linear motor, recognizing its potential in non-audio applications. The linear motor has been successfully deployed in several applications, including biomedical device testing, component testing and a variety of Schematic of Moving-Magnet materials testing applications that require exceptional precision and dynamic performance. ElectroForce® Linear Motor

The ElectroForce Motor Advantage The ElectroForce linear motor uses a moving magnet design supported by a flexure assembly that provides friction-free performance. In addition, the motor is quiet, energy efficient, clean, and simple to implement. ElectroForce motor technologies are scalable to fit a wide variety of applications that require superior performance attributes, including large dynamic force, and a broad frequency range requiring high accelerations and velocities. Bose can also customize solutions to meet the needs of novel linear motion applications. With no wear surfaces or friction, ElectroForce motors have proven to be very reliable. They have been tested over billions of cycles, and can provide nearly infinite life for a variety of applications. With its inherent low-noise operation and clean, environmentally friendly design, the ElectroForce motor is well-suited for many motion and force control applications. ElectroForce LM1 Linear Motor 8 Right Fit Applications The ElectroForce® linear motor has several technical attributes that provide exceptional performance and the right fit for a variety of motion and force control applications. ElectroForce linear motion systems excel in applications where: • Controlled force is essential • High frequency, bandwidth and velocity performance is critical • Power density is important • Near-instantaneous, precise and variable-speed motion is required • System durability and reliability is paramount • Quiet operation or a low noise level is desirable • Simple installation and setup is valued • Contamination risk must be minimized • Minimal infrastructure requirements are important The ElectroForce® Linear Motor Family • Environmentally friendly considerations are important.

Potential Motion and Force Control Applications Bose is extending the use of ElectroForce motors and proprietary controls to OEM applications that require accurate force and motion control. ElectroForce linear motion systems are particularly attractive for applications where efficient, clean, compact, and programmable linear motor technology is needed. ElectroForce linear motion systems are readily applicable to a number of applications, and the possibilities are limited only by your imagination. Examples range from programmable fluid pumping to pulsatile pressure control applications to active vibration isolation. The following list of potential applications is but a few of the possible areas for consideration: Fluidic or liquid control, such as fluid transfer, pulsatile control, mixing, or precision pumping applications over a range of flows Biaxial Motion System Manufacturing and automation, including a variety of controlled loading and positioning applications for tooling and other production support Vibration control, including platform stabilization, active isolation, control stabilization for imaging applications, and other types of active suspension systems Resonance applications to optimize force and motion efficiency for a variety of industrial and scientific applications Power regeneration techniques that require highly efficient, compact and environmentally friendly technologies Other general linear motion applications that require performance not generally available from traditional sources. Pulsatile Pressure System Steps to a Successful OEM System Implementation Working together with your technical staff, Bose can develop a customized motion control OEM package specifically for your new product development. For high-volume applications, there are several important milestones to fully realize a commercial solution: Exploratory discussions, to understand application and performance requirements Opportunity evaluation to assess potential areas for collaboration and address technology alignment Detailed business planning to outline requirements and determine relevant resources Development milestones that typically include the following important steps • Technology feasibility and proof-of-concept evaluation • Prototype development and validation to identify the custom OEM solution • Pilot system development and verification to commercialize the actual embedded Customized OEM OEM solution System Development • Production engineering to scale up processes to meet volume needs as required.

9 Bose® ElectroForce® Linear Motor Summary Specifications Motor: LM0 LM1 LM2 LM3

Force: 22 N 225 N 3000 N 7500 N

Stroke: 5 mm 12.7 mm 25 mm 50 mm (peak to peak)

Dimensions*: Length (L) 82 mm 166 mm 343 mm 458 mm Width (W) 65 mm 115 mm 254 mm 458 mm Height (H) 77 mm 77 mm 343 mm 458 mm

Weight*: 0.4 kg 2.0 kg 27.3 kg 113.6 kg (not including fan) (not including fan) *Weight and dimension specifications are approximate. Performance curves: Force/displacement curves as a function of frequency are available. Note: LM1, LM2 and LM3 motors can be stacked to double the force.

A Breadth of Capabilities for your Requirements ElectroForce® linear motion solutions can be customized to meet the needs of a number of linear motion applications. The linear motors are available in several sizes and capacities allowing scalability for a wide variety of applications. The range of performance characteristics includes the following:

• High dynamic force (up to 15,000 N) • Superior bandwidth (up to 300 Hz) • Broad frequency range (0.0001 – 300 Hz) • High acceleration (up to 150 G) • High efficiency (approximately 80% to 90%) • Precise position and force control with accurate waveform control

ElectroForce® LM2 Linear Motor • Clean and environmentally friendly design LM1 Motor Dimensions Reference

Bose ElectroForce Systems Group Profile The ElectroForce Systems Group of Bose Corporation is a leading supplier of materials testing and durability simulation instruments to research institutions, universities, medical device companies and engineering companies worldwide. In 1999, Bose Corporation began supplying its proprietary linear motors for dynamic testing systems, establishing a new standard in performance. Today, ElectroForce test instruments provide exceptional fidelity and precision for a variety of testing applications, including characterization of engineered materials, soft tissue and biomaterials, fatigue testing of components used in industrial and consumer applications, and durability simulation of medical devices.

Contact Information

EUROPE AMERICAS ASIA Bose GmbH Bose Corporation Bose Corporation ElectroForce Systems Group ElectroForce Systems Group ElectroForce Systems Group Max-Planck-Strasse 36 10250 Valley View Road, Suite 113 1038 West Nanjing Road, 36th Floor 61381 Friedrichsdorf Germany Eden Prairie, Minnesota 55344 USA Shanghai, 200041 China PHONE: +49 (0) 6172 7104-0 PHONE: 952.278.3070 PHONE: (86) 21-6271-3800-217 FAX: +49 (0) 6172 7104-19 FAX: 952.278.3071 FAX: (86) 21-5228-9035 [email protected] [email protected] [email protected]

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 10 ElectroForceElectroForce®® TestTest InstrumentsInstruments

Versatility, Exceptional Performance and Energy Efficiency

ElectroForce® test instruments incorporate proprietary Bose® linear motion technologies and WinTest® controls to provide a revolutionary approach to mechanical fatigue and dynamic characterization. The ElectroForce family of test instruments provides a full range of force and performance capabilities for a variety of test applications. ElectroForce test instruments are controlled by the WinTest digital control system. WinTest software features an intuitive design that enables the user to quickly set up tests with little training. ElectroForce test instruments are also very lab-friendly thanks to their practically maintenance-free operation. As a result, they have set a new standard for performance, simplicity and versatility in a single test system.

Important Features and Benefits of ElectroForce Instruments: • Simple and durable moving-magnet motor design that provides excellent dynamic performance • Efficient, direct electromagnetic conversion to force, resulting in great acceleration, high frequencies and high velocities • Powered from a standard electrical outlet, requiring no additional infrastructure, air conditioning or water cooling • Air-cooled, clean-room compatible and whisper-quiet operation in compact, space-saving packages • Energy efficient and environmentally friendly by using pollution-free and non-toxic technologies • Proprietary linear motor operates without friction, an important feature for high resolution, low-force testing • Intuitive software design to simplify test setup and a flexible hardware platform for changing test needs • A wide range of instruments, from 20 N maximum force to 15 kN maximum force to provide the proper choice for a wide variety of test applications.

11 ElectroForce® Table-Top Test Instruments ElectroForce® 3200 ElectroForce 3330 Series II Series II Configurations Table-top Configuration The 3200 Series II test instrument may be configured for 225 The ElectroForce® 3330 Series II test instrument is N or optionally, 450 N maximum force capacity. The system well-suited for long term durability studies. It provides has a wide bandwidth, capable of performing tests from static to 100 Hz performance with a load envelope of static test conditions to cyclic tests up to 200 Hz. ± 3000 N and versatility for a variety of fatigue test It includes the enhanced measurement capability of the applications. The system also includes the enhanced Bose® High Accuracy Displacement Sensor. This measurement capability of the Bose High Accuracy enables an even wider range of testing by improving Displacement Sensor. This enables an even wider low-amplitude displacement measurements, all through range of testing by improving low-amplitude a single, easy-to-use displacement channel. displacement measurements, all through a single, easy-to-use displacement channel. The table-top configuration is readily adaptable for a variety of testing applications from biomedical research Applications include durability testing of orthopaedic to the characterization of engineered materials. The implant devices as well as system may be configured with an optional torsion dynamic characterization of capability for biaxial applications, and a wide range of engineered materials and system options are available including hot/cold chambers components. The table-top and saline baths. configuration can be Typical test applications: integrated with a variety of environmental chambers and • Biomaterials specimen fixtures to meet • Medical devices specific test applications. • Microelectronics The ElectroForce 3330 • Elastomers table-top configuration is a • Fibers, foils, and films clean stand-alone package. • Small components • Compliant bio-tissues • Foods and fluids (rheology) Table-top 3330 Series II Test Instrument 3200 Series II Test Instrument with Saline Bath ElectroForce ElectroForce 3100 Test TestBench Instruments Instrument for the Laboratory, TestBench configurations were designed with component testing in mind, and thanks to their modular approach, a Office or Classroom wide array of configurations and performance capabilities Measuring less than 51.8 cm tall, the ElectroForce 3100 are possible. test instrument is the smallest in the ElectroForce product family. The 3100 will fit on a desk or table-top, and it is extremely lab friendly thanks to its practically maintenance-free operation. The 3100 instrument is well-suited for micro-characterization of materials and devices because of its exceptional control resolution up to 22 N maximum static force.

ElectroForce 200 N Motor with Reaction Bracket TestBench systems can be multi-channel and multi-axis. The WinTest® PCI controller can provide control for up to eight channels at a time. Reaction brackets are pre-designed to allow attachment of components or the test specimen to the mounting baseplate. In addition, a saline bath can be provided as an environmental option. For more information on these configurations, refer to the ElectroForce 3100 Test Instrument ElectroForce TestBench brochure.

12 ElectroForce® Floor-Standing Test Instruments ElectroForce 3330 Series II Floor-standing Configuration The ElectroForce® 3330 Series II test instrument is available as a table-top configuration or a floor-standing model. The floor-standing model provides additional versatility, such as the ability to incorporate a torsional motor for multiaxial test applications. It provides 100 Hz performance with a dynamic load envelope of ± 3000 N, and the capability to add an optional ± 24 N-m or ± 50 N-m torsional package. The system includes the enhanced measurement capability of the Bose® High Accuracy Displacement Sensor. This enables an even wider range of testing by improving low-amplitude displacement measurements, all through a single, easy-to-use displacement channel. The robust load frame was designed with versatility in mind. The spacious 40.6 cm wide by 50.0 cm high test space is easily adjusted using an integrated lift. In addition, the axial/torsion test instrument can be integrated with a hot/cold environmental chamber, thereby providing advanced test capabilities for a variety of engineered materials under realistic service conditions. Typical test applications: • Automotive components • Orthopaedic implants • Prosthetics • Fracture mechanics • Consumer products • Cyclic fatigue studies • Component durability

Floor-standing Axial/Torsion 3330 Series II Test Instrument with Hot/Cold Chamber

ElectroForce 3500 Configurations ElectroForce 3500 test instruments are available in three basic system configurations. The 3510 instrument, rated at 7.5 kN, is configured with the linear motor installed in the upper crosshead, making it well-suited for applications requiring a temperature-controlled bath. The 3520 instrument is rated at 7.5 kN, and the linear motor is installed in the lower baseplate. The 3550 instrument is a higher-force configuration rated at 15 kN. These systems can perform tests over a wide frequency range, providing versatility for a range of mechanical tests. Dynamic performance is dependent upon test specimen characteristics, fixtures, and test parameters. Torsion motor options are also available for all of the 3500 configurations.

Typical test applications: • Fatigue and general durability • Engineered materials property determination for elastomers, polymers and composites • Automotive and aerospace materials and components • Orthopaedic materials and implants • Consumer products, including sports equipment, household items and electronics ElectroForce 3510 ElectroForce 3550 Test Instrument Test Instrument

13 ElectroForce® Table-Top Test Instruments

Instrument Model: 3100 3200 3330 3510 3520/3550 Series II Series II

Electromagnetic Load Capacity: Peak/max sine ± 22 N ± 225 N ± 3000 N ± 7500 N ± 7500 N - Model 3520 High force option NA ± 450 N NA N/A ± 15000 N - Model 3550

Static or RMS (continuous) ± 22 N ± 160 N ± 2100 N ± 5300 N ± 5300 N - Model 3520 High force option NA ± 320 N NA N/A ± 10600 N - Model 3550 Displacement1: 5 mm 13 mm 25 mm 50 mm 50 mm

Electromechanical Option: NA 50 mm 150 mm NA N/A Note: Electromechanical actuator provides static test capability, slack/creep compensation and ease of test setup. Linear Velocity: Minimum2: 0.0025 μm/s 0.0065 μm/s 0.013 μm/s 0.025 μm/s 0.025 μm/s Maximum3: 1.0 m/s 3.2 m/s 2.0 m/s 1.5 m/s 1.5 m/s Frequency: Minimum: 0.00001 Hz 0.00001 Hz 0.00001 Hz 0.00001 Hz 0.00001 Hz Maximum3: 100 Hz 200 Hz 100 Hz 100 Hz 50 Hz DMA3,4,5: 75 Hz 150 Hz 75 Hz 40 Hz 35 Hz Note: Performance curves are available upon request. Dimensions (H/W/D)6: Height 51.8 cm 90.0 cm 122 cm 270 cm 250 cm Width 29.2 cm 50.2 cm 61 cm 99 cm 85 cm Depth 17.2 cm 48.3 cm 56 cm 82 cm 82 cm Weight: 18 kg 80 kg 118 kg 1050 kg 750 kg Test Space Size7: 0 to 165 mm 0 to 417 mm 0 to 525 mm 0 to 1000 mm 0 to 1000 mm 0 to 830 mm optional Torsional Motor Option: Standard Peak/max NA ± 5.6 N-m ± 24 N-m ± 49 N-m ± 49 N-m Static or RMS (continuous) NA ± 5.6 N-m ± 24 N-m ± 42 N-m ± 42 N-m High Torque Option Peak/max NA NA ± 49 N-m N/A ± 70 N-m Static or RMS (continuous) NA NA ± 42 N-m N/A ± 50 N-m Rotation NA Multi-turn Multi-turn Multi-turn Multi-turn (± 10 revolutions max) (± 10 revolutions max) (± 10 revolutions max) (± 10 revolutions max)

1 Series II systems include the Bose® High Accuracy Displacement Sensor and are calibrated to ASTM E-2309, Class A. 2 Slower velocities attainable with optional high resolution displacement transducers. 3 Varies depending on test protocol, fixture mass and specimen stiffness. 4 Optional Dynamic Mechanical Analysis (DMA) software. 5 DMA performance specification applies to base system. 6 Dimensions can vary with optional features. 7 Space between load cell and motor shaft for axial configurations. Test space may be reduced with other options. Specifications are subject to change Applications and Fixtures Bose carries an extensive line of test equipment accessories. ElectroForce test instruments can be integrated with a variety of specimen fixtures, measurement transducers, environmental chambers and saline baths. Contact the ElectroForce Systems Group for test frame options and accessory packages to meet your specific testing needs.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 14 ElectroForce® Series 7 Software

Easy-to-use, Intuitive Software

Advanced Testing Capabilities

Bose is pleased to announce the availability of new versions of its Industry-leading software for ElectroForce® test instruments. Research and product development organizations today are under more and more pressure to improve their testing productivity, and Bose has focused its efforts on implementing new ease-of-use and applications-oriented capabilities to address that critical need. ElectroForce Series 7 software incorporates a new version of the WinTest® control system and an accompanying new release of Dynamic Mechanical Analysis (DMA) software. The software is compatible with the Microsoft Windows® 7 operating system, allowing customers to benefit from its new features and improve the efficiency of their testing programs.

WinTest® 7 Controls

WinTest controls include advanced WinTest software and PCI control electronics to provide data acquisition, waveform generation and instrument control in one comprehensive package. WinTest 7 software, which runs on a desktop personal computer under the Microsoft Windows 7 environment, features new user windows that better organize test flow and test setup while providing additional advanced capabilities. WinTest 7 controls incorporates new conditional branching functions that allow the creation of complex test programs, providing more intelligent test control. In addition, the software includes an optional Advanced Security Suite to facilitate compliance with current industry standards for data security in the medical device industry and product development.

WinTest 7 DMA Software

A new version of Dynamic Mechanical Analysis (DMA) software is available with the release of the WinTest 7 controller. Bose® DMA software provides a flexible platform for advanced viscoelastic property measurement for a variety of materials, including engineered materials, such as elastomers, composites as well as biomaterials. WinTest 7 DMA software provides improved test control and analysis, including online test status graphics and better test metrics, enhancing the capabilities of ElectroForce test instruments for dynamic mechanical analysis applications.

15 Overview of WinTest® 7 Controls

The latest version of WinTest® controls has several new ease-of-use and applications-oriented capabilities to address test laboratory needs for added efficiency and faster results. WinTest 7 software is compatible with and uses many of the new capabilities of Microsoft’s Windows 7 operating system, allowing customers to benefit from the new capabilities of Windows 7. This section highlights some of the new capabilities and benefits of the WinTest 7 software.

Test Setup Window

Through a redesign of the core WinTest software and an innovative Test Setup window, users can now focus their efforts on the essential steps to create an efficient test program. The new Test Setup window organizes the workflow steps to set up and run a test, allowing users to have a simple step-by-step reference to make sure that a test is properly configured. For occasional users, the setup window provides a quick-start checklist approach that improves their productivity and helps them produce higher quality test protocols.

WinTest 7 Advanced Security Suite

Conditional Branching Capabilities

Many tests can benefit from the ability to change the sequencing of test protocols, or to change loading profiles based on measured conditions. To address this need, conditional branching features have been added to WinTest 7 software. This type of intelligent test control can result in more productive testing as specimen or test conditions change. An IF-THEN-ELSE function and a GOTO function have been added to the Block Waveform module in WinTest software. Protocol changes can be made based upon channel value, channel amplitude value, channel mean value, cycle count, or digital I/O state. Resulting actions include a jump to a specified program step, or a decision to carry out a system limit action. This capability along with a Repeat function allows the creation of complex test programs, greatly enhancing the capabilities of WinTest software.

16 Amplitude Control Performance Improvements The WinTest® real-time controller has been enhanced to allow over-programming of the amplitude magnitude while in test amplitude control, allowing increased dynamic performance to be achieved from Bose® linear motors. This capability provides significant extension of the dynamic response of ElectroForce® test instruments for periodic test waveforms. Relative Move This feature adds the capability to program the WinTest function generator to output a waveform with values relative to a value in another control mode. The test system can, for example, now be programmed to apply a preload in load control and then cycle in displacement control a relative amount about the position resulting from the preload. This eliminates the need to know the absolute position value after the preload is applied. The relative move capability can greatly simplify test setup and execution, leading to more efficient test programs.

Enhanced Test Layout WinTest 7.1 software now allows multiple instances of the on-screen scope to provide the ability to view the test status and progress as a function of different time base (total test progress in addition to current test condition), or as force versus displacement (hysteresis loop) or different control channels (force or torque or temperature, etc.). Bose has also added easy docking of meters to provide consistent sizing and easy grouping of meters within the WinTest project window, and the ability to save and open existing test layouts (scope and meters) to improve the consistency of user interface bewtween test configurations.

Enhanced Test Status Monitoring

This new feature adds the capability to program the WinTest function generator to output a waveform with values relative to a value in another control mode. The test system can, for example, now be programmed to apply a preload in load control and then cycle in displacement control a relative amount about the position resulting from the preload. This eliminates the need to know the absolute position value after the preload is applied. The relative move capability can greatly simplify test setup and execution, leading to more efficient test programs.

WinTest 7 Advanced Security Suite

Data security and integrity of test files is an increasing concern for testing departments since the loss of test results could jeopardize an entire testing program. To address this need, several security-related capabilities have been added to WinTest software. User login or authentication, with automatic timeout/ lockout, had been added to the software for access security, and an additional component, history tracking, allows for critical audit trial traceability if there is a specific concern. File system security has been implemented as well to protect user test data. These features and others enable organizations to implement laboratory protocols for either internal process requirements or to be compliant with current device industry standards such as 21 CFR Part 11. 17 WinTest® 7 DMA Software A new version of the WinTest® Dynamic Mechanical Analysis (DMA) software is also available with the release of the WinTest 7 controller. DMA software from Bose allows the user to easily define a series of test conditions that are then systematically applied to a test specimen. These test conditions allow the user to explore changes in material or component properties with respect to a variety of frequency, amplitude or temperature parameters. WinTest 7 DMA software provides improved test control and analysis, including an online test status display that enhances the capabilities of ElectroForce® test instruments for dynamic mechanical analysis applications.

Improved Test Control WinTest 7 DMA software utilizes improved amplitude control algorithms that provide better stability for a variety of test specimens. The DMA test controller provides a gradual change of amplitude from one test condition to another to better handle specimen conditions.

Online Test Status Graphics A new online test status window has been added to provide calculated information such as modulus, stiffness and tan delta as each test condition sequence completes. The test status window is similar to the post test analysis format, and provides valuable information as the DMA test is progressing. Based on the information shown, it can be confirmed that the test is proceeding as planned.

Improved Analysis An improved algorithm for Fourier analysis provides better resolution, thereby providing a more accurate determination of material phase and amplitude in response to applied test conditions. These parameters are critical for accurate and repeatable material property characterization, increasing the quality of property analysis.

Better Test Metrics During the DMA test, it is important to confirm that the quality of the control and measurement is sufficient to provide reliable material property data. As the test is progressing, measurements of the true harmonic distortion of load and displacement are periodically calculated to provide an indication of the quality of the excitation and measurement. The capabilities in WinTest 7 DMA software are focused at improving the productivity of a variety of DMA test applications. Every step of the way, valuable information is provided to confirm that the DMA test is progressing in a proper manner. With these on-line measurements, the DMA software enhances the ability of ElectroForce® test instruments to serve as a versatile tool for dynamic mechanical analysis.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. Other trademarks are property of their respective owners. 022613 18 ElectroForceElectroForce®® 31003100 TestTest InstrumentInstrument

Performance and Durability in a Compact Package

Measuring less than 20 inches tall, the ElectroForce® 3100 test instrument is the smallest in the ElectroForce product family. Like all ElectroForce test instruments, the 3100 is extremely lab friendly thanks to its practically maintenance-free operation. With its compact size, whisper-quiet operation and energy-efficient design, the 3100 test instrument will fit on any tabletop and can be plugged into a standard wall outlet. Due to its exceptional control resolution, the 3100 test instrument is well-suited for: • Tissue mechanics research • Micro-indentation of cartilage and soft tissue • Mechanical stimulation of tissue-engineered constructs • Individual fiber testing • BioMEMS evaluation and testing • Durability testing of medical devices • Dynamic Mechanical Analysis (DMA) Bose® ElectroForce Linear Motor The ElectroForce 3100 instrument utilizes the performance and resolution of the ElectroForce linear motor. The proprietary motor utilizes a simple and durable moving-magnet design to achieve the proper performance for many low-force applications. ElectroForce® 3100 Test Instrument WinTest® Controls WinTest® controls set the standard for dynamic mechanical fatigue testing. WinTest software provides an intuitive interface that enables the user to efficiently set up tests. The software features a fully integrated display that simplifies test operation while providing advanced test capabilities. Data acquisition, waveform generation and instrument control are all provided within this comprehensive package. Example of Minimum Displacement and Force Control with the ElectroForce® 3100 Test Instrument

Note: Tests conducted with 50 g force and ± 50 μm displacement transducers to show system capability. These transducers are not included in the standard system configuration.

19 ElectroForce® Test Instrument

Higher Resoultion Accessories and Fixtures The base configuration of the ElectroForce® 3100 test Bose carries an extensive line of test equipment instrument provides 22 N of linear force with 20 G accessories including a wide range of grips and fixtures, acceleration and frequency response to 100 Hz. The high transducers, environmental chambers and software resolution transducer configuration combines a 250 options, such as Dynamic Mechanical Analysis. Contact Bose gram force transducer, and a 1.0 mm full scale (± 500 μm) to discuss customized options for your ElectroForce 3100 test displacement transducer, to enhance control resolution in instrument. force and displacement.

Performance

Configuration Specifications

Maximum dynamic or static force capacity: ± 22 N (5 lb)

Minimum controllable peak-to-peak force: 6 mN (0.001 lb)

Minimum controllable peak-to-peak displacement: 0.0015 mm (0.00006 in)

Stroke: 5 mm (0.2 in)

Maximum frequency: 100 Hz

Specifications

Input Power: 115/230 VAC 7.0 in

Horizontal test space size: 178 mm (7.00 in)

Weight: 18 kg (40 lb) 20.4 in 9.9 in 8.0 in

Vertical test space size: 178 mm (7.00 in) (203 mm (8.00 in) without load cell)

Dimensions (H/W/D): 500 mm / 300 mm / 178 mm (19.38 in / 11.50 in / 7.00 in)

6.8 in 11.5 in

Other ElectroForce instrument configurations are also available. See our ElectroForce and TestBench product brochures, or contact an applications engineer at 1-866-TESTING (1-866-837-8464) for more information. Optional horizontal and inverted Specifications are subject to change configurations are available.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 20 ElectroForceElectroForce®® 32003200 SeriesSeries IIII TestTest InstrumentInstrument

ElectroForce® test instruments incorporate proprietary Bose® linear motion technologies and WinTest® controls to provide a revolutionary approach to mechanical fatigue and dynamic characterization. The ElectroForce family of test instruments provides a full range of force and performance capabilities for a variety of test applications. The 3200 Series II test instrument may be configured for 225 N or optionally, 450 N maximum force capacity. The system has a wide bandwidth, capable of performing tests from static conditions to cyclic tests up to 200 Hz.

First in the Material Testing Industry

The Bose High Accuracy Displacement Sensor is the first use in the material testing industry of a new technology that provides displacement resolution of a nanometer and accuracies in the range of microns. This allows for reliable tests of 10x smaller displacement amplitudes over the full range of motion of the system with no additional sensors required.

ElectroForce® 3200 Series II Axial Configuration

Applications Test Types Low amplitude testing accuracy is a growing need for research and product The design of new materials and products requires development applications such as: a thorough assessment of material properties and complete performance evaluation within the • Biomaterials intended end-use service environment. A variety • Medical devices of basic and advanced testing techniques are • Compliant biological tissues available in the 3200 to meet this need. • Microelectronics • Elastomers • Tension/Compression • Fibers, foils, and films • Bending • Small components • Stress Relaxation • Foods and fluids (rheology) • Torsion • Creep • Shear • Pulsatile

21 Important Features and Benefits What’s New

• Proprietary linear motor operates without friction, an important Series II feature for high resolution, low-force testing • Efficient, direct electromagnetic conversion to force, resulting in Features greater acceleration, high frequencies and high velocities Accuracy – Exceeds ASTM E-2309’s • Intuitive software design to simplify test setup and a flexible toughest standard, Class A hardware platform for changing test needs Resolution – Unparalleled 1 nm resolution • Powered from a standard electrical outlet, requiring no additional infrastructure, air conditioning or water cooling Noise – Over 10x improvements in noise • Air-cooled, clean-room compatible and whisper-quiet operation in Responsiveness – Reduced signal latency compact, space-saving packages results in significantly improved controls • Energy efficient and environmentally friendly by using responsiveness pollution-free and non-toxic technologies Absolute displacement measurement – • Lifetime Customer Support with free Technical Support and High resolution and absolute satisfaction guaranteed. measurement with a single sensor

Engineered Materials

Bose® ElectroForce® test instruments perform a broad range of materials testing tasks. These requirements range from simple static tests used to acquire tensile, compressive or bending data, to more complex fatigue and fracture mechanics testing applications often found in the following industries and application areas; • Electronics and Microelectronics • Smart Materials • Automotive • Aerospace • Universities and National Labs • Polymers, Plastics, and Composites • Tire and Rubber ElectroForce testing systems provide a multi-purpose, high performance, clean and reliable product platform that’s well-suited for use in research activities where mechanical testing is required. Optional Bose DMA software provides the capability for a Bose ElectroForce materials testing system to do double duty as a DMA/DMTA 3200 DMA System with Hot/Cold Chamber instrument with much higher force and displacement capability than what traditional DMA instruments offer, allowing larger specimens to be tested for DMA properties.

DMA of Elastomers Electronics Fatigue Flex Fatigue Testing of Tire Cord Thin Film or Filament 22 Biologics

The majority of the biomaterials testing applications of our customers have some unique feature. It may be the type of loading that needs to be applied, the measurements taken, the test setup in the software, the fixtures required for sample attachment, or the environmental conditions provided during the test. These challenges coupled with the Bose team’s application expertise have led to the design and development of a wide breadth of biomedical materials testing solutions. Examples include: • Bone and Cartilage • Tendon and Ligament • Spine • Dental • Blood Vessels and Heart Valves • Pericardium and Heart Muscle • Hydrogels and Scaffolds • Skin and other Native Tissues and Organs • Tissue-engineered Construct Stimulation and Characterization

Whether your test specifications require replication of physiological or pathological 3200 with BioDynamic® Option conditions or other regulatory inputs, Bose strives to offer complete materials testing solutions either through our large selection of existing capabilities or through the development of customized products and services.

3 Point Bend of Bone Orally Disintegrating Heated Saline Electronically Cooled BioDynamic Tablet Environment Tissue Grips Environment Medical Devices

• Septal Occluders • Dental Implants • Stents and Grafts • Small Joint Implants • Nitinol Structures • Sutures • Aneurysm Clips • Contact Lenses • Percutaneous Heart Valves • Biosensors • Annuloplasty devices • Vena cava filters and structures

Bose has configured a multi-specimen test system utilizing the versatility of the ElectroForce 3200 test instrument. These uniaxial dynamic systems, configured with multi-specimen fixtures, employ dynamic linear motors that achieve high frequency load or displacement control to simulate stress levels of specific materials or specific geometries or design areas of the medical devices.

3200 with MSF Option

23 ElectroForce® 3200 Test Instrument Configurations

This table-top test instrument is readily adaptable for a variety of testing applications.

3220 Base System 3230 Base System Torsion Option Extended Stroke (ES) Option BioDynamic® Option

Force Capacity Force Capacity Torque Capacity Force Capacity Force Capacity Peak/max sine : ± 225 N Peak/max sine : ± 450 N Peak/max sine : ± 5.6 N-m Equals base system Peak/max sine : ± 200 N Static or RMS: ± 160 N Static or RMS: ± 320 N (continuous) (continuous) Frequency Frequency Frequency Frequency Frequency 0.00001 - 200 Hz 0.00001 - 200 Hz 0.00001 - 100 Hz 0.00001 - 5 Hz 0.00001 - 20 Hz DMA max: 150 Hz DMA max: 150 Hz DMA: NA DMA max: 80 Hz DMA max: 10 Hz Displacement Displacement Rotation Displacement 12.5 mm 12.5 mm +/- 10 revolutions 150 mm Pulsatile Loading Motor Velocity Motor Velocity Motor Velocity Motor Velocity Static to 3.2 m/s Static to 3.2 m/s Static to 6000 deg/s Static to 60 mm/s Pulse Volume Min Ramp Rate Min Ramp Rate Min Ramp Rate Min Ramp Rate 8.8 mL/pulse 0.0065 micron/s 0.0065 micron/s 0.0036 deg/s 0.0065 micron/s Pressure Test Space Size Test Space Size Test Space Size Test Space Size 0-500 mmHg Vertical = 0 - 41.7 cm Vertical = 0 - 41.7 cm Vertical = 0 - 33.2 cm Vertical = 0 - 31.8 cm Mean Flow Horizontal = 35.5 cm Horizontal = 35.5 cm Horizontal = 35.5 cm Horizontal = 35.5 cm 17 - 1760 mL/min Facility Information Height=100 cm, Width=50.2 cm, Depth=48.3 cm. Torsion and ES options add 10 cm to the frame height. Weight=73kg. 3230 adds 2 kg to the base system. Torsion and ES options add 7 kg to the base. *Specifications are subject to change Software and Accessory Options

Bose carries an extensive line of test equipment accessories. ElectroForce® test instruments can be integrated with a variety of specimen fixtures, measurement transducers, environmental chambers, saline baths and optional software. Contact the ElectroForce Systems Group for test frame options and accessory packages to meet your specific testing needs.

Grips/platens Sensors Tension/Torsion Grips Force/Torque Wedge Grips Displacement/Rotation DMA Grips Strain Tissue Grips - Thermal-Electrically Cooled Pressure BioDynamic® Tensile Grips Chemical Compression Platens BioDynamic Compression Platens Fixtures and Chambers 3 and 4 Point Bend Software Options Multispecimen Fixture Advanced Security Suite Saline Baths Dynamic Mechanical Analysis BioDynamic Chamber 3200 System with Torsion Option and Saline Dynamic Link Libraries Hot/Cold Chambers Advanced Function Generation

Digital Video Extensometer Lifetime Customer Support

We’re committed to your testing success, and Bose has taken this commitment to a new level by offering free technical phone and E-mail support so you can keep your testing program moving forward. Timely and effective technical support can be critical to reach your testing goals. When you need help, we want to to to make it easy to get answers. • Commitment to on-time instrument delivery • Timely installation provided by our qualified field engineer team • Thorough training during installation to assure your testing productivity • Ongoing live web training classes for new users without charge

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 24 ElectroForceElectroForce®® 33303330 SeriesSeries IIII TestTest InstrumentInstrument

ElectroForce® test instruments incorporate proprietary Bose® linear motion technologies and WinTest® controls to provide a revolutionary approach to mechanical fatigue and dynamic characterization. The ElectroForce family of test instruments provides a full range of force and performance capabilities for a variety of test applications. The 3330 system provides static to 100 Hz performance with a load envelope of ±3000 N, allowing versatile performance for a variety of test applications such as durability testing of orthopaedic implant devices and dynamic characterization of engineered materials and components.

First in the Material Testing Industry

ElectroForce® 3330 Series II Table Top and Floor Standing Configurations

Applications Test Types The ElectroForce Series II 3330 test instrument is well-suited for a variety The design of new materials and products requires of tests that include ASTM and ISO a thorough assessment of material properties and standards tests for: complete performance evaluation within the intended end-use service environment. A variety • Automotive components of basic and advanced testing techniques are • Fracture mechanics available in the 3330 to meet this need. • Component durability • Orthopaedic implants • Tension/Compression • Consumer products • Bending • Prosthetics • Stress Relaxation • Cyclic fatigue studies • Torsion • Creep • Shear • Pulsatile

25 Important Features and Benefits What’s New

• Proprietary linear motor operates without friction, an important Series II feature for high resolution, low-force testing • Efficient, direct electromagnetic conversion to force, resulting in Features greater acceleration, high frequencies and high velocities Accuracy – Exceeds ASTM E-2309’s • Intuitive software design to simplify test setup and a flexible toughest standard, Class A hardware platform for changing test needs Resolution – Unparalleled 1 nm resolution • Powered from a standard electrical outlet, requiring no additional infrastructure, air conditioning or water cooling Noise – Over 10x improvement in noise • Air-cooled, clean-room compatible and whisper-quiet operation in Responsiveness – Reduced signal latency compact, space-saving packages results in significantly improved controls • Energy efficient and environmentally friendly by using responsiveness pollution-free and non-toxic technologies Absolute displacement measurement – • Lifetime Customer Support with free Technical Support and High resolution and absolute satisfaction guaranteed. measurement with a single sensor

Engineered Materials

Bose® ElectroForce® test instruments perform a broad range of materials testing tasks. These requirements range from simple static tests used to acquire tensile, compressive or bending data, to more complex fatigue and fracture mechanics testing applications often found in the following industries and application areas: • Electronics and Microelectronics • Smart Materials • Automotive • Aerospace • Universities and National Labs • Polymers, Plastics, and Composites • Tire and Rubber ElectroForce testing systems provide a multi-purpose, high performance, clean and reliable product platform that’s well-suited for use in research activities that require mechanical testing. Optional Bose DMA software provides the capability for a Bose ElectroForce materials testing system to do double duty as a DMA/DMTA instrument with much higher force and displacement capability than what traditional DMA instruments offer, allowing larger specimens to be tested for DMA properties.

3330 DMA System with Fracture Mechanics Tensile Test of Metals Axial/Torsion Vibration Hot/Cold Chamber of Composites or Polymers of Composites Isolation Device 26 Biologics

The majority of the biomaterials testing applications of our customers have some unique feature. It may be the type of loading that needs to be applied, the measurements taken, the test setup in the software, the fixtures required for sample attachment, or the environmental conditions provided during the test. These challenges coupled with the Bose team’s application expertise have led to the design and development of a wide breadth of biomedical materials testing solutions. Examples include: • Bone and Cartilage • Hydrogels and Scaffolds • Tendon and Ligament • Skin and other Native Tissues • Spine and Organs • Dental • Tissue-engineered Construct • Blood Vessels and Heart Valves Stimulation and Characterization • Pericardium and Heart Muscle

Whether your test specifications require replication of physiological or pathological conditions or other regulatory inputs, Bose strives to offer complete materials testing solutions either through our large selection of existing capabilities or through the development of customized products and services. 3330 with Dental Wear Fixture

Compression of Dental Wear Electronically-cooled Hydrogel Tissue Grips Medical Devices

ElectroForce® multi-specimen fatigue testing systems can be used for high cycle fatigue life characterization of coronary and vascular device structures, and evaluation of device materials for s/n curve development. In addition, the test systems can provide controlled loading for small soft structures and devices such as: • Septal Occluders • Vena Cava Filters and Structures • Stents and Grafts • Dental Implants • Nitinol Structures • Small Joint Implants • Aneurysm Clips • Sutures • Percutaneous Heart Valves • Contact Lenses • Annuloplasty Devices • Biosensors

Bose has configured a multi-specimen test system utilizing the versatility of the ElectroForce 3330 test instrument. These uniaxial dynamic systems, configured with multi-specimen fixtures, employ dynamic linear motors that achieve high frequency load or displacement control to simulate stress levels of specific materials or specific geometries or design areas of the medical devices.

3330 with Multi-Specimen Fixture

Joint Implant Dental Implant Spine Fixation 27 ElectroForce® 3330 Test Instrument Configurations

3330 Base System 3330 Torsion Option 3330 High Torque Option (table top) (floor standing) (floor standing) Force Capacity Torque Capacity Torque Capacity Peak/max sine: ± 3000 N Peak/max sine: ± 24 N-m Peak/max sine: ± 49 N-m Static or RMS: ± 2100 N Static or RMS: ± 24 N-m Static or RMS: ± 42 N-m (continuous) (continuous) (continuous) Frequency Frequency Frequency 0.00001 - 100 Hz 0.00001 - 100 Hz 0.00001 - 100 Hz DMA max: 75 Hz DMA max: NA DMA: NA Displacement Rotation Rotation 25 mm +/- 10 revolutions +/- 10 revolutions Motor Velocity Motor Velocity Motor Velocity Static to 2.0 m/s Static to 6000 deg/s Static to 6000 deg/s Min Ramp Rate Min Ramp Rate Min Ramp Rate 0.013 micron/s 0.0036 deg/s 0.0036 deg/s Test Space Size Test Space Size Test Space Size Vertical = 0 - 52.5 cm Vertical = 0 - 43 cm Vertical = 0 - 43 cm (with load cell) (with load cell) (with load cell) Facility Information Table top dimensions: Height = 123 cm, Width = 62 cm, Depth = 44 cm. Floor standing option: Height = 185 cm, Width = 70 .5 cm, Depth = 56 cm. Extended column option: adds 30 cm to the test space and frame height. Weight = 118 kg. Extended column adds 6 kg to the base system. Floor standing torsion options add approximately 130 kg to the base. *Specifications are subject to change

3330 System with Torsion Option Software and Accessory Options and T-slot

Grips/platens Sensors Tension/Torsion Grips Force/Torque Wedge Grips Displacement/Rotation DMA Grips Strain Tissue Grips - Thermal-Electrically Cooled Pressure BioDynamic® Tensile Grips Chemical Compression Platens BioDynamic Compression Platens Fixtures and Chambers 3 and 4 Point Bend Software Options Multispecimen Fixture Advanced Security Suite Saline Baths Dynamic Mechanical Analysis BioDynamic Chamber Dynamic Link Libraries Hot/Cold Chambers Advanced Function Generation Digital Video Extensometer

Lifetime Customer Support

We’re committed to your testing success, and Bose has taken this commitment to a new level by offering free technical phone and e-mail support so you can keep your testing program moving forward. Timely and effective technical support can be critical to reach your testing goals. When you need help, we want to to to make it easy to get answers. • Commitment to on-time instrument delivery • Timely installation provided by our qualified field engineer team • Thorough training during installation to assure your testing productivity • Ongoing live web training classes for new users without charge

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 28 ElectroForce® Extended Stroke Test Instruments

Exceptional versatility, unlimited applications

Bose Corporation’s ElectroForce Systems Group introduces two new long stroke test systems: the ElectroForce® 3200-ES (Extended Stroke) Series II test instrument and the ElectroForce LM1-ES TestBench test instrument. The fidelity, control and dynamic performance you expect from a Bose® test instrument is now available with over 160 mm of displacement in a single instrument. This capability is highly attractive for a variety of high-strain materials test applications. Product Overview

The new ElectroForce ES instruments combine two electromagnetic linear motor technologies to increase the range of displacement available on the ElectroForce 3200 and LM1 TestBench by more than a factor of 10. The ES motor is mounted in the moveable crosshead of a 3200 test frame or, alternatively, it can be mounted on a TestBench reaction base. In both instances, the ES actuator replaces the microadjustor, which is typically used for positioning of the specimen, and opposes the ElectroForce motor. ElectroForce® 3200 Extended Stroke Test Instrument

1 µm

50 µm peak-to-peak Waveform with an Force vs. Displacement Curve with an ElectroForce® Series II 3200 Test Instrument ElectroForce® 3200 Extended Stroke Test Instrument Extended Stroke System Benefits

High-fidelity Performance Real-time Test Control High accuracy, dynamic response Independent or synchronous with over 160 mm of displacement control of the two actuators using advanced WinTest® controls

Ease-of-use Versatility Flexible test setup for a wide The extended stroke actuator upgrade can range of applications in a single be retrofitted onto any existing ElectroForce table-top system 3200 or TestBench instrument

29 Application Overview

The ElectroForce® ES family of instruments provides more than 160 mm of testing displacement that is beneficial for biomaterials and soft tissue applications in which high strains are often expected. In addition, there are many traditional material testing applications in which the ES motor is also advantageous. Applications include the characterization of materials such as: • Soft tissues including tendons and ligaments • Compliant biomaterials including tissue engineered scaffolds • Engineered polymers • Rubbers and elastomers • Thin films and membranes

Preconditioning (10 Hz) and Pull-to-failure Test of PCL Scaffold

LM1-ES TestBench Test Instrument

Flexible, Real-time Controls

WinTest® 7 controls provide the flexibility to utilize the ES motor in conjunction with the ElectroForce motor or independently, depending on the application. When used together, the ElectroForce and ES motors can be used to conduct cyclic creep tests in which the LM1 motor applies a cyclic force (2 – 200 Hz) to the sample and the ES motor compensates for elongation that occurs during the test. WinTest 7 control software enables the user to program a block waveform, utilizing the conditional branching feature, to automatically adjust as the sample creeps beyond a user-defined value.

WinTest Block Waveform Cyclic Creep Compensation Setup with Conditional Branching

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613

30 ElectroForce® 3510 Test Instrument

Versatility, Exceptional Performance and very Lab Friendly

ElectroForce® test instruments from Bose provide exceptional fidelity, precision and versatility for a variety of test applications. The ElectroForce 3510 test instrument features a 7.5 kN dynamic force capability, and has the largest range of displacement of all the ElectroForce instruments. Dynamic performance is dependent on test specimen characteristics, fixturing and test specimen configuration.

Typical test applications for the ElectroForce 3510 test instrument: • Orthopaedic materials and implants

• Engineered materials, including reinforced plastics and composites

• Automotive and aerospace components

• Elastomeric components and materials

• Consumer products, including sports equipment, household items and electronics.

Advantages and benefits of the ElectroForce 3510 test instrument: • Versatility for a variety of mechanical fatigue and dynamic characterization tests

• The linear motor subsystem is powered from a standard electrical outlet, requiring no additional infrastructure

• The load frame is air-cooled, clean-room compatible and provides quiet operation in a compact, space-saving package

• The ElectroForce linear actuator uses direct electromagnetic conversion to apply force, and features a proprietary design to provide greater ® acceleration, higher frequencies and high velocities ElectroForce 3510 Axial/Torsion Test Instrument • An optional ± 49 N-m torsional motor is available for multi-axial test applications.

31 ElectroForce® 3510 Test Instrument Dynamic Performance Curves: Figure 1: This plot shows estimated Bose® linear motor performance for single sided (tension-tension) or (compression-compression) tests. Figure 2: This plot shows estimated Bose linear motor performance for fully reversed (tension-compression) tests. Figure 3: This plot shows estimated performance of torsion actuator option for tests with peak to peak displacements up to 360°. Figure 4: This plot shows estimated performance of torsion actuator option for tests with peak to peak displacements Figure 1 up to 60°. Figure 2

Figure 3 Figure 4 Note: Actual attained force and frequency is dependent on test conditions, specimen, grips and environment.

General Specifications: • 7.5 kN (1,685 lb) dynamic force capability • 50 mm (2 in) displacement range • Maximum test space height 1000 mm (39 in) • Test space width 558 mm (22 in) 2.7 m (8.9 ft) • 208 - 230 V (400 V Europe) three phase power 8 ft - 10 in Max at 39 in Test Space ElectroForce Test Instrument Overview: ElectroForce® test instruments incorporate proprietary Bose linear motor technologies and WinTest® controls. WinTest software features an intuitive design which enables the user to quickly set up tests with little training. The ElectroForce linear motor utilizes a simple and durable moving-magnet design that provides excellent dynamic performance. ElectroForce .99 m .81 m 39 in 32 in test instruments are also lab-friendly thanks to their practically maintenance-free operation. As a result, they have set a new ElectroForce® 3510 Test Instrument standard for performance, simplicity and elegance in a single test system. Specifications are subject to change

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 32 ElectroForce® 3520 Test Instrument

Versatility, Exceptional Performance and very Lab Friendly

ElectroForce® test instruments from Bose provide exceptional fidelity, precision and versatility for a variety of test applications. The ElectroForce 3520 test instrument features a 7.5 kN dynamic force capability, and has 50 mm displacement range. Dynamic performance is dependent on test specimen characteristics, fixturing and test specimen configuration.

Typical test applications for the ElectroForce 3520 test instrument: • Engineered materials, including reinforced plastics and composites

• Automotive and aerospace components

• Elastomeric components and materials

• Consumer products, including sports equipment, household items and electronics.

Advantages and benefits of the ElectroForce 3520 test instrument: • Versatility for a variety of mechanical fatigue and dynamic characterization tests

• The linear motor subsystem is powered from a standard electrical outlet, requiring no additional infrastructure

• The load frame is air-cooled, clean-room compatible and provides quiet operation in a compact, space-saving package

• The ElectroForce linear actuator uses direct electromagnetic conversion to apply force, and features a proprietary design to provide greater acceleration, higher frequencies and high velocities

• Optional torsional motors are available for multiaxial test applications. ElectroForce® 3520 Test Instrument

33 ElectroForce® 3520 Test Instrument

Dynamic Performance Curves:

Figure 1: This plot shows estimated Bose® linear motor performance for displacement as a function of force and frequency (fully reversed loading).

Figure 2: This plot shows estimated Bose® linear motor performance for displacement as a function of force and frequency (single-sided loading).

Note: Actual attained force and frequency are dependent on test conditions, specimen, grips and environment.

General Specifications: • Dynamic force capability: 7.5 kN • Maximum frequency: 50 Hz • Displacement range: 50 mm • Test space size: 0 to 1000 mm • Maximum linear velocity: 1.5 m/sec • Power: 208 - 230 V (400 V Europe) three phase power

ElectroForce Test Instrument Overview: ElectroForce® test instruments incorporate proprietary Bose linear motor technologies and WinTest® controls. WinTest software features an intuitive design which enables the user to quickly set up tests with little training. The ElectroForce linear motor utilizes a simple and durable moving-magnet design that provides excellent dynamic performance. ElectroForce test instruments are also lab-friendly thanks to their practically maintenance-free operation. As a result, they have set a new standard for performance, simplicity and versatility in a single test system.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 34 ElectroForce® 3550 Test Instrument

Versatility, Exceptional Performance and very Lab Friendly

ElectroForce® test instruments from Bose provide exceptional fidelity, precision and versatility for a variety of test applications. The ElectroForce 3550 test instrument features a 15 kN dynamic force capability, using two linear motors in tandem, and has the largest range of displacement of all the ElectroForce instruments. Dynamic performance is dependent on test specimen characteristics, fixturing and test specimen configuration.

Typical test applications for the ElectroForce 3550 test instrument: • Engineered materials, including reinforced plastics and composites

• Automotive and aerospace components

• Elastomeric components and materials

• Consumer products, including sports equipment, household items and electronics.

Advantages and benefits of the ElectroForce 3550 test instrument: • Versatility for a variety of mechanical fatigue and dynamic characterization tests

• The linear motor subsystem is powered from a standard electrical outlet, requiring no additional infrastructure

• The load frame is air-cooled, clean-room compatible and provides quiet operation in a compact, space-saving package

• The ElectroForce linear actuator uses direct electromagnetic conversion to apply force, and features a proprietary design to provide greater acceleration, higher frequencies and high velocities

• Optional torsional motors are available for multiaxial test applications. ElectroForce® 3550 Test Instrument

35 ElectroForce® 3550 Test Instrument

Dynamic Performance Curves:

Figure 1: This plot shows estimated Bose® linear motor performance for displacement as a function of force and frequency (fully reversed loading).

Figure 2: This plot shows estimated Bose® linear motor performance for displacement as a function of force and frequency (single-sided loading).

Note: Actual attained force and frequency are dependent on test conditions, specimen, grips and environment.

General Specifications: • 15 kN dynamic force capability • Maximum frequency: 50 Hz • 50 mm displacement range • Test space size: 0 to 1000 mm • Maximum linear velocity: 1.5 m/sec • 208 - 230 V (400 V Europe) three phase power

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 36 TestBenchTestBench InstrumentInstrument

Versatility for Component and Material Testing Applications

Two Motor TestBench Instrument with Reaction Brackets for Simultaneous Testing of Two Specimens

TestBench configurations are a versatile addition to the ElectroForce® line of high performance test instruments from Bose. They were designed with component testing in mind, and thanks to their modular approach, a wide array of configurations and performance capabilities are possible. The multiple specimen inputs can be synchronized and phased with one another to provide complex loading and simulations. If your needs change, you can reconfigure your existing components or add new components or capabilities at any time. Actuator Technologies Choose the type of actuators that are best suited for your needs: ElectroForce motors for high bandwidth linear performance or rotary actuators for rotation or torque control performance.

• Bose® ElectroForce linear actuators are the same proprietary high-bandwidth, low-distortion actuators used with ElectroForce test instruments. They feature “plug-in-the-wall” operation, making them clean, quiet, energy efficient and practically maintenance-free.

• Rotary brushless motors are available for fine control, low torque applications. They are also available with continuous rotation for applications such as screw Four Motor Planar Biaxial TestBench Instrument insertion simulation. with Saline Bath and Digital Video Extensometer Benefits Some of the many benefits of Bose TestBench instruments include:

• The modular design allows you to choose the components and configurations to suit your testing needs in one small, compact, space-saving package

• TestBench systems can be configured for different test applications Axial-Torsion TestBench Instrument

• TestBench systems can be multi-channel and multi-axis. The WinTest® PCI controller can provide control for up to eight channels at a time.

37 TestBench Instruments Fixturing Base plates can be provided in a variety of sizes. All are supplied with a bolt pattern that makes it easier to mount the TestBench components for your desired configuration. Smaller base plates can be oriented vertically with the addition of mounting legs. Base Plate Specifications† Dimensions (W x L x T) Weight 600 x 600 x 50 mm 36 kg (24 x 24 x 2 in) (78 lb) 600 x 915 x 50 mm 55 kg Single Motor 3000 N TestBench Instrument with Reaction Bracket (24 x 36 x 2 in) (117 lb) 915 x 915 x 50 mm 84 kg (36 x 36 x 2 in) (175 lb) Transducers and Environmental Systems 508 x 1016 x 100 mm 72 kg Displacement or rotation transducers are included with each actuator, (20 x 40 x 4 in) (156 lb) and there are many options for local measurement including laser 600 x 1524 x 100 mm 128 kg micrometers, strain gages and a video extensometer. (24 x 60 x 4 in) (281 lb)

Single or multi-axis force or torque transducers are also included Reaction brackets are pre-designed to allow you to depending on the configuration. Because the use of these attach your components or test specimen to the transducers is often application specific, consult with our applications base plate in vertical or horizontal configurations. A engineers for details. microadjuster is included for easier specimen positioning.

Vertical or horizontal saline chambers can be provided to simulate Standard grips and accessories can be used to connect real life conditions for the characterization of material properties in a the specimen to the base plate or to the movers. We can 37°C environment. also customize grips for your specific test requirements.

Typical TestBench Component Specifications*

Peak Force/ Stroke/ Maximum Approximate Approximate Torque Rotation Velocity ‡ Dimensions Weight (H x W x L) ElectroForce 200 N ± 200 N ± 6.5 mm 3.2 m/s 216 x 280 x 254 mm 7.3 kg (± 45 lb) (± 0.25 in) (126 in/s) (8.5 x 11 x 10 in) (16 lb) ElectroForce 400 N ± 400 N ± 6.5 mm 3.2 m/s 236 x 305 x 361 mm 14.1 kg (± 90 lb) (± 0.25 in) (126 in/s) (9.3 x 12 x 14.2 in) (31 lb) ElectroForce 3000 N ± 3000 N ± 12.5 mm 2 m/s 361 x 356 x 457 mm 34.0 kg (± 450 lb) (± 0.5 in) (79 in/s) (14.2 x 14 x 18 in) (75 lb) Rotary Motor 5.6 N-m ± 5.6 N-m ± 3600° 3000o/s 191 x 185 x 338 mm 14.5 kg (± 50 in-lb) (± 10 revolutions) (7.5 x 7.3 x 13.3 in) (32 lb) Rotary Motor 28 N-m ± 28 N-m ± 3600° 3000o/s 330 x 381 x 508 mm 73.0 kg (± 250 in-lb) (± 10 revolutions) (13 x 15 x 20 in) (161 lb)

* Components can be combined to meet your unique testing needs. Other components available upon request. Some actuators are not compatible with other actuators. Please consult Bose for further details. † Some actuator options and applications may require alternate bases. ‡ Varies depending on test protocol, fixture mass and specimen stiffness. Specifications are subject to change

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613

38 ElectroForceElectroForce® Planar Biaxial TestBench Test Instrument

Advancing Tissue and Biomaterials Research

Biomedical researchers are constantly looking to characterize and develop constitutive models to predict the mechanical behavior of new materials and compare them to biological soft tissues. This comparison and characterization is important to the development of essential tissue replacements such as tissue-engineered heart valves. Biological and tissue-derived soft biomaterials are used for many physiological, surgical, and medical device applications where rigorous constitutive models are required.

Examples include natural and prosthetic skin, myocardium, heart valves, and blood vessels. The challenge in constitutive modeling these materials is that they often exhibit mechanical anisotropy in addition to highly non-linear Four Motor Planar Biaxial TestBench Instrument stress-strain relationships, large deformations, and with Saline Bath and Digital Video Extensometer viscoelasticity. Soft biological materials defy simple material models and require more intensive study. Bose has developed the ElectroForce® planar biaxial TestBench instrument for the characterization of such tissues and biomaterials. The instrument consists of four Bose® linear motors mounted on a horizontal baseplate and two load cells, one for each axis of loading. A heated saline bath can be added to the baseplate to provide a physiological environment, and a digital video extensometer is available for strain measurements. A simplified version of the instrument consists of two Bose linear motors and two reaction brackets as shown below.

The ElectroForce planar biaxial TestBench test instrument incorporates Bose motor technologies and WinTest® controls. The friction-free motor design offers exceptional reliability and durability resulting in practically maintenance-free operation. WinTest controls include advanced WinTest software and PCI control electronics to provide data acquisition, waveform generation and instrument control in one comprehensive package. WinTest software features a fully integrated display and user windows that simplify test operations while providing advanced capabilities such as recreation of real-life waveform profiles and multi-channel synchronization. Two Motor Planar Biaxial TestBench Instrument with Saline Bath and Submersible Load Cells Features and Benefits: • The ability to characterize mechanical properties of natural and artificial tissues in a 37°C saline bath.

• Both uniaxial and biaxial tests can be performed to aid in the research and development of constitutive models.

• Proprietary ElectroForce linear motors operate without friction, an important feature for high resolution, low-force testing.

• Two-dimensional strain is measured without contacting or damaging the soft tissue specimen while it floats in the heated saline bath.

• Load cells are provided on the X and Y axis.

39 ElectroForce® Planar Biaxial TestBench Test Instrument

The Bose® digital video extensometer uses digital video techniques along with an integrated software application to optically monitor the two-dimensional (planar) displacement relationships between five markers made on a soft specimen. Using these five markers, the extensometer software acquires the Green-Lagrange primary strain, secondary strain, and shear strain values as the specimen is subjected to a waveform via WinTest® software. The software also calculates the two principal strain values at the same time. Strain values are obtained real-time and can be recorded along with other data using WinTest’s data acquisition feature.

A major challenge in planar biaxialtesting of soft tissues and biomaterials is specimen gripping. Depending on specimen size, clamp-style or hook grips are Bose 2D Digital Video Extensometer Software available to mount samples as small as 10 x 10 mm. Customer-supplied grips and fixtures can also be integrated for specialized applications.

The combination of specimen gripping, mechanical loading and properties characterization capabilities are specifically tailored to planar biaxial testing of soft tissues and biomaterials. These capabilities coupled with the Bose linear motors that provide excellent dynamic performance and years of reliable operation make the Specimen Mounting with Hook Grips ElectroForce® planar biaxial TestBench instrument the system of choice for a variety of test applications.

Product Guide and Specifications* Four Motor Configuration Two Motor Configuration

Motors Four (4) independently controlled ElectroForce Two (2) independently controlled ElectroForce linear motors linear motors with two (2) reaction brackets

Peak Force ±200 N ±200 N Static (RMS) Force ±140 N ±140 N Displacement 25 mm 12.5 mm Displacement Transducers Four (4) Two (2) Two (2) 225 N Load Cells Lower force and/or submersible load cells are also available.*

Minimum sample length and width: 25 mm Tensile Grips Maximum sample thickness: 5 mm Minimum sample length and width: 40-50 mm Hook Grips Maximum sample thickness: 2.5 mm Maximum force: 20 N Hook grips suitable for smaller samples are also available.*

Digital video extensometer to measure primary, secondary, shear strain and principal strains • ±200% strain measurement range Non-contact Strain Measurements • 200 Hz update rate • 5 Hz maximum recommended test frequency • 0.5% strain noise band Heated saline bath with temperature sensor and controller • Room temperature to 45°C temperature range Environment • 10 L volume Low volume saline bath is also available.* Dimensions 914 mm x 914 mm x 50 mm (36 in x 36 in x 2 in) base plate

Specifications are subject to change *Note: Consult Bose about your test application.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613

40 ElectroForce® 3330 Dental Wear Simulator

Advanced Simulation of Wear Motion Profiles

The Bose® ElectroForce® 3330 test instrument can be configured with an additional horizontal ElectroForce linear actuator to simulate the masticatory cycle (chewing) for the evaluation of dental biomaterials and/or restoration techniques. Now the effectiveness of sealants or enamel replacements can be more accurately assessed in the laboratory. For example, the full potential of esthetic ceramic-based dental restorations has not yet been realized. Shaping-induced damage, exacerbated by fatigue damage during normal chewing, dramatically reduces the initial strength of these inherently brittle materials.

The ElectroForce 3330 dental wear simulator is ideal for the evaluation of the fatigue and wear characteristics of these inherently brittle materials, such as all-ceramic dental crowns. The wear simulator can effectively run hundreds of thousands of cycles for the evaluation of two-body wear investigations. The masticatory cycle can be characterized in three phases: ® 1. The preparatory phase during which the mandible is positioned ElectroForce 3330 Dental Wear Simulator 2. The crushing phase during which the molars compress the bolus 3. The gliding (grinding) phase during which the bolus is ground between the molars. The three phases of mastication operate under different system control modes. The preparatory and crushing phases (vertical motion) are accomplished under load control while the gliding phase (horizontal) is carried out in displacement control as defined by the tooth anatomy. Mastication during the gliding phase is described by eccentric contact of the mandibular buccal cusps with the inner inclines of the maxillary buccal cusps followed by the working movement to the centric occlusion.

The three-dimensional masticatory motion can be simplified into two-dimensional motion by aligning the two linear motors to the desired planes of motion. One linear motor is positioned vertically to provide frontal plane motion that is defined by the occlusal anatomy, while the second linear motor provides a straight-line approximation of horizontal motion.

Dental Wear Simulation Software Bose has developed application software to set up and accurately simulate complicated wear profiles and test conditions. The software can be used to simulate tooth wear over a variety of test situations. The wear simulation software allows the user to easily define test conditions and automatically adjust the system variables to maintain these test settings. The Designer Test Language, a proprietary Bose application tool, was used to create a user interface specifically for the wear application. It allows easy definition of the complex parameters of the test, display of the test status, and the ability to pause the test during the test execution. In addition, through the use of this software, the researcher can create wear profile templates, which can be archived and retrieved later for different test programs. This application is an excellent example of how the advanced features the WinTest® Controller can be used to accurately simulate complicated test conditions.

Tooth Sample being Tested

41 Test Software Features and Benefits Mastication is dictated by the horizontal motion that is under displacement control while the vertical actuator The application software uses a combination of advanced is under load control during the glide phase. The system features that are critical for effective simulation of wear can provide a glide phase duration ranging from 0.1 to 0.4 profiles, such as: seconds but 0.25 - 0.30 seconds is typical. Control of the • Multiaxial control and synchronization; vertical motor switches to displacement control in the preparatory and crushing phases and back to load • Ramp-to-level control mode that allows the intial control on contact with the opposing tooth during the ramp to occur in displacement control up to an gliding phase. The control loops for the ElectroForce® applied force value; linear motors are synchronized to provide accurate 2-dimensional motion mastication cycle frequencies up • Bumpless mode switch to quickly and easily change to 2 Hz. The following is a graphical representation of the from displacement to force control and back again; test sequence for the vertical axis of the test system.

• A user interface (based on the Bose® Designer Test Language), and run-time software to simplify the test setup, and to easily program the multi-axis test conditions and data acquisition.

The following plot measured by the WinTest® digital scope provides an impression for the complexity of the test conditions for simulating the masticatory cycle, and the time frame for the test sequence. In this example, the biaxial complex waveform is repeated approximately every 3 seconds.

Summary The compact ElectroForce dental wear simulator system allows researchers to perform advanced studies faster and more accurately. The simulator is ideal for the evaluation of the effectiveness of sealants and enamel replacements through wear studies, and other research Masticatory Cycle Waveform Setup that requires simulation of wear motion profiles. Vertical loading during the glide phase is accomplished by programming a load profile (waveform) to the linear motor that is under closed-loop load control. This load waveform is a haversine constant load, which closely simulates anatomical loading. Typical load profiles range from 5 - 1000 N, although the system is capable of providing up to 3000 N.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 42 ElectroForceElectroForce® Series II Multi-specimen Fatigue Test Instruments

Fatigue Testing of Nitinol Materials and Structures

To reduce time and costs for developing fatigue life (s/n) curves for NiTi, CoCr, and SS stent materials and structures, Bose has configured multi-specimen test systems utilizing the versatility of the ElectroForce® 3200 Series II and 3330 Series II test instruments. Both systems include the enhanced measurement capability of the Bose® High Accuracy Displacement Sensor. This enables an even wider range of testing by improving low-amplitude displacement measurements, all through a single, easy-to-use displacement channel. The sensor is calibrated to the highest accuracy class, Class A, of ASTM E-2309. ElectroForce multi-specimen fatigue test systems are designed to provide tension-tension, or compression-compression displacement controlled loading for small soft structures and devices, such as stents, stent structures, stented grafts, vena cava filters, septal patch structures or other similar devices. The multi-specimen loading sites and a temperature controlled saline bath are integrated into the 3200 or 3330 loading system to provide computer controlled axial displacement for all loading stations. Each loading site has an independent load cell that may be used to monitor the load on each test specimen, or for failure detection. Standard ElectroForce 3200 or 3330 Series II multi-specimen systems are available with 12 loading sites, and optional 20 site ElectroForce® 3330 Series II configurations or higher force 6 site configurations are available with longer Multi-specimen Fatigue Test Instrument delivery. ElectroForce 3200 and 3330 multi-specimen fatigue testing systems can be used for high cycle fatigue life characterization of:

• Coronary and vascular device materials for s/n curve development: - Diamond material samples - V-shaped material samples

• Coronary and vascular device structures: - Stents (vascular and heart valve) - Stent segments - Vascular graft structures/hooks/wear - Vena cava filter structures - Septal closure devices - Annuloplasty devices

37°C Circulating Saline Bath ElectroForce Test Instrument Overview: with 12 Loading Sites By incorporating proprietary Bose motor technologies and WinTest® controls, ElectroForce instruments provide exceptional fidelity, precision and versatility for a variety of test applications. The ElectroForce linear motor utilizes a simple and durable moving-magnet design that provides excellent dynamic displacement at accelerated test frequencies, and years of reliable operation. As a result, ElectroForce test instruments have set a new standard for performance, simplicity and elegance in a single test system.

43 ElectroForce® 3330 Series II and 3200 Series II Multi-specimen Fatigue Test Instruments

Performance: Dimensions:

ElectroForce 3330 Series II Loading Site Dimensions2: test instrument: • 100 mm vertical space3 • 3.0 kN capacity • 20 mm vertical adjustment at • 25 mm dynamic displacement each site4 • High Accuracy Displacement • Sites are spaced evenly around a Sensor5 200 mm specimen loading circle • 0.01 to 100 Hz • 50 mm diameter clearance space (12 sites)

ElectroForce® 3200 Series II • 30 mm diameter clearance space test instrument: (20 sites) • 225 N capacity1 • Load cells are mounted above the bath • 12.5 mm dynamic displacement • High Accuracy Displacement Sensor5 • 0.01 to >100 Hz ElectroForce® 3200 Series II Multi-specimen Fatigue Test Instrument

37°C Circulating Saline Bath with 20 Loading Sites

Bath Specifications: • 280 mm x 280 mm x 200 mm high (inside dimensions) • Designed for 37°C saline • Circulation and heating WinTest® Control Software Monitors Each Loading Site • Flat sides for video-graphic validation Specifications are subject to change • Removable front and rear panels for 1 Represents the overall capacity of the test instrument. easy access Typically each loading site is less than 5 N load. 2 Twelve (12) sites are standard. Twenty (20) sites are available as an option. 3 Distance between upper pullrod and lower mounting surface. 4 This is a pre-test ‘tare’ adjustment to ensure that all samples are at the same level of stress. 5 Series II systems include the Bose® High Accuracy Displacement Sensor and are calibrated to ASTM E-2309, Class A.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 44 ElectroForceElectroForce® Stent/Graft Test Instruments for Pulsatile Distention

Accelerated Performance to Reduce Testing Time

Ten year FDA in vitro tests take only weeks with ElectroForce® stent/graft test instruments. Using Bose® proprietary high-bandwidth, low distortion linear actuators, the instruments reduce test time and provide multi-billion cycle reliability. The ElectroForce stent/graft test instrument verifies the fatigue life of intravascular prostheses such as stents, grafts, occluders and shunts under simulated physiological displacements. The instruments are designed to provide automated control for long-term, 400-600 million cycle tests.

The proprietary dual pulsatile power head provides ElectroForce® 9110-12 Small Vessel Stent/Graft Test Instrument uniform pulsatile distention at accelerated test frequencies. The system is capable of achieving mock artery diametric distention that is equivalent Features and Benefits to a test-to-success requirement, or, the system may be used to achieve greater than in vivo conditions • Accelerated closed-loop control of pulsatile distention* for a fatigue-to-fracture test. This allows stent developers to evaluate the fatigue life of a stent design • 6, 8, 12 or 20 mock arteries for testing** under a variety of programmed loading conditions.

The Bose direct measurement system uses a laser/ • 2.5 mm to 50 mm diameter device capacity** optical measurement system that is capable of providing closed loop control of pulsatile distention, or • Programmable control and system monitoring using it may be used to provide real-time measurements of ® distention for stented mock arteries. WinTest controls

• Meets or exceeds international standards such as ISO 25539-2 and ASTM F2477

• Direct diametric distention measurement using a laser micrometer

• Configurations available for testing complex geometries such as bifurcations and aneurysms.

* Demonstrated to >120 Hz on the 9110-12 instrument. Dependent on stent and tubes used. ** Dependent on the model used. ElectroForce® 9110-12 Test Instrument with the Pulse-on-a-Bend Option

45 ElectroForce® Stent/Graft Test Instruments Programmable closed-loop servo control of pulsatile distention using the Bose® WinTest® Control System offers real-time control and integrated data acquisition. The user may choose to use diameter control, pressure control, or volumetric displacement control as the primary feedback for the servo control loop.

Diametric distention amplitudes and frequency may be adjusted at any time ElectroForce® 9150-6 Instrument for Testing of without the need to stop the test. Built-in Thoracic Stent Grafts monitoring software looks for unexpected conditions, and it may be programmed to automatically stop the test if problems are detected. The system is provided with an uninterruptible power supply back-up system to smooth out power bumps or ensure a smooth shut down in the event of a power failure.

Accelerated multi-mode stent fatigue ElectroForce® 9140-20 Instrument for Small Diameter Stents may be performed using the model 9400 multiaxial peripheral stent test instrument. ElectroForce® 9120-4B Instrument for Testing of AAA Bifurcated Devices

Product Guide and Specifications

Instrument Mean Stent Number of Maximum Pulsatile Frequency Dimensions Model Diameter Range Tubes Demonstrated By Users

9110-12 2.5 to 14 mm 12 >125 Hz 50 cm x 46 cm x 84 cm (20” tall x 18” deep x 33” wide)

9120-8 2.5 to 32 mm 8 80 Hz 50 cm x 46 cm x 92 cm (20” tall x 18” deep x 33” wide)

9120-4B 12 to 30 mm 4 60 Hz 50 cm x 46 cm x 99 to 112 cm (20” tall x 18” deep x 39”-44” wide)

9140-20 2.5 to 10 mm 20 60 Hz 91 cm x 38 cm x 38 cm (36” tall x 15” deep x 15” wide)

9150-6 To 50 mm 6 80 Hz 83 cm x 64 cm x 108-118 cm (33” tall x 15” deep x 42”-47” wide)

Power Requirements All models except 9150-6110/220V Single Phase, 10 amps Model 9150-6 - 110/220V Single Phase, 30 amps

Specifications are subject to change

46 ElectroForce® 9210 Drug-Eluting Stent Test Instrument

Accelerated Pulsatile Distension for Coated Stent Durability

Ten-year FDA accelerated bench testing of coated stents can be performed in weeks with the new ElectroForce® 9210-12 drug-eluting stent test instrument. This application of Bose® high bandwidth linear motors provides the capability to test more stents faster. The modular design allows the stent developer to acquire additional test capabilities as they are needed. The test modules consist of: • The ElectroForce 9210-12 pulsatile fatigue instrument • The automated particle capture module • Interface to real-time particle counters. The base ElectroForce drug-eluting stent/graft test instrument provides several test capabilities to the stent developer, including: • Accelerated 10 to 15 year (400-600 million cycles) fatigue durability testing at relevant physiological distensions • Accelerated fatigue to fracture testing at greater than physiological distensions • Demonstrated performance bandwidth to perform physiological or ElectroForce® accelerated (from 1 Hz to >100 Hz*) durability testing of coated stents. Model 9210-12 Drug-Eluting Stent Pulsatile Fatigue Instrument Features and Benefits • Accelerated closed-loop servo-control of pulsatile distension • Up to 12 mock arteries per test - This leaves as many as 10 tubes available for testing when using the recommended ‘blank’ tube and optional ‘bare metal stent’ tube • 2.0 mm to 14.0 mm mean device diameter capacity* • Adjustable tube length for optimal testing of longer or shorter stents • Programmable control and system monitoring using WinTest® Controls. This provides the user with real-time computer control and monitoring of: - Distension control - Pressure control - Flow rates

Laser micrometer for measurement and - Filter condition and automated filter changes control of pulsatile distension • Direct diametric distension measurement using the integrated laser micrometer • Meets or exceeds international standards such as ISO 25539 and ASTM F2477 as well as related FDA guidance documents.

*Maximum distension levels and test frequencies dependent on tube diameter, wall thickness, and length.

47 The automated particle capture module is designed to simplify the tasks of monitoring and changing laboratory capture filters for each flow loop. The flow from each stent is digitally monitored, and each stent has a laboratory filter element (available in sizes from 1 to 10 micron porosity) in-line and downstream from the stent to capture particulate of interest. The computer monitors the flow and the condition of each filter in use. When a predetermined condition occurs, the computer can change the filter element without the need for stopping the test. Redundant elements for each tube allow the test to continue while the test engineer changes out the first filter. Each filter element is a module that Automated Particle Capture Module can be disconnected, sealed and labeled to be sent to the lab for particulate analysis. Real-time particle counting may be added to the system at any time. The ElectroForce® 9210-12 instrument has been tested using commercially available laboratory quality laser counters and counting software. The 9210-12 instrument is also available as an attractively-priced base configuration for those situations where there isn’t an immediate need for particle capture or real-time particle counting. The base system provides high-frequency pulsatile distention testing for up to 12 specimens, and then the system can be upgraded in the future. Please contact the Interface to Real-Time Particle Counting Bose ElectroForce Systems Group for more information. ElectroForce® Model 9210-12 Product Specifications Description: Specification: Additional Information: Number of tubes: 12 tubes Allows two (2) control tubes with ten (10) test samples

Tube configuration: Straight or curved are available Other configurations are possible. Tube length: Adjustable to 200 mm Lumen/tube diameter range: 2.0 mm to 14.0 mm Typical distension: 2% to 5% of tube ID Distensions validated using thick wall tubes Maximum distension: 10% for 3-6 mm ID Distensions validated using thick wall tubes Pulsatile fluid: Water Saline (PBS) may be used for fatigue tests. Distilled or deionized water is required for particle counting. Fluid temperature: 37° C (+/- 2° C) Instrument incorporates isolated reservoir with temperature controller Flow rate: 10-250 ml/minute (typically 70-100 ml/minute) Instrument incorporates isolated flow pump Maximum mean pressure: 300 mm Hg Instrument is provided with automated servo-controlled pressure system. Test control method: Diameter control or pressure control Pressure control is run with thin tubes, and diameter control is run with thick wall tubes. Chosen method depends on user test protocol. Particle Capture Module (PCM) Specifications Description: Specification: Additional Information: Number of flow paths: 12 tubes Flow paths are isolated from pulsatile system. Filter packages: 2 sets per flow path Filter modules allow easy isolation and transport. Pore size of capture filters: 1 micron Filters are consumables and are available in 1, 3, and 5 micron sizes.

Scrubbing filter: 0.2 micron Bulk scrubbing filter Dimensions and Power Requirements Module: Dimensions (H x W x D): Power Required: Weight: 9210-12 SGT 150 cm x 100 cm x 80 cm 100 - 220 VAC single phase (50-60Hz); 10 A 115 kg Capture module 80 cm x 120 cm x 70 cm 100 - 220 VAC single phase (50-60Hz); 10 A 42 kg

Specifications subject to change without notice

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo and ElectroForce are registered trademarks of Bose Corporation. 022613 48 ElectroForce® 9400 Multiaxial Peripheral Stent Test Instrument

Advanced Performance to Simulate In Vivo Conditions

Bose Corporation has developed a multiaxial peripheral stent (MAPS) test instrument to simulate the multi-mode biomechanical conditions found in the peripheral arteries. This programmable instrument simulates the complex loading that stents experience in the peripheral arteries. These include the renal arteries, the carotid arteries, and the femoral-popliteal arteries.

Many medical studies have shown that peripheral arteries have greater bending, twisting, and stretching motions than coronary arteries, so stents placed in peripheral arteries will undergo greater stresses and strains. Agencies such as the US FDA and ISO recommend that stents being considered for use in peripheral arteries be analyzed and pre-clinically bench tested under those combined loading conditions prior to regulatory approval.

Bose has developed a new test instrument capable of simulating the multiple axes of displacements to replicate in vivo conditions. This system is capable of combining dynamic bending, rotation, extension/compression, and radial distention on multiple stents under controlled conditions. The instrument is capable of testing an accelerated 10 year simulated life, or performing fatigue to fracture studies. Multiaxial Peripheral Stent Test Instrument The ElectroForce® multiaxial peripheral stent test instrument is designed for the demanding displacements required to test stents and stented grafts for the superficial femoral artery (SFA). It is also capable of being programmed for carotid artery stenting and renal artery stenting. The MAPS test instrument may also be used to test overlapped stents under these conditions.

Versatile, Easy to Configure Laser Micrometer Measurement of Pulsatile and Axial Distention Synchronized WinTest® Software Radial Distention with Rotation and Bending (Assembly showing 90° bend) (Proprietary multiaxial loading capability)

49 ElectroForce® 9400 Multiaxial Peripheral Stent Test Instrument

Operating Frequency Specifications

Pulsatile Distension Bending Extension Rotation

5% on 5-8 mm 0 to 90 Parameter for Frequency Specifications 0 to 20% strain 0 to 60 degrees ID mock artery degrees 1.5 Hz 1.5 Hz 1.5 Hz Maximum Frequency 60 Hz** equivalent* equivalent* equivalent*

* When combined with bending, extension and rotation such that the combined ‘equivalent’ waveform is completed at 1 Hz. ** Actual attained frequency is dependent on test conditions, specimen geometry/compliance, mock artery diameter/wall-thickness, and radial distension desired. (Consult Bose) Note: The ElectroForce® peripheral stent instrument is configured to provide a 10 year life test on 200 mm (20 cm) SFA devices in a period of 90 to 120 days under the above excursions. Example Peripheral Artery Motions Superficial Femoral Carotid Renal Loading Condition Artery (SFA) Artery Artery (Location) (Leg - Hip to Knee) (Neck) (Below Diaphragm)

Pulsatile Distension 1.2 Hz (72 bpm) 1.2 Hz (72 bpm) 1.2 Hz (72 bpm) (Heart Beating) (40,000,000 cycles/year) (40,000,000 cycles/year) (40,000,000 cycles/year)

Activity Causing Walking Neck Movement Breathing Multi-Axis Loading:

Bend (1,000,000 cycles/year) (1,000,000 cycles/year) (6,000,000 cycles/year)

Twist (1,000,000 cycles/year) (1,000,000 cycles/year) (6,000,000 cycles/year)

Stretch (1,000,000 cycles/year) (1,000,000 cycles/year) (6,000,000 cycles/year)

Number of Cycles Needed for a 10 Year Durability Test

Pulsatile Distention 400 million 400 million 400 million

Multi-Axis Loading 10 million 10 million 70 million

Approximate Days / Test 90-120 90-120 135-180

ElectroForce Peripheral Stent Fatigue System Facility Footprint

Width: 1220 mm (48 in) Depth: 864 mm (34 in) Height: 1930 mm (76 in) Weight: 1100 lbs ~ 500 kg Power: 208/230 VAC 50-60 Hz 20 Amp Service

Specifications are subject to change

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo and ElectroForce are registered trademarks of Bose Corporation. 022613 50 ElectroForce® 9500 Multiaxial Coronary Stent Test Instrument

Advanced Performance to Simulate In Vivo Conditions

Bose Corporation has developed the ElectroForce® 9500 multiaxial coronary stent (MACS) test instrument to simulate the combinations of biomechanical deflections and displacements that stents experience after deployment into coronary arteries. The 9500 instrument is capable of simulating multiple axes of motion to provide a better representation of in vivo conditions for fatigue and durability evaluation. The system can combine independently programmable dynamic bending, rotation, extension, and pulsatile distension on multiple stents under controlled conditions.

A New Approach. Recent studies have shown that coronary arteries have substantial bending, twisting, and stretching motions that are phased with each systolic/diastolic cardiac cycle. In the past, coronary stent developers have had to rely on simple, single motion bench tests and then attempt to combine the loading results into a predictive model for design. These simple bending, tension, torsion and pulsatile fatigue tests have not been able to validate combined motion predictive models, and simulating these motions in an in vitro laboratory test has been difficult for device developers. Agencies such as the US FDA and ISO recommend that new stents ElectroForce® 9500 being considered for complex loading conditions be analyzed by finite element Test Instrument analysis (FEA) and pre-clinically bench tested under combined loading conditions prior to regulatory approval.

Multiaxial Test Capability. The ElectroForce 9500 test instrument provides closed loop servo-electric control of the multiple axes of motion to simulate in vivo biomechanical conditions. The primary motions are; axial extension (stretch), torsion (twist), bending (flexion), and pulsatile distension (inflation/contraction) due to the cardiac cycle. Each axis of motion can be combined with other motions and adjusted for the proper phase between each motion, or run independently. Device manufacturers can now evaluate worst case conditions for a coronary stent design, or program a typical movement profile to perform a simulated 10 year accelerated life test on up to twelve (12) specimens at one time. The ElectroForce 9500 test instrument from Bose represents a major advancement in multiaxial motion simulation, and provides the coronary stent device manufacturer with a versatile in vitro laboratory testing system. The ability to use representative biomechanical motion data for the evaluation of fatigue durability Multiaxial Angular and Linear Motion Assembly of an entire stent structure, and then to compare that motion with for Multiple Specimens finite element modeling and clinical studies, is a critical step forward for systematic coronary stent design and validation.

51 ElectroForce® 9500 Multiaxial Coronary Stent Test Instrument

Flexible and Versatile Software. The ElectroForce® 9500 MACS instrument provides flexible programming to allow the definition of multiple axes of linear and angular displacements in a straightforward manner. For example, the stent developer can choose a prescribed amount of bend at a particular radius, and then combine these motions with a desired rotation and programmed extension. In addition, the motions can be coordinated with the systolic or diastolic phase of each cardiac cycle. Through a motion-predictive model, the system will also automatically compensate for cross-axis motion effects, further simplifying test setup and control.

The ElectroForce 9500 test instrument has programmable phase control to allow the developer to program the instrument to meet a variety of worst case loading conditions. The user can also choose to simplify the loading deflection by reducing, or Multiaxial Testing of up to Twelve (12) Specimens Simultaneously eliminating, an undesired motion by simply programming it into the instrument.

Performance Specifications Parameter Specification Rating

Number of tubes 12

Working length (maximum stent length) Up to 80 mm

Lumen diameter (mm) 2.0 - 6.0 mm

Lumen material Standard SGT mock arteries

Bend (degrees of wrap) 10° - 120°

Bend tool radii (measured at tube centerline) 6 - 40 mm

Torsion (degrees of twist measured at mechanism) ± 55°

Extension (measured at mechanism) 0 - 12%

Fluid temperature 37± 2°C

Mean pressure Up to 200 mmHg

Stent deployment Using standard balloon delivery device, 4 mm lumen compatible. Fittings for smaller ID tubes may have smaller lumen.

Pulsatile distension 5% to 7% for 2-6 mm lumen diameter

Pulsatile frequency 1:1 ratio coupled with mechanical motions

Specifications are subject to change

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo and ElectroForce are registered trademarks of Bose Corporation. 022613 52 ElectroForceElectroForce®® BioDynamicBioDynamic®® TestTest InstrumentInstrument

Characterization of Biomaterials and Tissues in a Biological Environment

Bose® ElectroForce® BioDynamic® test instruments provide accurate characterization of biomaterials and biological specimens within a sterile cell culture media environment. The ability to precisely load specimens and simulate biological conditions in one system opens up new research possibilities for tissue engineering and biomaterials research.

The instruments can be used for the evaluation of a variety of specimens, including biomaterials, acellular and cell-seeded scaffolds, native tissue samples and tissue-engineered constructs. Since BioDynamic test instruments can be used to simulate in vivo conditions for the culture and testing of three-dimensional samples, they can be a valuable tool to bridge the gap between basic in vitro exploratory studies in culture dishes and in vivo animal experiments.

BioDynamic test instruments provide specimen loading and media circulation control under a variety of programmable conditions. Each test chamber is packaged with its own closed media flow loop system to minimize contamination. The instruments are well-suited for research needs in tissue construct and biomaterial performance, scaffold engineering, as well as many other biocompatibility evaluations. Long-term, time-dependent experiments can ElectroForce® BioDynamic® also be carried out under a variety Instrument for Dynamic Compression of conditions. and Perfusion Flow

The availability of material property information provides important benchmarks for the performance requirements of new biomaterials as well as tissue-engineered medical products. Application areas include characterization of vascular tissue and myocardial patches for cardiovascular tissue engineering, as well as bone, cartilage, meniscus, ligament, tendon and spinal disc tissues for musculoskeletal applications.

BioDynamic test instruments are available either as single or multiple specimen configurations. Either way, the ability to integrate sample conditioning and properties characterization in the same environment is a significant advancement over traditional 200 N Pulsatile Flow Instrument for test systems. Vascular Tissues 200 N Dynamic Tension Instrument

53 BioDynamic® Test Configurations

Bose® BioDynamic® test instruments are integrated systems that combine ElectroForce® linear motors with environmental technologies and fully-automated computer control and software. Proprietary ElectroForce motors provide exceptional fidelity because of their simple and durable moving-magnet design. Thanks to their advanced performance and clean packaging for biomedical laboratories, ElectroForce instruments have been well received by researchers worldwide.

New advances in biomedical research depend upon understanding the mechanical properties of tissues and biomaterials under many different conditions. Of significant value is the ability to perform in vitro testing under controlled conditions to more efficiently study biofunctionality and biocompatibility factors. BioDynamic instruments from Bose provide a versatile platform for biomaterials research, including tissue-engineered constructs and scaffolds.

Compact BioDynamic Instrument The compact BioDynamic instrument is suitable for incubator use in a biomaterials or cell/tissue culture laboratory. The system is available in a single-axis (tension/compression) or dual-axis (tension/compression and pulsatile flow) configuration, and optional capabilities are available depending on the application. The test chamber can be easily removed from the motor assembly to accommodate experimental setup, or to conduct experiments with multiple test chambers on a revolving basis.

The BioDynamic instrument is provided as a complete system with amedia perfusion flow loop, load cell, displacement transducers, pressure transducers (if applicable), and a chamber stand for use in a sterile flow hood. The testing assembly can be placed in a suitable cell culture incubator for precise environmental control.

200 N Tension/Compression and Pulsatile The compact BioDynamic instrument is available as a 20 N or 200 N maximum Flow Instrument for Vascular Tissues force system, and can be packaged for a variety of tissue applications.

Orthopaedic Research The compact BioDynamic instrument can be equipped with an ElectroForce linear motor for dynamic tissue and biomaterial characterization under tension/compression and perfusion flow loading regimes. Porous and non-porous platens used for compression are interchangeable with tensile grips in the same orthopaedic chamber to accommodate a variety of orthopaedic applications. Bone, cartilage, meniscus, spinal disc, ligament and tendon tissues and biomaterials can be characterized under sterile conditions while stimulated in a biocompatible chamber. A fully integrated digital video extensometer can be added to the system for primary, secondary and shear strain measurements.

Orthopaedic Chamber with Porous Platens 20 N Dynamic Tension and Chamber Perfusion Setup

Vascular Applications ElectroForce linear motors are used to provide accurate pulsatile loading (with programmable stroke volume and frequency) and tension/compression to tubular specimens such as native arteries and veins, vascular grafts, tissue-engineered blood vessels and other tubular biomaterials. The pulse generated by the ElectroForce motor is combined with steady flow from a media pump to generate the desired pulsatile waveform. A laser micrometer can be added to the system to measure diametric changes in the samples due to pulsatile flow and to Vascular Chamber for Pulsatile Flow or study creep and elasticity. Tension/Compression and Pulsatile Flow

54 BioDynamic® Instrument Design Features Chamber and Flow Loops • The BioDynamic® test chamber is constructed from materials suitable for autoclaving or ethylene oxide sterilization and is designed for long term use. Several porting options are provided as standard features for flow inlets/outlets and monitoring purposes. These ports can be used to insert pressure, temperature, dissolved oxygen, carbon dioxide, and pH sensors, thus allowing flexible setup and measurement for many biomedical research applications.

• A support stand is provided with each BioDynamic test instrument for secure chamber positioning during specimen mounting and harvesting inside a sterile flow hood. The BioDynamic chamber can be mounted horizontally and partially filled with saline or culture media, or positioned vertically to facilitate specimen mounting. In addition, one or both chamber doors can be opened to provide better access to the chamber for attaching tissues or biomaterials to the hose barb fittings, grips, or platens.

• The orthopaedic and cardiovascular chambers use interchangeable modular components so that a BioDynamic chamber can be adapted to either an orthopaedic or a vascular assembly. Each chamber has its own closed-loop media system to minimize contamination risk, while a media pump is utilized to circulate nutrients in the flow loop. A media reservoir is also available to facilitate media gas exchange in an incubator and serve as an additional sampling port.

• Bone, cartilage, or other disc-shaped specimens are compressed between platens, and the flow loop can be configured to provide chamber perfusion and/or specimen perfusion through porous platens. Vascular grafts or other tubular specimens are mounted on hose barb fittings and stimulated by lumen and/or chamber perfusion. Ligaments, tendons, skin, or other thin and elongated specimens are attached with tensile grips while the chamber is perfused with nutrients.

Bone/Cartilage Vascular Ligament/Tendon

Clamp Filter Filter Lock Filter Clamp Lock Mean Flow Height Height Pump Adjustment Adjustment G1 Tissue Engineered Blood Vessel Flask/Reservoir Tissue Tissue Engineered Load Engineered Cell G1 Cartilage/ G1 Dynamic Ligament Bone Pump

Media Flask/Reservoir Media Flask/Reservoir Pump Pump

Load Cell Load Cell

Control and Measurement • The BioDynamic test instrument is controlled by a PC using Bose® PCI digital controls and WinTest® software. WinTest software is an intuitive control system for performing complex test routines with minimal training.

• When the instrument is integrated with optional Dynamic Mechanical Analysis (DMA) software from Bose, tissue viscoelastic properties can be determined for comparison and correlation under a variety of dynamic conditions.

• Measurement transducers are provided for each active control channel, including pressure sensors, axial load and displacement measurement. WinTest® Software

• An optional precision laser micrometer or digital video extensometer can be used to monitor tissue response.

55 BioDynamic® Test Instrument Product Guide and Specifications

Application Vascular Orthopaedic Blood vessels and stents Cartilage, bone, ligaments and tendons Force 20 N 200 N 20 N 200 N Loading Pulsatile Axial/Pulsatile Pulsatile Axial/Pulsatile Axial Axial Motor(s) One Two One Two One One Motor Capabilities ± 2.5 mm stroke ± 2.5 mm stroke ± 6.35 mm stroke ± 6.35 mm stroke ± 2.5 mm stroke ± 6.35 mm stroke 3.6 mL/pulse 3.6 mL/pulse 8.8 mL/pulse 8.8 mL/pulse 0-300 mmHg 0-300 mmHg 0-800 mmHg 0-800 mmHg Mean Flow Rate 17-1700 mL/min 17-1700 mL/min 17-1700 mL/min 17-1700 mL/min 1-280 mL/min 1-280 mL/min Displacement Transducer(s) One Two One Two One One Load Cell(s) One One One One One One Pressure Transducer One One One One Optional Optional Laser Micrometer (optional) Yes Yes Yes Yes – – Video Strain Extensometer (optional) Yes Yes Yes Yes Yes Yes DMA (optional) – – – Yes (Axial only) Yes Yes Chamber Features Transparent viewports, horizontal or vertical setup and testing, sterilizable by autoclaving or ethylene oxide Perfusion Flow Loop Mean flow pump, media reservoir, tubing and fittings Cell Culture Sensors (optional) Real-time monitoring of pH, temperature, dissolved oxygen, carbon dioxide, lactate and glucose (consult Bose) Environment Incubator-compatible (consult Bose)

Specifications are subject to change

Additional BioDynamic Configurations • Consult Bose on combined tension/compression and torsion BioDynamic® test instruments for orthopaedic applications.

• Bose also offers dynamic (pulsatile) flow through porous platens in addition to compression loading for bone, cartilage, meniscus and intervertebral disc applications.

• Refer to the multi-specimen BioDynamic test instrument brochure for experiments that require simultaneous characterization and stimulation of several specimens in the same or individual frames. TestBench Instrument with Vascular BioDynamic® Chamber

Biomaterials and Tissue Testing Options • BioDynamic chambers are compatible with other ElectroForce® instruments such as the TestBench and ElectroForce 3200 for experiments with less critical temperature requirements.

• Planar biaxial configurations are available for dynamic testing of tissues and strain measurement in a saline bath. TestBench Planar Biaxial Instrument with Heated Saline Bath and Video Extensometer ElectroForce® 3200 Instrument with Orthopaedic BioDynamic Chamber

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and BioDynamic are registered trademarks of Bose Corporation. 022613 56 Multi-specimenMulti-specimen BioDynamicBioDynamic®® TestTest InstrumentsInstruments

Characterization and Stimulation of Multiple Specimens

ElectroForce® multi-specimen BioDynamic® test instruments provide a new standard of performance for characterization and stimulation of multiple biological specimens within a cell culture media environment. Multi-specimen BioDynamic test configurations can be used for a variety of tissues and biomaterials, and allow independent programmability or the same stimulation program for statistical characterization of multiple specimens.

The ability to perform multi-specimen characterization and stimulation in the same environment is a significant advancement over traditional systems. With multi-mover capabilities for tension/compression loading and dynamic (pulsatile) flow stimulation, BioDynamic instruments from Bose open up new research possibilities for advanced tissue engineering and biomaterials research.

200 N Multi-chamber ElectroForce® BioDynamic® Test Instrument for Orthopaedic Specimens

Advanced Capabilities in a Compact Package • Versatile chambers adaptable to blood vessels, cardiac muscle, bone, cartilage, meniscus, spinal discs, ligaments, tendons, and skin. • Multi-frame design for parametric studies: - 2, 3 or 4 frame configuration with independent media loops - Independent programmability for axial load and dynamic pressure for each specimen. • Multi-chamber system for statistical analysis: - 4 chamber frame with independent media loops - Controlled loading of all samples to measure statistical variability. • Displacement, load and pressure measurements for characterization of mechanical properties. • Mechanical stimulation capabilities: - Dynamic (pulsatile) perfusion flow control - Tension/compression loading. 200 N Multi-frame Pulsatile Loading for • Chambers and flow loops compatible for use in cell culture incubators. Vascular Specimens • Real-time monitoring and imaging capabilities.

57 Multi-specimen BioDynamic® Test Instrument Specifications

Applications: Cardiovascular and Endovascular Blood vessels Tubular specimens are mounted with hose barb-style fittings and secured with cable ties/sutures. Orthopaedic Cartilage and bone Disc-shaped samples are placed between porous (40 µm and 100 µm pore size) or nonporous platens. Ligament and tendon Sheet or rod-like specimens are secured with clamp-style grips. Chambers: Chamber Features Each chamber includes easy-to-assemble components and transparent viewports. Sterilizable by autoclaving (steam sterilization) or ethylene oxide (ETO) Chamber stand for mounting specimens in flow hood when chamber is not attached to the test frame Complete flow loop with mean flow pump, media reservoir, tubing and fittings Chamber Ports 12 ports available for flow paths and sensing/monitoring: - 2 ports for lumen perfusion - 2 ports for external loop perfusion - 2 ports for media sampling - 2 ports for chamber filling/draining - 4 ports for monitoring Multi-frame Configurations for Independent Loading: One (1) Chamber per Frame 20 N (4.5 lb) ± 2.5 mm displacement 200 N (45 lb) ± 6.35 mm displacement Cardiovascular and Endovascular Pulsatile Up to 4 chambers: 4 motors Axial/Pulsatile Up to 2 chambers: 4 motors Orthopaedic Axial (tension/compression) Up to 4 chambers: 4 motors Axial/Dynamic Flow (perfusion) Up to 2 chambers: 4 motors Specimen Setup Two (2), three (3) or four (4) specimens can be simultaneously characterized and stimulated (one specimen per chamber) under independent loading regimes. Dynamic Volume/Pressure 20 N (4.5 lb) motor: 3.6 mL/pulse and 0 to 300 mmHg differential per sample (pulsatile loading) 200 N (45 lb) motor: 8.8 mL/pulse and 0 to 800 mmHg differential per sample Mean Flow Loop 17 mL/min to 1700 mL/min high flow drive 1 mL/min to 280 mL/min low flow drive Four (4) pump heads and four (4) media reservoirs are included for independent media flow loops. Sensors Each motor includes a displacement transducer. Each chamber includes a load cell, and each vascular chamber includes two (2) pressure transducers. Multi-chamber Configurations for Shared Loading: Four (4) Chambers per Frame 200 N (45 lb) for 4 specimens ± 6.35 mm displacement Cardiovascular and Endovascular Pulsatile 4 chambers: 1 motor Axial/Pulsatile 4 chambers: 2 motors Orthopaedic Axial (tension/compression) 4 chambers: 1 motor Axial/Dynamic Flow (perfusion) 4 chambers: 2 motors Specimen Setup Four (4) specimens can be simultaneously characterized and stimulated in one test frame. Load rating is shared among specimens, and displacement is the same for all 4 specimens. The nutrient environment around the samples and through the porous platens (for bone/cartilage samples) or lumens of vascular grafts can be either shared or independent. Dynamic Volume/Pressure 200 N (45 lb) motor: 6.0 mL/pulse and 0 to 500 mmHg differential per sample (pulsatile loading) Mean Flow Loop 17 mL/min to 1700 mL/min high flow drive .36 mL/min to 36 mL/min low flow drive; extra low flow available Four (4) pump heads and four (4) media reservoirs, tubing and fittings Sensors Each motor includes a displacement transducer. Each chamber includes a load cell, and each vascular chamber includes a pressure transducer. Additional Features: Optional Sensors and Monitoring Laser micrometer for vascular distension Video strain measurement for axial strain Cell culture media pH, temperature, dissolved oxygen, lactate and glucose Custom fittings for catheters and other endoscopic devices Incubator Customer-supplied incubator for chamber and flow loop placement Consult Bose on incubator requirements

Specifications are subject to change

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce, WinTest and BioDynamic are registered trademarks of Bose Corporation. 022613 58 ElectroForce® 5900 BioDynamic® Test Instrument

Advanced Performance to Simulate In Vivo Conditions

Bose Corporation has developed a multi-specimen BioDynamic® test instrument, in collaboration with Dr. David Williams’ group at Loughborough University, for intervertebral disc and other orthopaedic applications to mimic the complex loading that tissues experience in vivo. Spinal discs, cartilage and bone tissues, scaffolds and tissue-engineered constructs can be characterized under multiaxial stimulation. The 5900 BioDynamic test instrument accommodates four disc specimens in a single chamber mounted between porous compression platens. The specimens are subjected to axial compression, pulsatile flow through porous platens, and radial cyclic hydrostatic pressure while maintaining sterility in a cell culture incubator. All system components in contact with the samples and the fluid are sterilizable to allow long term stimulation and characterization in an incubator.

Bose® BioDynamic test instruments are integrated systems that combine ElectroForce® linear motors with environmental technologies and fully-automated computer controls and software. The simple and durable proprietary moving-magnet motor design provides excellent dynamic performance and operates without friction, which is an important feature for high resolution, low force testing. ElectroForce test instruments are controlled by the WinTest® digital control system which provides data acquisition, waveform generation and instrument control. Up to 8 actuators can be operated from the same personal computer and up to 32 input channels are available for measurements. This control and software capability allows multiaxial loading to mimic physiologic conditions and data acquisition from multiple sensors. ElectroForce® 5900 BioDynamic® Test Instrument System Description The chamber accommodates 4 samples with a Axial compression clear membrane sheath surrounding each sample circumferentially. The chamber’s cyclic hydrostatic pressure is exerted on each sample via the flexible membrane and is the same for all 4 samples. Compression loading is applied by an ElectroForce motor so that displacement is the same for all samples while the load is divided among the Pressure control number of samples. Samples are perfused by steady or pulsatile flow through porous platens to improve nutrient delivery to cells. Fluid flow parameters are programmable to suit different phases of stimulation and characterization.

Each sample has its own load cell as well as two pressure transducers, one upstream (flow inlet) and Pulsatile one downstream (flow outlet) of each sample while flow Mean flow pumps an additional pressure transducer measures chamber pressure.

ElectroForce® 5900 BioDynamic® Test Instrument and Main Subsystem Components

59 System Control Modes to Provide Biomechanical Cues The 5900 BioDynamic® test instrument has multiple control capabilities to allow for suitable stimulation and characterization regimes based on the samples’ response. Feedback from the system’s different transducers can be used to apply loading in the following control modes:

• Axial displacement control for compression of all four samples with porous or non-porous compression platens

• Cyclic hydrostatic chamber pressure control to apply radial stress to all four samples

• Independent pressure control for each sample which can be based on sample inlet pressure, outlet pressure, or the average of the inlet and outlet pressures

• Pulse volume control for all four samples with dynamic (pulsatile) perfusion flow through porous compression platens.

Chamber Stand for Sample Mounting in a Sterile Flow Hood Biochemical Monitoring and Sensors Cellullar metabolic activity is monitored non-invasively using sensors in the fluid flow perfusion loop to measure the effects of biomechanical loading on biological samples. Lactate/glucose, pH, dissolved oxygen, and carbon dioxide concentrations in the fluid canbe monitored upstream and/or downstream of the samples. Real-time data acquisition from these sensors can be programmed in the software to assess the metabolic activity of the cells and help determine how often the culture fluid medium should be replaced.

In biomaterials research where biodegradable materials with acidic by-products are used such as polyglycolic and polylactic scaffolds, pH monitoring can be used to indirectly assess the degradation rate of the material as it is dynamically loaded.

Chemical Sensors Mounted in the Flow Perfusion Loop

ElectroForce® BioDynamic Test Instrument Product Guide and Specifications

Hydrostatic Chamber Pulsatile Flow Through Axial Compression Pressure Porous Platens Force ±405 N* N/A N/A

Dynamic Volume N/A N/A 0.3 mL/pulse Maximum Pressure N/A 2250 mmHg (0.3 MPa) 2250 mmHg (0.3 MPa) Displacement 6 mm N/A N/A

Maximum Test Frequency 2 Hz 1 Hz 2 Hz Displacement Displacement Pressure Transducers Four load cells (one per sample) Eight pressure (two per sample)

Mean flow pump: Four mean flow pumps N/A Mean Flow Rate 1-102 mL/min (one per sample): 1-102 mL/min

Number of samples: Four or two samples can be used in the chamber Sample Specifications Sample diameter: 5 or 10 mm Sample length: 0-10 mm

Digital video extensometer for strain Optional Measurements Laser micrometer for outer diameter pH, dissolved oxygen, carbon dioxide, and lactate/glucose

Environment Cell culture incubator-compatible (consult Bose)

*Note: Sample axial stress is dependent on number of samples, sample diameter, sample inlet pressure, and chamber pressure.

Specifications are subject to change

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and BioDynamic are registered trademarks of Bose Corporation. 022613 60 MechanicalMechanical TestingTesting ofof PorcinePorcine TracheaTrachea

The Challenge: Characterize the Mechanical Response of Tracheal Rings Under Multiple Loading Configurations

Background The trachea, a stiff cartilaginous tube that regulates airflow outer diameter of each sample were recorded prior to to the lungs, was long treated as a linearly elastic material. experimentation for stress and strain calculations. However, more recent studies have noted the importance of accounting for its viscoelastic properties when considering The BioDynamic 5500 test instrument was selected potential causes of tracheal trauma or when designing to meet the needs of the sample size and material artificial trachea replacements. Tracheal damage can occur properties. This system utilizes the patented ElectroForce as a result of compression, like blunt trauma, or as a result of linear motor to obtain high resolution data in low force tension, such as the increased internal pressure that applications. The frictionless motor design ensures precise ® presents in patients with a mechanical ventilation aid. control over testing parameters with the WinTest software package. The system, which has a 13 mm stroke capacity, was equipped with a 250 g load cell to perform testing Meeting the Challenge in both load and displacement control. Displacement An ElectroForce® BioDynamic® sensors are calibrated within 0.5% of full scale, and 5500 test instrument was load cells are calibrated to ASTM E4 standards for high used to investigate the accuracy measurements. response of the trachea under compressive and tensile The instrument’s compact size is suitable for applications loading (Figure 1). Trachea that require testing inside of a cell culture incubator. samples were loaded under a The mounting fixtures can be easily changed to perform variety of conditions to a variety of mechanical testing experiments. Standard examine the viscoelastic fixtures were selected to test the tracheal rings in this tissue response as study. Samples were mounted to the test instrument in characterized by: three ways. For compression tests, samples were placed between platens in an axial or longitudinal position (Figure • Creep 2 A,B, respectively). For tensile testing, the samples were • Stress Relaxation clamped between two grips in an axial position (Figure 2C). • Hysteresis Typical viscoelastic characteristics include increasing deformation Figure 1 – The ElectroForce® at a constant load, decreasing BioDynamic® 5500 test stress at a constant strain, instrument is ideal for and different loading/unloading biological tissue testing. responses on the stress-strain curve.

Materials and Methods Six-month-old porcine trachea was obtained from a local slaughterhouse and stored in saline solution. The trachea was then cross-sectioned between cartilage rings Figure 2 – Samples were loaded in three different configurations: to obtain ring samples. The width, inner diameter, and (A) axially between platens, (B) longitudinally between platens and (C) axially clamped with grips.

61 Results The hysteresis response was investigated by cyclically Viscoelastic materials exhibit a creep response when they preconditioning a ring sample, followed immediately are held at a particular load. Creep testing was performed by loading and unloading. The ring was placed between by compressing rings in the axial and longitudinal two platens in the axial position, and 25 g of force was configurations. The samples were compressed to 120 g applied at a frequency of 1.0 Hz for 10 cycles. The sample of force and held for four minutes while the strain was was then compressed with 50 g of force (corresponding observed (Figure 3). A nonlinear deformation response to 30% compressive strain), and the load was subsequently was observed in both compression configurations, removed. A lag between the loading and unloading portions consistent with viscoelastic material behavior. of the curve can be seen in Figure 5. The area between Compressed samples appeared to have greater these portions of the curve signifies the energy that is longitudinal strength than axial strength. dissipated as a result of the material’s viscoelastic nature.

Figure 5 – A ring placed axially between platens was loaded and Figure 3 – Rings were loaded and held at 120 g of force for four then unloaded to demonstrate hysteresis. minutes while the nonlinear deformation response was observed. Summary Viscoelastic materials also exhibit stress-relaxation, in ® ® which a nonlinear stress response is observed when a The ElectroForce BioDynamic 5500 test instrument was constant strain is applied. Stress relaxation tests were used to illustrate the viscoelastic properties of the performed with the sample under tension and compression. trachea. The user-friendly system was operated in load Samples were either pulled (+) or compressed (-) to 25 % control to demonstrate creep behavior, and in displacement strain and held for four minutes while the stress response control to demonstrate stress relaxation. A third protocol ® was allowed to equalize. Results (Figure 4) indicate that was defined in the WinTest software package to cyclically the tensile strength of the tracheal ring is greater than the precondition a sample prior to loading and unloading. The compressive strength. resulting stress-strain curve demonstrated a hysteresis lag between loading and unloading. This highly adaptable instrument is ideal for characterization of biological materials, such as the tracheal samples in this study. The compact size of the system is suitable for use inside of a cell culture incubator, and the system is compatible with customer-designed fixtures and chambers. On top of these application-specific attributes, biological tissue testing also requires a high level of precision, accuracy, and control. The ElectroForce BioDynamic 5500 test instrument offers all of these features along with an easy-to-use interface, making it ideal for biological tissue testing.

Figure 4 – Axially-mounted samples were pulled or compressed to ± 25% strain for four minutes while the nonlinear stress response was recorded.

Specifications are subject to change.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce, WinTest and BioDynamic are registered trademarks of Bose Corporation. 022613 62 Degradation of PLGA Scaffolds Under Dynamic Loading

The Challenge: To Determine Degradation of PLGA Scaffolds Subjected to Unsteady Mechanical Loading

Background To mimic the dynamic loading conditions that are seen in vivo, PLGA scaffolds were stimulated with cyclic strain for PLGA is a commonly chosen 8 days while axial displacement, load, chamber pressure, material for many biomedical and scaffold diameter were recorded once every hour. applications due to its During the experiment, the chamber was perfused with biocompatibility and saline at a rate of 5 mL/ min to maintain scaffold hydration biodegradability. Many studies (Exp Group). Three additional groups without axial loading have been developed to were used for control comparisons: determine the degradation rate of PLGA under static loading • Dry scaffolds (Ctrl Group) conditions and in the presence • Hydrated scaffolds with perfusion only of common solvents. However, (+Perf Group) few studies have investigated the • Hydrated scaffolds without perfusion or axial effect of dynamic mechanical loading (-Perf Group) loading on scaffold degradation, Figure 1 – The degradation of a disc PLGA scaffold was a relationship that needs to be investigated under dynamic investigated, as PLGA scaffolds loading conditions. are subjected to dynamic mechanical forces in many in vivo applications. In this study, the ElectroForce® 5110 BioDynamic® test instrument was used to impose cyclic loading on a standard, disc PLGA scaffold (Figure 1) while changes in sample geometry were monitored over time.

Meeting the Challenge The ElectroForce BioDynamic 5110 test instrument is ideal for in vitro scaffold degradation Figure 3 – The PLGA scaffold in the Exp. Group was subjected to studies because it applies sinusoidal loading from 5 to 30 grams at a frequency of 1 Hz. axial loading, such as compression, and fluid The cyclically loaded PLGA scaffold (Exp) was subjected to perfusion all inside of a a 1 Hz sinusoidal load compressing the sample from 5 to sterile culture chamber 30 grams (Figure 3). This data, collected over 8 days, was (Figure 2). In this study, used to calculate the PLGA modulus as a function of time the chamber was used (Figure 4). The displacement curve shown in Figure 4 is with porous platens for representative of the absolute mover position as it relates compression experiments to the total travel of the motor. During experimental and fluid perfusion. straining, the bottom platen was moved while the top platen remained in a fixed position (-5.1 mm absolute). Figure 2 – The PLGA sample was mounted between two porous platens inside of a BioDynamic® chamber. The ElectroForce® BioDynamic 5110 test instrument can be used to apply dynamic loading (such as compression) and fluid perfusion.

63 As the scaffold height was reduced over the eight test The stress-strain analysis of the four PLGA sample days, the displacement of the bottom platen increased groups indicated that full dynamic loading with axial to maintain the defined loads. This degradation-related compression and fluid perfusion (Exp) increased sample change in scaffold geometry is associated with a decreasing compliance, as compared to the unloaded states (Ctrl modulus over time. A dramatic decrease in the modulus and –Perf, respectively) (Figure 5). Fluid perfusion can be seen during the first two days of the loading period, alone (+Perf) was also shown to increase compliance but this time-dependent effect appeared to stabilize by the (degradation) as compared to hydration alone (-Perf). eighth experimental day. Finally, dynamic loading through cyclic compression (Exp) led to increased scaffold degradation, or compliance, as compared to static loading through fluid perfusion. Ultimately, these results indicate that studying only the effects of static loading on scaffold degradation is insufficient to fully capture the degradation characteristics of the scaffold material. Dynamic loading protocols that mimic the dynamic stress state of the body must also be applied to properly characterize scaffolds.

Summary In this study, the ElectroForce® 5110 BioDynamic® test instrument (Figure 6) was used to precisely load PLGA scaffolds and record finite changes in the sample material response and geometry. Scaffold degradation, indicated Figure 4 – When cyclic loading was applied to the PLGA, the scaffold by increased compliance, was greater when dynamic modulus decreased over the 8 day test period. Sample thickness decreased during the test period, so to maintain loading, the loading was applied to hydrated samples, as compared absolute mover displacement increased over time. to dry, unloaded controls. Dynamic loading with cyclic compression and fluid perfusion was also shown to End point testing was then performed to compare the increase scaffold degradation, as compared to static degradation of the experimental group (Exp) to the three loading with fluid perfusion alone. control groups (Ctrl, -Perf, and +Perf). A stress-strain The BioDynamic system is ideal analysis was selected to account for any alterations in for scaffold characterization sample geometry due to extended loading that would not applications that require be represented accurately with a force-displacement highly-controlled sample analysis. The Green strain and 1st Piola-Kirchhoff stress, stimulation in a sterile, cell respectively, are given by: culture environment. The

1 2 Fz system’s automated control Ezz = –– (λ z -1) and t zz = –– 2 Ac mechanisms, accessible through the user-friendly ® where the stretch ratio is λz = ɭ/Lo with the loading height, WinTest software package, ɭ, and unloaded height Lo; Fz is the current force; and Ac is allow researchers to generate the contacted area. reliable results without the need to constantly adjust or monitor an experiment. The frictionless design of the patented Bose® linear motor assures precisely-controlled Figure 6 – ElectroForce® ® compressive (or tensile) loading BioDynamic 5110 Test Instrument over billions of cycles.

Figure 5 – Stress-strain data showed that axial compression and liquid perfusion resulted in the most compliant scaffold group (Exp) and dry scaffolds were stiffer than any hydrated groups (Ctrl).

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce, WinTest and BioDynamic are registered trademarks of Bose Corporation. 022613 64 ElectroForce® BioDynamic® Instruments Drive Stem Cell Differentiation

The Challenge: Direct Stem Cell Differentiation in 3D Matrices

Background Meeting the Challenge Mesenchymal stem cells (MSCs) are present throughout To apply environmental cues, MSCs are first seeded into the body and naturally renew tissues.1 MSCs have widely a 3D matrix, or scaffold. The MSCs are then stimulated been targeted as therapeudic agents for a number of to differentiate into a specific cell-type. The expanded, medical ailments because they have two key characteristics: transformed MSCs can then be delivered to target tissues via direct injection or through implantation of a • Self-renewal carrier (scaffold).1 • Multi-lineage differentiation One application area for MSC differentiation is in fibrous To take advantage of these properties, researchers seek to tissues, such as tendons. Tendons must withstand and expand MSCs in vitro and direct their differentiation into transfer high tensile loads, leaving them vulnerable to particular cell types. By culturing MSCs in controlled failure. Researchers are now looking at MSCs to develop conditions, stem cell fate can be directed with biochemical better treatments for tendon injuries. Dr. Wan-Ju Li’s lab and mechanical cues such as: at the University of Wisconsin-Madison has developed • Soluble factors in the culture media a braided nanofibrous scaffold to tissue-engineer tendons.3 • Tensile load Dr. Li’s group cultures human MSCs on the collagen fibril-like • Compressive load scaffold and uses an ElectroForce 5210 BioDynamic system • Torsion to mimic the physiological environment of a tendon. • Shear stress During a 10-day culture period, cyclic tensile strain of 10% is applied at a frequency of 1 Hz for 2 hours each day. In Cells of each tissue type are exposed to a unique, dynamic addition to axial loading, media containing tenogenic combination of these loads, so the correct replication growth factors is actively perfused to the MSCs at 20 mL/ of these biochemical and mechanical factors must be min. After conditioning with the 5210 system, the MSC 2 precisely controlled to duplicate physiological conditions. population successfully differentiates into tenocyte-like When the native environment of a particular tissue is cells expressing tendon-related markers. successfully replicated in vitro, MSCs will differentiate into that tissue’s cell type. For example, when a scaffold containing MSCs is subjected to cyclic tension in the presence of particular biochemical factors, the MSCs differentiate into tenocytes.3

When MSCs are subjected to cyclic tensile loading of the supporting scaffold, they differentiate into tendon cells (tenocytes). This differentiation can be further directed by the addition of tenogenic factors to the culture media. The ElectroForce 5210 BioDynamic system can be used to direct stem cell differentiation through culture media perfusion and Control of stem cell fate is facilitated by an in vitro system compressive (or tensile) loading. that is as complex as the physiological environment it is meant to mimic. Bose Corporation ElectroForce® BioDynamic® test instruments offer the versatility, precision, and control required to biomechanically direct stem cell differentiation.

65 At the University of Sheffield (U.K.), Dr. Gwendolen Reilly and collaborators are using an ElectroForce® 3200 biomaterials test instrument with a media-filled BioDynamic® chamber to examine the effects of dynamic compression on stem cell differentiation.4 By applying a cyclic compressive load to an MSC-seeded scaffold, they are able to induce MSC differentiation into osteocyte-like cells, providing valuable insight to future treatment options for weakened bone. After a 9-day static culture period, a 5% compressive strain Vascular BioDynamic Chamber is applied to the scaffold at a frequency of 1 Hz for 2 hours. This loading protocol is repeated two more times at 5-day In addition to vascular constructs, cardiac loading intervals. After the 19-day total culture period, the waveforms are suitable for regenerative medicine loading regimen drives osteogenic differentiation, even treatments of cardiac infarction. Stem cell injection at in the absence of biochemical stimulation. the infarction site has been proposed to stimulate myocyte regeneration. To investigate this potential therapy, an in vitro study can be performed to physiologically condition infarcted tissue that has been injected with stem cells in a BioDynamic system. The damaged muscle and injected cells can be mechanically loaded using waveforms that mimic cardiac contraction, and stem cell tissue penetration and homing can be assessed. Using this in vitro approach, researchers can identify the appropriate conditions to optimize mechanically-induced stem cell differentiation into cardiac myocytes for repair of infarcted heart muscle. There are several BioDynamic configurations that can be tuned to direct stem cell differentiation in various physiological environments:

• Tensile loading for tendons and ligaments • Compressive loading for bone and cartilage • Fluid shear stress for arteries

Combinations of these mechanical factors can be easily customized to meet the needs of each application that seeks to control stem cell fate. The ElectroForce Bio- A BioDynamic chamber can be added to the ElectroForce 3200 Biomaterials test instrument to apply compressive (or tensile) Dynamic systems take advantage of MSC environmental loading on biological samples. responsiveness, allowing the user to direct stem cell differentiation with precisely controlled biochemical and In cardiovascular applications, fluid shear stress has mechanical cues. been shown to drive MSC differentiation into vascular endothelial cells. Additionally, when fluid shear stress is coupled with cyclic strain, MSCs differentiate into References cardiomyocytes (heart muscle cells).5 To replicate the 1Concise Review: Mesenchymal Stem Cells and Translational complex and dynamic nature of the cardiovascular Medicine: Emerging Issues. Ren G, Chen X, Dong F, Li W, Ren X, Zhang Y, Shi Y. Stem Cells Translational Medicine, 2012; 1: 51-58. system, each mechanical factor must be precisely 2 defined and integrated into a single system. For vascular Controlling Self-Renewal and Differentiation of Stem Cells via Mechanical Cues. Nava MM, Raimondi MT, Pietrabissa R. Journal of specimens, BioDynamic systems can be used to apply pul- Biomedicine and Biotechnology, 2012; 2012: 797410. satile (dynamic) flow, along with axial loading, while moni- 3Braided Nanofibrous Scaffold for Tendon and Ligament Tissue toring vessel pressure and distension. In this way, Electro- Engineering. Barber JG, Handorf AM, Allee TJ, Li WJ. Tissue Force BioDynamic instruments can mimic Engineering: Part A, 2011; doi: 10.1089/ten.tea.2010.0538. the physiological cardiovascular waveforms that are 4Short Bouts of Mechanical Loading are as Effective as associated with cardiac contraction and hemodynamics, Dexamethasone at Inducing Matrix Production by Human Bone making them optimal for the differentiation of MSCs into Marrow Mesenchymal Stem Cells. Sittichokechaiwut A, Edwards JH, Scutt AM, Reilly GC. European Cells and Materials, 2010; 20: 45-57. cardiomyocytes and other cardiovascular cells. 5Effect of Cyclic Strain on Cardiomyogenic Differentiation of Rat Bone Marrow Derived Mesenchymal Stem Cells. Huang Y, Zheng L, Gong X, Jia X, Song W, Liu M, Fan Y. PLoS ONE, 2012; 7(4):e34960.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce, WinTest and BioDynamic are registered trademarks of Bose Corporation. 022613 66 MicromechanicalMicromechanical MulticyclicMulticyclic CreepCreep TestsTests ofof HumanHuman CorticalCortical BoneBone

The Challenge: Determine the Mechanical Properties of Small Bone Specimens

Background Bone is a living organ whose structure and function are affected by various factors including mode and frequency of loading, age, and disease1. It is a hierarchical composite material that is made up of a collagen matrix and a mineral reinforcement. This dissimilar structure in the transverse and longitudinal orientations results in the anisotropic mechanical behavior of bone2.

The material properties of bone are being researched on multiple levels (macro, micro, cellular) in order to gain a better understanding of the material changes and their relevance to applications such as fracture assessment and prediction. This research varies from analyzing the forces acting upon whole bone structures, micro-scale machined bone specimens and individual collagen fibers. To add to the complexity for researchers, each level interacts with the next level, and bone has demonstrated a size dependence on its mechanical properties3.

One specific area of research involves the examination of age-related effects of collagen on the mechanical properties of bone. Creep behavior, commonly used to assess polymeric materials, is appropriate for studying the effects of age-related changes in the collagenous component of bone.

Meeting the Challenge Research performed at Rensselear Polytechnic Institute by Simon Tang and Deepak Vashishth studies the effects of multicyclic loading on human cortical bone4. The ElectroForce® 3200 Test Instrument Electroforce® 3200 test instrument, in conjunction with a custom 4-point bend fixture, with Standard 4-point Bend Fixture was used to perform the testing in order to assess the viscoelastic and viscoplastic properties of bone on a micro-scale level5. This study has a threefold purpose: 1) to study the creep response of bone to multicyclic loading under anatomically-correct loading; 2) to perform these types of tests on a small scale; and, 3) to illustrate and identify age-related trends on the mechanical properties of bone.

Materials and Methods Eighteen longitudinal specimens of cortical bone, 1 mm thick, were harvested from the medial side of the femur below the lesser trochanter from 6 human cadavers (3 specimens per donor). The specimens (Figure 1) were then cut into parallelpipeds with dimensions of 0.8 mm~1.2 mm x 0.8 mm~1.2 mm x 6.0 mm using a diamond saw blade. Small markings were made on each specimen outside of the mid-span section to note the anatomically correct loading orientation. This was done to ensure that each microbeam was loaded in a manner similar to in vivo conditions.

Figure 1 - Cortical bone specimen sizing.

67 Materials and Methods (Continued) A custom designed 4-point bend fixture (Figures 2 and 3) was attached to the ElectroForce® 3200 instrument. The bend fixture, which has adjustable upper and lower spans, was set so that the upper span was 0.70 mm and the lower span was 2.68 mm. The support points of the top and bottom fixtures are rounded blade edges, thereby minimizing the damage to and contact with the specimen. The Electroforce 3200 test system utilizes a proprietary electromagnetic linear actuator design, which provides exceptional force and displacement control. For these tests, the standard system load cell [50 lbf (225 N)] and standard system linear variable displacement Figure 2 - Bottom span of transducer (LVDT) [+/- 6.5 mm] were used. This configuration was suitable for the tests custom 4-point bend fixture. due to the robustness of the system and the level of measurability achieved by the LVDT. A customer-provided high resolution digital camera was used to take photographs of the specimens to independently confirm strain measurements. The WinTest® control software’s block waveform function was used to Figure 3 - Close-up of specimen in implement the test protocol. An initial custom 4-point bend fixture. monotonic displacement-controlled test to 0.5% strain (based upon each specimen’s geometry) was applied to each specimen to determine the elastic bending modulus. The multicyclic testing was subsequently performed in load control (Figure 4) and the force, displacement, Figure 4 - Sample data of multicyclic and geometric parameters of each specimen were used to calculate the stresses creep test of cortical bone. and strains desired. The waveform itself consisted of a ramp to a load level, holding that load for 60 seconds, ramping to a nearly unloaded state at -0.1 N, again holding for 60 seconds, and then ramping to a load larger than the previous value. This process was repeated until all loading levels were completed. The stress values were 35, 65, 70, 75, 80, and 85 MPa. Results and Summary The bending modulus, which was calculated from the initial bending test, was found to range from 3.7 to 14.7 GPa. Based upon the agreement of these values with those found in existing literature for similar specimen sizes and loading configurations, it was determined that micromechanical testing can now be used to determine the mechanical properties of smaller bone specimens. In addition, the study also revealed age-related differences in the material properties of bone. Significant differences were observed in the creep rate and creep strain between younger and older donor bone (Figures 5 and 6). It was hypothesized that these results demonstrate a degradation of the collagen network in bone as creep is exhibited by polymers, and the primary polymer in bone is collagen.

Figure 5 Figure 6 Figure 5 - Steady state creep rate plotted against load with exponential fits. The creep rate was determined via a linear regression from t=10 to t=50 during the 60 second hold at each load level.

Figure 6 - Creep strain plotted against load with exponential fits. The percent strain was determined by comparing the initial unloaded state with the unloaded state immediately after the removal of the load at each level. References 1) Moore KL, Dalley AF, Clinically Oriented Anatomy. 4th Ed., Lippincott Williams & Wilkins, Maryland, 1999. 2) Nordin M, Frankel VH - Basic Biomechanics of the Musculoskeletal System. 2nd Ed., Williams & Wilkins, Pennsylvania, 1989. 3) Choi K, Kuhn JL, Ciarelli MJ, Goldstein SA., The elastic moduli of human subchondral, trabecular, and cortical bone tissue and the size-dependency of cortical bone modulus. J Biomech. 1990; 23(11):1103-13. Review. 4) Tang SY, Vashishth D., Micromechanical multicyclic creep tests show increased fragility of human cortical bone with age. Trans. Of Orthopaedic Res. Soc., 2005. 5) Fondrk M, Bahniuk E, Davy DT, Michaels C., Some viscoplastic characteristics of bovine and human cortical bone. J Biomech. 1988; 21(8):623-30.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 68 TestTest ResearchResearch LeadsLeads toto aa BetterBetter UnderstandingUnderstanding ofof TissueTissue EngineeredEngineered CartilageCartilage

The Challenge: Quantify the Pre-failure and Failure Mechanical Properties of Articular Cartilage

Background Cartilage is a remarkably complex biocomposite This complex loading profile needs to be duplicated in material that exhibits outstanding compressive stiffness, the in vitro test. Once the specimen has been stabilized toughness, strength, resiliency, and shock absorption. and creep has been taken into account, dynamic loading Diseases such as osteoarthritis damage the tissue, leading is introduced to characterize the pre-failure properties. to changes in mechanical properties. Focus will then be on failure properties. Methods to measure fracture toughness and fatigue strength are Accurate characterization of these properties and relating being developed. This requires large displacements them to changes in tissue microstructure is an appealing during cyclic loading, a feature for which the ElectroForce means to understand the importance of microstructure on 3200 instrument is especially suited. the disease process. This may in turn guide diagnosis and treatment. This is especially true for failure properties, since cracks in cartilage do not heal. Cartilage fracture is an irreversible process. Understanding the connection Bovine Cartilage between microstructure and mechanical properties can also Indentation Relaxation be useful in the engineering of cartilage replacement tissue. Test with Different Loading Rates Meeting the Challenge The goal of this work is to develop methods for characterizing failure properties of native cartilage and engineered cartilage constructs, including fracture and fatigue, and show how these properties vary with changes in tissue micro-structure. Bovine Cartilage Indentation Creep Test Researchers at the University of Minnesota, under the with Different Loading guidance of Dr. Jack Lewis, have been reviewing the issues Rates of characterizing the mechanical properties of articular cartilage. In order to quantify the properties, cartilage must be tested in a unique dynamic loading system capable of providing precision creep capabilities while also providing a dynamic loading component during the same cycle. The ElectroForce® 3200 test instrument provides the capabilities required in a compact tabletop package. Specimen preparation and preloading are important as articular cartilage has both a short time viscoelastic behavior and a long time constant for fluid retention. Cartilage tissue in vivo is under a constant compressive load with superimposed dynamic loads.

Stress Relaxation in Indentation Test with Multi-step Loading

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 69 DynamicDynamic TestingTesting CharacterizesCharacterizes thethe ViscoelasticViscoelastic PropertiesProperties ofof VocalVocal FoldFold TissueTissue

The Challenge: To Measure the High Frequency Performace of Healthy Vocal Fold Mucosa

Background Mechanical properties of vocal-fold tissues are important in the study of acoustics and biomechanics of voice production. Biomedical engineering researchers at MIT and voice scientists in the Department of Audiology and Speech Sciences at Purdue are key participants in a new research initiative to understand the physical properties of vocal fold tissue and behavior of the vocal cord structure. Laryngeal trauma and cancer can seriously damage the mechanical and vibratory properties of the vocal folds. Such scarring and trauma reduces the natural elasticity of ® the vocal folds and can cause partial or complete loss of ElectroForce 3200 instrument in horizontal position with saline or incubator chamber a person’s vocal capability. The research teams are working long-term to develop a tissue-engineered implant that would restore functionality to damaged vocal folds. Materials and Methods A complete porcine vocal cord with the cartilage attached was tested in lateral compression using a 3-point bend fixture adapted specifically for these dynamic mechanical tests. The section of the sample being tested Meeting the Challenge was 5 mm long x 2.5 mm wide x 1 mm thick. Samples were Published data on the dynamic properties of vocal fold held in the fixture under minimal tension. Care was taken tissue is rare and typically limited to frequencies of up to to keep the sample hydrated during testing. The standard 1 15 Hz. Dynamic Mechanical Analysis data in the frequency system LVDT was used for displacement range of typical human speech (150-300 Hz) would be measurement with a 45 N maximum capacity strain-gaged useful to fully evaluate the mechanical properties of native force transducer. or replacement tissue. In addition, stress relaxation and strain creep data help determine the range of mechanical The following graphs properties of vocal tissue. represent typical data using this test method. Due to its combination of dynamic performance, precision Tan delta agrees very and sensitivity for resolving force and displacement, the well with published ElectroForce® 3200 test instrument was chosen to test data.1 The compression healthy porcine and sheep vocal fold mucosa. The pig modulus is higher than and sheep are common animal models of the human existing data in shear or larynx. The ElectroForce 3200 test instrument is rated tension primarily due to for cyclic testing up to 200 Hz. For this study, a custom the pre-compressive 3200 instrument was used with a 450 Hz maximum stress (in excess of 2000 A porcine vocal cord sample in a custom 3-point test frequency. Pa) required to maintain bend fixture undergoing contact during testing. DMA tests

70 Refinement of the test methodology may permit a reduction in the pre-stress and, thus provide more representative modulus measurements. The first graph is from a sample that was frozen in air. The second graph is from a fresh unfrozen tissue that was well hydrated. There is an order of magnitude difference in modulus and the tan delta is also higher in the frozen specimen. There is considerable noise in the data above 100 Hz that further optimization of fixtures and transducers could reduce.

To test the soft tissue, a shear fixture was developed of lightweight rigid plastic material. The bottom reaction assembly was designed to allow vertical motion to preload the sample to create a frictional bond between the sample and the reaction fixtures. The amount of preload was not measured but is estimated to be 10-50 grams. A 50 gram strain gage force transducer was used to measure the small forces generated in shear.

Sheep vocal fold tissue sample

Porcine Vocal Fold in Compression A different test set up was used to test the sheep vocal fold tissue in shear. The ElectroForce® 3200 test instrument was placed in a horizontal configuration and a single lap shear fixture was used to excite the sample. As proof of concept, an uncured rubber sample was tested using a piezoelectric force transducer, which has excellent high frequency performance. The following is an image of the shear fixture used for testing the elastomer and an example of typical Single lap shear of tissue sample with fixture assembled data. Other than one out lying data point for tan delta, the data is reasonable out to 450 Hz. The following test data is from a sheep vocal fold. The specimen is mounted so that it is loaded in shear. The sample size is approximately 10 mm x 7.7 mm x 1.2 mm and sheared in the direction of the 7.7 mm dimension. It shows very good complex shear modulus and tan delta data well past 100 Hz with an indication of a resonance at around 450 Hz.

Single lap shear of uncured rubber

71 The measured modulus is many orders of magnitude lower than that measured from the compression tests and agrees well with published data taken at frequencies below 15 Hz using a torsional shear rheometer. The tan delta measured in all tests, including the torsional shear rheometer, agree very well with values in the 0.2 to 0.4 range for data falling outside resonance areas.

Sheer Strain Ramp to Failure As a final test, the sample used for the higher force creep testing was tested to failure at a rate of 0.1 mm per second (4% strain per second for a 2.5 mm thickness). Recorded forces were as high as 2 N at initial failure with bridging occurring after initial failure.

The timed data shows that the noise to signal ratio is relatively high. The use of a higher resolution piezoelectric force transducer and displacement transducer would be desirable to optimize the frequency response of the test system above 100 Hz. A shear fixture that has higher stiffness and the ability to measure and control the pre-compressive stress might also reduce the amount of resonance at high frequencies.

Creep and Relaxation Data Summary Additional data was collected to evaluate the creep and relaxation properties of the tissue. Various levels of stress This initial series of tests demonstrates that the ® (for creep) and strain (for relaxation) were applied to the custom ElectroForce 3200 instrument with DMA specimen and the changes in the relative force and software provides an excellent tool for determining displacement were measured. Of particular note is the the viscoelastic properties of soft tissues such as vocal ability to control small amplitude forces with the soft folds. Although the dynamic testing of vocal fold tissue at tissue sample at relatively high levels of displacement. high frequency by the MIT and Purdue teams is still in the 28 Pa stress represents 2 mN force and 30% strain early stages, the capabilities of the system will allow them represents 0.300 mm displacement. The following graphs to better determine the elasticity of human vocal folds and are representative of the data collected during this help pioneer the use of tissue engineering in vocal fold segment of the evaluation. restoration. (1) Chan, R. W., and Titze, I.R. (1999). “Viscoelastic shear properties of human vocal fold mucosa: Measurement methodology and empirical results” in J. Acoust. Soc. Am. 106, 2008-2021

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 72 CharacterizingCharacterizing MechanicalMechanical PropertiesProperties ofof CartilageCartilage inin SituSitu

The Challenge: Using Indentation Testing to Characterize Cartilage

Background Modeling of Cartilage Articular cartilage is often characterized as an isotropic elastic material with no interstitial fluid flow during The method for reducing data from an indentation test instantaneous and equilibrium conditions, and indentation depends on the material model assumed, the two most testing is commonly used to deduce Young’s modulus common being a single phase, isotropic, homogeneous under these assumptions. With indentation testing, linear elastic model, and a biphasic isotropic, homogeneous specimen shape is greatly simplified and avoids the need linear elastic solid and incompressible, inviscid fluid model. for large tissue volume. The test can also be performed on The single phase linear elastic model is assumed when small animals, making indentation a particularly appealing modeling either the short time response or the long time test method. A limitation of this type of testing is that equilibrium response. Although an isotropic, homogeneous only one of the two independent elastic constants can be elastic model is a significant approximation of the real deduced from the single indentation test. Poisson’s ratio is cartilage behavior, it is used to avoid the greater complexity usually assumed or measured by an independent test. The of the more realistic models when desired, or in situations goal of this work was to develop a method that would allow when experimental conditions make more detailed determination of both elastic constants from indentation experimental testing of the cartilage impractical. For the testing alone. linear elastic model, the material parameters are Young’s modulus, E, or shear modulus, G, and Poisson’s ratio, v, where both contribute to the indentation stiffness (the ratio of indenting load to indenting depth). In previous cartilage testing studies, other configurations have been used along with indentation. Hayes (1971) and Hori (1976) used confined compression and torsion tests to obtain the Poisson’s ratio. Kempson (1971) measured Poisson’s ratio in a tensile test of full thickness cartilage cut parallel to the surface. Jurvelin (1997), Wong (2000) and Korhonen (2002) measured Poisson’s ratio by directly measuring the lateral expansion of an unconfined compression test. A method for determining all the material constants by a single indentation test was introduced in the context of the biphasic theory (Mak, 1987; Mow, 1989). Subsequent studies have reported the values of Poisson’s ratios Meeting the Challenge (Setton, 1992; Schenck, 1994; Hale, 1993; Athanasiou, 1994). Researchers Dr. Hui Jin The Poisson’s ratio in the biphasic theory is that of the and Professor Jack Lewis equilibrium state (Mow, 1989). (University of Minnesota The linear elastic biphasic theory has been modified Department of Orthopaedic by making the solid phase linear viscoelastic (Mak, 1986). Surgery) used the dynamic The long time response has been assigned to the loading capabilities of the biphasic fluid flow; the short time response has been ElectroForce® 3200 instrument assigned to the viscoelastic solid (DiSilvestro, 2001). to characterize the mechanical Garcia (2000) extended the linear biphasic theory to a properties of articular cartilage transverselyisotropic solid and inviscid fluid, including by investigating novel test large deformations. methods. This article is provided courtesy of Dr. Jin and Professor Lewis.

73 Materials and Methods Comparison to Experimental Results The method is based on the use of a flat-ended cylindrical rigid After validation testing, the method was applied to bovine punch with radius a indenting on the surface of a linear elastic articular cartilage. Seven square-shaped samples (20 x 20 mm) layer with thickness h, shear modulus G, and Poisson’s ratio, ν were cut from the relatively flat part (medial and lateral (Hayes, 1972). The layer is bonded onto a flat rigid substrate. facets) of seven fresh adult cow patellae with normal appearing cartilage. Each sample included the full thickness The indentation stiffness, defined as the ratio of the indenting of the cartilage, subchondral bone and a layer of cancellous load p to the indenting depth, ω, in the linear elastic case may bone that served as the rigid substrate in the indentation. be expressed as: p 4Ga The same impermeable indenters used to test the (1) – = –––– κ(a/h,ν) ω 1-ν polyurethane rubber were used in the cartilage tests. Samples were thawed and then bonded onto the bottom of where, is a correction factor that accounts for the κ(a/h,ν) the holding cup that was attached to the adjustable holder finite layer effect. Under the same condition, and following using cyanoacrylate cement. The bath was then filled with the same procedure, indenting the sample twice using two phosphate buffered saline (PBS). different sized indenters, results in: Displacement controlled cyclical loading (displacement p – peak/valley = -0.25/-0.125 mm, at 0.5 Hz, for 20 cycles) was ω 1 a1 κ(a1 / h , ν ) performed to precondition the sample. The sample was given (2) –––– = –– –––––––––– p a κ(a / h , ν ) 40 minutes to recover. The indenter was then brought into – 2 2 ω 2 contact with the sample surface, and a 0.15 mm indenting depth was applied at a nominal loading rate of 1.5 mm/sec, In Eq. (2), Poisson’s ratio is the only unknown and can be followed by a 1200 second displacement hold. Between obtained by solving this nonlinear equation. Once the Poisson’s tests, each sample was given 40 minutes to recover from the ratio is obtained, the shear modulus G can be determined from: previous loading. Indentation testing from the 3 indenters was (3) E = 2G(1+ν ) used in Eq. (2) to predict E and ν at both the very fast rise region (instantaneous) and the end of the hold period (equilibrium). The method was validated first by simulating the indentation on a finite element model in which material properties were Predicted E and v for the bovine cartilage samples are assumed, a load-deflection test simulated, and then this data shown in Table 2. On-going work suggests that, for cartilage entered into Eq. (2). The predicted E and ν agreed with the modeled as an isotropic, homogeneous, linear elastic input values, supporting the numerical solution algorithm for material in instantaneous and equilibrium states, the Eq. (2). The method was next tested on a polyurethane rubber introduced indentation method may be used to determine 2 mm thick (Measurements Group, Inc. Raleigh, NC USA) and an the associated effective Poisson’s ratio and elastic moduli. elastic foam 5.5 mm thick that was removed from a computer Continued development of the method may be especially mouse pad. The Young’s modulus of each material was first suited to the determination of cartilage material properties measured from an unconfined compression test. Material in small animals where other test methods are impractical. specimens (radius 5 mm, thickness 2 mm for the rubber and 5.5 Poisson’s Ratio Poisson’s Ratio E(MPa) E(MPa) mm for the foam) were compressed between two metal plates t=0 t=∞ t=0 t=∞ on the ElectroForce 3200 instrument at a rate of 0.2 mm/min 0.485 0.483 2.811 0.917 to 10% compressive strain. The plate-to-sample interfaces were 0.539 0.508 1.09 0.15 lubricated with silicon grease to reduce friction. 0.511 0.495 1.566 0.277 The materials was then tested by indentation on the ElectroForce 0.535 0.526 1.283 0.311 3200 instrument. Three flat-ended cylindrical indenters 2 mm, 0.465 0.326 2.077 0.518 4 mm and 6 mm in diameter were used in the indentation tests. 0.478 0.401 1.573 0.328 Data from the tests was used in Eq. (2) to predict E and ν. Results 0.508 0.504 2.145 0.646 are shown in Table 1, along with the manufacturer’s nominal data and the E measured by the compression tests. There was good AVG 0.503 0.463286 1.792143 0.449571 agreement between the three sets of data. SD 0.02829 0.0727 0.59092 0.263078

Young’s Modulus (Mpa) Poisson’s Table 2: Effective Poisson’s Ratio and Young’s Modulus for bovine cartilage Indenter as determined by indentation tests with seven different cartilage specimens. Material ratio from Unconfined Size (mm) Indentation indentation Compression Each specimen was tested with three different sized indenters, and data was reduced for three combinations of indenter diameters. Elastic 13.0/6.0 0.347 0.432 0.418 Foam 6.0/4.0 0.489 4.420 Summary Urethane 6.0/2.0 0.489 4.416 Rubber 4.712 The ElectroForce 3200 test instrument is well suited for 4.0/2.0 0.490 4.402 4.413 characterizing soft, viscoelastic biological materials such Average 0.489 4.413 as articular cartilage. Researchers Dr. Hui Jin and Professor Jack Lewis (University of Minnesota Department of Table 1: Elastic properties of urethane rubber and an elastic Orthopedic Surgery) continue their quest to characterize the foam obtained from indentation (two different sized indenters) mechanical properties of articular cartilage by investigating and unconfined compression tests. Manufacturer’s nominal E for novel test methods using the dynamic loading capabilities of urethane rubber is 4.5 MPa and for v=0.5. ElectroForce systems technology.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 74 CharacterizingCharacterizing HeelHeel TissueTissue toto DevelopDevelop aa DynamicDynamic FiniteFinite ElementElement ModelModel ofof thethe FootFoot

The Challenge: Quantify Heel Tissue Response to Dynamic Input to be Used in a Finite Element Model

Background A survey of conventional servo-hydraulic test systems In 2007, 23.6 million people or 7.8% of the population in the indicated that durations of United States were diabetic. About 60% to 70% of people less than 35 ms would with diabetes have mild to severe forms of nervous require significant investment system damage that results in impaired sensation or pain in larger hydraulic supplies in their feet. This often causes the patient to be unaware and valves. As space and of high pressure, or stress concentrations, on the foot that cleanliness are also important would normally be sensed and avoided by a healthy person. in a hospital research Diseased individuals are often unaware of a problem until laboratory, the hydraulic after severe damage has already occurred. Severe forms of systems proved to be undesirable for this task. diabetic neuropathy and resulting tissue over-stressing are a major contributing cause of lower-extremity amputations. The ElectroForce® 3400 test instrument was chosen for its high dynamic response as well as its cleanliness due to its If physicians have a tool to model a patient’s gait and foot, all-electric design. they may then be able to predict potential ‘high pressure’ zones on the patient’s feet. They may then prescribe an orthosis to better distribute the load and improve the Results survivability of the diabetic patient’s feet. The ElectroForce 3400 instrument was benchmarked using a soft tissue analog material. The initial tests indicated an uncontrolled compression of 8 milliseconds. When properly Meeting the Challenge damped to ensure no overshoot, the system reached 15 mm Research led by Dr. William Ledoux at the VA Puget Sound and compression in 10 milliseconds (see graph below). the University of Washington has focused on viscoelastic models of the soft tissue beneath the foot. These models will be incorporated into a finite element model of the foot. The foot model will be used to study the effect of foot shape and muscle imbalances on plantar pressure. It will also be used in the future to develop orthotic devices to redistribute plantar pressure for diabetic neuropathic patients. In order to properly characterize the heel tissue, an actuator had to be found that would provide the fast rate ‘ramp and hold’ protocol required of the viscoelastic soft tissue Summary model. The model assumes that no relaxation occurs during The Veterans Administration & the University of the ramp portion of the testing. The worst case scenario is a Washington are using the ElectroForce 3400 instrument displacement of 15 mm in 20 to 25 ms. to characterize cadaver heel tissue to provide inputs for their finite element model. Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 75 ToothTooth FractureFracture StudiesStudies LeadLead toto LongerLonger LastingLasting TeethTeeth

The Challenge: Determine the Fracture Properties of Dentin in Restored Teeth

Background Recent examination of restored molars suggests that cyclic All specimens were prepared under a water-based flood crack growth may contribute to a greater understanding coolant. The fatigue crack growth rate was estimated of restored tooth fracture. It was found that molars with from crack length measurements conducted after typical amalgam restoration could experience cusp fracture specific intervals of loading. The expected crack path within twenty-five years if flaws greater than 25µ m were was accentuated with silver nitrate to heighten contrast introduced into the margin of the restored area during between the crack and dentin, and the crack length was restoration. This could explain the greater likelihood for measured through visual observation using a scaled restored tooth failure in comparison to untreated teeth. optical microscope (60X).

Tooth fractures originating at the boundary of a repair may indicate the presence of cyclic crack growth While it is possible that the rate of fracture occurrence following restoration may be dependent on the type of material that is used for initial repairs (i.e., reinforcement Results through composite or amalgam), study results suggest that the failure rates are similar for both materials. Some Using the ElectroForce® contend that this is the result of the method of tooth 3200 test instrument, preparation rather than restorative material. Past in Dr. Dwayne Arola’s group at vitro studies involving the rate of tooth fracture are the University of Maryland, limited as they use only monotonic loads, ignoring the Baltimore County has cyclic nature of mechanical and thermal stresses during shown that fatigue crack typical oral activities. growth exponent tested at a load frequency of 5 Hz Meeting the Challenge was found to range from 3.7 to 4.3 for crack growth Fresh molars were harvested from young calves and in-plane with the dentinal sectioned along the mesial/distal axis of the crown. tubules. This falls right Elongated Compact Tension (CT) specimens were machined in-between the range from the crown sections to produce dentin published for bone (2.8-5.1). specimens. The longitudinal groove was introduced to channel the direction of cyclic crack growth during loading. Summary Although results are preliminary, this study and similar ones, will help guide researchers in producing new materials and methods for longer-lasting restorations.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 76 ViscoelasticViscoelastic CharacterizationCharacterization ofof AgaroseAgarose GelGel ScaffoldsScaffolds

The Challenge: To Determine Viscoelastic Behavior of Low Concentration Agarose Type VII Gel

Background Agarose hydrogels are rapidly becoming a popular These mean amplitudes, as measured by stretch ratio, option for an implantable scaffold material due to their ranged from 0.99 to 0.70, where the stretch ratio, λ, is biocompatibility, native tissue-like viscoelastic defined asλ = l / L0, where l is the loaded height and L0 is mechanical properties and ease of casting into complex the unloaded height. The displacement amplitude was shapes and sizes. Hydrogel implants have been used in ±0.5% of the unloaded height. applications where structural integrity is necessary, such as cartilage and skin. With a key functional role of cartilage Results being force dampening, any potential substitute must be The DMA software immediately produces usable results capable of sustaining high impact loading. This series of at the end of the experiments. One example of this is the experiments uses the ElectroForce® 3200 test instrument to complex modulus shown in Figure 1. As the frequency is characterize the dynamic mechanical properties of agarose increased, complex modulus asymptotically increases. In gels at high frequencies. addition, the software generates the two components: storage and loss modulus. Meeting the Challenge Dr. Murakami and Dr. Sawae, lead researchers at the Kyushu Institute of Technology in Japan, were interested in investigating the mechanical behavior (dynamic modulus and tan delta) of low concentration agarose gels at high frequencies. To accomplish this, the ElectroForce 3200 test instrument, in combination with WinTest® software, was used to perform DMA (Dynamic Mechanical Analysis) experiments at frequencies that ranged from 0.1 Hz to 100 Hz at different mean displacements.

Materials and Methods Figure 1 - 1% Agarose Modulus at λ = 0.9 1% and 2% (wt.) agarose gels were produced from agarose The contribution to the complex modulus at lower frequencies type VII powder (Sigma-Aldrich) using a standard gelling is approximately equal, while the storage modulus protocol supplied by Dr. Murakami. Test specimens, cut dominates at higher frequencies. This is an indication that from the bulk gels, were approximately 18 mm in diameter less energy is dissipated at higher frequencies. and 2.5 mm in height. 50 mm diameter solid platens were While this figure provides insight into the material behavior used to secure the at λ = 0.9, there is a wide range of other loading scenarios sample. An ElectroForce this material can experience. Figures 2 and 3 quantify the 3200 test instrument material responses at different mean stretch ratios. Tan equipped with a 1000 g load delta, an indication of the phase shift between displacement cell was used in these and load, is shown for the 1% agarose gel. There is a much experiments. DMA was set larger phase shift at lower frequencies. This effect can be up as a frequency sweep from understood in Figure 1 as the loss modulus does not greatly 0.1 Hz to 100 Hz at a range of contribute to complex modulus at higher frequencies. mean displacements.

77 Figure 2 - 1% Agarose, Tan Delta at Different Mean λ Figure 4 - 2% Agarose, Tan Delta at Different Mean λ

Figure 3 - 1% Agarose, Modulus at Different Mean λ Figure 5 - 2% Agarose, Modulus at a Different Mean λ

Figure 3, complex modulus at different λ, provides more Incorporating tan delta into the model would further insight into the material behavior. It can also be seen that strengthen the predictive capabilities of the model. With as the mean stretch ratio is decreased (i.e., the material is this knowledge of material behavior, scaffold design more compressed), the modulus of that material is parameters and clinical application of agarose gels can be significantly increased. Analyzing this graph along with tan understood prior to development. delta information from Figure 2 shows that the material behaves significantly differently depending upon pre-stretch. As the stretch ratio is decreased, the contribution by the loss modulus to the complex modulus is substantially reduced. Therefore, as the material is initially more compressed, the behavior resembles a more purely elastic material. Similar results can be seen for the 2% agarose gel with different magnitudes. Tan delta for the 2% agarose gel is less than 1% gels at lower frequencies (Figure 4). Additionally, the complex modulus of the 2% agarose gel, shown in Figure 5, is greater than the modulus for the 1% agarose gel. Figure 6 - 1% Agarose, Complex Modulus Plotting this data in three dimensional space leads to further understanding of experimental results, as shown in Figure 6. This figure displays the complex Summary modulus of a 1% agarose gel as a function of both the This series of experiments demonstrates that the ® frequency and mean stretch ratio. A surface can be fit ElectroForce 3200 test instrument is capable of operating to this data using mathematical models which would at the desired high frequencies while measuring small lead to predictive capabilities. Similar graphs can be magnitude loads with accuracy and precision. With a developed displaying tan delta as a function of both mean variety of options for load cells and platens, the stretch ratio and frequency. ElectroForce 3200 is well suited for use in testing weak viscoelastic materials.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 78 EvaluationEvaluation ofof OrallyOrally DisintegratingDisintegrating TabletsTablets (ODTs)(ODTs) UsingUsing PrecisionPrecision CompressiveCompressive LoadingLoading

The Challenge: Quantify the Disintegration Rates of ODTs

Background Orally disintegrating tablets (ODTs) are a new and exciting alternative to traditional tablet and liquid medication dosages. ODTs are a tablet form of medication that dissolves on the tongue, aided only by saliva. ODTs can dissolve in as little as 1 to 2 seconds or as long as 2 to 3 minutes, depending on the different fast dissolve/disintegration technologies used to manufacture the tablets.

ODTs are an appealing dosage form for many reasons. Health professionals find that ODTs are a good alternative where traditional tablet and liquid forms do not work. Pediatric, geriatric, bedridden, and developmentally disabled patients are especially well suited for this alternative to traditional tablets. Medications used for treating nausea, allergies, migraines, arthritis, depression, and schizophrenia are already available in ODT form.

Meeting the Challenge Manufacturers and regulatory agencies can monitor the different fast dissolve/ disintegration technologies of ODTs using the ElectroForce® 3100 test instrument. The 3100 test instrument is a tabletop system designed for low force applications that require greater control resolution than typically available with moderate to high force test instruments. The goal of these tests was to simulate dissolving ODTs in the mouth. The tests monitored the disintegration of four different brands of ODTs under controlled conditions via force and displacement as a function of time.

ElectroForce® 3100 Test Instrument Materials and Methods Four different brands of ODTs were tested on the ElectroForce 3100 test instrument equipped with a 250 g load cell. Two brands, each manufactured with a different fast dissolve/disintegration technology, had an average disintegration time ranging from 1 to 20 seconds. The other two brands were also manufactured with different dissolve/disintegration technologies and had an average disintegration time ranging from 120 to 225 seconds. Force and displacement data as a function of time was recorded for each of the four ODTs tested.

Each ODT was placed on the lower platen on the ElectroForce 3100 test instrument. The lower platen was raised until a preload less than 10 mN was achieved on the ODT. Approximately 5 mL of 37ºC water was placed around the ODT to simulate disintegration of the tablet in the mouth. A ramp waveform was immediately run in load control using WinTest® software to achieve and maintain an end level of 10 mN at a rate of 0.1 N/s.

As the water reacted with the tablet and the tablet disintegrated, the Bose linear motor maintained a load of approximately 10 mN on the remainder of the tablet. Once the tablet was mostly or wholly ODT mounted onto test dissolved, the test was manually stopped. ODT after test platen before loading. is complete.

79 Results Figure 1 shows typical test results of an ODT whose dissolve time was approximately 20 seconds. A load of 10 mN was achieved on the tablet initially, and water was added to dissolve the ODT. However, the ODT dissolved very quickly in an effervescent manner. The load reading fluctuated during the quick dissolve period, and then a load of 10 mN was achieved on the effervesced remains of the tablet.

Figure 2 shows typical results of an ODT whose dissolve time was approximately 225 seconds. The 3100 test instrument achieved a load of 10 mN prior to the ODT dissolving. Just as with the ODT with the shorter dissolve time, the ODT dissolved in approximately 225 seconds, and the load reading fluctuated during the quick dissolve period. A load of 10 mN was achieved on the effervesced remains of the tablet.

Figure 1 Figure 2

Summary These tests demonstrate the ability of the ElectroForce 3100 test instrument to maintain desired low-force loads and measure small displacements while monitoring the disintegration of a variety of ODTs.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 80 DynamicDynamic TestingTesting CharacterizesCharacterizes FrequencyFrequency DependenceDependence ofof LiverLiver TissueTissue

The Challenge: Correlate Elastic Contrast from Imaging to Actual Liver Tissue Mechanical Properties

Background Sonoelastography imaging is being investigated as a The magnitude of the complex Young’s modulus was found method of imaging the creation of thermal lesions induced to fit the Kelvin-Voigt fractional derivative model. This model a by high intensity focused ultrasound (HIFU) or radio gives the complex Young’s modulus as E(w) = Eo + h(jw) , frequency (RF) ablation. When experimenting with liver where Eo is the Young’s modulus at zero frequency, h is tissue, higher frequency vibration (above 300 Hz) did not the dashpot parameter and a is the fractional exponent. enhance the contrast of RF ablation lesions. It was Experimental data was fit to the model to extract the hypothesized that viscoelastic effects were the cause of this parameters. The two normal tissue samples, from different a phenomenon. Since tumor detectability in sonoelastography cow livers, measured Eo = 0.6 kPa, h = 6.35 kPa sec , a = 0.17 (1) a depends on the elastic contrast between lesion and healthy and Eo = 0.6 kPa, h = 8.5 kPa sec , a = 0.09 (2) respectively. Two tissue, it is necessary to determine the frequency response thermally ablated tissue samples from the same calf liver, a to predict the contrast. Cyclic testing of normal and ablated measured Eo = 130 kPa, h = 55.5 kPa sec , a = 0.29 (3) and a tissue was investigated as a means of determining the Eo = 95 kPa, h = 30.5 kPa sec , a = 0.29 (4) respectively. frequency dependence of liver. Meeting the Challenge Researchers at the University of Rochester (NY) utilized an ElectroForce® 3200 test instrument to perform uniaxial, unconfined cyclic compression testing. The test system is rated for cyclic testing up to 200 Hz and is ideal for low load testing of soft tissue for determining its viscoelastic properties. Samples of normal (n=2) and ablated (n=2) bovine liver were tested. All four samples were tested in the range of 0.1 to 25 Hz. The sample geometry was 15 mm x 15 mm x 20 mm high for the normal sample while the ablated bovine liver was cylindrical (15 mm x 20 mm tall). The Bose® DMA software adjusts for various shape factors. Testing also included strain Dynamic modulus of normal vs. ablated liver ranges of 1, 2, 5 and 8% strains and frequency sweeps to 200 Hz. Typical load values for 1% strain to 25 Hz ranged to 0.2 N. These results show that liver has a frequency-dependent Young’s modulus. Future work will involve testing normal and ablated tissue from the same animal so that the lesion elastic contrast can be measured as a function of frequency. This would help determine optimal frequencies for sonoelastography imaging of thermal lesions. The ElectroForce 3200 instrument is rated for cyclic testing up to 200 Hz. During the testing of sample 1, resonance was observed at 150 Hz. Initially it was believed that this was a resonance in the test system; however, preliminary calculations suggest that the sample itself is resonating. Correct selection of sample size should allow testing in the Typical modulus vs. frequency curve for 2% strain range of frequencies normally used for sonoelastography.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 81 DynamicDynamic MechanicalMechanical AnalysisAnalysis ofof HydrogelHydrogel

The Challenge: To Determine the Dynamic Material Properties of Soft Polyvinyl Alcohol Hydrogels

Background Hydrogels, which are water-swollen cross-linked polymers, are The second test performed becoming increasingly important in a wide array of biomedical was a frequency sweep from applications. One of the earliest uses of 1 to 100 Hz for a variety of hydrogels was in the development of soft strains, from 4% to 14% contact lenses. Currently hydrogels are also compression, using the being used in areas including cosmetic and DMA software. A 0.001 N reconstructive surgery, drug delivery systems compressive contact force and tissue engineering. It has become was applied to the specimen increasingly important to determine the to ensure that the data material properties of hydrogels, particularly for applications collected was repeatable. This also ensured that the upper where they are being used as structural components in vivo. compression platen did not lose contact with the hydrogel sample. Upon completion of data acquisition, the DMA software Meeting the Challenge calculates the modulus and tan delta for the specimen and exports the data for plotting as a function of frequency at the various Cambridge Polymer Group, a Boston, MA based contract research levels of strain. The plotted data agrees with the expected laboratory specializing in polymers, contacted Bose® with the material modulus and tan delta; however, there appears to be a challenge of accurately determining the dynamic stiffness and ® specimen resonance or other abnormality as other specimens do modulus of a polyvinyl alcohol hydrogel. The ElectroForce 3100 not show this behavior between 20 and 100 Hz (Fig. 2). test instrument and DMA (Dynamic Mechanical Analysis) software, in conjunction with the WinTest® control software, were used to determine the specimen stiffness and material properties of the The 3100 system is hydrogel. The ElectroForce 3100 test instrument is a tabletop well-suited to very low system that is uniquely designed for low force applications that force applications as is require greater control resolution than is typically available with demonstrated in Fig. 3. moderate to high force testing systems. The plot presents data taken at a frequency of Materials and Methods 1 Hz and a mean strain Cambridge Polymer supplied small irregularly-shaped cylindrical of 4%. Fig. 3 shows that samples of the hydrogel for testing. The specimens were peak-to-peak approximately 3 to 4 mm in diameter and 3 to 4 mm in height. loading on the hydrogel was approximately 2 mN with a Testing was performed in compression with platens 12.7 mm (0.5 corresponding peak-to-peak displacement of 28 μm. in) in diameter, a 5 mm (0.2 in) displacement transducer and a 250 gram (2.45 N) force transducer mounted on an ElectroForce 3200 test instrument. Summary This series of tests demonstrates the Results capabilities of the ElectroForce 3100 test The initial test performed was a displacement ramp from contact instrument to characterize the material to 430 mN at a rate of 0.02 properties of very soft viscoelastic materials mm/s (0.0008 in/s). The such as hydrogels. The material properties of resultant data was plotted on the hydrogel agreed very well with a force-displacement curve to properties measured by other industry determine the linear region of standard testing protocols where there was the material (Fig.1). A distinct overlap with test conditions. The 3100 test linear region was not observed instrument is able to provide an expanded as the specimen made a very range of test conditions in an easy to use, gradual change in stiffness as versatile product. a function of % strain.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 82 CompressiveCompressive LoadingLoading ofof PolyvinylPolyvinyl AlcoholAlcohol MicrobeadsMicrobeads

The Challenge: Resolve Small Compressive Forces Applied to a Single Layer of Hydrogel Microspheres

Background Polyvinyl alcohol (PVA) hydrogels are used in A contained, single layer of microspheres was pipetted embolization therapy, a minimally invasive treatment from the syringe delivery device onto a 2 in (50 mm) for hypervascularized tumors and arteriovenous compression platen (Figure 1). Excess liquid was used to malformations. During embolization therapy, an embolic compress the microspheres. material such as PVA hydrogel microspheres is injected into the selected vessels to block the blood flow feeding the tumor or malformation. This causes the tumor or malformation to gradually shrink over time. Figure 1 - Monolayer of Embolization therapy can be used to treat such health microspheres issues as liver tumors, uterine fibroids, varicose veins, and prior to test aneurysms. It offers benefits over more standard surgical treatments, including shorter hospital stays, shorter procedure recovery times, and decreased treatment costs. The test performed was a displacement ramp, subjecting Microspheres of PVA hydrogel as an embolic agent are the microspheres to an 80% strain at a rate of 5 mm/min. ideal; they are well suited to the flow dynamics of the bloodstream. They are hydrophilic, can be colored for Results increased visibility, and are compressible. These features Load-displacement curves indicated that the 3220 test allow for smoother delivery to the target area of the body. instrument started picking up data at approximately 650 μm, as shown in Figure 2. At 80% strain, the maximum force recorded was approximately 0.4 N. Meeting the Challenge A manufacturer of PVA embolic agents contacted the ElectroForce® Systems Group of Bose Corporation with the challenge of accurately resolving the forces required to compress the microspheres they produce. The ElectroForce 3220 test instrument with WinTest® software was used to subject the microspheres to 80% strain in compression and accurately resolve force and displacement. The ElectroForce 3220 is a tabletop test instrument capable of measuring loads up to 50 lb (225 N) and displacements up to 0.50 in (12.5 mm). The embolic agent manufacturer supplied the ElectroForce Systems Group with the PVA hydrogel microspheres for testing. The microspheres, in their syringe delivery device, Figure 2 - Load-displacement curve were 700 – 900 μm in diameter. Summary The testing was performed in compression with platens Load-displacement curves indicated that the 3220 test and with the ElectroForce 3220’s standard 0.5 in (12.5 mm) instrument started picking up data at approximately 650 displacement transducer and 50 lb (225 N) force transducer. μm, as shown in Figure 2. At 80% strain, the maximum force recorded was approximately 0.4 N.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 83 Small Diameter Vascular Graft Elasticity Measurement in Response to Pulsatile Pressure

The Challenge: Measure Wall Distention of Vascular Grafts in Response to Pulsatile Pressure Background There is currently a large demand for small diameter (< 5 mm) vascular grafts to replace diseased arteries of the coronary and peripheral vasculature. Particularly vascular grafts developed from synthetic scaffolds (e.g., polyurethane, polyglycolic acid) do not have tissue-like compliance and elasticity. Therefore, measuring the elasticity of the vascular wall of graft materials is essential for predicting their success and patency in vivo. A linear pressure ramp was also applied to the sample from 0 to 295 mmHg. While the pressure was held constant, the Meeting the Challenge vascular graft OD continued to increase with time until the Bose ESG has developed the BioDynamic® test instrument pressure was returned to zero. for the simultaneous characterization and mechanical stimulation of orthopaedic and cardiovascular tissues and biomaterials. This system can accommodate vascular grafts in a biological environment and measure wall distension and elasticity under pulsatile flow and pressure conditions using a laser micrometer. Gel-Del Technologies, Inc. (St. Paul, MN) contacted Bose ESG for the elasticity measurements of their composite vascular graft biomaterial. Experimental Setup and Tests After each pressure loading cycle, the sample OD did not return to its initial value within the time frame of the test, Vascular graft distension with increasing pressure was indicating potential creep behavior. evaluated in a single axis TestBench configuration with a vascular BioDynamic chamber using a laser micrometer. Summary The graft material used (Gel-Del Technologies, Inc., St. Paul, Preliminary results with vascular grafts show that the MN) is composed of proteins and polymers fabricated to BioDynamic test instrument is a powerful tool for the mimic the viscoelastic properties of native blood vessels. evaluation of critical mechanical properties pertaining to Tube clamps were used to arterial substitutes. The data obtained confirmed the secure the grafts (3 mm biphasic composition of the specimen that is composed of inner diameter and 30 mm a protein-rich material and synthetic polymers. The results long) on hose barb fittings in indicate that this prototype the BioDynamic chamber. A vascular graft material may not laser micrometer was placed possess all the elastic properties over the chamber with the required in vivo. The vascular laser beam penetrating the transparent chamber doors and BioDynamic test instrument measuring outer diameter (OD) changes with pressure and equipped with a laser micrometer time. The sample was loaded under pressure control with can precisely measure wall two cycles of a sinusoidal pressure waveform from 0 to 25 elasticity in response to mmHg, followed by a cycle of pressure increase to 100 mmHg. pulsatile flow that can be The diameter response followed the pressure accurately prescribed to mimic changes very closely throughout the test. physiologic hemodynamics.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce, WinTest and BioDynamic are registered trademarks of Bose Corporation. 022613 84 TestingTesting toto ImproveImprove thethe DurabilityDurability ofof ArtificialArtificial HeartHeart ValvesValves

The Challenge: Evaluate the Durability of an Innovative Composite Polymer-based Heart-valve Prosthesis

Background Heart valve prostheses have been used successfully in heart procedures since 1960 resulting in an overall improvement in the quality of life of the patients. Currently, there are two kinds of valves used: mechanical and bioprosthetic. Generally, mechanical valves are more durable than bioprosthetic valves. However, they sometimes involve side effects with irregular blood flow and clotting of blood around them. Bioprosthetic valves have better hemodynamic (blood flow) properties, but are more susceptible to wear as a result of material fatigue. Stretched Specimen The ElectroForce® 3200 Test Setup Polymer trileaflet (PT) valves offer natural hemodynamics with the potential for better durability. Tensile and tension fatigue properties for each material PT heart valves usually fail in long-term use with tearing are performed according to ASTM standards. The and calcification of the leaflets due to high dynamic tensile tensile test is displacement controlled, and the specimen and bending stresses borne by the material and the is stretched at a constant rate until failure. The tension oxidative reactions with blood. It was postulated that fatigue test is load controlled; that is, the specimen is synthetic valve leaflets that mimic the natural valve leaflet being cycled between two tensile loads. The loading structure fabricated from fiber-reinforced composite frequency is 100 Hz. Cycling continues until failure for material will minimize leaflet stresses and decrease tears each specimen. Since there can be significant fatigue and perforations. damage without actual fracture, failure is defined as 50% loss in residual strength of the material.

Meeting the Challenge The aim of the research, performed under the supervision of Dr. Richard Schoephoerster in the Cardiovascular Engineering Center at Florida International University, is to manufacture and test an innovative composite PT heart valve prosthesis. In order to identify the better material from which to manufacture valves, a certain proprietary polymer is compared to an existing implant-approved polymer (IAP). Static and dynamic properties of the polymers are being determined in order to establish the right polymer composite for the heart valve prosthesis. All the testing is performed on the ElectroForce® 3200 test instrument. Preliminary results show the fiber-reinforced composite material has the potential for longer fatigue life when compared to an existing implant-approved polymer.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 85 Dynamic Testing Brings Running into the Laboratory

The Challenge: Predict which Materials Make the “Best” Running Shoe

Background One of the biggest recurring expenses runners face is the The test profiles were fit with a series of haversine cost of new running shoes. Runners who regularly log forty, segments. A dwell was added at the end of the pulse to fifty, or sixty plus miles a week can easily use up a pair of simulate the time between shoe impact. training flats in two months or less. The physical properties of the materials chosen for shoe construction will determine the longevity of the shoe in addition to the perception of fit, comfort, cushion, and stability. The storage and loss modulus of the materials would seem to be key measurements to predict shoe performance. In addition, the ability of materials to recover the original thickness and structure from step to step will influence the performance during typical running conditions.

If the recovery time is greater than the time between steps, the residual compression will lead to mechanical properties different from those initially measured. Measuring the dynamic properties can help predict which materials will provide the “best” running shoe.

Meeting the Challenge Researchers at a major running shoe manufacturer provided Bose with evaluation material and test conditions for a typical “light” and “heavy” runner. The pulse represents the output of a force platform for a typical heel The force profile of the complex waveform used to simulate strike and lift-off event. heel strike and lift-off was easily recreated under demanding conditions. The stiffness of the material at maximum force The ElectroForce® 3300 test instrument with pneumatic was over 25 times higher than the stiffness at first contact. preload was used to recreate both runner profiles in By following the displacement feedback over a series of compression. An indenter developed by SATRA was used pulses, the compression set of the material can be tracked. which measured 45 mm in diameter with a 37.5 mm radius The ElectroForce 3300 test instrument with pneumatic on the face. preload has shown its value in laboratory evaluations of running shoe materials.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 86 DynamicDynamic TestingTesting LeadsLeads toto ImprovedImproved FiberFiber

The Challenge: To Measure the Material Properties of a Single Fiber

Background The fiber industry is highly competitive and relies on The initial test was tension to failure. Multiple samples innovation for new and improved products. Manufactured were used to determine the repeatability of the breaking fibers are used in a wide variety of applications in modern force of 60 grams and to reduce the ringing in the data apparel, home furnishings, medicine, aeronautics, energy, due to fiber pull-out through optimized specimen building construction, industrial belts, filters and more. preparation and fixturing. Fibers form the basis for today’s high-tech composite materials that are inexorably replacing traditional materials in applications from artificial organs to super-absorbent diapers, to construction materials for aircraft, automobiles and space stations. Customer demand for products that have higher load bearing capabilities and greater durability led to research at the Georgia Institute of Technology on the physical properties of individual fibers. The premise is, if you improve the individual fiber, you improve the finished product. The properties measured in this study will be used as a baseline for developing new and better fibers and fiber processing techniques.

Meeting the Challenge The ElectroForce® 3220 test instrument was chosen to Next, a cyclic fatigue test was conducted at 10 Hz between test a series of nylon fibers 5 to 10 6 and 50 grams. Force control was optimized through the microns in diameter because of its use of an advanced control technique. outstanding precision and sensitivity for resolving forces and displacements. The standard system displacement transducer was used in conjunction with a 250 gram force transducer to provide optimal capacity and resolution. A single fiber was bonded to each sample card to provide alignment and prevent damage to the fiber This series of tests shows the ElectroForce 3220 during handling. The paper frame instrument with advanced WinTest® control features was cut just prior to testing after is well-suited for determining the tensile and fatigue the specimen was installed. properties of individual fibers. This capability will allow the development of optimized materials for many different applications.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 87 DynamicDynamic TestingTesting Testing PredictsPredicts Predicts SuccessSuccess Success ofof NanocompositesNanocomposites of Nanocomposites

The Challenge: Determine the Effect of Adding Nanoparticles to Commodity Plastics

Background The definition of a nanocomposite material has broadened However, the energy to failure for 0.5 mm/s stress-strain significantly to include a wide variety of materials made of tests is more than 300% (3x) greater than the distinctly dissimilar components and combined at the polypropylene matrix, suggesting that the impact nanometer scale. measurements will be significantly improved. The general class of nanocomposite materials is a fast growing area of research. The properties of these materials depend not only on the properties of their individual components but also on their morphology and interfacial characteristics. This rapidly expanding field is generating many exciting new materials that are intended to yield unusual sets of properties that do not currently exist in commercial systems.

Meeting the Challenge Dr. Charles Beatty of the University of Florida, Gainesville, is a world leader in in situ reactive polymer processing. DMA tests show differences between the original He used the ElectroForce® 3200 test instrument with a polypropylene and the nanocomposite for various types hot/cold chamber to measure steady state and dynamic of nanoparticles and reactive processes. material properties on the original commodity plastics, and the modified polymer blends including blends of various nanoparticles such as clay and magnetic ferrite, to determine the extent of modification/enhancement of the desired material property. For typical polypropylene/ montmorillonite clay systems, they have produced transparent nanocomposites (although slightly tan colored due to chromophores) that have the usual increase in modulus and tensile strength. The final test of efficacy is the measurement of engineering properties such as impact properties, tensile stress-strain behavior, DMTA and fatigue propertiesafter reprocessing several times to ensure domain interface stability. The ElectroForce 3200 test instrument can be used to determine all of these critical material properties, and more.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 88 TireTire CordCord DynamicDynamic PropertiesProperties MeasuredMeasured forfor FEAFEA ModelModel

The Challenge: Measure Loss and Storage Modulus for Tire Cord up to 200 Hz in Force Control

Background Textile cords in a rubber matrix are an important class of The material exhibits extensive creep behavior at this level composites. Applications of such composites can be found of mean force so a precondition was set to cycle for 35,000 in tires, air springs, shock isolators, and hoses. The most cycles at 10 Hz prior to collecting any dynamic data. complicated of these designs is the modern automobile tire. The development process for a new line of tires is expensive and long, often consuming 18 months or more. Finite Element Analysis (FEA) is one tool used to model the tire as a structure to reduce the cost and time to market for new tire designs. For example, Ohtsu Tire Company reported that it eliminated 200 physical tests per month and 10% of its tire development cycle time by implementing tire modeling and simulation. Accurate models require accurate properties of individual materials, components, and structures. One of the components that has been difficult to characterize under appropriate conditions is the tire cord. The modulus at 250°F was approximately 50% of the modulus at room temperature. The measured phase angle (tan delta) was the same at either temperature.

Meeting the Challenge The ElectroForce® 3200 instrument was also used to A major tire manufacturer supplied a tire cord specimen conduct a traditional stress relaxation test on the tire cord that consisted of two strands of tire cord embedded in to a displacement that produced an initial force of rubber tabs at both ends to facilitate gripping without 42 N per cord. damaging the tire cord. Tests were conducted in an ElectroForce® 3200 test instrument with a hot/cold chamber at room temperature and at 250°F (121°C) over a frequency range from 2 to 200 Hz in force control. The requested mean value correlated to 58 N per cord with a dynamic amplitude of 8.9 N per cord.

This test showed a reduction in force to 28.5 N per cord after 10 seconds. Level crossing data acquisition was used to optimize the data file size for this test.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 89 AutomotiveAutomotive FatigueFatigue LifeLife andand DynamicDynamic MechanicalMechanical AnalysisAnalysis ofof aa MatrixMatrix PolymerPolymer

The Challenge: To Determine the SN Curve and DMA of a Medium Hard Matrix Polymer

Background Many exterior components on modern automobiles are Multiple tests and multiple fabricated from advanced polymer and composite materials. applied stress levels were Knowledge of the strength and durability of these raw materials is conducted to generate a becoming increasingly important for suppliers who support the traditional S-N curve for automotive industry. These the material. materials must have the appropriate strength and durability. Additionally, The second round of tests the finished components must resist was performed on the second environmental extremes and be able sample geometry. These to sustain significant deformation in tests were typical DMA tests which consisted of a frequency service. As a result, many automotive sweep from 0.1 to 10 Hz using the force control capability in manufacturers are seeking consistent the DMA software. A 15 N pull contact force was applied to material properties data. the specimen to ensure all the samples were subjected to the same loading history. The force applied on the matrix Meeting the Challenge polymer was a mean force A manufacturer of polymer materials contacted Bose with the of 100 N and dynamic need to assess fatigue response and also to perform a DMA amplitude of 60 N. Upon assessment on their raw materials. The ElectroForce® 3330 test completion of the test data instrument with DMA (Dynamic Mechanical Analysis) software, acquisition, the DMA in conjunction with WinTest® control software, was used to software calculated the conduct these tests. The ElectroForce 3330 test instrument is modulus and tan delta for a table-top system that is uniquely designed for testing small the specimen and exported the data for plotting as a function of and medium size samples. The ElectroForce 3330 has excellent frequency. The plotted data agreed with the expected material control resolution at lower forces and loading capacity up to 3 kN. modulus and tan delta behavior. The Bose ElectroForce system is well-suited to applications Materials and Methods where there is a need to apply low forces but still have capacity The manufacturer supplied two specimen configurations of the to perform tests up to several kiloNewtons. matrix polymer for testing. The testing was performed using Bose® 3 kN tension grips. The 3330 test Summary system was configured This series of tests demonstrates the with the standard 25 capabilities of the Bose ElectroForce 3330 test mm displacement instrument to characterize the material transducer and 3 kN properties of raw materials for automotive force transducer. industry applications. The material properties of the matrix polymer agreed very well with The initial testing properties measured by other industry performed was force standard testing protocols where there was controlled fatigue overlap with test conditions. The instrument testing from 15 N to 145 also is well-suited for testing components of N using a 5 Hz sinusoidal waveform. Typical single test resultant products made of the same raw material. The data is plotted below (Fig. 1). The accumulation of plastic strain is evident over the course of the test up to failure at 2700 cycles. 3330 test system is able to provide an This type of testing is simple and easily accomplished with the expanded range of test performance in an easy 3330 table-top instrument and standard WinTest software. to use, versatile instrument.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 90 GenerationGeneration ofof MasterMaster CurvesCurves forfor CuredCured RubberRubber

The Challenge: Predict the Frequency Response of Cured Rubber Materials using Time-Temperature Superposition

Background The Williams, Landel & Ferry model (WLF) uses time-temperature superposition to generate master curves These data can that predict the dynamic behavior of materials at be sorted by frequencies outside the range of practical measurement. frequency to This model relies on the observation that time and show the glass temperature have equivalent effects on the properties of transition of viscoelastic materials. the different materials as a The master curve is created with data from a dynamic function of mechanical analyzer (DMA) that produces modulus (E) and temperature. loss (tan delta) values over a moderate range of frequencies and temperatures. The master curve predicts the dynamic behavior of the material over a very wide frequency range at a constant (usually room) temperature. Time-temperature superposition can be used to predict the behavior of Meeting the Challenge the material from Dr. Joey Mead of the University of Massachusetts, Lowell 1x10-8 to 1x108 Hz worked with the U.S. Army Research Laboratory and the at a any chosen Michigan Technical University to optimize the rubber temperature. bushings used in tank track applications. Tests were conducted on four rubber compounds to compare the measured material properties to real-world bushing successes or failures.

The ElectroForce® 3200 test instrument was used with a hot/cold chamber to measure the dynamic modulus and tan delta of the material over a frequency range of 0.1 Hz to 100 Hz at 25 different temperatures ranging from -50 to 150°C.

Four samples were tested in this manner and the measured properties will be used to predict the durability of candidate bushing materials.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 91 DynamicDynamic TestingTesting UncoversUncovers RheologyRheology ofof RubberRubber

The Challenge: Determine Level of Branching in Uncured Rubber

Background Molecular weight, molecular weight distribution, and long chain branching of uncured rubber compounds are important parameters to understand for predicting the curing process and final material properties of cured rubber.

The ElectroForce® 3200 test instrument has been used to measure the dynamic shear moduli and tan delta of four The compound with little or no branching exhibits a uncured rubber compounds of crossover of G’ and G” when plotted as a function of Butyl rubber and carbon black. frequency. There is no crossover in the data from the These tests clearly show highly branched material. the amount of branching of each compound.

Meeting the Challenge The specimen was excited with a sinusoidal strain at an amplitude of 5% (0.2 mm peak to peak displacement) from 0.001 to 16 Hz (0.006 rad/s to 100 rad/s). Temperature was controlled to 125°C. Also tan delta should decrease more at lower frequencies for branched materials as shown in the following figure. The test specimen was a double lap shear sample with thickness of 4 mm and 400 mm2 area (20 mm by 20 mm). The transmitted force was measured using a strain gaged load cell. Timed data was analyzed using an FFT to determine the amplitude and phase relation of the The ElectroForce 3200 instrument measures these fundamental frequency at each test condition. properties as well as the properties of the fully cured rubber which makes it one of the most versatile material test systems in the industry.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 92 FatigueFatigue TestingTesting ofof ThinThin MetallicMetallic FoilsFoils andand WiresWires

The Challenge: Predict the Fatigue Life of Products Made From Thin Metal Foil and Wire

Background Metal foils and wires are used in a wide variety of applications The graph to the such as radiators, Micro-Electro-Mechanical Systems right shows a (MEMS), electronics, optics, and food preparation. Knowing standard 3200 how long the foil and wire will survive the loading instrument at the associated with the specific application is important in maximum load range predicting the success of the product itself. running at 100 Hz. Knowing the fatigue life of the material in a traditional ASTM specimen geometry does not necessarily predict the fatigue life of the material as applied in the final product. Foils and wires may be only a few molecules thick which makes standard The next two graphs show data from an ElectroForce 3200 manufacturing defects a source of crack initiation and failure. system modified with a 250 g (2.5 N) capacity load cell at The process used to manufacture a thin foil or wire may alter the minimum load range running a 70 Hz test on a 28 gage the mechanical properties of the metal, and the chances of wire sample. damage during normal handling and production are much The first graph shows timed data from two cycles and the higher than for thicker materials. These effects can make second shows the measured peak and valley of the the foil and wire prone to fatigue damage at stress levels controlled load at the minimum load range for the first dramatically lower than the commonly accepted material 100,000 cycles. fatigue life thresholds. Meeting the Challenge The ElectroForce® 3220 test instrument was chosen to test a thin 60 µm aluminum foil over a range of stress amplitudes that would cover a wide range of the fatigue life (S-N) curve at a stress ratio (minimum stress/maximum stress) of 0.1. The maximum load range was; L-max =24.50 N and L-min = 2.45 N and the minimum load range was;

L-max = 0.098 N and L-min = 0.010 N The sample, as shown in the photo to the right had a width of 10 mm and a reduced gage length 20 mm long. Fatigue life at the low stress levels is expected to exceed 10,000,000 cycles. At 15 Hz each test would last more than 7 days so the desire is to test at the ® highest frequency possible with accurate control of the force This data demonstrates that the ElectroForce 3200 test end-levels and a high fidelity waveform. As shown in the instrument, with optimized configurations, can obtain the following data, the ElectroForce® 3200 system met all the data required for the complete fatigue life prediction of a required conditions. thin foil or wire material.

Bose Corporation – ElectroForce Systems Group 10250 Valley View Road, Suite 113, Eden Prairie, Minnesota 55344 USA Email: [email protected] – Website: www.bose-electroforce.com Phone: 952-278-3070 – Fax: 952-278-3071 ©2013 Bose Corporation. Patent rights issued and/or pending in the United States and other countries. Bose, the Bose logo, ElectroForce and WinTest are registered trademarks of Bose Corporation. 022613 93 Customer Support and Training to Enhance Testing Skills

Technical Support

We’re committed to our customers testing success, and our overriding goal is to create value for them by offering products and services that consistently meet their needs. We put customers at the center of a dedicated focus on quality and service, and we measure success by the satisfaction of our customers.

When you buy a Bose® product, you become a valued, lifelong customer. Bose has taken this commitment to a new level by offering free technical support so you can keep your testing program moving forward. If you need assistance, please contact us by e-mail or phone.

Introductory WinTest® Software Training

Bose offers regularly scheduled, free introductory online WinTest® software training classes. Whether you need to train a new student, new employee, or just need a WinTest user refresher course, Bose is committed to providing several training options to keep your technical users fully qualified to operate your instruments and software.

The Bose ElectroForce Systems Group also offers short, “on-demand” WinTest software training videos that are available anytime you need them. There is an overview video, and then separate videos that cover each of the steps to set up and run a test using WinTest software. Bose is committed to providing industry-leading support, and “on-demand” training is a new way to deliver timely support when you need it.

Advanced Training Services

Beyond introductory WinTest software training, Bose offers training options for customers desiring additional training support. These curriculums can be provided as either online training webcasts or onsite training sessions at your facility using your test equipment. Advanced training courses are offered for both WinTest 7 software and DMA software.

For on-site training, a qualified training engineer will travel to your site and provide a tailored training class, or the session can be customized to answering specific software, hardware, or test applications questions. Training will be based on your organization’s needs and can be performed on a particular ElectroForce® test system at your facility. A Full Line of Accessories and Upgrades for your Ongoing Needs

Accessories Sensors Grips/Platens Axial Force Transducers Grips • High Force • Tension/Torsion Grips • Low Force • Tension/Compression Grips • Submersible • Low Force Grips • Mini-Beam • Wedge Grips • Axial/Torsion • DMA Grips • Tissue Grips Other Sensors • Tissue Grips - Thermal-Electrically Cooled • Rotation • BioDynamic Tensile Grips • SGT Pressure • BioDynamic® Pressure Platens • Extensometers • Compression Platens • Digital Video Extensometer • BioDynamic Compression Platens • SGT Optical Micrometer • High-Temperature Compression Platens • BioDynamic Micrometers SGT and BioDynamic Accessories Fixtures and Chambers Stent/Graft Testers (SGT) Fixtures • SGT Fittings • 3 and 4 Point Bend • SGT Pulse-on-a-Bend Fixtures • Tubes Environmental Chambers • Saline Baths Platens • Hot/Cold Chambers • BioDynamic Accessory Kits • BioDynamic Peristaltic Pump • BioDynamic Multi-Channel Peristaltic Pump • BioDynamic Gear Pump Upgrades Controls Upgrades 3200/3300/3500/TestBench Upgrades • WinTest® Electronics Upgrade • Extended Stroke Upgrades • DMA Software • Multi-specimen Fixture (3200 and 3300 only) • Series II Upgrade • Torsion Upgrade • Axial Force Upgrade Stent/Graft Tester (SGT) Upgrades • Electric Lift Upgrade • SGT Mean-pressure Controller • BioDynamic Chamber Upgrade • SGT 9110 to 9120 Upgrade • TestBench Planar Biaxial Upgrade BioDynamic Upgrades • Off-Axis BioDynamic Pulsatile Upgrade • BioDynamic Burst Pressure Upgrade Worldwide Support Research fuels technology, and superior technology leads to superior performance. Since Bose Corporation was founded in 1964 by then Massachusetts Institute of Technology Professor Dr. Amar G. Bose, the original philosophies and founding principles have not changed. Bose maintains an exceptionally strong commitment to research, for it is within the discipline of research that yesterday’s fiction becomes tomorrow’s reality. We strive to identify things which, when made better, improve people’s lives. Our commitment has served us well. Today, Bose has over 9,000 employees, and operations in the United States, Europe, Canada, Mexico, Australia, Asia and South America.

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Americas Europe Asia Bose Corporation Bose GmbH Bose Corporation ElectroForce Systems Group ElectroForce System Group ElectroForce Systems Group 10250 Valley View Road, Suite 113 Max-Planck-Strasse 36 1F, Building A1, No. 1528 Gumei Road Eden Prairie, Minnesota 55344 61381 Friedrichsdorf, Germany Shanghai, 200233 China T: 952 278 3070 T: +49 6172 7104-0 T: +86 21 6037 1767 F: 952 278 3071 F: +49 6172 7104-19 F: +86 21 6082 3172 E: [email protected] E: [email protected] E: [email protected] www.bose-electroforce.com