Core Capabilities for Medical and Instrumentation OEMs

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Our vision is to be the world’s leading provider

of turnkey solutions for vital electronic interconnect systems,

cable assemblies, connectors, and plastic and metal components

for OEMs in the medical and instrumentation markets.

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Introduction

Your project starts with a great design and finishes with

delighted customers. At Tyco Electronics, our engineering

expertise and broad range of manufacturing capabilities put

our best at your service. From drawing board to volume

production, we bring metal and plastic parts, connectors,

cable assemblies, subassemblies and complete turnkey

solutions from concept to reality.

We’ll manage your project from concept through production.

With modern design tools, simultaneous engineering and

project management systems, we can reduce your time to

market. Take advantage of our vertical capabilities to

optimize components for integration into complete solutions.

Whether the product calls for micro miniature dimensions for

tiny devices...tight tolerances for signal integrity...

materials that can survive sterilization cycles...or the vital

connections required by critical care equipment, Tyco

Electronics solves your interconnect challenges with years

of experience, modern design tools, precision equipment

and global manufacturing service.

Let us help you bring your ideas to completion.

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Applications

Tyco Electronics components, subassemblies and devices are inspired by your end users’ needs—for patient comfort, ergonomics, signal integrity, compact packaging, durability or sterilization. Tyco Electronics designs for medical and instrumentation OEMs can be found on ultrasound equipment, surgical instruments, patient monitors, thermometers, glucose meters, oscilloscopes, logic analyzers and semiconductor test equipment.

We start with a lot of questions. Medical devices and scientific instruments have critical power and signal requirements. Components must be reliable, durable and sometimes survive in extreme conditions. We want to understand how your end user will handle the product. What is its environment? What are the mechanical stresses? The electrical requirements? The regulatory and industry issues?

We’ll respond with innovative designs, engineering experience, material expertise, and our extensive test and validation centers. Our sales team’s background in the medical and instrumentation industries helps us understand your market and your market’s requirements. We are also experienced with the agency, federal and international guidelines and regulations for your industry. Our global manufacturing facilities are close to your factories in North America, Europe and/or Asia, and our service centers support you around the world.

Custom components, connectors and cable assemblies have been developed for high-performance applications such as MRI and ultrasound imaging, blood gas analyzers and automated test equipment.

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Design and Engineering

Tyco Electronics expertise is the result of years of experience as a vertically integrated supplier. We have developed core processes in connector design, precision metal stamping and forming, die casting, screw machining, plating, molding, cable and assembly to create a unique solution to meet your challenging electrical and mechanical requirements.

With design teams focused on medical and instrumentation applications, we can provide solutions that meet your unique performance demands. Ease of use, ergonomics, aesthetics, sterilization methods, industry standards and regulatory guidelines are taken into consideration. The goal is a product optimized for its application, use and life cycle.

We use the most advanced tools and methods to maximize the engineering skill, experience and speed that we bring to every project. In-house research and resources in materials, signal transmission, contact physics, shielding effectiveness and other expert areas enhance the design. Solid modeling programs, finite element analysis (FEA), and software for mold tools, harnesses and connector design support rapid development of concepts, prototypes, tooling and production schedules. Root-cause failure analysis (RCFA) and failure mode and effects analysis (FMEA) protocols identify issues for remediation and/or prevention.

Disciplined three-phase design reviews audit and document the product development cycle to ensure that the product meets your requirements. And our operational excellence initiatives—Six Sigma and Lean—improve processes and efficiency by reducing variation and eliminating waste.

Custom connector design for high mate/demate medical application.

Rapid PrototypingReduce time to market with prototypes that are quickly turned for your approval. With solid modeling programs, engineering analysis tools and harness software support, product concepts are turned into reality.

Our model shops offer rapid production of SLAs, as well as machined and molded parts. Single station tools and assembly areas take advantage of solid model input to directly produce parts and tooling. That means prototypes of contacts, housings, and other plastic and metal components can be shipped to you in less than a week (depending, of course, on part complexity).

CNC and SLA equipment make precision prototypes quickly.

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Metal Parts

From design to tooling and production, Tyco Electronics can build the precision metal-formed, stamped, screw-machined and die-cast parts needed for your products.

Our in-plant tool shops support design and build stages with vertically integrated milling, grinding, turning, EDM, welding and other processes needed for producing smooth-running production products. Facilities are available for quick turn-around of product modifications and development support for prototype and production tools.

Tyco Electronics has expertise and capabilities in• Various die capabilities, including progressive

forming and high-speed processes · Contacts, lead frames, brackets, gears and

complex geometric forms • Automated reeling • In-house design and build • Copper and steel alloys including stainless steel • Tin, nickel, silver, gold and palladium applied

over the entire part or selectively electroplated • Parts cleaning and specialized lubrication

application processes • Vision inspection/verification systems

Environmental protection devices for air and water filtration protect employees and the environment throughout the material handling, staging and manufacturing processes.

Screw-machined parts are designed to fit unique applications.

Selective plating makes efficient use of precious metals.

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Molding

Experience, in-house tooling and optimized facilities allow us to design unique parts, housings, flex-reliefs, tubings and extrusions for your products. Our on-site capabilities to design, build and/or modify tooling allow quick turnaround of product modifications and development support for prototype and production tools.

A scientific approach to molding is practiced at multiple plants to form identical parts consistently with reduced cycle time and waste. Thin-walled components, complex parts and high-volume production are possible with process monitoring, state-of-the art setups and world-class equipment. MOLDFLOW software simulates the injection molding process to predict and avoid potential defects. MELTFLIPPER technology manages the material flow properties throughout the runner system to optimize part consistency and minimize processing inefficiencies.

With both vertical and horizontal injection molding machines and liquid injection molding (LIM) equipment, we can overmold or insert mold (discrete or continuous strip). Overmolded housings can incorporate your geometry, color and logos. Our molding operators are proficient in running nylons (unfilled, filled and high temp), ABS, PBTs, LCP, polycarbonate, polyurethane, polypropylene, polyester, PCTs, silicone and TPE.

The ability to plate plastics with conductive material allows the development of specialized molded interconnect devices (MID), eliminating separate components and wiring in your device.

Tyco Electronics facilities feature computer-controlled equipment in controlled environments for product consistency and employee welfare. Safety-cycle vision systems and cavity pressure technology control process and product variation. When the application is a medical device, materials compliant with FDA and other regulatory guidelines are used.

On- or off-shore, molding processes are tightly controlled for precision forms, product cosmetics and volume production. Injection, overmold and two-shot molds create discrete parts, strain reliefs and integrated components.

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Cable

Performance, durability and ease of use top the list of cable design issues critical to device manufacturers. Special applications may require exceptionally precise electrical characteristics, extra flexibility, or reduced weight and diameters. Cables may need to be resistant to crush, abrasion, cut-through, hazardous environments or repeated sterilization cycles.

We are experienced in processing conductors, insulation materials, various types of shielding and thermoplastic and thermoset jackets for OEMs of medical and instrumentation equipment. Closed-loop control systems help provide the highest levels of product quality and consistency.

Count on Tyco Electronics for • Coax, twin-ax, round multiconductor, ribbonized

and flat ribbon cables • Conductors from 50 AWG to 18 AWG • Up to 2,000 signal conductors in a single cable • Solid and stranded tinned or silver-plated copper

and high-strength copper alloys • Extruded, tape and cellular dielectrics/insulations

selected for desired electrical and mechanical properties

• Braided, spiral and foil-tape shields, including constructions for microphonic/triboelectric noise and EM compatibility

• Jacket materials to address flammability issues; resistance to chemicals, radiation, abrasion, crush, cut-through or sterilization processes (including autoclave)

• Extended flex-life and increased flexibility • Temperature capability from –55°C to +200°C

Micro wire cabling is performed by precision equipment.

Closed-loop control maintains tight tolerances on dimensions and electrical characteristics.

Precision ribbonization and laser prep produce cables ready for termination.

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Assembly

We organize our assembly facilities for maximum productivity and quality, each matched to the complexity and volume of the product. Our global facilities support cost-effective assembly in Mexico, China, India or wherever your manufacturing facilities dictate.

Flexible manufacturing allows us to handle low- or high-volume production requirements as well as any level of product complexity. Assembly operations include terminating wires and circuits by soldering, crimping, welding and bonding. We can build wire harnesses for inside portable equipment or inside equipment racks. Molding processes can create discrete or integrated parts. To ensure product quality each and every time, our production processes include online documentation, vision system inspection and closed-loop process control. When required for a part or product, processing and assembly is performed in Class 100,000 clean rooms.

Integrated solutions can involve custom contacts, connectors, cables, and insert molded or overmolded parts.

Assemblies are fabricated on the plant floor or in clean rooms, depending on the application’s requirements.

Micro soldering terminates wires to flex circuits for the smallest of medical devices.

Turnkey services

Our printed circuit facilities manufacture on a variety of substrates and handle sub-assemblies from bare boards to fully assembled racks. Identification and labeling capabilities are performed on-site or prepared for customer overprinting and handling. Kits, subassemblies and finished products complete with your printed materials and packaged to your specifications are ready for you to ship to your customers.

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Quality

An infrared camera images a device under test.

A video microscope is used to inspect parts.

Tesing and Validation

When Tyco Electronics delivers completed products, customers can be certain that each component, as well as the whole system, has been thoroughly tested. In-house and third-party labs test for reliability and performance to your specifications and your customers’ expectations as well as compliance with applicable agency requirements.

Our in-house labs perform electrical, mechanical and environmental testing to qualify and verify designs and monitor product processes. Outside services provide testing for biocompatibility and EtO and gamma withstand.

Environmental

• Temperature and humidity • Temperature cycling • Thermal shock • Heat age • Sterilization withstand

Electrical

• Low-level resistance • High-resistance measurements • Dielectric withstand voltage and breakdown • Temperature rise vs. current • RFI/EMI • BERT testing

Mechanical

• Vibration • Physical shock • Tension/compression • Mate/demate • Normal force (contact retention) • Flex-life • Crush resistance

Regulatory Compliance

Engineering and manufacturing teams are familiar with agency standards and regulations as they apply to specific applications. Our goal is to ensure that our products meet your requirements for agency approval, including qualification testing, periodic retesting, labeling and marking. UL/CSA, CE, ANSI/AAMI, FDA, IEC, Japan Ministry of Health, Telecordia, federal and military specifications are adhered to where required by use, industry or governments. • ANSI/AAMI EC-53 • IEC 60601-1 • Directive 2002/95/EC (RoHS) compliant • ISO 9001:2000 • ISO 13485:2003

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Global Manufacturing

After first article approval, we can quickly ramp up into full production, understanding and appreciating your urgent time-to-market cycles. With manufacturing plants all over the world, Tyco Electronics can leverage procurement, volume manufacturing and distribution to your advantage and that of your customers.

• Purchasing power and worldwide facilities for raw materials

• Complete project management from conception to commercial production

• Vertical process integration and manufacturing synergies

• Broad product range and manufacturing experience• Manual assembly or automated processes depending on volume

• Design-for-manufacturing, process control and cost-reductions over life cycle

• Class 100,000 clean room processing, assembly and sterilization capabilities

• Manufacturing and distribution centers close to your customers in North and South America, Europe and Asia

• Six Sigma and Lean directives for operational excellence

Global Service and Support

• Our sales team is focused on your industry—medical and instrumentation.

• Our engineers and manufacturing teams come from such top names in the business as AMP, RAYCHEM, ELO TOUCHSYSTEMS, PRECISION INTERCONNECT, MADISON CABLE, M/A-COM, AXICOM, CII, OEG, ALCOSWITCH and others.

• With advanced design, assembly and testing services, we optimize design performance and manufacturability.

• Our dedicated global logistic teams streamline transitions. Product centers in the Americas, Asia and Europe are close to your facilities.

• We support dock-to-stock and just-in-time distribution systems for efficiency and convenience.

Our product diversity, engineering expertise, manufacturing experience and global presence provide you with the product you spec, the turnaround you need, and the distribution scheme you pick—all in proximity to your factory.

Tyco Electronics CorporationHarrisburg, PA 17001

800-522-6752 Tel

medicalsales@tycoelectronics.com Email

tycoelectronics.com/medical

©Copyright 2007 by Tyco Electronics Corporation7-1773441-1-5M-GIC-03-28-2007

TYCO is a trademark. MOLDFLOW is a trademark of Mold Flow corporation. MELTFLIPPER is a trademark of Beaumont Technolgies, Inc.