TEKTRAN. RF/High Frequency Medical Systems Developer EMS PARTNER. and EMS Firm Team up. Tektran is located in Edmonds, Washington.

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1 TEKTRAN SM Incorporated RF/High Frequency Medical Systems Developer EMS PARTNER and EMS Firm Team up Tektran is located in Edmonds, Washington. Tektran is classified as a third party designer according to the FDA. We ve been in business since 1991 specializing in the design and development RF/High Frequency energy sources that power cutting edge proprietary surgical devices developed by our clients. We recently teamed up with one of the most modern EMS (Electronics Manufacturing Service) firms in the greater Pacific Northwest. Schippers & Crew is located in Ballard, a business district of Seattle about 20 minutes away from Tektran. Schippers is a Contract Manufacturer. Can we X-Ray that for you? DAGE XD 7600 Schippers & Crew is a perfect fit for our company. It has the equipment and people to service our EMS requirements from first article prototypes, through small lot protocol validation runs, to full production. S&C also offers a full scope of EMS services - boards, wire prep, box build, and final test. S&C is also devoted to quality control and has made a considerable investment in sophisticated equipment to ensure boards are fully tested before they get to box build, like automated Optical Inspection and Boundary Scanning. This reduces overall assembly cost. It is no wonder S&C has OEM customers with class II and even Class III devices that rely on them for their EMS needs. Sub-Micron system able to view items up to 18 x 18 inches, providing ability to scan in False Color, 3D and inverse gray scale. Lead-Free! S&C was one of the first EMS firms in the Pacific NW to go RoHS compliant. Chip makers focused first on SMD and then thru-hole components. Sourcing some RoHS compliant parts is still a challenge. Typically, ESUs (Electro surgical Units) or high frequency power sources for RF ADs (Ablative Devices) are designed with SMD components for controller boards and plated thruhole components for power boards. This is due to both availability and aftermarket requirements. Some designers forget about serviceability. SMT is well suited for consumer based products, but for health care equipment internal packaging and designing equipment so that it can be easily serviced by hospital Biomets or Clinical Engineers is key to product acceptance. Not one, but two Piliarhouse JADE S-200 machines for Lead-Free thru-hole board production. The JADE S-200 is a selective wave soldering system for thru-hole boards. Of course, S&C has other equipment for RoHS compliant production of SMD boards as well. Go to their web site for more information on their Lead-Free and RoHS protocols. www. schippers.com

2 Digital Counter for parts on reels Schippers & Crew maintains a large, well organized inventory area. Their turnkey team source, purchase, and prep build kits for OEM customers. By the time we complete the validation lot run and move to full production we are ready to allow the EMS to continue on with turnkey builds. Whether turnkey builds involve material for just PCBs and wire harnesses or also cabinet hardware, will be determined by the nature of the production lots. A Perfect Fit in addition to offering both consigned and turnkey kit builds for PCB work, S&C also has equipment on its factory floor to follow Tektran through its typical three level protocols: first article prototypes, validation lots, and full production. You can see below S&C not only has the selective wave soldering machines pictured on the front page for RoHS compliant thru-hole boards, but also both manual SMD Pick & Place bench model machines for short lot runs and fully automatic Pick & Place machines for production lots. S&C has a full scope of services that are a perfect fit for a developer of electro-medical systems. Digital Sampling Scale for counting bulk parts Tektran has similar equipment in its inventory and kitting area. The difference is we ll buy in bulk, rails, or tape strips and S&C buys full reels. Kitting Schippers &Crew has a large inventory and receiving area pictured above where they store hundreds of parts in bulk, rail, or on reels for their auto Pick & Place machines. Like Tektran, S&C has an MRP system to manage the scheduling and purchase of components it employs for its consigned or turnkey builds. Consigned builds are when Tektran purchases and kits parts and Turnkey builds are when the EMS purchases, kits, and assembles. Conceptronic Freedom 3000 BGA/SMT rework system This machine also is used for short lot runs of SMT board assembly. Close-up of reels feeding parts into the machine Typically, Tektran will spec, source, purchase and kit components for its first article working prototypes from its LN coded BOMs. It also provides Rev. coded CDs or hyperlinks to data sheets stored on our host web server for parts qualification and incoming inspection. S&C refers to this as a consigned build. The next level in the development process is a protocol lot run to validate all build and line control documents. This is also a time when we turn over our BOMs to the EMS to determine what they may have in their inventory. Obviously, an EMS purchases parts for a number of OEMs and can typically reduce the material cost with their economy of scale purchases. Europlacer Vitesse* Automatic Pick & Place machine feeds parts from reels and places them on PCBs for production

3 Production Plan The entire production process is mapped out on a flow chart and that Production Plan is placed in the FDA(c)GMP file set, on-site at the EMS facility for inspection. Another High Speed Pick & Place Machine PDFs are provided to our clients with hyperlinks to related numbered and Rev-coded Process Control Directives, similar to the hyperlinks we employ on our BOMs for corresponding component data sheets for incoming. These directives include in-process inspection procedures. With regard to PCB assembly, some parts are included in primary operations, and other components are referred to as secondary operation parts. Secondary operation components are marked on our PCB Assembly Sheets for both SMT and thru-hole boards. Close-up of a PCB as it passes over a bath a molten solder. All documents related to the build and production line process are included on summary and detailed listing sheets in the DMR (Device Master Record). Tektran employs a sustained engineering protocol to make sure there is a signed receipt for all ECO transmittals. Then, we follow-up by monitoring production and conduct Quality System audits to ensure production and test procedures are according to the current Production Plan before each lot run. ESD Protection S&C has an ESD program based on ANSI/ESD Standard established by the ESD Association of America to prevent static charge from damaging components as they go through the production process. This starts in incoming and is enforced all the way through sub-assembly, final assembly, and final test. Visitors are not allowed into their inventory, PCB, or box build staging area without an escort and proper ESD attire. All containers - bags, rails, and tote tubs are ESD type to further protect parts as it moves through production. Schippers & Crew just put a new Ekra-X2 / in-line screen printer on their factory floor - not shown here High-Performance Seven Zone Reflow System Supports Ball-Grid Arrays. Temperature Control Lead-Free is great for the environment, but there are a host of concerns for the design engineer with respect to processing and reliability. RoHS means much more than just Lead-Free, although that is a big part of the new EU directive. Lead reduces the melt temperature in solder and makes the solder ductile. When a component manufacturer declares their device RoHS compliant it should not only be Lead-Free, but be able to withstand the higher process temperatures. Board laminates, adhesives, and coatings must be able to withstand these higher temperatures and facilitate a good ductile solder joint. Ekra-E5 / in-line screen printer - pictured above S&C has gained a great deal of experience with the Lead- Free process. In fact, it has offered seminars to designers with questions. Their Quality Control Manager is an expert at this process and has posted invaluable information on the S&C website. Go to

4 Line Inspection There is no substitute for a clean set of build documents, personnel training, and performance review. Wire Dereeler Auto Wire Stripper & Cutter The Production Plan also includes process control directives, like documented inspection procedures at key points in the build cycle. QC stamp assignments and Process Travelers are required for all Class II devices. This is in addition to documented TCPs and Certs for final test. Simple things like continuity checks of all wire assemblies or test fixtures for detecting broken leads in ribbon cables can save countless hours in box build and functional test. Typically, in electronics production there are two basic levels of in-process inspections - visual and instrument supported. This includes incoming as well as in-process. S&C has both bases covered with sophisticated Optical Inspection equipment and a computer aided (ICT) In- Circuit-Test System as well as a Jtag Boundary Scanner. Tektran will normally work with its EMS to detail the I/O electrical characteristics. All boards are throughly tested before they are released to the staging area for box build - final assembly and test. Programmed peg-boards (not shown here) are programmed for color-coded wire harnesses Crimping Machines with die heads to insure leads are properly dressed, crimped, and insulation is properly flagged. Box Build In addition the formal review process for release and transfer of build documentation, Tektran will prep a four drawer locking file set with copies of all validated build documents, the Production Plan, and process control directives. Astaging area will be set up by the EMS. Tektran has extra sets of test instruments and apparatus related to testing ESUs, calibrated and traceable to NIST as well as spare PCs to configure ATE work stations. If required we can configure any number of custom test figures. NSpec F Series Automated Optical Inspection (AOI) system The DHF (Design History Files) are secured by Tektran, but made available during FDA or third party inspections along with a matrix chart of Management Responsibilities, DMRs, and the Device History Records. As the General Contractor, Tektran is ultimately responsible for all output to its client. A checklist will be included for packaging and Tektran will consign a container kit to the EMS - including, blank forms, package labels, unit serial tags, and an assortment of container documentation. Tektran offers both hard copy container documentation and e-media tools for aftermarket support. Refer to our web site Unit cartons are packed one or two up in protective master cartons. Unit cartons are normally shipped unsealed in master cartons to allow clients to easily remove the contents to run checklist tests or add starter kits. Agilent (HP) 3070 In-Circuit Test System We even have a protocol to retire records and return them to Tektran when systems are replaced with new models.

5 Computer controlled wave solder and reflow ovens Spacious PTH and box build assembly area Stencil screen printers at the front of each SMT line Four separate SMT Pick-n-Place production lines Automated optical board assembly Inpection Disclaimer: Tektran, Inc. and Schippers & Crew, Inc. are separate and independent companies and as such neither is liable to third parties for the actions of the other. The relationship as presented in this document is that of a customer and vendor only, respectively. Tektran has entered into a licensing agreement with Schippers & Crew to provide EMS (Electronic Manufacturing Services). Nothing in that agreement creates a warranty other than the warranties they provide to each other in the normal course of business. Any business third party clients have with Tektran, Inc. is based solely on the terms of those agreements between Tektran and its clients. TEKTRAN SM Incorporated P.O. Box 665 Edmonds, WA TEL: FAX: sales@tektran.com Form No. 03-P002-C