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Articles from 1997 In November


Polycarbonate Material Meets Critical Needs of Heart Surgery Device

Polycarbonate Material Meets Critical Needs of Heart Surgery Device

Provides reliability, biocompatibility, and sterilizability

When a product will be serving as the lungs of a patient during heart surgery, there is zero tolerance for material failure. Therefore, in designing the components for its Maxima Forté oxygenator, Hardshell venous reservoir, and arterial filter, Minneapolis-based Medtronic Inc. needed a material suitable for the critical functions of these products. The manufacturing processes for the reservoir and oxygenator each include more than 30 steps. In addition to traditional injection molding, the components undergo ultrasonic welding, urethane potting, adhesive bonding, pad printing, and insert molding. The oxygenator and reservoir are EtO sterilized, while the filter can be sterilized by either EtO or gamma radiation. The chosen material would have to withstand all of these processes without degradation.

The company selected Makrolon 2558 polycarbonate made by Bayer Corp.'s Polymers Div. (Pittsburgh). "Sterilizability, ease of processing, biocompatibility, and clarity" were some of the key characteristics of the Bayer polycarbonate, according to Robert Gremel, oxygenator project manager for Medtronic.

Medtronic used a supercomputer to determine the product shapes that would optimize the blood flow path. The results were unusual geometries with deep draws and numerous curves. Most challenging was the design of the reservoir, whose six-component assembly measures 11 X 16 in., with a snout-shaped lower end. The oxygenator, which also has six separate polycarbonate components, measures 41Ž2 X 61Ž2 in., while the two-component arterial filter is 3 X 5 in. Wall thicknesses range from 0.60 to 0.85 in.

Medtronic and Bayer paid special attention to reducing molded-in stress in order to prevent breakage. Bayer's design support staff assisted throughout the design process, mold-flow analysis, and actual processing. "With Bayer's help, the components came out of the molds with low in-molded stress and free of visual cosmetic defects common to parts of this size," said Mike Van Driel, Medtronic's project engineer for the Forté Hardshell reservoir program.

The parts have passed propylene carbonate testing at 400 psi, according to Gremel, representing a "well-controlled molding process and material quality." In addition to the 2558 polycarbonate, Medtronic is also qualifying Bayer's Makrolon DP1-1452 for all three Class III medical devices.

For more information on Makrolon polycarbonates from Bayer Corp.'s Polymers Div., call 412/777-2000.

Gasketing material provides EMI/RFI shielding

Products Featured on the Cover of Medical Product Manufacturing News

Gasketing material provides EMI/RFI shielding

Suitable for use in medical equipment, an EMI/RFI-shielding gasketing material offers high compressibility and recovery. Elastomet consists of monel, phosphor bronze, or aluminum wires oriented in silicone. The wires are chemically bonded for fail-safe retention and are positioned perpendicular to mating surfaces. Die-cut and assembled gaskets are provided according to customer specifications. Tecknit, 129 Dermody St., Cranford, NJ 07016. Ph: 908/272-5500.

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Ac power connectors are designed for medical applications

A line of locking ac power connectors meet international and European safety standards and can be used in medical instrumentation in nonsterile environments. The PowerCon connectors offer a three-pole connection system with contacts for live, neutral, and protective earth handling power up to 20 A, 240 V. Neutrik USA, 195 Lehigh Ave., Lakewood, NJ 08701. Ph: 908/901-9488.

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Fluoropolymer tubing features ultrathin walls

A company extrudes fluoropolymer extrusions in a range of diameters and special profiles. Sub-Lite-Wall tubing features IDs as small as 0.001 in. and wall thicknesses down to 0.0005 in. PEEK can also be extruded for high burst pressure resistance and tensile strength. All tubing undergoes a rigorous quality control program and is inspected in a Class 10,000 cleanroom. Extrusions can also be supplied with USP Class VI approval certification. Zeus, 620 Magnolia St., Orangeburg, SC 29115. Ph: 800/526-3842.

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MPMN Hotline : Process Speeds Prototyping of Silicone Medical Products

MPMN Hotline

Contract Services

Process Speeds Prototyping of Silicone Medical Products

Can reduce prototype times up to 70%

Vesta Inc., a manufacturer of custom silicone medical devices based in Franklin, WI, has developed a prototyping process that can reduce prototype times by as much as 70% as compared with traditional methods. The Quick Response process is based on the company's ability to mold medical-grade liquid silicone rubber (LSR) in low volumes. Liquid injection molding (LIM) equipment with specially designed pumping systems deliver LSR directly into the mold. This, combined with the ability to achieve rapid curing cycles in LIM by elevating mold temperatures, enables Vesta to produce 1 to 100 or more prototypes quickly and with minimum setup cost.

The prototypes are molded using the same material and GMP traceability standards specified for full production. This gives customers a working model of the part, with performance characteristics equivalent to those desired in the final part. As a result, customers can evaluate a new part or device in its final form, helping to achieve more accurate test results and to shorten the approvals process.

Examples of products that can benefit from this prototyping process include seals, strain reliefs, manifolds, connectors, breathing cannulas, and valves. All design, raw material, drawing, and tooling changes in the prototype process are documented under GMP guidelines and can be provided during clinical trials. Vesta's prototyping and manufacturing capabilities range from small parts weighing 1g to 525-g devices.

For more information, contact Vesta at 414/423-0550.

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Rapid Prototyping

Stereolithography Systems Use Solid-State UV Laser

Offer high speed, ease of use, and low ownership cost

A series of next-generation stereolithography systems that use high-power solid-state ultraviolet lasers has been developed by 3D Systems (Valencia, CA). The Millennium series requires less space and lower power consumption than traditional stereolithography machines. The systems offer fast part throughput and provide 0.05-mm layer thickness for many geometries.

The 0.05-mm tooling build style represents a 50% improvement in fine-part detail over the standard 0.10-mm layer thickness. Faster throughput is derived from SmartSweep, which features the Zephyr recoating system that sweeps only the active area of the part build, resulting in up to 20% throughput improvement, depending on part geometry. New resin has a faster photospeed and improvements in the build station software optimize speed.

The SL-5000 requires 25 sq ft of facility space, nearly half that of its predecessor. Features include automatic resin refill and leveling to reduce operational time, increased window visibility, controller access door, a backwards swivel movement of the CRT for easier maintenance, and a modular design for faster operation and service. The system also uses six times less power and does not require external cooling. Its Windows NT build station software allows users to specify duplicate builds, preview jobs during the build, and display estimated completion time.

Other models in the Millennium series include the SLA-3500 and the SLA-250/50HR, a system that focuses the laser into an ultrasmall beam width, providing nearly three times improvement in feature resolution. This high-resolution system is suitable for building small, intricate medical components.

For more information, contact 3D Systems at 626/852-8840.

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Industry News

Medical Design Excellence Awards Program Announced

Will honor finished medical devices as well as materials and components

Recognizing the need to salute exceptional quality and innovation in the medical device industry, Canon Communications llc (Santa Monica, CA), publisher of Medical Product Manufacturing News is collaborating with the Industrial Designers Society of America (IDSA) to present the first annual Medical Design Excellence Awards.

The awards program seeks to recognize excellence in the design and engineering of finished medical devices as well as materials and components intended for medical applications. "We congratulate Canon on its leadership in sponsoring this breakthrough awards program," said Robert T. Schwartz, IDSA executive director and COO. "We hope this competition will foster commitment to design excellence, which is so crucial to success in the medical products, materials, and components markets."

A jury assembled by IDSA will evaluate entries based on their functional improvement, business benefit, and innovation. IDSA also sponsors the annual Industrial Design Excellence Awards in conjunction with Business Week magazine.

While some existing awards programs recognize medical device design, the Medical Design Excellence Awards is the first to focus exclusively on the medical manufacturing industry. "It's important for the medical industry to have its own design awards because no praise is as meaningful as praise from your peers--they understand what it took to get there," says Kent Ritzel, IDSA Medical Section chair and director of Metaphase Design Group (St. Louis). "Moreover, such an awards program provides a valuable educational vehicle that should help companies improve their competitiveness. The Medical Design Excellence Awards are focusing attention on the complexity of product development in this industry and will showcase examples of how it can be done well. The program will foster the development of better products by encouraging investment in high-quality design and engineering."

The deadline for entry submission is January 26, 1998, and entries must be commercially available in the United States by that deadline. Finalists will be announced in the May 1998 issues of MPMN and MD&DI, and winners will be recognized during Medical Design & Manufacturing East 98 in New York City, June 2­4, 1998. The winning entries will also be featured in the July/August 1998 issue of MPMN and the July 1998 issue of MD&DI.

For more information, visit http://www.devicelink.com/awards/, or call IDSA at 703/759-0100 for an entry form and rules.

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GE and EG&G Team Up on a Digital X-Ray Detector

GE and EG&G Team Up on a Digital X-Ray Detector

Multipurpose instrument to provide fast, cost-effective x-rays

GE Medical Systems (Milwaukee) has given EG&G Inc. (Santa Clara, CA) exclusive rights to manufacture a multipurpose digital x-ray detector designed to perform fast and cost-effective x-ray examinations.

Designed by GE to replace conventional x-ray film and chemicals, the detector system features computer images that can be stored electronically or sent anywhere in the world via telecommunications technology.

The digital detector is based on amorphous silicon technology that converts x-rays into digital data, which then become high-quality images to be viewed by a physician, stored electronically, or transmitted to consulting physicians worldwide. The digital detector is the product of one of GE's 10-year, $100-million R&D efforts.

A provider of complete systems and components to the medical industry, EG&G's participation in the project accelerated prototype development by at least one year, according to GE. For more information, contact EG&G at 408/565-0850 or GE Medical Systems at 414/544-3530.

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Travelers Expands Liability Coverage

Will insure medical product manufacturers

Travelers Specialty (Hartford, CT), a division of Travelers Property Casualty that provides hard-to-find commercial insurance products, has expanded its general liability class business coverage to include medical product manufacturers and distributors.

Included in the broad range of higher hazard classes are risks associated with clinical trial exposures, personal protective shields (Class I devices), bone-cutting equipment and bronchial tubes (Class II devices), and endometrial equipment (Class III devices).

Travelers' coverage offers clients flexibility in that both occurrence and claims-made coverages are available as well as prior acts coverage. The company can write an entire general liability program or the product liability only. Coverage is also available for all of an insured's products or specific product lines. Policies may be written over a self-insured retention where claims are handled by a third-party administrator. For more information, contact Travelers Specialty at 860/277-9878.

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Phillips Plastics Opens Regional Design Center

Gives customers better access to company's resources

Phillips Plastics Corp. (Prescott, WI) has completed construction on a facility in Framingham, MA, that will house Customer Center Northeast. The center provides complete services from concept to design for manufacture. Services include stereolithography, selective laser sintering, rapid prototyping, tooling, injection molding, decorating, and assembly, all supported by complete program management.

Like the company's other regional locations, the Massachusetts facility will allow customers greater access to all of its resources. For more information, contact Phillips Plastic Corp. at 715/262-5451.

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RELA to Produce Analyzer Instrument for Xylum

Company has expertise in product design

Xylum Corp. (Scarsdale, NY) has chosen RELA (Boulder, CO), a subsidiary of Boulder-based Colorado MEDtech Inc., to produce an analyzer instrument for its clot signature analyzer (CSA) system. RELA's experience in developing and producing automated diagnostic instruments was key in Xylum's selection.

Xylum develops flow technology for assessing homeostasis and coagulation. The company's CSA system is designed for use in university, hospital, and pharmaceutical research centers. Colorado MEDtech is an integrated custom product development and manufacturing services company specializing in electronic and electromechanical products and software systems for the medical device industry. For more information, contact Colorado MEDtech Inc. at 303/530-2660.

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Needleless Syringe Improved by Replacing Metal Parts with Plastic

Needleless Syringe Improved by Replacing Metal Parts with Plastic

In the competitive medical device market, it is every manufacturer's goal to improve its devices and make them less expensive to manufacture. Designers at Medi-Ject (Minneapolis, MN) achieved this goal when they significantly improved their Medi-Jector needleless syringe, a product that had already achieved market success, by replacing some of the unit's metal parts with plastic.

Under the Skin

Triggered by a push button, the device uses a plunger to force liquid through an orifice one-third smaller than the diameter of a 30-gauge needle. The high-velocity microjet penetrates the skin with little discomfort or scarring. The 7-in.-long syringe administers insulin, human growth hormone, or other pharmaceuticals in a three-step operation. The user rotates the device's upper body to compress an internal spring and extend the firing button. Next, he or she attaches the adapter and medicant bottle and dials the dose into the system. With the adapter removed, the stainless-steel drug chamber of the Medi-Jector is then held against the skin and the firing button is pressed.

Internally, the winding action compresses the spring and stresses its containment tube with more than 90 lb of force. Pressing the button releases the spring and drives a steel ram through the injector body housing into a stainless-steel plunger. The impact of the plunger on the noncompressible liquid generates peak pressures in the drug chamber. As the dose is injected, the ram comes to a sudden stop at the end of its travel.

Design Challenges

Four years ago, Medi-Ject began evaluating the use of internal parts made of plastic rather than steel or aluminum. "We were going from small-volume production to much larger volumes," says Peter Sadowski, the company's vice president of product development. "As you go up in scale, you don't gain a lot of manufacturing economies with machined metal. Plastic parts bring you lots of cost advantages." The change in materials would also reduce the weight of the injector and improve ergonomics. Furthermore, different drug manufacturers in partnership with Medi-Ject might request modifications in the device, either to accommodate different fluids or to provide a competitive advantage, and a given patient population might require a different type of trigger or a different display. "Making these modifications in plastic is not as problematic," says Todd Leonard, vice president of sales and marketing. "Changes in injection-molded parts are far less costly than those in machined components in large production quantities."

When the Medi-Ject engineers looked for thermoplastics to replace the anodized-aluminum injector body housing and stainless-steel spring containment tube, they faced unique challenges. Sadowski recalls, "We knew we had to have something that could take high shock loads and high impact loads. The primary property we were looking for was strength over the long term." The Medi-Jector syringe was expected to deliver more than 3000 doses, and therefore materials were needed that could withstand even worst-case high-impact loads, such as an accidental firing with no liquid in the device. Filled with a 1/2 cm3 of insulin, the syringe completes its stroke in about a quarter of a second, but with an empty chamber the stroke takes less than 1 millisecond, thereby multiplying inertial and impact loads dramatically.

Easy Action

The engineers considered which parts they could make out of plastic. Since the high-power spring needed the resilience of steel and the injector ram needed its metal mass to work effectively, they settled on the injector body housing and spring tube. Both were vital structural items and required relatively thin walls and dimensional stability. "The challenge was to make the device as small as possible given the mechanical requirements," says Sadowski.

Medi-Ject engineers also wanted to eliminate the lubrication that metal parts in the power pack required to turn freely. These lubricants broke down with time and use, making the winding action difficult. To preserve easy rotation, the selected plastic had to provide lubricity as well as strength.

A survey of engineering resins found few with the qualities needed for the Medi-Jector syringe. Polyetherimide was considered but soon rejected because it was not strong enough for the high loads placed on the tube and housing. "Strength was of primary importance," Sadowski reports. Vectra liquid crystal polymer (LCP) from Hoechst Technical Polymers (Summit, NJ) delivered the needed strength, impact resistance, and dimensional stability. Medi-Ject engineers tested several grades before settling on one that had the strength to take repeated impact loads as well as the lubricity to make winding easy.

Overmold

Molding tolerances for the spring tube and containment body are proprietary, but since the threads on the plastic help regulate the size of the dose, dimensional tolerances had to be appropriate for medical devices. Vectra LCP reproduced the key details accurately. "Vectra has a low, predictable shrink rate, and good moldability in thin sections," observes Sadowski. The molding task was complicated by the need to overmold a jacket of ABS. "We wanted an outer skin on this that was pleasing to the eye and had also had a nice texture," says Sadowski. With assistance from Hoechst, the overmolding produced a containment body that was both attractive and able to take the impact loads.

The Medi-Ject engineers' efforts have been rewarded with a successful design that makes the Medi-Jector lighter, easier to use, and less expensive to manufacture. Using Vectra LCP, they are able to mold critical internal parts 75% lighter than and half as expensive as metal.

For more information on liquid crystal polymers from Hoechst Polymers, call 908/598-4162.

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Spotlight on Surface Treatment

Spotlight on Surface Treatment

Thermal spray coatings

Pictured is a stainless-steel vibratory feeder bowl coated with a self-lubricating thermal spray coating for protection against wear and contamination. Tough, flexible Plasmadize coatings are a true composite of the latest developments in metals, ceramics, polymers, and/or dry lubricants. These materials are combined to produce a new material with an extremely low coefficient of friction and other unique properties. They create a nonporous, nonstick, corrosion-resistant surface but can also be formulated to produce a gripping or nonslip surface. General Magnaplate, 1331 Rte. 1, Linden, NJ 07036. Ph: 908/862-6200.



Surface modification

Surface modification using PhotoLink technology provides a variety of surface properties for a wide range of materials. Achievable surface characteristics include improved lubricity, hemocompatibility, infection resistance, wettability, drug delivery, tissue engineering, and functional surfaces for biomolecule immobilization. Each PhotoLink reagent can modify a product's surface with simple and environmentally sensitive processing steps. SurModics Inc., 9924 W. 74th St., Eden Prairie, MN 55344. Ph: 612/829-2700.



Electrical surface treatment

Production equipment for surface treatment of syringe hubs improves adhesion using electrical surface treatment (EST) technology. The equipment increases the surface energy of the inside surfaces of the syringe hub and greatly increases the pull strength of the needle and hub. EST technology uses electrical discharge to surface treat polymers. The treatment is done at atmospheric pressure and can be easily integrated into production lines. Tantec Inc., 630 Estes Ave., Schaumburg, IL 60193. Ph: 847/524-5506.



Diamondlike coatings

A process has been developed for depositing diamondlike coatings (DLC) on the surface of virtually any substrate capable of withstanding heat up to 200°C. This enables metals, carbides, ceramics, and even high-temperature plastics with a continuous 5-µm-thick monofilm with the properties of diamond. The substrate's surface characteristics are accurately reproduced and in most cases do not exceed the component's dimensional tolerance. The diamond film deposits uniformly on the substrate regardless of its shape or geometry. The resulting DLC is much harder than tungsten carbide and has an ultralow coefficient of friction, improved electrical conductivity, and good adhesion to the coated substrate. Surface Conversion Technologies Inc., 6160 Wellington Ct., Cumming, GA 30130. Ph: 404/889-6240.



Infection-resistant coating

An "actively sterile" infection-resistant coating for medical device components can be applied to the surfaces of metal, polymer, or ceramic devices. The deposition process, known as ion beam­assisted deposition, combines metal evaporation with state-of-the-art ion beam technologies. The result is a permanent, adherent thin film that is effective against a variety of nosocomial bacteria including gram- positive and gram-negative strains as well as fecal and fungal agents. In addition to being infection resistant, the minimally leaching SPI-Argent coating provides a slick surface that prevents biodeposit and thrombosis attachment while reducing mucosal irritation. Spire Corp., One Patriots Park, Bedford, MA 01730. Ph: 617/275-6000.



Parylene coating

Custom parylene coating services are available to medical device manufacturers. Complete process engineering, precoat cleaning and masking, parylene vacuum deposition, and final inspection are all offered. The result is a thin, biocompatible, bioinert coating that resists chemicals, body fluids, electrolytes, proteins, enzymes, and lipids. Applications include esophageal and vascular stents, heart pacers, catheters, endoscopic components, circuit boards, needles, and other components. Specialty Coating Services Inc., 5707 W. Minnesota St., Indianapolis, IN 46241. Ph: 800/356-8260.



Chrome plating

Chrome plating may extend the wear life of medical devices up to 1000 times while also providing a harder, more lubricious surface. Applications include surgical and biopsy needles, tools for orthoscopic surgery, screws and pins for bones, surgical cutters, and machined parts, including cams, shafts, and pistons. A proprietary high-chromium coating that is thin, dense, hard, and nonmagnetic can be applied to all ferrous and most nonferrous metals. Electrolizing Inc., 1947 Hooper Ave., Los Angeles, CA 90036. Ph: 213/749-7876.



Lubricious coating

A specialized lubricious coating has been formulated to adhere to metallic surfaces. LubriLast-B hydrogel coats flexible wires and springs without stiffening the wire or bridging the coils. Unlike lubricants such as silicone fluid, the coating is imperceptible when dry but becomes very slippery once in contact with body fluids. This property reduces patient trauma by facilitating insertion while maximizing physician control of the device. Advanced Surface Technology Inc., 9 Linnell Cir., Billerica, MA 01821. Ph: 508/663-7652.


Gas plasma systems

Advanced gas plasma systems for surface treatment of small, molded medical parts incorporate rotating baskets that ensure that all parts receive equal exposure to the plasma, guaranteeing uniformity from part to part and batch to batch. Standard systems are offered with basket capacities of 1 and 4 cu ft. The manufacturer provides complete plasma system support, including equipment, process development, and contract treatment services. 4th State Inc., 1260 Elmer St., Belmont, CA 94002. Ph: 415/596-1600.



Thin-film surface coatings

A technological advance in thin-film surface coatings allows the low-temperature deposition of pure polytetrafluoroethylene. These molecularly bonded coatings offer controllable thickness down to submicron levels. The result is a thin-film surface coating with good adhesion, electrical, and mechanical properties. It can be applied to most materials without the need for a high-temperature cure. The coatings can be applied with no overspray or high buildup in tight dimensions. Suggested uses include release coatings, barrier coatings, friction coatings, and device coatings. Advanced Surface Engineering Inc., 5320 Enterprise St., Ste. L, Eldersburg, MD 21784. Ph: 410/552-0376.



Microwave plasma system

A low-pressure microwave plasma system provides ultrapure cleaning of metals, glass, ceramics, and optics, as well as polymer surface modification and plasma polymerization. The Model V15-G is designed for R&D and small-device production. It features a 2.45-GHz microwave frequency, an electrode-free aluminum process chamber, a mass-flow controller, microprocessor control with stored recipe capability, a graphic display for visual monitoring of process parameters, and an electronic plasma sensor. PLASMAtech Inc., 1830 Airport Exchange Blvd., Ste. 120, Erlanger, KY 41018. Ph: 606/647-0730.



Electropolishing

Electropolishing is a stress-free electrochemical process that, by removing surface impurities in metal, improves the fatigue life of springs, stampings, and other manufactured parts. The process removes the high points on stainless steel and redeposits a clear, chemically bonded oxide layer. This layer retards corrosion and resists impregnation by bacteria. The absence of scratches, strains, metal debris, and embedded abrasives characterizes the electropolished surface. New England Electropolishing Company, Inc., P.O. Box 845, Fall River, MA 02722. Ph: 800/672-6616.



Hydrophilic coatings

Catheter-associated infections are a leading cause of hospital-acquired illnesses. According to the results of a company's in vitro study, its Medi-Coat hydrophilic coatings, which contain silver compounds, may significantly reduce such catheter-related infections. Greater aqueous diffusion in the hydrogel coatings produces a greater silver ion concentration at and just above the device surface. Antimicrobial agents are entrapped in the coatings, and the hydrophilic property of the coating allows drug molecules to dissolve in water and diffuse out of the polymer matrix. This provides an antimicrobial environment near the surface of the catheter, preventing adhesion and propagation of bacteria. STS Biopolymers, 336 Summit Point Dr., Henrietta, NY 14467. Ph: 716/321-1130.



Diamond coating

A wear-resistant amorphous carbon coating offers corrosion resistance, hardness approaching that of natural diamond, and good adherence to stainless steel, titanium, and Co-Cr alloys. TetraBond, which is primarily sp3-bonded carbon, has good biocompatibility and a pleasing black color. The manufacturer's performance tests show that it reduces cutting forces and temperature on sharp-edged drills, burrs, and blades while extending instrument life. The coating is also being evaluated for use on orthopedic and cardiovascular implants. Multi-Arc Inc., 200 Roundhill Dr., Rockaway, NJ 07866. Ph: 973/625-3400.

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Metal surfacing

A company offers complete metal-finishing services including polishing, graining, blasting, and anodizing for both aluminum and titanium products. Marking capabilities include laser, silk screen, and deep imaging techniques. With its Steri-Color method, the company recently completed a qualification process for fade-resistant-color aluminum anodizing that is compatible with Sterrad sterilization methodology. The company also has an electropolishing facility for stainless steel. Danco Metal Surfacing, 44 La Porte St., Arcadia, CA 91006. Ph: 818/445-3303.



Gas plasma treatment

Gas plasma technology is used to modify a variety of materials and surfaces. The process can achieve several results: transform surfaces to be hydrophobic, hydrophilic, or lubricious; increase bond strength; improve wettability; ultraclean; etch; and deposit coatings. A few of the products currently treated with the gas plasma are catheters, guidewires, intraocular lenses, syringe hubs, sensors, and filters. The process is environmentally sensitive, yields uniform results, and is reproducible. Advanced Plasma Systems Inc., 12000 28th St. N., St. Petersburg, FL 33716. Ph: 813/573-4567.



Titanium nitride coating

Titanium nitride (TiN) coating is a molecular bond of TiN to properly prepared metal surfaces. It provides surface hardness and lubricity to reduce friction and improve wear. TiN is FDA compliant and gold colored, and it provides an extremely hard surface (85 Rc) at 0.0001 in. thick. Galling of mating stainless-steel components is eliminated. The coating can be repeatedly autoclaved or otherwise sterilized, and it provides wear resistance, corrosion resistance, improved release from tissue, and less glare than uncoated instruments. BryCoat Inc., 976 4th St. N., Safety Harbor, FL 34695. Ph: 800/989-8788.

Top Products and Services of the Year: Reader's Choice

Top Products and Services of the Year: Reader's Choice

This feature comprises the top 80 products and the top 20 literature items from the past year.





Surgical Drape Adhesives

Single- or double-coated systems

Flexible, conformable surgical drape adhesive systems are offered by a manufacturer of medical pressure-sensitive adhesive tapes and films. Available in both single- and double-coated configurations, the Series 2203 products use hypoallergenic, pressure-sensitive acrylic adhesives. Features include good adhesion to both skin and most drape fabrics and bleached silicone-coated easy-release liners. Single-coated versions are available in 1.7- and 3.6-mil polyethelene films; double-coated constructions feature polyester or polyolefin carriers. The products can be sterilized with EtO or gamma irradiation. Betham Corp., Lincoln Blvd. and River Rd., Middlesex, NJ 08846.



Hot-Air Sealer

Features autoreverse function

A fixed-speed, continuous hot-air sealer is designed to meet the requirements of FDA process validation guidelines. The sealing temperature of the Saxon 5 MS is fully PID-controlled, and the seal pressure is air regulated, thereby allowing for complete system calibration of the dynamic parameters that affect seal integrity. Consistent sealing performance is further enhanced by the autoreverse function that allows bag sealing only when the conditions are within established limits. O/K International Corp., 73 Bartlett St., Marlborough, MA 01752.



Metal Injection Molding

Surface finishes of 16­32 rms

Offering the same level of design flexibility as plastic injection molding provides for plastic parts, the metal injection molding (MIM) process makes possible the economical production of highly configured small metal components from a wide range of materials including steels and stainless steels. Parts weighing as much as 150 g, measuring 6 in. in length, and with wall thicknesses as great as 0.5 in. can be molded with tolerances of ±0.003 in. Material strength is nearly that of wrought metal, and density is 97% of theoretical. Surface finishes of 16­32 rms are achievable. A contract manufacturer using MIM offers design assistance and accepts part print details via modem or disk. Kinetics Inc., 10085 S. West Commerce Cir., Wilsonville, OR 97070.



Biodurable Polyurethane

For long-term implants

Designed for long-term implants, a line of polycarbonate-based polyurethanes is now available. ChronoFlex polyurethane is offered in both thermoplastic versions and as solution-based segmented polymers. All have been subjected to biocompatibility testing and are the subject of a polymer master file at FDA. CT Biomaterials, 11 State St., Woburn, MA 01801.



Contact Springs

Allow flexible interconnection

A company offers paired bellows contact springs. The gold-plated miniature springs, which have ODs of 0.037 to 0.125 in., allow for flexible interconnection. The contact springs are unique for their pairing of a contact with a convex conical tip and a contact with a concave conical receptacle tip. This allows the tips to self-align as they connect, even if they are misaligned. The contact springs are made of electrodeposited nickel and are gold plated to MIL-G-45204 to enhance their conductivity and to provide extremely low dc resistance with a minimum of insertion loss. Servometer Corp., 501 Little Falls Rd., Cedar Grove, NJ 07009.



Plastics Joining and Welding

Catalog features books and software

A catalog lists technical books and software for plastics designers, engineers, processors, and educators. The catalog features The Handbook of Plastics Joining--A Practical Guide, a hands-on guide to selecting effective processes for welding, fastening, and joining plastics and elastomers. More than 25 techniques used to join plastics to themselves and to other materials are reviewed. Plastics Design Library, 13 Eaton Ave., Norwich, NY 13815.


Stock Shapes

Sourcebook lists specifications

In 216 pages, a sourcebook of plastic materials presents a comprehensive range of mechanical plastics, sheet, rod, film, tube, and accessory items. Featured products include Hygard laminates, Hydex, Tygon 2000 tubing, Caseway adhesives, Fluorglas Duraseal, and Dow Trademate sealants. Precut sheets are available, priced individually. Designed for easy sourcing, the book details available sizes, thicknesses, specifications, and tolerances. With more than 25 years of experience, the supplier can accommodate requests for immediate delivery through a network of 12 service branches. AIN Plastics Inc., Dept. 96 BAC, P.O. Box 151, Mt. Vernon, NY 10550.



Polymeric Liquids

Exhibit hydrophilicity, conformability, and more

A range of polymeric liquids react with water to produce hydrophilic foams and hydrogels. The inherently low toxicity of Hypol-based prepolymer foams or gels suits them for use in medical products. The prepolymers can be produced in the form of molded or cut pieces, cast sheet, slabs, or coatings. Hypol polymeric liquids feature such properties as hydrophilicity, versatility, conformability, and resistance to protein absorption. A wide range of foam characteristics from extremely soft to semirigid can be achieved with the material. Hampshire Chemical Corp., 55 Hayden Ave., Lexington, MA 02173.


Packaging Containers

Capacity up to 16 gal

A catalog of packaging containers and closures includes a wide selection of items ranging in capacity from 1Ž2 dram to 16 gal. The sourcebook also provides guidelines for improving product packages and gives a pictorial representation of the supplier's facilities, services, and management structure. Serving as a complete packaging resource for diverse industries, the supplier specializes in glass, plastic, and aluminum containers and metal and plastic closures. O. Berk Co., 3 Milltown Ct., P.O. Box 1690, Union, NJ 07083.



Catheter Totes

Custom designed

Rigid and flexible totes are designed to facilitate the transport of catheters, extrusions, and other medical products throughout a cleanroom environment. Custom designed for specific applications, the C-Totes come in many sizes, shapes, and colors and can incorporate Velcro closures, zippers, or snaps. Hundreds can be stored in a single bin. C-Tote Medical, a division of Great White Ventures, 1116 Windswept Cir., Chesapeake, VA 23320.


Miniature Wire

For medical applications

Wires, tubes, cables, and related microelements are produced for use in medical devices. Capabilities of the contract manufacturer include wire drawing, straightening, profiling, laminating, cutting, forming, soldering, end rounding, tapering, and grinding. The firm can supply small and moderate quantities of wire in diameters ranging from 0.02 to 2.0 mm. Products made for the medical sector include braided wires and springs, guides and leads, tubes, and stylets. Microfil Industries SA, CH-1020 Renens, Lausanne, Switzerland.



Lubricious Coatings

Can reduce friction up to 90%

According to the manufacturer, lubricious coatings can reduce surface friction from 60 to 90% on a variety of commonly used medical-grade polymers, compared with uncoated products. PhotoLink low-friction coatings reduce the forces required for both insertion and passing obstructions in vascular or urogenital applications. The coatings are typically 200­500 nm thick and do not change the appearance of the device. Covalent bonding renders the coatings very durable under normal clinical-use conditions. SurModics, 9924 W. 74th St., Eden Prairie, MN 55344.


Nickel-Cadmium Batteries

Exhibit high energy density

Cylindrical nickel-cadmium batteries are available in A and 4/5A sizes rated at 1.2 V at 1400 mAh and 1000 mAh. High charge/discharge rates render the sealed cells suitable for cyclic applications such as portable instruments. The batteries also exhibit high energy density and low internal resistance and operate in temperatures ranging from ­20° to 60°C. Resealable vents automatically control cell pressure, ensuring safety and reliability. Power-Sonic Corp., P.O. Box 5242, Redwood City, CA 94063.



Solvent Dispenser

Delivers solvent at an adjustable rate

A dispensing system can accurately apply a uniform amount of solvent to a part's inner diameter, outer diameter, or both simultaneously without the need to rotate the part. The SD7200 delivers solvent at an adjustable rate, allowing the user to optimize solvent application according to the size and shape of the component. The use of porous materials in the dispense area further inhibits unwanted capillary filling even on parts with very small IDs. The SD7200 uses a pneumatic drive to eliminate explosion hazards and has no electrical power requirements. PTFE seals, integral fluid pathways, and specialized gaskets minimize the emission of solvent vapors. The system is easy to maintain, with a self-cleaning applicator and an inlet filter on the pump to prevent contaminants from reaching the 1-L reservoir. Ventrex Inc., 3007 Bunsen Ave., Unit K, Ventura, CA 93003.



Adhesives and Sealants

For thread locking, sealing,and more

A short product catalog presents a broad range of adhesives and sealants, all available from stock, manufactured to the same specifications in 80 countries. Separate sections address common categories such as thread locking, thread sealing, gasketing, flange sealing, retaining, bonding, and sealing porosity. Additional chapters cover specialty chemicals expressly designed for the electronics and medical market, as well as dispensing and curing equipment. Loctite Corp., 1001 Trout Brook Crossing, Rocky Hill, CT 06067.


O-Rings and Fittings

Made from Teflon, nylon, and Delrin

Specializing in parts made from Teflon, nylon, and Delrin, a manufacturer offers a selection of O-rings, straight tube fittings, flat and step washers, shoulder bushings, slipper seals, piston rings, and bearings. O-rings range in size from 1Ž8 to 13 in. ID with cross sections from 1Ž32 to 1Ž2 in. Metric sizes are also available. Machine and screw-machined parts can also be manufactured according to custom specifications. Brocklake Corp., 23206 S. Normandie Ave., #5, Torrance, CA 90502.



ISO 9000 Guide

Describes documenting procedures

A manual and accompanying disks provide an easy-to-understand approach to documenting ISO 9000 procedures, with an overview of the five standards. The guide and disks explain how to document quality systems using a four-level approach, define quality objectives, and increase understanding of the registration process. Also included is a prewritten sample of a quality manual that addresses all the required areas of ISO 9001. A section of prewritten policies and procedures is provided for complete and comprehensive coverage of the areas required for ISO 9001 registration. ASI Publishing Inc., 14550 E. Easter Ave., Ste. 1000, Englewood, CO 80112.



Prototype Switches

Available in eight days

Prototype membrane switches are available in as little as eight working days from a manufacturer specializing in short to medium production runs and 100% quality testing. Well suited for use in medical devices, the membrane switches are easily cleaned and resist damage caused by exposure to disinfectant cleaning solutions. An almost unlimited range of graphics are available, and the firm can also furnish such features as embedded LEDs, metal backers, and PCB modules. Technomark Inc., 5026 Hwy. 169 N., Minneapolis, MN 55428.



Polyethylene Foam Tapes

For electromedical applications

Designed for use in various electromedical applications, a series of polyethylene foam tapes feature resistance to debonding due to moisture. MED 5630 consists of a 1/8-in. thick cross-linked polyethylene foam coated on one side with nonsensitizing Wetstick adhesive, which is protected by a release liner that offers moisture-stable processability and easy removal upon application. It is designed for conversion into stress, defibrillating, TENS, and monitoring electrodes and other medical devices that are applied to skin for sustained time periods. MED 5631 and MED 5632 have similar constructions but feature thinner polyethylene foam facestocks. Avery Dennison, Specialty Tape Div., 250 Chester St., Painesville, OH 44077.



Miniature Pumps

Flow and pressure can be regulated

Suited to applications requiring minimal power consumption, a full line of high-efficiency miniature pumps provides a comprehensive range of free flows from 50 ml/min to 18 L/min with pressures up to 15 psig. Weights of the Micro Air pumps range from 2 to 13 oz, and the units measure as small as 2.2 x 1 x 1.5 in. Because voltage is supplied directly to the pump, flow and pressure can be regulated, and the diaphragm design allows the pumps to be configured for suction or pressure applications. An extensive selection of pump configurations is available. Sensidyne Inc., 16333 Bay Vista Dr., Clearwater, FL 34620.


Optical Fiber

Offers high pixel count

Available from a manufacturer and marketer of fiber-optic components is high-pixel-count optical fiber. UltraVue fiber is available in pixel counts of 10,000, 15,000, 30,000, 50,000, and 70,000. The fiber offers the high optical clarity and performance required by smaller-diameter endoscopic medical devices used in minimally invasive surgical applications. Galileo Corp., Galileo Park, P.O. Box 550, Sturbridge, MA 01566.



Injection-Mold Tooling

Allows fast turnaround

Based on selective laser sintering technology, a fast-turnaround injection-mold tool enables manufacturers to prototype parts made of actual injection-molded resin in less than 2 weeks. Any design flaws in medical parts can be detected early in the product development cycle. Up to 10,000 parts can be molded using the Rapidtool. The supplier is also capable of creating P-20 injection molds for customers within a 2- to 6-week time frame. Global Tool & Engineering, 2009 McKenzie Dr., Ste. 116, Carrollton, TX 75006.


Medical-Pouch Sealers

Use 10-mm-wide heating element

Two series of rugged medical-pouch sealers use a 10-mm-wide heating element for secure sealing. The MS-350 and OPL systems are controlled by a microprocessor that monitors and controls sealing temperature. An autosealing/cooling cycle provides seal-to-seal consistency. Both sealers offer an enhanced heat-sink system that provides increased element life, thereby minimizing downtime and lowering operating costs. Fuji Impulse America, P.O. Box 2423, Wrightwood, CA 92397.


Adhesives and Sealants

Listed in technical support manual

A 280-page catalog and technical support manual references adhesives, sealants, coatings, encapsulants, tapes, and application equipment from major suppliers. The engineering catalog includes a section covering custom packaging of resin materials for improved productivity. It also recommends application equipment and techniques for maximizing manufacturing efficiency. The supplier has offices throughout the country with technical representatives available to assist in designing new adhesive applications or analyzing existing problems. Ellsworth Adhesive Systems, N117 W18711 Fulton Dr., Germantown, WI 53022.



Stainless-Steel Electropolishing

Removes burrs and improves surface finish

A company's brochure describes the process of electropolishing stainless-steel parts to remove burrs and improve surface finish without buffing or tumbling. The brochure describes this reverse plating process and how it selectively removes the high points on stainless-steel parts to produce a bright, burr-free surface finish. According to the company, the process improves the fatigue life of stampings and springs by removing surface impurities. Electropolishing deburrs both interior and exterior surfaces simultaneously and eliminates multiple finishing steps. New England Electropolishing Company, Inc., 220 Shove St., P.O. Box 845, Fall River, MA 02722.

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Top Products and Services of the Year: Reader's Choice (continued)

Top Products and Services of the Year: Reader's Choice (continued)




EDM Dictionary

Contains 350 definitions

A 44-page illustrated pocket dictionary contains 350 definitions of terms pertaining to EDM. The booklet can help EDM personnel of all levels, from students and apprentices to operators and managers, and includes common abbreviations and cross-references. Words and concepts range in complexity and specificity from polarity and platen to arc duration, quill, and crater depth. The dictionary is published by a manufacturer of ram, CNC-ram, and wire EDM systems for contract job, mold, die, and forge shops. Hansvedt EDM, P.O. Box 6099, Urbana, IL 61801.



Miniature Parts

As small as 1Ž8 in.

Ultraprecision machining and assembly of miniature, complex, and critical mechanical components as small as 1Ž8 in. long are available from a company. A range of materials are routinely machined including conventional metals, titanium, all grades of stainless steel, and aluminum, as well as precious and exotic metals, for industries requiring tolerances to 0.00005 in. A large QC staff supported by up-to-date microscopes, gages, and other inspection equipment perform quality checks after each step of the machining process. The company is certified for MIL-I-45208. Owens Industries Inc., 7815 S. 6th St., Oak Creek, WI 53154.



Nickel­Metal Hydride Battery Packs

For use in medical OEM applications

Standard and custom high-capacity nickel­metal hydride rechargeable batteries and battery packs are designed for use in medical OEM applications. The nontoxic, recyclable, and quick-charging units are designed to work with the user's existing nickel-cadmium chargers. Also available are custom cells modified to suit specific requirements regarding self-discharge, capacity, discharge rate, cycle life, and charge rate. Harding Energy Inc., One Energy Ctr., Norton Shores, MI 49441.


Thermoplastic Polyurethane

Features high tear strength, elongation, and more

Thermoplastic polyurethane (TPU), as presented in an eight-page design guide, can be supplied in a range of durometers characterized by high tear strength, elongation, abrasion resistance, and resistance to substances such as hydrocarbons, chemicals, ozone, bacteria, and moisture. Focusing on the supplier's own TPU film and sheet, the guide compares TPU to other commonly used thermoplastic materials such as vinyl. TPU can be fabricated in various ways, including die-cutting, heat and RF sealing, laminating, and vacuum forming. The high-performance material is recommended for use in diverse critical applications. The supplier can provide urethane as blown film or extruded sheet, tubing, cord, and profiles. JPS Elastomerics Corp., 9 Sullivan Rd., Holyoke, MA 01040.


Lithium Power Sources

For portable devices

Available are several models of lithium batteries designed for use in portable medical equipment. The manufacturer reports that the 9-V, UL-recognized U9VL-J lithium battery with full metal jacket lasts up to 4 times longer than any alkaline and 10 times longer than any carbon-zinc 9-V batteries. The high-energy 2/3A cell--Model UB123A--for 3-V industrial applications can be used to supply power backup to computers and other sensitive equipment. The compact U3VL contains a capacity of 3600 mAh in the same volume as a standard 9-V battery. Also available are Thin-Cell batteries featuring thicknesses of as little as 0.019 in., high-rate lithium­manganese dioxide cylindrical cells, and lithium-ion rechargeable units. Ultralife Batteries Inc., Summit Plaza, 160 Summit Ave., Montvale, NJ 07645.



Label Engineering Guidelines

Analyze common errors

An eight-page publication entitled Label Engineering Principles and Guidelines is written to help engineers create accurate label specifications. The brochure begins by analyzing common errors, most of which arise from mistakes during engineering and ordering, not from manufacturing. The second section details the five key components of documentation and explains the proper use of blueprints and color proofs. The booklet also discusses how to create printable artwork and gives tips on supplying reflective art or transmitting digital art. The guidebook finishes with an engineering checklist of 15 questions designed to ensure that critical performance requirements are properly documented. By implementing the procedures outlined in the booklet, engineers can help reduce defect rates and minimize production costs. Steven Label Corp., 11926 Burke St., Santa Fe Springs, CA 90670.


Plastic Buckles

Feature slim-profile design

Strong, lightweight side-release buckles employ a slim-profile design that blends into webbing. The L-series buckles feature contoured openings for comfortable and easy release and can be molded from nylon or acetal. The buckles weigh only 1Ž5 oz and have a 100-lb break strength. Two sizes are available for use with 3Ž4- and 1-in. webbing. Custom color matching is available. American Cord & Webbing Company, Inc., 88 Century Dr., Woonsocket, RI 02895.



Hydrogels

For use in a variety of devices

An FDA-registered firm specializes in the development and manufacture of adhesive and conductive hydrogels for use in a variety of medical devices including electrodes, ostomy appliances, wound dressings, and other applications requiring a unique adhesive that is highly compatible with skin. The company's product line includes a variety of natural and synthetic polymer hydrogels that differ in terms of adhesion levels, physical characteristics, and conductive properties. Hydrogels are available in master rolls, slit rolls, or die-cut sheets. LecTec Corp., 10701 Red Circle Dr., Minnetonka, MN 55343.



Heat-Shrink Tubing

Shrinks quickly at 275°F

Biocompatible heat-shrink tubing shrinks quickly at 275°F onto unprimed materials, stainless steels, glass, and Kynar. Insul-Grip HS-714 creates a moisture-resistant seal and can be sterilized via EtO, autoclave, hydrogen peroxide gas, and glutaraldehyde. The tubing exhibits a dielectric strength of 1800­2000 V/mil and meets USP Class VI requirements. Supplied cut to length and coiled, the tubing can be specified with shrink ratios ranging from 1.3:1 to 3:1 and ID sizes from 3Ž64 to 1 in. Longitudinal shrinkage is ±5%. Insultab Inc., 50 Everberg Rd., Woburn, MA 01801.


Miniature Self-Tapping Screws

Eliminate need for drilling holes

By eliminating the need for drilling and tapping holes, self-tapping screws speed up assembly. The screws can be inserted directly into existing holes and are self-locking. They allow designers to vary the hole size and torque requirements according to the material. They are made from 303 stainless steel and are available in flat and flat-fillister head styles in sizes from #000 to #2. Available lengths are 1Ž8, 3Ž16, and 1Ž4 in. They can be custom made in brass, steel, and nickel-silver. J.I. Morris Co., 394 Elm St., P.O. Box 70, Southbridge, MA 01550.



Light-Measurement Instruments

Catalog includes tutorials

A catalog of light-measurement instruments includes tutorials describing basic light-measurement concepts such as power measurement, wave effects, and hardware considerations. Written as a resource for technical personnel of all levels, the 36-page guide is organized according to instruments and applications. The publication describes detectors, filters, input optics, and accessories and examines the configuration of turnkey systems for photometry, radiometry, phototherapy, UV curing, photoresist processing, germicidal applications, laser processing, LEDs, and flash measurement. Featured products include the IL1400A radiometer/photometer, which uses smart preprogrammed detectors; the IL1700 research radiometer; and the IL1800 lock-in radiometer for precise measurement of low light levels. International Light Inc., 17 Graf Rd., Newburyport, MA 01950.



Casters

Catalog includes selection guide

Industrial casters and wheels from eight major suppliers are collected in an illustrated 112-page buyers guide. The catalog includes a selection guide written to help designers choose the appropriate caster, wheel tread, and brake for a given application. A separate section is devoted to casters used in the health-care industry. An additional 32-page section lists casters and wheels by manufacturer and distributor ordering information, enabling users to cross-reference and identify casters using only a serial number. Most items are available from stock. Youngs, 55 Cherry Ln., Souderton, PA 18964.



Rechargeable Cells

For medical applications

Nickel­metal hydride rechargeable batteries for portable devices are available for such applications as data collection, control and measurement, medical devices, and computers. Available in a variety of standard sizes, Duracell batteries range in voltage current from 4.8 to 12 V and have rated capacities of 1200 to 3200 mAh. Many of the batteries are offered with PowerSmart technology, which permits them to communicate 34 different battery data values to a host device--including number of cycles and state of charge--by means of a microchip. Duracell Inc., Berkshire Corporate Park, Bethel, CT 06801.


Luer Components

Including rotating-collar male luer-lock adapters

High-precision, reusable luer components are presented in a catalog. Standard components in plated brass and type 316 stainless steel are available, as well as a series of rotating-collar male luer-lock adapters for use where rotation of the male and female luer is difficult or impossible. The catalog also contains expanded listings of tube barb and threaded fittings. S4J Manufacturing Services Inc., 374 Remsen Ave., New Brunswick, NJ 08901.



Tube-Gripping Device

For tubing, wire, and fiber optics

A device is designed to handle small- to medium-diameter tubing, wire, and fiber optics during such operations as tip forming, soldering, polishing, and bonding. The Tube Gripper uses a pressurized elastomeric bladder that prevents damage to the item being held. Capable of withstanding axial loads up to 10 lb without slippage, the stainless-steel device is available in five sizes that can accommodate components up to 0.500 in. diam. Multiple Tube Grippers can be used for high-throughput or automated applications. Medical Device Manufacturing, 1020 N. Lemon St., Orange, CA 92867.



Heat-Sterilizable Epoxy

Withstands up to 500°F

An epoxy formulation withstands temperatures up to 500°F and can be used to assemble, bond, and insulate instrumentation requiring hot sterilization. Resbond S5H13 cures at room temperature to provide good thermal-shock resistance, high-temperature stability, and electrical insulation. The machinable material also resists corrosion, common chemicals, and solvents. Containing no solvents or volatile compounds, the epoxy is safe and easy to use, requiring only simple mixing before application. Resbond S5H13 has been successfully used to bond bipolar electrocautery devices requiring repeated steam sterilization cycles at 375°F. The epoxy comes packaged in premeasured kits, pint containers, gallon containers, and 5-gal pails. Cotronics Corp., 3379 Shore Pky., Brooklyn, NY 11235.


Medical Batteries

For infusion pumps, oxygen monitors, and more

A manufacturer of replacement battery packs offers an extensive product line. Available are specifically biomedical replacement, sealed lead-acid, lithium, and nickel-cadmium batteries, among others. Typical applications include ambulatory monitoring units, infusion pumps, oxygen monitors, and other compact medical equipment. Unipower Corp., 1216 W. 96th St., Minneapolis, MN 55431.


Miniature Peristaltic Pump

Flow rates from 0.004 to 18 ml/min

A low-flow fluid pump is designed for applications where space is limited. The Model P625 has built-in control circuitry that provides precise bidirectional speed regulation using a single power supply and an analog control voltage. The pump's operating current is low enough for battery-powered applications. Tube sets are available in a range of materials and sizes. The pump measures 1.06 x 1.25 x 2.40 in. and weighs 55 g. Instech Laboratories Inc., 5209 Militia Hill Rd., Plymouth Meeting, PA 19462.


ISO 9000 Manual

Discusses policies, procedures, and forms

A manual, complete with policies, procedures, and forms, is available to ease documentation of quality systems for ISO 9000 certification. The manual is arranged in five sections. Part I provides ISO 9000 background, with an overview of the five ISO standards. Part II guides the user through planning, formatting, and writing policies and procedures for operations. Part III is a quality manual that addresses all aspects of ISO 9001. Part IV contains sample responses for each of the 20 key topics addressed by the ISO 9001 standard. Part V consists of reports, forms, checklists, and documents for operations and manufacturing. The manual is available in both text and software formats. American Business Resources Inc., 1550 Dover St., Ste. 1, Lakewood, CO 80125.


Precision-Machined Parts

Tolerances as tight as ±0.0001 in.

A contract manufacturer of miniature precision-machined parts with tolerances as tight as ±0.0001 in. offers services that include complex drilling, cross-drilling, centerless grinding, threading, milling, and burnishing. From prototypes to full production runs, parts can be produced from exotic, precious, and base metals as well as machinable plastics. Typical medical applications for the parts are pacing devices, catheter connectors, dental and orthopedic implants, and angioplasty devices. Microcision Inc., 5805 Keystone St., Philadelphia, PA 19135.



PVA Sponge

Provides good liquid absorption

A sponge made of polyvinyl alcohol (PVA) provides good liquid absorption, wicking characteristics, and excellent chemical resistance. The Clinicel PVA sponge consists of 3-D, interconnected open cells that are soft and pliable when wet. The interconnected cell structure produces a sponge that is highly absorbent and is virtually lint- and fiber-free. The PVA sponge is an inert material that is not affected by hydrocarbons, acids, or most chemicals. Standard sizes and densities are offered. Custom sizes are available to meet individual requirements. M-Pact, 1040 OCL Pky., Eudora, KS 66025.


Miniature Pressure Sensors

Feature rugged sensing member

A family of miniature stainless-steel diaphragm pressure sensors has been designed for applications that require small size and an environmentally rugged sensing member. The sensors come in a variety of styles, including a cylindrical probe with a 0.125-in. diam, a 0.04-in. low-profile surface mount, and a 10-32 UNF or M5 x 0.8 threaded unit with either a flush or recessed diaphragm. Available in full-scale pressure ranges of 5­5000 psi and 0.35­350 bar, they are useful for both static and dynamic measurements. Some models are capable of a flat response rate to greater than 90 kHz. Entran Devices Inc., 10 Washington Ave., Fairfield, NJ 07004.


Laser Microdrilling

For holes as small as 30 µm

A manufacturer of drilling and machining systems offers turnkey laser systems and contract services for the noncontact microdrilling of holes as small as 30 µm. Delicate substrates such as fused silica, polyester, and multilumen catheters as well as Teflon, polypropylenes, polyethylenes, and nylons can be machined easily. The drilling systems feature a self-contained CO2 laser that prevents material distortion or particle migration. Depth penetration can be precisely controlled, eliminating back-wall strike when drilling miniature and multilumen tubes. A proprietary processing technique also prevents cratering or the formation of raised edges around drilled holes. The Industrial Laser Source, 1C Spaceway Ln., Hopedale, MA 01747.


Custom Fiber Optics

For lighting and imaging

A firm specializes in producing custom optical fibers for both lighting and imaging applications. In addition to optical fibers, the company offers a broad range of custom high-loss, short-distance fiber-optic products for numerous computer and medical applications. Available are UV, laser, visible illumination, and special-effects products. Offered is a patented compact fiber-optic light source that uses natural convection for heat management. Both small- and large-scale projects can be accommodated. Fiber Touch International Inc., 5942 Edinger Ave., Ste. 113, Huntington Beach, CA 92649.


Automatic Heat Sealer

Provides strong seals

Built on the band-sealing principle and designed to control temperature instead of voltage, a heat sealing machine consistently provides strong seals. The BD-II sealer handles lightweight bags and sachets of polyethylene, vinyls, coated papers, and other materials. It has a capacity of up to 70 bags per minute and a sealing speed of up to 9.3 m/min. The sealer comes with a height-adjustable conveyor and with casters for easy moving. The conveyor can be tilted from the horizontal position to about 45°. Optical equipment includes a continuous coder, hot printer, emboss coder, dust cleaner, wider conveyor, and special-pattern compression sealing rollers and gusset rollers for gusseted bags. American-Newlong Inc., 5310 S. Harding St., Indianapolis, IN 46217.



Coating/Surface Modification

For medical applications

Ion implantation and coating equipment and services are available to biomedical and dental companies. Ion-beam texturing modifies surface topography to create desired nanoscale structures and increase effective surface area on such devices as electrophysiology catheters and pacing leads. Extremely dense, strongly adherent radiopaque coatings for use on stents, catheters, guidewires, and other intravenous devices are customized to suit the substrate and application and can be selectively deposited to make any particular area opaque under fluoroscopy. Silver-based multilayer antimicrobial coatings for transcutaneous devices can be deposited on a wide variety of substrate materials and geometries. Implant Sciences Corp., 107 Audubon Rd. #5, Wakefield, MA 01880.



Catheter-Bonding Adhesives

Solids and solvent free

A line of catheter-bonding adhesives is formulated to provide a 100% solvent-free, low-cost solution for catheter manufacturing. The CTH adhesives have good adhesion, flexibility, and high cure speeds and processability. In-line quality control is made possible with their fluorescing characteristics. The adhesives bond to a variety of rigid and flexible plastics, glass, and metals. One transparent surface is needed to allow UV or visible light to penetrate. With this combination the bond is clear and colorless and will maintain structural integrity of assembly. The adhesives are USP Class VI compliant. Dymax Corp., 51 Greenwoods Rd., Torrington, CT 06790.


Metal Tubing

Available in metric and fractional sizes

Mill lengths and sizes of 300-series stainless-steel, aluminum, and nickel­nickel-based alloy tubing and pipe are supplied from stock from a manufacturer. Both metric and fractional sizes are available, and custom cutting capabilities and prototype through mill runs are also offered. The firm supplies stock and cut-to-order tubing to a diverse range of industries including medical, biomedical, laboratory, and instrumentation. Eagle Stainless Tube Corp., 10 Discovery Way, Franklin, MA 02038.


Lead-Acid Batteries

Use thin lead foil

Lead-acid batteries use an extremely thin lead foil as the basis for spiral-round plates that take the place of traditional sponge lead or lead calcium. The cells in the TMF batteries offer the advantage of the 2.0 open-circuit cell voltage associated with lead acid, yet they exhibit a flat voltage profile under a broad range of discharge currents; the units are also rechargeable. The TMF cells can replace nickel-cadmium and nickel­metal hydride batteries in many applications. Also available from the firm are battery chargers and custom assemblies. House of Batteries, 16512 Burke Ln., Huntington Beach, CA 92647.


Electrically Conductive Tapes

Provide long-term stability

Pressure-sensitive adhesive tapes are constructed with a patented electrically conductive acrylic adhesive that maintains long-term stability while resisting environmental stress. Several standard products are available, including ARclad 8001, which is recommended for low-amperage electrical connections, and ARclad 8257, a transfer adhesive providing instant high-strength bonds for instrumentation components. Also available is Flexshield 8269, a highly flexible metallized-fabric tape for use in die-cut EMI shields. In addition, the supplier offers a patented adhesive that absorbs moisture from skin and reduces bacterial growth. Adhesives Research Inc., P.O. Box 100, Glen Rock, PA 17327.


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Top Products and Services of the Year: Reader's Choice (continued)

Top Products and Services of the Year: Reader's Choice (continued)




PVA Sponge

Durable, biocompatible, and hydrophilic

An ultrapure, chemical-resistant sponge is made from a patented polyvinyl acetal polymer that is durable, biocompatible, and highly hydrophilic. Available in a range of densities, the sponge can be manufactured in various shapes and sizes through molding and die-cutting. Surface-treated and impregnated versions can also be supplied. Private-label products, components, and complete assemblies are provided. Merocel Scientific Products, 950 Flanders Rd., Mystic, CT 06355.



Precision Micromachining

Variety of materials can be processed

The machining of intricate shapes and sizes while maintaining tolerances to ±0.00005 in. is the specialty of a company. A wide variety of materials can be processed such as platinum, platinum-iridium, stainless steel, titanium, aluminum, brass, exotic alloys, plastics, and composites. Production and prototype services are available with quick turnaround capabilities. Applications include cardiovascular, ophthalmic, neural, laparoscopic, endoscopic, orthopedic, dental, and surgical devices. Kelco Industries Inc., 6420 Zane Ave. N., Minneapolis, MN 55429.


Impulse Heat Sealers

Feature temperature-control system

A line of impulse heat sealers can achieve high levels of accuracy and performance due to the incorporation of a temperature-control system. Available as an option on the Medical H400 heat sealer, the Accu-Temp system provides 100% temperature accuracy from cycle to cycle. It continually monitors the heat seal temperature without the use of a thermocouple or RTD sensor. Instead, the system takes a direct reading of the heat seal band to measure temperature, thus eliminating any lag in the reading. An optional compact data logger provides a printed record of critical seal parameters such as seal temperature, seal duration, and cooling temperature. The printed record of each cycle provides an additional means of qualifying a given lot. Packworld USA, 539 S. Main St., Nazareth, PA 18064.


Lead Rechargeables

Housed in flame-retardant case

Sealed, pure-lead rechargeable batteries are suitable for a variety of primary, standby, and portable power applications. The Genesis 13-Ah 12-V batteries (Model G12V13Ah10EP) offer high performance in a small, light package. Among the advantages are a high rate discharge performance of 60 W per cell at a 15-minute rate and a low internal resistance of 8.5 m(omega). Hawker Energy Products Inc., 4318 Rainbow Blvd., Ste. 730, Kansas City, KS 66103.


Manufacturing Simulation

Features powerful visualizations

Manufacturers are able to explore new ways of improving their processes with simulation software. The ProModel Optimization Suite 3.5, a Windows-based package, features powerful visualizations, costing features, and statistical capabilities. ProModel Corp., 1875 S. State, Ste. 3400, Orem, UT 84058.


Umbrella Valve

For controlling air- or fluid flow

A molded silicone umbrella valve is supplied for controlling the flow of air or fluids. The flexible valve contains an attachment pin that enables fast and easy snap-fit installation. PressCut Industries, 2828 Nagle St., Dallas, TX 75220.


Surgical Tubing

Made of composite material

A composite tubing material can replace stainless steel and other exotic metals in minimally invasive surgical devices used in laparoscopy, arthroscopy, endoscopy, obstetrics, gynecology, orthopedics, and ophthalmology. Poly-Med II has been tested to withstand 900 V/mil and displays good rigidity, torsional strength, and hoop strength. Available in diameters of 5 mm and larger, the lightweight, radiolucent composite tubing is autoclavable and sterilizable by any other standard method. It is suitable for both disposable and reusable tubing applications. Polygon Co., 440 S. Byrkit Ave., Mishawaka, IN 46544.



Medical-Grade Adhesive Tapes

Offers high tensile strength

Designed with a lightweight, hybrid woven backing, a medical-grade adhesive tape offers high tensile strength and good porosity for products that come into contact with sensitive skin. The Polyken SS 612 tape is made of polyester, cotton, and nylon and is flexible and conformable. It consists of a medical-grade polyacrylate adhesive and is available with a white, silicone-coated release paper. All products are manufactured under GMP standards and are supported by extensive safety testing. Kendall-Polyken, 15 Hampshire St., Mansfield, MA 02048.



Lead-Acid Cells

Provide high discharge rates

Valve-regulated lead-acid batteries are well suited for use in UPS and other applications where high discharge rates are required. The NPX-150 delivers 150 W per cell at the 15-minute discharge rate (1.67 end volts per cell), ensuring high power during the critical 15 minutes following a loss of power. The NPX-100 delivers 95 W per cell at the 15-minute rate. The units are housed in a flame-retardant plastic case, suiting them for use in almost any UPS application. Yuasa-Exide Inc., P.O. Box 14145, Reading, PA 19612.


Tight Tolerances

Components as small as 0.002 in. can be made

Components as small as 0.002 in., and 0.0055-in.-diam holes can be produced by a manufacturer of tight-tolerance medical components. Among the materials routinely processed are stainless steels, platinum, titanium, and plastics. The firm specializes in the manufacture of implantable and precision instrument components for cardiac-pacing, orthopedic, dental-implant, and drug-delivery systems. CAD/CAM systems support several CNC machines including Swiss-type turning, wire and plunge EDM, YAG laser, and multiaxis machining centers. rms, 8600 Evergreen Blvd., Minneapolis, MN 55433.


Pouch Sealer

Available in two versions

A continuous sealer for processing medical pouches is available in two versions. The horizontal version has an integral conveyor, and the vertical version seals longer pouches. Both machines have digital controls for seal temperature, jaw pressure, and conveyor speed. The controls can be calibrated to permit machine validation. An alarm function prevents pouches from entering the machine if the established seal parameters are not met. Standard seal width is 7Ž16 in., but other widths can be specified. Machines can be furnished with painted or stainless-steel finishes. Additional options include a hot-stamp printer or embossing unit for pouch coding and a cutter for trimming the excess pouch material above the seal. Packaging Aids Corp., 24 Tiburon St., P.O. Box 9144, San Rafael, CA 94912.



Microfabrication Process

Allows complex structures

Complex three-dimensional structures can be created from small-gauge metal tubing using a company's proprietary microfabrication process. The Nµetch process produces spiral slots, straight slots, and holes as well as complex ribbed, surface-recessed, and serpentine patterns in thin- and thick-walled metal tubing. Applications include the production of recessed features for insert molding, micromechanical components, endoscope assemblies, EMI shielding, and connector assemblies. Neuman MicroTechnologies Inc., 26 S. Main St., #112, Concord, NH 03301.



Adhesive-Lined Tubing

Reduces contamination risk

A line of medical-grade, heat-shrinkable tubing products offers adhesive lining to reduce the risk of contamination from bioburden and fluids in surgical and electrosurgical instruments, catheter systems, and other equipment. When heat is applied to the Altera tubing, the outer jacket shrinks while the inner adhesive layer reflows to seal and bond to most substrates, creating a barrier to fluids and bioburden. The adhesive makes the tubing suitable for strain relief and joining components. It also makes the tubing suitable as a seal in reusable instruments, with the seal preventing tissue and fluids from seeping between the tubing and the instrument. Raychem Corp., 300 Constitution Dr., Menlo Park, CA 94025.



Ultraslim Fans

Only 6 mm thick

Cooling fans measuring only 6 mm thick are available in sizes ranging from 25 to 40 mm2 and in voltage ratings from 5 to 12 V dc. The fans employ a highly integrated motor construction that reduces the overall size of the hub to optimize airflow performance. In addition, a single ball bearing system decreases overall resistance to the motor and minimizes power consumption. As a result, the fans require a low start-up voltage. Indek Corp., Elina Fan, 2360 Qume Dr., Ste. A, San Jose, CA 95131.


Single-Key Switch

Maximum switching voltage of 48 V

A single-key membrane switch is designed as an alternative to the long lead times and high minimums associated with ordering custom membrane panels. The MCS membrane switch measures 3Ž4 in. and has a profile of 4 mm. It is available in a PCB design with through-hole terminals, or a snap-in panel-mount design with solder terminals. The metal diaphragm is constructed from gold-plated stainless steel; operating travel is 0.5 mm, switching current is 125 mA (maximum), and switching voltage is a maximum of 48 V. Gold contacts are available for low-voltage requirements (<5 V). Schurter Inc., 1016 Clegg Ct., P.O. Box 750158, Petaluma, CA 94975.


High-Precision Machining

For prototypes and production runs

A full-service manufacturer specializes in high-precision machining of device components and implants with tolerances from 1 µm to 0.0010 in. With Swiss CNC five-axis lathes, mills, and grinders, the company can deliver both prototype and production runs. Materials include all stainless alloys as well as titanium and other exotic materials. Processes and products are subject to SPC and stringent inspection in order to uphold ISO and FDA GMP quality standards. LaVezzi Precision Inc., 999 Regency Dr., Glendale Heights, IL 60139.



Miniature Bearings

For IV pumps and other applications

Miniature and instrument ball bearings are available in metric and inch sizes ranging from 0.1181 to 1.0 in. OD. Automated facilities maintain high-volume output while providing tight control over quality and economy. The precision bearings are recommended for use in applications requiring reliable performance, such as IV pumps, surgical drills and saws, blood analyzers, recorders, printers, and other critical medical devices. NMB Corp., 9730 Independence Ave., Chatsworth, CA 91311.


Nickel-Cadmium Cells

Suitable for portable equipment

Rechargeable nickel-cadmium batteries are suitable for demanding high-drain or long-run applications. Rated at 6 V dc at 5.7 Ah, the TE-6757 units feature a slide-in design with quick-disconnect terminals. The cells deliver more than 500 cycles at 100% discharge and measure 6.1 x 2.6 x 1.3 in. Typical applications include portable medical equipment and a broad range of scientific equipment. The units also meet current requirements for state and federal certified recycling programs. Tauber Electronics Inc., 10656 Roseslle St., San Diego, CA 92121.


Adhesive Components and Assemblies

For the medical device and other industries

A contract manufacturer provides custom adhesive components and assemblies to the medical device, diagnostic, and electronics industries. Rotary and reciprocating die-cutting, laminating, slitting, level winding, and sterilizable packaging services are available. The FDA-registered company adheres to GMP standards and maintains multiple cleanrooms with pressure, particulate, and temperature- and humidity-monitoring controls. Pressure-sensitive adhesives, films, foils, and double- and single-coated foams, conductive adhesives, hydrogels, and hydrocolloids are offered. Tapemark Medical/Industrial Fabricating Div., 1685 Marthaler Ln., West St. Paul, MN 55118.



Low-Pressure Sensors

PC-board mountable

Micromachined silicon pressure sensors measure pressures from 1 in. of water to 1 psi. The Sursense family of pressure sensors eliminate the traditional limitations of piezoresistive technology for measuring low pressures, such as offset errors related to gravity, temperature sensitivity, vibration, and long-term drift. The sensors can replace hot-wire anemometers for airflow sensing, thereby eliminating position-sensitivity problems. PCB-mountable sensors for medical instrumentation is one application incorporating the Sursense sensors. Data Instruments Inc., 100 Discovery Way, Acton, MA 01720.


Fluoropolymer Coatings

Increase surface hardness

Four formulations have been added to a line of fluoropolymer coatings for medical and industrial use. Applied through the supplier's infused-matrix technology, the coatings can increase surface hardness to Rc 68 and enhance corrosion resistance. The coatings also function as a permanent dry-film lubricant and can lower a component's coefficient of friction. Endura Coatings, 2099 Riggs, Warren, MI 48091.


Needleless Valves

Reduce risk of infection

Disposable needleless valves were developed for use as substitutes for needle ports in IV applications. Needleless valves reduce the risk of infection to health-care providers by replacing hypodermic needle ports. The line consists of a variety of low-priming-volume disposable parts including slip luer valves, y-ports, t-ports, 1Ž4-in. tubing valves, and ANSI-standard valves. Parts are available in a variety of materials that can with stand gamma, EtO, or autoclave sterilization. The ISO 9001­certified, GMP-compliant company offers a variety of plastic components and assemblies for use in disposable medical devices. Halkey-Roberts Corp., 11600 9th St. N., St. Petersburg, FL 33716.



Manufacturing Documentation

Software manages critical information

A software program is the first in a series of Windows tools designed to manage critical information used to control manufacturing documentation. DocuStat's main screen lets the user navigate up to four additional areas. The Document Information screens have all the document attributes listed. The user can also search for and view text documents and drawings from these screens. Engineering Change Control allows the user to log and track engineering changes. When a product code is entered in DMR Reconciliation, a list shows documents that have been changed and those that have remained the same since the last build. Wellport, 3495 Winton Pl., Bldg. B, Rochester, NY 14623.


Membrane Switches

Tested to ensure reliability

State-of-the-art screen printing, color matching, die-cutting, and laminating processes combined with environmental and life-cycle testing ensure the production of reliable membrane switches. The manufacturer works closely with customers during the design of new parts to make sure that all application requirements are met. The use of laser cutting allows fast, precise prototyping without tooling. Readily available from the firm are a series of design guides and engineering aids. Nelson Name Plate Co., 3191 Casitas Ave., Los Angeles, CA 90039.


Winding Machines

For converting metals, plastics, rubbers

Winding equipment and control systems are engineered for use in converting metals, plastics, and rubbers. A full-color brochure details the supplier's line of traverse winders, pancake winders, horizontal winders, accumulators, and specialized strip-handling equipment. The publication also lists accessories such as expanding mandrels, precision investment spools, hub adapters, interleaf tensioners, interleaf take-ups, spool-flange spreaders, and stock guides. Coil Technology Inc., P.O. Box 477, Wadsworth, OH 44282.


Miniature Bearings

In metric and imperial sizes

An extensive selection of miniature bearings is presented in a manufacturer's product catalog. Miniature bearings are available from stock in metric and imperial sizes. The supplier offers fast delivery on orders ranging from a few bearings to several thousand units. Boca Bearing Co., 7040 W. Palmetto Park Rd., Ste. 2304, Boca Raton, FL 33433.


Adhesives Development

New materials tested

A laboratory offers adhesives development, research, and pilot production. Examples of medical applications include the formulation of medicine-impregnated pressure-sensitive adhesives, electrically conductive adhesives, hydrophylic adhesives, wound-management films, and artificial lens­delivery systems. A pilot production laboratory is designed to test new materials at a fraction of the cost of full-scale production. Adhesive Consultants, 383 Stanton Ave., Akron, OH 44301.



Ultraprecision Components

Machined with eight-axis CNC equipment

A firm's eight-axis Swiss-style CNC equipment permits ultraminiature parts to be machined in one operation. The use of simultaneous multitool/multifunction processing results in reduced machining and handling times as well as lower costs. Continuous and short-run SPC manufacturing techniques ensure the production of accurate and precise parts. Batch and continuous-run processes are available for a variety of applications and materials. Remmele Engineering Inc., Production Machining Div., 17701 U.S. Hwy. 10, Big Lake, MN 55309.


Wound-Care Products

Including island dressings

A line of wound-care products including island dressings is available on a contract basis. The company offers die-cutting, laminating, slitting, printing, and packaging of adhesive devices and components. Tolerances to within ±0.005 in. can be achieved. Adhesives include hypoallergenic, transfer, pattern-coated, high-temperature, acrylic, and rubber-based systems. Orders can be filled within 1­3 weeks, and qualifying prototype runs are available. Precision Converters Inc., 10969 Shady Trail, Ste. 101, Dallas, TX 75220.

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Top Products and Services of the Year: Reader's Choice (continued)

Top Products and Services of the Year: Reader's Choice (continued)




Silicone Adhesive

Adheres to skin, metals, glass

A pressure-sensitive silicone adhesive available in various solvents adheres to skin, metals, glass, paper, fabric, plastics, silicone, and organic rubber. MED-1355 retains its adhesive properties in the presence of perspiration or other moisture, and is not affected by normal temperature variations or the passage of time. NuSil Technology, 1050 Cindy Ln., Carpinteria, CA 93013.


Dispensing Needles

For manual or air-operated systems

An assortment of more than 600 needles, tin caps, and covers for manual and air-operated dispensing systems is included in a single kit. Blunt, stainless-steel, nonsterile needles with plastic luer-lock hubs are supplied in lengths of 1Ž2, 1, and 11Ž2 in. along with 11Ž4-in. plastic tapered needles in five gauges. Teflon needles are also provided in various lengths and sizes. Packed in a clear plastic box containing 20 movable compartments, the kit can be conveniently situated in production areas for manual or metered dispensing of solder masks, pastes, oils, cyanoacrylates, epoxies, adhesives, and greases. Kahnetics Dispensing Systems, 2260 S. Vista Ave., Bloomington, CA 92316.


Adhesives Manufacturing

For medical applications

Adhesive-backed medical devices and components are manufactured from wovens, nonwovens, films, hydrogels, foils, papers, foams, and hook-and-loop fabrics. Products can be imprinted with the OEM's logo, instructions for use, or other information. The ISO 9002­certified specialist in wound-care products offers contract packaging as well as manufacturing, producing heat-seal and cold-seal pouches from a variety of materials. A turnkey package also includes contract sterilization and sterilization validation. TTL Medical, 10537 Lexington Dr., Knoxville, TN 37932.



Metal Components

Machined from medical-grade materials

Precision components and miniature subassemblies are machined from stainless steel, titanium, precious metals, and other medical-grade materials. Detailed parts can be provided in diameters ranging from 0.005 to 2.000 in. with tolerances to ±0.000050 in. Assemblies and subassemblies for medical devices, implants, and surgical equipment are available. An SPC program is in place. Cal-Swiss, Div. of Gorko Industries, 390 S. Fair Oaks Ave., Pasadena, CA 91105.


Epoxies and Polymers

Applications for medical instruments and devices

A brochure explains how a company's materials are optimized for bonding, coating, encapsulating, and interconnecting in various applications including medical instruments and devices. The company has capabilities for manufacturing and customizing epoxies and polymers and offers hundreds of materials with electrical, thermal, and physical properties that can be selected and modified to meet specific user requirements. Epoxy Technology Inc., 14 Fortune Dr., Billerica, MA 01821.


Heat Exchangers

With copper or stainless-steel circuits

Liquid-to-air heat exchangers with copper or stainless-steel circuits are presented in a manufacturer's full-color brochure. A line of 24 standard models includes the 720-series copper-circuit heat exchangers for closed-loop liquid cooling in applications ranging from process and test equipment to industrial power supplies. Also available are the 730-series heat exchangers featuring stainless-steel circuits; they meet ultraclean coolant-circuit requirements for deionized water in medical and industrial lasers and resist aggressive gases and coolants. Both the 720 and 730 series are available with or without fans and can be modified to suit specific application requirements. In addition to product descriptions, performance charts, photos, diagrams, and specifications, the publication outlines a recommended procedure for selecting the proper size of heat exchanger and provides application notes. Thermatron Engineering Inc., 687 Lowell St., Methuen, MA 01844.


Precision Processing

For polymers, glass, and more

A company specializes in the high-precision processing of polymers, diamond, glass, ceramics, and thin metal films. Ultraviolet lasers vaporize most materials with minimal heat transfer to the surrounding area and can achieve spot sizes as small as 1 µm. Available processes include hole and shape cutting, wire stripping, marking, scribing, and pattern removal. Quantities from prototypes to production runs can be accommodated. Potomac Photonics Inc., 4445 Nicole Dr., Lanham, MD 20706.



Regulatory Information

Available on CD-ROM

CD-ROM databases provide quick desktop access to current regulatory information. Reference sources targeting the health-care industry include the Medical Devices Library, which contains information concerning demonstration of substantial equivalence, current products and processes, and means of complying with GMP regulations. The electronic publications can help regulatory affairs professionals make accurate and reliable compliance decisions, learn from competitors, and forecast the direction of regulatory change. The databases are supported by unlimited toll-free technical support. IHS Regulatory Products, 15 Inverness Way E., Englewood, CO 80112.


Hot-Bar Heat Sealers

Feature digital control and display

A line of precision hot-bar heat sealers provides seal quality for medical pouch­sealing applications. The Series AS/2 units feature individual digital control and display of temperature, pressure, and dwell time in order to provide control, accuracy, and repeatability. Each of the sealing parameters is tied into an alarm with a lockout feature to prevent cycling of the machine if any parameter exceeds the set limits. The Series AS/3 units feature PLC to control temperature, pressure, and dwell time with password protection, data acquisition, and communications capabilities. They also offer full process alarms with lockout features. Sencorp Systems Inc., 400 Kidds Hill Rd., P.O. Box 6001, Hyannis, MA 02601.



Brushless Dc Motors

Feature thread-on design

A series of high-speed brushless dc motors feature threaded housings that accept the manufacturer's planetary gearheads and flanges for design flexibility and ease of use. The SFB-series motors are available in sizes 5, 9, 11, 15, and 21 with stall torque of 0.75­12.4 N-m. Over 4500 variations are available. With a stainless-steel housing and shaft and operating speeds up to 75,000 rpm, the motors are suitable for a variety of medical applications. API Harowe Inc., 110 Westtown Rd., West Chester, PA 19382.


SOIC-8 Plastic Pressure Sensors

Suitable for high-volume OEM applications

SOIC-8 plastic-package pressure sensors are designed to provide a cost-effective solution to high-volume OEM applications that require small size and mild corrosive-media isolation capabilities. Intended for use with automatic handling and insertion equipment, the NPP series of pressure sensors improves manufacturing efficiency by eliminating costly manual handling operations. The proprietary silicon piezoresistive pressure die is gel coated to provide protection from dust and high humidity. The user can provide the sensors with signal conditioning circuitry to amplify the output signal or to maximize OEM value added. The sensors are compatible with most corrosive gases and dry air. Operating temperatures range from ­40° to 125°C. They feature a four-element Wheatstone bridge configuration for circuit design flexibility. Lucas NovaSensor, 1055 Mission Ct., Fremont, CA 94539.


Hot-Stamp Imprinter

Produces more than 600 imprints per minute

A high-speed label imprinter can produce more than 600 imprints in one minute. The Champion PS-1 mounts easily in-line on labelers, baggers, and vertical form-fill-seal machines. Another model, the Jaguar J2800 thermal-transfer printer, is computer programmed and requires no type, plates, or dies, thereby allowing quick message changes. It can print graphics, product description, and consecutive numbering, all directly onto packaging film. For hot-stamp multilane applications, the MVP model is designed to mount onto multilane packaging machines to imprint lot numbers, expiration dates, and bar codes. Norwood Marking Systems, Div. of ITW, 2538 Wisconsin Ave., Downers Grove, IL 60515.


Teflon Seals and Bearings

Sizes from 3/8 to 60 in. diam

Custom seals, seats, and bearings are cold molded and machined from virgin PTFE and PTFM in diameter sizes from 3Ž8 to 60 in. The components are chemically inert and impervious to moisture. Standard shapes include V-rings, U-rings, split seals, cup seals, and lip seals. Base materials can be mineral filled to provide greater steam resistance, glass filled to enhance wear resistance and stiffness, or bronze filled for applications requiring a strong, self-lubricating bearing. Materials can also incorporate pigments for color coding. Prototype and production quantities can be supplied. Engineering Plastics Inc., 190 Turnpike Rd., P.O. Box 1440, Westboro, MA 01581.


Drive Components

Available in unusual sizes

Prototype engineers looking for small drive components in unusual inch or metric sizes stand a good chance of finding them in a supplier's 768-page catalog of design components. The sourcebook features a 250-page technical reference that covers such topics as constant-force springs, motors, nonmetallic fasteners, speed reducers, gear trains, and vibration mounts. The catalog itself contains 12 sections, each with its own photographic and descriptive index, listing more than 9400 stock components in inch and metric sizes and commercial and precision tolerances. Major sections focus on vibration and shock mounts, specialty fasteners, speed reducers and gearheads, and linear-motion products. Also listed are clutches and brakes, differentials, proximity switches, dials, hubs, knobs, right-angle and dual drives, and an engineering prototyping kit. A comprehensive product index is included. Stock Drive Products and Sterling Instrument Divs., Designatronics Inc., 2101 Jericho Tpke., Box 5416, New Hyde Park, NY 11042.


Tabletop Packaging System

Offers sealing and label printing

Specifically designed for in-house packaging of small medical products, a tabletop machine is easy to operate and maintain. In addition to heat sealing packages, the Smallpak system offers computerized label- printing capabilities. The unit is suitable for packaging dental bits, pregnancy test kits, sutures, ophthalmological tools, bone screws, capsules, and pills. Stock packaging materials are available for quick delivery. Odessa Packaging, 202 N. Bassett St., P.O. Box 487, Clayton, DE 19938.



Thermoplastics

In standard and custom colors

A supplier of precolored thermoplastics, color concentrates, and specialty compounds offers a capabilities and applications brochure. TPE, polypropylene, polyethylene, polystyrene, HIPS, ABS, polycarbonate, and ABS/
polycarbonate compounds can be provided in standard and custom colors and formulated to accentuate particular physical properties. Color concentrates for a wide range of polymers can meet requirements outlined by FDA, UL, and other standards bodies. QA systems, certified to ISO 9001, include stringent process control measures to ensure lot-to-lot consistency. The supplier can readily accommodate small lot runs and short lead times. Plasticolors Thermoplastic Products Div., P.O. Box 816, Ashtabula, OH 44004.


Membrane Separation

Custom designs available

Separation media can be modified or custom designed to suit specific applications involving lateral- and through-flow diagnostic assays, hydrophobic and oleophobic venting, blood separation, DNA detection, protein immobilization, and sample preparation. A brochure details the supplier's production capabilities. A large staff of scientists and engineers, working at 22 technical centers throughout the world, provides technical, scientific, and laboratory assistance in evaluating and optimizing separation applications. Staff technicians can help manufacturers select the appropriate material for a given application and help to develop specialized media for unusual or problematic applications. Pall BioSupport Div., Pall Corp., 25 Harbor Park Dr., Port Washington, NY 11050.

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