Medical Device Link.

Originally Published May/June 2000

SHOWSTOPPERS

A selection of innovative new products exhibited at Medical Design and Manufacturing West 2000 (Anaheim, CA, USA)

Manufacturing equipment

Sealing machine incorporates printer

A validated continuous film-sealing machine offers an integrated, computer-controlled printing unit. The Series hm 850 dc features a range of advantages over previous models, including increased speed, improved seal integrity, and a more-intuitive control system.

A control desk and display system features menu-driven user guides, a screen with adjustable contrast and reading angle, a resettable piece counter, a clock and calendar function, automatic maintenance control, and a multilingual programming option. The printer can accommodate sterilization dates with automatic transmission, batch number, and personnel number; the CE mark and accompanying text; and EN 980 symbols.

Using a variable sealing temperature, the hm 850 dc can produce sealing distances of 5–30 mm. A digital display allows for monitoring of the target and actual seal temperature. Hans Wolf, director of Hawo Gerätebau GmbH (Obrigheim, Germany), says, "The hm 850 dc offers a higher-integrity seal than other sealing machines. It is also safer and faster, and it has a smaller footprint." He adds that the company has been active in the medical market for 25 years, and exports 80% of its products. Hawo operates according to quality systems certified to EN/ISO 9001. The Series hm 850 dc, which bears the CE mark, was displayed at MD&M West 2000.

Adhesives

Wound-care system offers high breathability

Launched at MD&M West 2000 in Anaheim, CA, USA, a skin-friendly medical-grade adhesive aids in the control of excess moisture to provide for faster healing. AD2000 is a patented adhesive notable for its highly breathable characteristics. The adhesive is produced by the Specialty Tapes Div. of Avery Dennison Belgie N.V. (Turnhout, Belgium).

Medical market manager Lori Weinstein explains that AD2000 is the result of two years of extensive marketing research, including a series of focus group panels with clinicians. The goal, says Weinstein, was to develop an easily removable formulation that "delivered the desired adhesion performance to skin while withstanding the rigours of sterilization."

In wound-care applications, the high moisture-vapour transmission rate of AD2000 has been found to allow the skin to breathe by letting moisture evapourate through the adhesive, preventing skin maceration. At the same time, the adhesive coating provides a bacterial barrier preventing infection. "This is the best in the marketplace in terms of breathability," Weinstein claims.

AD2000 will be supplied to converters and OEMs. Avery also plans to supply a highly breathable cast film as a carrier for the adhesive. Other recent introductions from the company include a new family of hydrocolloid adhesives, polyurethane foam, and a polyurethane foam/polyurethane film laminate.

Manufacturing equipment

Versatile tube expanders streamline production

As many as three tube expanders can be mounted on a workstation and used in combination. Lakeview Equipment Inc. (Glenview, IL, USA) manufactures both the Model 995HD tube expander—for large-diameter, heavy-walled, or tough-durometer tubing—and the Model 595C—an economical expander with a cushioned jaw stroke and infinitely variable jaw expansion. Straight or right-angle jaws are available for tubing from 0.062 to 0.375 in. ID, and special jaws are available upon request. Pressure is adjustable from 60 to 100 psi, and a gauged and regulated foot pedal is provided.

The units are mounted on the WS-1 multitube expander, a rotary table that facilitates quick changes from one size of tubing to another. A common air line is used and can be switched between units. Lakeview's tube expanders are especially suited for PVC, polyurethane, silicone, latex, rubber, and other elastomeric tubing.

Also introduced at the MD&M West 2000 show was the company's Model 700-1 tube expander with autocycler. The unit, designed for use with the company's Models 595C and 995HD expanders, semiautomatically operates single-acting pneumatic cylinders. "You don't need a foot pedal to operate the unit," says company spokesman Irv Epstein, "and production speed can be increased by up to 25%."

Lakeview specializes in solving difficult tube expansion, cutting, and bonding problems. The company offers a free evaluation of tubing and assemblies.

Electronics

Foot switches offer remote transmission

A line of foot switches that enable remote transmission via radio and infrared signals was introduced at MD&M West 2000 by Steute Schaltgeräte GmbH & Co. KG (Löhne, Germany). The microprocessor-based units enable sensing distances of up to 20 m for radio transmission and 4 to 8 m for infrared, with response times from 10–50 milliseconds; radio operating time lasts up to a year. The cable-free foot switches eliminate location constraints, wire breaks caused by high mechanical stress in operating rooms, and cord-related accidents.

According to product manager Thomas Kutschan, "This is the first line of foot switches that meets the requirements of the Medical Devices Directive." The control units have received the CE marking and adhere to IEC 601 and European Medical Devices Directive (93/42/EEC) requirements. "In the medical arena, safe signal transmission is very important. Switch number one needs to start device number one, not device number two," he says. A first-fault recognition feature provides fail-safe signal transmission, even when several of the wireless switching devices operate simultaneously.

The units are available in single- and multipedal configurations, with analogue and digital control functions. Customers can choose from custom housings and switching functions, and a range of colours, protective shields, and rocker, push-button, joystick, and foot-mouse actuator options. Samples are available from the company for evaluation.

Manufacturing equipment

Ultrasonic system offers programmable weld force

A welding system features multiple modes for applications requiring a high level of process control and weld quality. The 2000f ultrasonic assembly system allows users to program actual weld force and control distance, time, energy, energy compensation, or peak-power modes.

Manufactured by Branson Ultrasonics (Hayes, Middx, UK) and displayed at MD&M West 2000, the 2000f is designed for use in manual, semiautomated, or used fully automated environments and can interface with external devices and controls. The actuator can be mounted directly to a machine frame, or used as a stand-alone system with ergonomic light-force palm button switches. The system includes a user interface with a four-line vacuum fluorescent display designed for ease of use in setup, operation, and troubleshooting.

The 2000 series is equipped with Branson's patented autotune feature, which allows the power supply to track and compensate for changes in horn frequency that occur during production. Specialized circuitry monitors overload, overcurrent, and overvoltage operating conditions. The system also has enhanced data capabilities for configuration and information management. "With the 2000f, manufacturers are better able to monitor and control the welding process for critical applications," says Branson medical marketing manager Ralf Schuster, suggesting that the system is particularly well suited for the joining of small or thin-walled components. The company offers the system in 20-, 30-, and 40-kHz models. The 20-kHz units are rated at 1100, 2200, and 3300 W; the 30-kHz units have an output of 1500 W; and the 40-kHz models are available in 400- or 800-W configurations.

UV curing equipment

Spot-curing system combines performance, ease of use

"Manufacturers are always asking for equipment that is simpler, more reliable, more intuitive, and maintenance-free," says Charles Tucker, sales and marketing manager at UVEXS Inc. (Sunnyvale, CA, USA). Such were the concerns that led to the development of the company's new UV Bright Cure system, which was introduced at the MD&M West 2000 show in Anaheim, CA, USA.

The Bright Cure, an improved version of the company's Model SCU 110 UV spot-curing system, was developed to provide advances in mechanical, optical, and electronic properties. The system features a brighter and more powerful UV intensity range, simplified operations, improved power supply with universal power input (98–240 V ac, 50/60 Hz), a compact footprint, and more-flexible controls, including a programmable timer with a widely adjustable time-delay setting.

Tucker points out that the Bright Cure system's plug-and-play lamps offer an advantage to device manufacturers: "You used to have to focus and tune each lamp to optimize its intensity. Now, with the UV Bright Cure, you won't have to disturb your manufacturing process," he says.

Well suited for curing adhesives and coatings, the Bright Cure can be used on catheters and IV tubing assemblies.

Manufacturing equipment

Compact laser features increased output power

A self-contained 25-W Nd:YAG laser was unveiled at MD&M West 2000 by Equilasers Inc. (Santa Clara, CA, USA). The laser is suitable for a variety of applications, including use in the company's EDWS-25 laser welding workstation.

Equilasers president Richard Sam explains that the laser was developed in response to a desire to increase the average welding power of the company's EDWS-15 welding workstation. Both the EDW-15 and the EDW-25 are designed for high-precision, low-energy laser welding applications. "The increased power and compact size [of the laser] make it ideal for research and development engineers who are looking for innovative manufacturing solutions for ultrasmall medical devices," says Sam. The EDW-25 is reportedly one of the most compact, powerful, and affordable laser welding systems of its kind on the market. Designed for ease of use, versatility, and portability, its new laser requires only 110-V-ac current to operate.

Reported By Benjamin Lichtman and Michelle Stuckey