Originally Published EMDM September 2001
SHOWSTOPPERS
A selection of innovative products and services displayed at Hannover Messe (Hannover, Germany), Sensor 2001 (Nürnberg, Germany), and Medical Design & Manufacturing (MD&M) East (New York City).
Electronic components
Oxygen Sensor Features Rapid Response Time
An electrochemical oxygen sensor designed for incubators was introduced at Sensor 2001 in Nürnberg, Germany. The In-Q-OX O2 MediceL, developed by City Technology Ltd. (Portsmouth, Hants, UK), is suited for use with all types of incubators, including battery-powered models, and has a –20° to 50°C operating temperature range.
“Electrochemical sensors have no moving parts,” notes John Warburton, business development manager, making them less fragile than sensors based on alternative technologies. In addition, the In-Q-OX has a <5-second T90 response time, he adds, “and it has a two-year operating life in 50% oxygen, which equals four years in ambient oxygen.” The sensor can operate in a range of 0–99% relative humidity, making it suitable for use within the humid environments of infant incubators.
The company also presented its NO sensors, which have been approved by US FDA for use in the treatment of neonates with hypoxic respiratory failure, more commonly known as blue baby syndrome. “Nitric oxide at high levels is toxic,” explains sales executive Teresa Standen, “but at low levels it promotes breathing.” The MNO-1 and MNO-2 sensors are not affected by cross-interference from agent gasses or N2O. They feature a <10-second T90 response time and temperature compensation, and are unaffected by operation in 100% oxygen.Solvents
Processing Fluids Sidestep Regulatory, Environmental Hurdles
In advance of an impending EU ban on solvent uses of HCFC-141b, 3M Specialty Materials (Bracknell, Berks, UK) exhibited a range of alternative solvents at the Medical Design and Manufacturing East show in New York City.
The company’s Novec engineered fluids were developed for use by medical device manufacturers who must eliminate hydrochlorofluorocarbons such as HCFC-141b and other ozone-depleting substances (ODSs) from their processes to conform with regulatory requirements. Novec engineered fluids offer performance capabilities closely matching those of the chemicals they replace, but they have zero ozone-depletion potential, short atmospheric lifetimes, and lower potential to contribute to global warming than many fluorinated compounds. The fluids are nonflammable, low in toxicity, noncorrosive, and low in surface tension and viscosity. Bill Loomis, the company’s medical markets team leader, notes that in precision cleaning applications, the fluids exhibit faster and better spot-free drying than aqueous processes.
Other uses in medical device manufacturing include service as carrier solvents for the deposition of coatings on devices, in tube swelling, as an inert spacer fluid in diagnostic testing devices, and as reaction media for gaseous reactions or oxygenation. Loomis adds that the company can provide application guidance and full technical support to OEMs preparing to comply with the ODS regulation. “We can offer a wealth of technical expertise,” he says, noting that 3M can advise clients on such topics as solvent recovery and the reduction of operating temperatures.Motion control
Microgear Offers Power and Precision in Tiny Package
First introduced to the public at the 2001 Hannover Messe, a microdrive features a miniature gear that is reportedly the smallest backlash-free gear in the world. With a diameter of 8 mm and a height of 1 mm, the gear provides a highly efficient torque increase and achieves repeatability in the range of a few seconds of arc. The unit’s maximum output torque is 10 mN.m at a maximum output speed of 100 rpm.
Packaging materials
Thermoformable Film Offers Alternative to Nylon-Based Packaging
A thermoformable blown film produced with a polyolefin blend promises to provide the physical properties of a nylon polymer to European manufacturers without the cost. FlexForm B formable bottom web is now available in Europe after the formation of a partnership between Pactiv Corp.’s Sengewald business unit (Halle/Westfalen, Germany) and Rollprint Packaging Products Inc. (Addison, IL, USA).
At the MD&M East show in New York City, the companies explained the advantages of using FlexForm B instead of nylon. “Unlike in nylon-based materials, there is little snapback or shrinkage in the blended film,” says Michael Troedel, Pactiv director of sales and marketing.
Procurement
Internet-Based Procurement System Automates Quote Process
An on-line system allows small to mid-sized manufacturing companies to conduct private sourcing with suppliers of CNC machining, moulding, casting, and rapid prototyping. Providing a private negotiating forum for contract services, the site (http://www.manufacturingquote.com) also displays a wide variety of industrial products and services, including software and translation services.
We've
found that some manufacturers using our systems saved up to 60% on items that
they were already buying, says Mitch Free, president of ManufacturingQuote Inc.
(Smyrna, GA, USA). Exhibiting the system at MD&M East in New York City, Free
said companies can get a quote, build projects, find out a target price, automate
the rejection process, and restrict who bids on projects.
Companies buying manufacturing services post a quote request by completing an on-line form and attaching a drawing. Vendors who are members of the site can search for requests that match their area of expertise. To bid, the vendors fill out an on-line quote submission form that is sent directly to the buyer by e-mail.
Electronic components
Composite Tubing
Features More Strength, Less Weight
Combining the benefits of silicone and PTFE, fluoropolymer silicone composite tubing provides multimodality sterilization capability and higher lubricity, lighter weight, and added strength compared with single-material tubing. Sil-Kore tubing and cable jacketing material from W. L. Gore & Associates (Putzbrunn, Germany) was on display at MD&M East in New York City.
“Sil-Kore is one of the only materials that has low-to-zero elongation, and is flexible and limp with high strength properties,” said Edward Rubin, W.L. Gore’s product leader for medical electronics. Primarily used as an endoscope component for light guides and other fibre-optic buffering applications, the tubing is suitable for a variety of applications that require a sterilizable cable assembly. The tubing offers longer field use, high crush resistance, improved flexibility, and high tensile strength. Its smooth surface allows for greater durability and comfort compared with conventional silicone. Sil-Kore is 30 to 50% lighter than silicone and has less than half the surface area. The material’s low surface friction allows for greater fibre-packaging density, which provides increased light output for a given diameter.
The tubing is available in a variety of sizes ranging from 0.5 to 14 mm. The company supplies a wide selection of medical electronic products, including miniaturized high-density ribbon cables and medical probe cables.Surface treatment
Parylene Coating Challenges Dip and Spray Methods
A conformal coating for protective applications was presented at the MD&M East show in New York City. The coating from Parylene Coating Services Inc. (Rosenheim, Germany) is used in various medical applications including forming mandrels, stents, pacemakers, and implantable wires. Through vacuum deposition, the parylene condenses and polymerizes on the product surface. Compared with liquid processes, there is no bridging, thin-out, puddling, runoff, or sagging. “You have less coating failure using parylene coating instead of dip or spray coatings. Parylene has no cure time and no pinholes, so the chances of contamination are greatly reduced,” says Bob Shaftoe, Parylene Coating Services director of sales and marketing.
Since the process takes place at room temperature, there is no thermal or mechanical stress on the product, and the process provides a conformal, biocompatible, protective coating.
The parylene films range from 1 to 30 µm in thickness, but they provide a barrier that is equivalent to a thickness range of 50 to 150 µm in other coatings. Any product that can be exposed to medium vacuum can be processed with parylene.Manufacturing software
Web-Based Software Streamlines Product Development
A Web-based collaborative manufacturing software package from SDRC (Hitchin, Herts, UK) encompasses all aspects of the manufacturing process: requirements, designs, configurations, documents, and related business information. On display at the MD&M East show in New York City, the software system allows customers to integrate not only SDRC’s software components, but also their own software components, components from other products, and components developed by third parties.
Bill Weyand, chairman and CEO of SDRC, says the software allows manufacturers to get a product to market sooner by quickening the product development process. “TeamCenter provides manufacturers exactly what is needed to stay competitively viable in today’s product development process,” he says. The software reduces product development costs by synchronizing tasks and schedules, allows customers and suppliers to set up regulatory and customer requirement parameters early in the product development process, and reduces development cycle times and costs by managing all of the product information on the Web. The software works with all CAD systems and provides an easy user interface.Manufacturing
equipment
Handheld Dew Point
Meter Features Modular Design
Designed to check compressed-air lines and other dry gas applications in industrial settings, a portable meter accurately determines dew point temperatures across a –60° to 60°C measurement range. Vaisala Oyj (Helsinki, Finland) previewed the DM70 meter at Sensor 2001 in Nürnberg, Germany.
Long-term stability has been enhanced through the use of a polymer sensor in the DM70 in lieu of metal oxide, which has been the industry standard, according to product manager Jan Grönblad. “When it is used to measure dry process gases with high humidity and is exposed to liquid water, metal oxide tends to decay,” says Grönblad. The instrument’s handheld probe also responds rapidly to moisture changes from start-up in ambient conditions to low and high process dew points. Metal oxide can take some time to stabilize, according to Grönblad. The device is pressureproof and resists condensation.
The company will also be introducing a probe to measure CO2 that plugs into the modular device. The unit can be fitted with either probe, or both probes can be inserted to conduct simultaneous dew point and CO2 readings. The instrument has applications in a range of process industries where moisture can be a contaminant.Materials
Polyolefin Has Look and Feel of PVC
Although it is not being marketed as a PVC replacement, Solmed polyolefin film captured the attention of numerous visitors to MD&M East in New York City because of its potential as a substitute material. Solvay Draka B.V. (Enkhuizen, Netherlands) introduced the polyolefin elastomer film to the North American market at the show.
“We have had a lot of interest from OEMs sourcing a non-PVC material that has the tactile qualities of vinyl,” says Solvay’s US director of technology Robert Elcik. Other materials that exhibit properties similar to PVC do not share its soft, dry feel, he says, thus limiting their market potential.
The most recent additions to the Solmed family of medical-grade materials, EM-8300, EM-8400A, and EM-8600-B4 feature minimal extractables, strength, chemical resistance, clarity, flexibility, and ease of fabrication. Potential applications include IV, drug delivery, and blood processing and storage products. The material is also suited for the production of stem-cell containers and nutritional, drainage, and CAPD devices. The product’s strength-to-thickness ratio permits downgauging: a 9-mil polyolefin film has the strength and durability of a 14-mil soft PVC film, according to the firm.
Heat-weldable EM-8400A withstands autoclave, gamma, and EtO sterilization; exposure to high levels of gamma radiation, however, may result in slight visual or physical property changes. EM-8600-B4 is suited for gamma and EtO sterilization and can be either heat or RF welded. EM-8300 is RF sealable and can be EtO or gamma sterilized. It has low-temperature properties.
These films can
be manufactured in thicknesses ranging from 6 to 20 mil and in widths up to
34 in. Polish/matte, taffeta/matte, and matte/matte finishes are available.
Electronic components
Pressure Sensor’s Profile Saves PCB Space
Specifically designed to conform to the surface-mount land pattern of a DIP package, a pressure sensor supports gauge, vacuum gauge, differential, and wet/wet differential applications associated with medical equipment. The 20PC-series SMT microstructure sensor was previewed at Sensor 2001 in Nürnberg, Germany, by Honeywell Sensing & Control (Offenbach, Germany).
Ceramic components
High-Frequency Parts Can Be Applied Directly to a Substrate
A company that supplies piezoelectric ceramics for industrial and medical applications has introduced self-supported discs with 20–50-MHz resonance frequencies. Developed by Ferroperm Piezoceramics a/s (Kvistgaard, Denmark), the products help to eliminate costly in-house processes and improve production yields, according to the firm. The discs, which were shown at Sensor 2001 in Nürnberg, Germany, are suited for use in high-frequency medical scanners, NDT transducers, and integrated and low-force sensors.
“The components can be applied directly to a substrate, thereby eliminating secondary machining,” says technical director Torsten Bove. They can be manufactured in very thin profiles, he adds, “and the thinner they are, the higher the frequency.” The pictured 65-µm-thick Pz21 discs are typically produced in diameters of 1, 5, and 10 mm.
Ferroperm supplies
piezoelectric ceramics in soft and hard lead zirconate titanate, modified lead
titanate, lead metaniobate, and bismuth titanate.
Manufacturing equipment
Guidewire Grinder Machines Multiple Shapes
A guidewire-grinding machine introduced at MD&M East in New York City can produce balls, tapers, arcs, flats, threads, barrels, teardrops, and a variety of other shapes with micrometre-level accuracy. Exhibited by Glebar Company, Inc., (Franklin Lakes, NJ, USA), the machine’s versatility and ease of use received high marks from attendees, according to vice president, engineering, Robert Gleason.
“Our clients want longer, more precise wires . . . that can go into the brain to treat aneurysms, among other applications,” says Gleason. Machining the guidewire shouldn’t be akin to brain surgery, however, and Glebar designed the CAM SXE with simplicity in mind. For example, CAD files can be easily and quickly downloaded to the grinder from a floppy disk or network.
“To my knowledge, this is the only commercially available machine with this amount of flexibility and accuracy,” says Gleason.
“In the past, device OEMs have developed machines like this internally,” adds marketing manager Mark Bannayan, “but they tend to be difficult to set up, and maintenance can be a problem. They also do not have the level of automation of our machine.”
The CAM SXE features fully automated guidewire processing, including loading and unloading, and it is equipped with a NEMA 4 touch screen.Electronic components
Paramagnetic Oxygen Sensor Offers Savings in the Long Run
Paramagnetic sensors use a nondepleting technology that allows them to operate for the life of the host device. This longevity has come at a steep cost . . . until now. The Paracube, developed by Servomex Group Ltd. (Crowborough, E Sussex, UK) for use in ventilators and neonatal incubators, reportedly narrows the price gap. The firm, which showed the product at Sensor 2001 in Nürnberg, Germany, contends that the true cost of the component will be less than that of an electrochemical sensor when the cost is calculated over a five-year period.
“The Paracube is extremely reliable,” says Jörgen de Vos, business manager Europe. “Electrochemical cells have a finite life and need to be calibrated daily,” he says, whereas the Paracube can operate reliably for months without calibration. Unlike other paramagnetic sensors, this digital device has no feedback system, he adds. “A coil is wrapped around the dumbbell [two connected nitrogen-filled glass spheres] to make a dc motor. When oxygen is introduced, the coil oscillates, and this oscillation is a measurable representation of oxygen.” Other advantages of the technology include a fast response time, high accuracy, and minimal maintenance requirements.
Because of the underlying technology, the sensor is not suited for mobile systems. “It’s not an issue if it’s part of a device that is being wheeled around the hospital,” says de Vos, “but you wouldn’t want to integrate the Paracube into a system used in ambulances, for example.”
Servomex manufactures a range of paramagnetic, infrared, and zirconia transducers for integration into OEM instrumentation used in medical and industrial applications.Electronic components
Sensor Simultaneously Measures Differential and Absolute or Gauge Pressure
In many medical applications, sensors are required to measure both the differential pressure (to monitor flow) and the line pressure, which can be specified as absolute or gauge. Sensortechnics GmbH (Puchheim, Germany) introduced a piezoresistive two-in-one pressure sensor at the Sensor 2001 show in Nürnberg, Germany, that monitors differential and absolute or gauge pressure simultaneously.
“Normally, this task requires mounting two sensors on a PCB, which means more space and more dead volume,” says marketing manager Armin Wellhöfer. “In addition, the two sensors need to be matched up, but they are positioned at different locations on the PCB and, therefore, have different thermal and mechanical surroundings.” Putting the sensors in the same housing and in a common environment saves engineers time and money, and it increases the component’s accuracy, Wellhöfer adds.
The sensor package is an industry-standard moulded glass-filled nylon housing ready for PCB mounting. Three pressure ports provide pneumatic connections; the two amplified and compensated output voltages are proportional to the two input pressures. A selection of output voltage characteristics offers OEMs the choice between different offset and span calibrations with output signals between 0.1 and 4.8 V.
“The OEM can specify the two types of sensors he wants, and we will build [the combined part],” says Wellhöfer. “Hundreds of combinations are possible,” he adds, and the turnaround time, even for unusual requests, can be extremely rapid. “Our chief engineer has been with the company since 1982, and it’s not uncommon for him to come up with a solution for an OEM customer in one day.”
Other products from Sensortechnics that were also presented at the show included miniature pressure sensors with enhanced temperature compensation and a series of stainless-steel pressure sensors with a selection of pressure ranges from 0 to 200 mbar.
Sensors
Pressure Transducers Feature Steady Measurements
Customer-specified transducers for pressure measurement on display at Hannover Messe in April includes polysilicon pressure sensors that are based on an insulated thin-film strain gauge and capacitive ceramic sensors that register applied pressure as a change in the distance between an attached body and membrane. Envec, a division of Endress + Hauser GmbH + Co. (Weil am Rhein, Germany), also produces OEM transducers that feature a low temperature coefficient and provide stable measurements even as temperatures change.
Applications for the transducers include medical and vacuum technology and level measurement. The miniature Ceracore M capacitive sensor measures absolute and gauge pressure and has a diameter of 17.5 mm. This sensor boasts a measurement range of 0–100 mbar to 0–200 bar and features vacuum stability, integrated temperature compensation, high overload tolerance, and long-term stability. Jochem Kreutzer, marketing manager at Envec, reports that the company was drawn into the medical sector by a dialysis project completed for a major international medical client.
Reported by Norbert Sparrow, Jamie Graham, and Benjamin Lichtman
Copyright ©2001 European Medical Device Manufacturer
