Medical Device Manufacturing Software

Master Control, Salt Lake City, UT, has released a software platform designed to automate production and improve operational quality. MasterControl Manufacturing Excellence™ removes remaining paper from the shop floor to ensure that product reviews and releases are fully digital, connected, and accelerated; eliminates preventable errors, long review cycles, and costly waste created by manual data entry processes to get production right the first time; and reduces friction between operations and quality assurance priorities and metrics to improve line performance and accelerate production. A builder tool allows organizations to configure the digital solution to their existing processes, streamlining both implementation and adaptability. The builder tool houses the global elements of the manufacturing processes, allowing users to update once and have information propagated throughout the system.

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Additive Manufacturing Platform

Nanofabrica, Tel Aviv, Israel, has launched a mass production additive manufacturing (AM) platform aimed at micromanufacturing applications. Using single micron resolution, the technology is targeted microelectronics, microfluidics, life sciences, and other sectors. It brings the benefits of AM to micromanufacturers with no tooling costs, minimal set up costs, and the ability to mass customize and personalize products. It is appropriate for prototyping, small batches, and mass manufacturing. The platform uses a digital light processor (DLP) engine in conjunction with adaptive optics. Once the image is projected through the DLP unit, the light then passes through an adaptive optics module, which electronically controls various critical optical working point parameters such as focus, tilt, and astigmatism.

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Metal 3D Printing

Protolabs, Minneapolis, MN, has launched production capabilities for its metal 3D printing service. The new capabilities use secondary processes to improve the strength, dimensional accuracy, and cosmetic appearance of metal parts. As part of the launch, enhanced inspection reporting is also available. The company uses direct metal laser sintering (DMLS) technology to 3D print metal production parts. Once parts are built, several secondary options like post-process machining, tapping, reaming, and heat treatments are possible, and quality control measures like powder analysis, material traceability, and process validation are taken.

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Low-Voltage Drives

American Control Electronics, South Beloit, IL has introduced microprocessor based, low-voltage PWM drives for brushed DC motors up to 24 and 48 VDC, respectively. The DCR300-60 and DCR600-60 series can be easily programmed for use in the field without trim pots, saving time and money on installation, calibration, and field support. The microprocessor allows for custom programming to fit specific OEM requirements, potentially eliminating the need for a PLC and supporting devices. The drives are rated for 30 A continuous operation or 60 A for one minute. The regenerative controls are capable of braking or reversing on the fly.

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RF Capacitors

Exxelia, Paris, France has launched a new line of broadband RF capacitors. Series UBZ, UBL, and XBL combine high technical performances (ultra-low insertion loss and excellent return loss over a wide bandwidth up to 40 GHz), quick installation (available in standard EIA sizes compatible with SMT pick and place), and easy soldering (made of reliable ceramic material compatible with any soldering process). The series is RoHS compliant. Applications include optoelectronics and high-speed data.

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Voice Motor Coil

Moticont, Van Nuys, CA, has released a new linear DC motor with internal shaft and bearing. The GVCM-051-127-01 offers high speed, high acceleration/deceleration, zero backlash, high accuracy, high repeatability, and a high force-to-size ratio of 5.0 lb (22.2 N) continuous force and 15.8 lb (70.3 N) of peak force in either direction, in a housing measuring 2 in. (50.8 mm) dia. × 5 in. (127 mm) long. The 3.75 in. (95.3 mm) stroke of the precision ground 0.236 (6.0 mm) diameter shaft with an internal thread, is guided by a long-life plain bearing that can allow side loads up to 1 lb (4.4 N).

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Cleaning Solvent

A fluorinated precision cleaning solvent from AGC Chemicals, Exton, PA, provides medical device manufacturers a safer, highly effective, and environmentally friendly alternative to n-propyl bromide and trichloroethylene solvents. Amolea AT2 is used to clean a range of medical devices such as orthopedic implants, catheters, tubes, scopes, needles, dental devices and surgical tools. The solvent has no ozone depletion potential and low global warming potential. It is non-flammable and offers low latent heat of vaporization.

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Nonfluorescing Adhesive

Dymax, Torrington, CA, offers medical device adhesives that cure with UV/visible light for rapid bonding of COC and COP, as well as a variety of other plastics typically used in the manufacture of medical devices. Applications for MD® 1072-M include lab-on-chip lamination, reservoir assembly, transducer assembly, and medical potting. The resilient, moisture-resistant product bonds a wide variety of substrates from stainless steel to PVC and more. The adhesives contain no nonreactive solvents and cure upon exposure to light.

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Machining Center

Methods Machine Tools, Sudbury, MA, has launched a new high-performance machining center. The FANUC RoboDrill ecoPLUS offers a larger 21 tool capacity and increased speed via an optional 24,000 RPM spindle. Two ecoPLUS models are available, including one with a large x-axis travel and table size. The ecoPLUS D21MiB has a working cube of 19.7 × 15.7 × 13 in. (500 × 400 × 330 mm). The exoPLUS D21LiB offers travels of 27.6 × 15.7 × 13 in. (700 × 400 × 330 mm). Standard features on both systems include a 14.75 HP (peak) 10,000 rpm or 24,000 rpm direct drive spindle with precision-enhancing thermal compensation, HRV control, and a 21-station tool changer.

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Rechargeable Li-ion Cells

Tadiran, Lake Success, NY, has introduced rechargeable Lithium-ion (Li-ion) batteries that are specifically modified for medical applications requiring autoclave sterilization cycles at temperatures up to 125 °C. Common applications for TLI-1550HT batteries include surgical saws, drills, reamers, staplers, shavers, and wire/pin drivers. The batteries enable medical devices to be reused hundreds of times without having to remove or replace the battery prior to autoclave sterilization. The cylindrical cells (51 × 14.8 mm) feature high capacity (0.4 Ah), high energy density (170 Wh/L), and high power density (210 Wh/L).

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SMT Test Points

Keystone, New Hyde Park, NY, has introduced new color-keyed SMT test points. The test points are manufactured in phosphor bronze with a silver plate for soldering and low electrical resistance for a variety of applications. The colored identification bases are manufactured of high-temperature nylon, suitable for most SMT reflow solder operations with an operating temperature of up to 150 °C. Test points are available in 10 different colored bases: red, black, white, yellow, orange, green, blue, purple, and gray.

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Cybersecurity Software

Thirdwayv, Irvine, CA, has introduced new mission-critical software. The AppAuth software enables users to control mission-critical IoT devices in the medical and other markets with their own smartphones. The software protects communication links as well as the surrounding environment of such links. It provides a digital cryptographic identity to each element of the IoT system and enables each system element to validate the authority and privileges of the others. AppAuth can be used alone or in conjunction with the company's SecureConnectivity solution.

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Temperature Control System

A temperature control system from Laird Thermal Systems, Durham, NC, offers an alternative to compressor-based systems in a smaller package for heating and cooling inside the incubator chamber. The compact SuperCool series of thermoelectric assemblies do not use refrigerants. The series is available in three models to provide heat transfer mechanism options on the control side. Heat can be absorbed via liquid, conduction, or convection. The liquid-to-air unit has a cooling capacity of 202 W, direct-to-air offers 193 W, and air-to-air provides 166 W.

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Thermal Jumper Chip

TT Electronics, Woking, UK, has introduced a series of thermal jumper chips, enabling circuit designers to manage temperature rise in compact power electronic assemblies. The TJC parts provide a thermally conductive pathway with electrical isolation for management of PCB hotspot areas. Aluminum nitride is employed in the thermal jumper chip to keep compact electronic assemblies cooler, which enhances product reliability.

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Microcontrollers

Mouser, Mansfield, TX, now offers NXP Semiconductors’ LPC55S6x microcontrollers, the first members of the NXP LPC5500 series. The microcontrollers feature dual Arm®Cortex®-M33 cores and Arm TrustZone® technology for diagnostic equipment and other applications. The LPC 55S6 microcontrollers are based on the Armv8-M architecture and a low-power 40 nm embedded flash process. The microcontrollers offer enhanced realtime parallelism, using an autonomous programmable logic unit (PLU) for offloading and execution of user-defined tasks.

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Motorized Pan-Tilt Stages

OES, Van Nuys, CA, has added high-resolution, motorized pan-tilt stages to its line of motion control products. The pan-tilt stages are available in two sizes: the PT60-1 is a combination of two 60 mm (2.362 in.) rotary stages and the PT100-1 is a combination of two 100 mm (3.937 in.) rotary stages, set at a 90° angle to each other. Each rotary stage features a high repeatability of 0.005° (18 arc-sec), a positional accuracy of 0.005° (18 arc-sec), and a resolution of 0.001 ° = 3.6 in. (10 micro-steps per step motor driver in use). The pan and tilt axes on both stages have precision V-grove and crossed roller travel guides.

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DC/DC Converters

Traco Power, San Jose, CA, has released a new family of 1 and 2 W DC/DC converters in the industry standard SIP-7 package. Features include an integrated short-circuit protection circuit, higher I/O isolation, and extended temperature range. The TBA/SIP-7 family consists of three platforms: 1 W TBA-1E with 1500 VDC isolation; 1 WTBA-1HI with 3000 VDC isolation; and 2 W TBA-2 models with 1500 VDC isolation. Providing basic I/O isolation of circuits for a broad range of low-power applications, the converters are ideal for applications where low cost and space are critical.

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Components

A new catalog is available from Qosina, Ronkonkoma, NY. The full-color catalog includes more than 5,000 stock components depicted in full-scale photos on a 1-cm grid. The company has added nearly 400 new and innovative components to its new catalog. Material and measurement details are included on each product to help determine suitability for use. A dedicated ISO 80369 chapter has been added, as well as ISO 80369 callouts on applicable products. It also includes a list of recommended sterilization methods and conversion charts that assist with calculation of metric, weight and length measurements.

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Adhesives for Wearables

3M, St. Paul, MN, has added an extended wear transfer adhesive to its lineup of advanced adhesives for medical devices. Designed to laminate many substrates, 3M medical transfer adhesive 4075 features an extended wear pressure sensitive transfer adhesive and allows design engineers to use a variety of backings. The adhesive offers excellent initial skin adhesion with up to a 14-day wear time, depending on the backing material used. It has been tested to ISO:10993-5 and ISO:10993-10, which assess the in vitro cytotoxicity and a product's potential to produce irritation and skin sensitization, respectively. It is ethylene oxide sterilization compatible.

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COM Modules

New COM Express Type 6 modules are available from Congatec, San Diego, CA. The four Intel Xeon, three Intel Core, two Intel Celeron, and one Intel Pentium processors are all based on the same Intel microarchitecture (codenamed Coffee Lake H). This enables the company to provide all 10 new processors on one COM Express module design — the conga-TS370. The two 6-core modules with a TDP of 25 W on Intel Xeon E-2276ML and Intel Core i7-9850HL processors enable developers to create completely passively cooled embedded edge computing systems that can run up to 12 standalone virtual machines in parallel.

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Stepper Motors

Nippon Pulse, Radford, VA, has added a new series of bipolar hybrid stepper motors. The PJE series, available in sizes from 20 to 86 mm in diameter (NEMA sizes 8-34), provides high torque in each of its form factors (single, double, and triple stack lengths), so OEMs can utilize a smaller-sized motor to achieve the required amount of torque. Larger frame sizes also include an option for a motor with a built-in encoder, while some smaller frame sizes include a linear hybrid (PJEL) model. All bipolar hybrid motors are RoHS and CE compliant.

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Safety Foot Switch

ZF Electronic Systems, Pleasant Prairie, WI, offers Steute's Series GFS two-stage safety foot switch. In use, the operator depresses the pedal to a detent position to close NO control contacts, allowing machine operation. Depressing the pedal through the detent position (as often happens when the operator is in distress), opens (and latches) positive-break NC contacts to stop the controlled function. Units feature a reset button; a rugged powder-coated, die-cast aluminum housing; and IP65, EN ISO 13849-1 and cCSAus-compliance.

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Isolation Transformers

All ISO-PUCK models of medical grade transformers from Bridgeport Magnetics Group, Shelton, CT, are now potted inside polycarbonate enclosures. They range from 200 to 3000 VA, 60 Hz or 50/60 Hz with cord lengths of 2–20 ft. The new portable 1200 VA ISO-PUCK Tower contains a hospital-grade power strip. For a wet location, installing an ISO-PUCK rather than a ground fault circuit interrupter (GFCI) avoids interruption of power during surgery caused by excessive leakage current. The transformers also help speed up product certification by making the ISO-PUCK an integral part of the device.

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Packaging Sealer

Accu-Seal, San Marcos, CA, has released a new packaging sealer. The 6300P series produces seal lengths of 15, 20 and 25 in. at a width of 0.375 in. The series features heavy-duty linear pneumatic seal actuation and high strength stiffened seal bar construction. A digital high-speed PLC controller is included with an LCD touchscreen. This series includes selectable and programmable seal modes and external calibration verification ports for seal temperature, time and pressure. An optional data acquisition system offers seal parameter collection and reporting, as well as peripheral interface capability such as a barcode scanner.

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Metal Film Chip Resistors

New high reliability metal film chip resistors are available from KOA Speer Electronics, Bradford, PA. The RN73R series are designed to meet the demanding requirements of high heat and high moisture applications. These new resistors provide improved electrolytic corrosion resistance and high stability compared to KOA's existing RN73 thin film resistors. The RN73R offers excellent heat tolerance with an operational temperature range of –55 °C ~ +155 °C and a rated ambient temperature of +85 °C.

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UV-C LEDs

CEL, Santa Clara, CA has added a new family of deep ultraviolet (UV-C) LEDs for a wide range of sterilization and disinfection applications. The UV-C LEDs include an emitting wavelength of 275 nm, which is a particularly effective wavelength in the UV-C spectrum at killing bacteria for sterilization applications. The devices provide high efficiency with long lifetimes. For example, the 3-mW output version, with a 25-mA current requirement, has a lifetime exceeding 10,000 hours. The LEDs consist of an AlGaN chip in a very high thermal conductive 3.5 × 3.5 mm ceramic package with a shielded transmittance glass lid.

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Medical Design Briefs Magazine

This article first appeared in the August, 2019 issue of Medical Design Briefs Magazine.

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