The 22mm x 23mm miniature multi-turn kit encoder for integrated motor feedback features a self-powered rotation counter that eliminates the need for backup batteries or complex gear systems. They are suitable for builders of servomotors, feedback-controlled stepper motors, micro-drives, miniature robots, and other machines requiring high-precision position feedback and space.
The Wiegand energy harvesting system that powers the rotation counter has also been miniaturized. This system ensures reliable absolute multi-turn position measurement without high-maintenance batteries or gear systems.
17-bit electronic resolution, up to 32-bit multi-turn measurement
SSI, BiSS C interfaces
Integrated self-calibration
Magnetics, integrated temperature sensor for diagnostics, multi-turn functionality, maintenance-free operation
Gantry motion system for inspection, assembly, 3D printing
Linear motors and precision mechanical linear bearings allow the A-351 gantry motion system to provide high speed and accuracy more cost-effectively than the A-341 hybrid air bearing gantry. Absolute linear encoders increase accuracy and reduce startup time by making homing procedures unnecessary. Ironless linear motors eliminate cogging for smooth, vibration-free motion and better velocity control. The system integrates easily with factory automation through the ACS-based motion controller with EtherCat connectivity.
For applications requiring a motorized vertical axis, several Z-stage options are available with screw-driven platforms or linear motors and pneumatic counterbalance. Mounting platforms for vision systems and dispensers are also available.
The compact brushless EC-i motor with an EPOS4 positioning controller provides field-oriented control (FOC), high efficiency, and maintenance-free components in a high-quality industrial housing. IDX drives are suitable for use from standstill to maximum speed and have high overload capability. Together with a positioning controller, the integrated sensor (single-turn) enables absolute positioning.
The ring-shaped safety torque sensor can be integrated at each collaborative robot (cobot) joint to meet up to ISO13849 Category 4 PL e safety requirements due to two electrically segregated channels with no common-cause failure. Optimized for cobots, the sensor provides low susceptibility to crosstalk, allowing increased accuracy. With available customized mechanical interfaces, the sensor can be adapted to meet specific customer applications.
The Vicore two-camera smart system inspects applications using 2D, thermal, and 3D imaging. Its small, book-style format provides convenient, front-accessible connections for cameras, I/O, and system components. This includes a dedicated industrial Ethernet port that communicates with complementary factory devices using Ethernet/IP or Profinet. Vicore can be set up as a standalone system with attached HDMI display and keyboard, or as a remotely accessible networked device through its LAN port.
As surgery and other medical procedures rapidly grow and advance, motion control technologies have become more important. These solutions help improve work efficiecy, provide more patient comfort, and reduce stress on medical professionals.
“We are seeing an increasing need for automation to increase process flow,” says Tarek Bugaighis, Ewellix president for North America. “If we look at surgical applications with new access requirements, it certainly is leading to new design decisions on how to achieve access compliance.”
Linear actuators – key automation solutions – are becoming more common in the operating room. Whether a physician is using a surgical chair during an operation, or if they need to transfer a patient to the operating table, linear actuators provide the smooth movement and necessary precision of movement.
Play-free actuator
Current surgical demands have led to a new level of requirements, often mandating an actuator that eliminates play. To meet these needs, linear motion and actuation solutions supplier Ewellix designed the CAMT actuator to assist with surgical table and chair movements. The actuator has virtually zero play throughout the unit’s lifetime, offering a higher level of patient comfort. CAMT moves smoothly in all directions due to the play-free/backlash-free feature. Consequently, the CAMT actuators maintain smooth movement throughout any procedure.
“That’s why we believe the CAMT is unique in the market,” says Medical Sales Manager Neil Hesselsweet. “The ability to give everyone more confidence, due to play-free equipment. This ties into the imaging aspect as well; now you don’t need to move a patient since the patient is on a stable apparatus which supports image quality. Physicians can take an X-ray: the table is stable enough, the patient is stable enough, and you can multitask off one position.”
This is essential for specialized surgeries, such as neuro and spinal. Any play in these surgeries is unacceptable, especially when changing actuator directions.
The actuator is self-locking, so there is no need for a separate locking mechanism for safety. Replacing hydraulic systems with electromechanic systems allows for a cleaner environment and lets surgeons accurately reproduce the positioning. The CAMT actuator is maintenance-free, and because it’s electromechanical, has no hydraulic oil that can leak.
Equipment performance
In a lengthy operation, a surgeon may experience some fatigue. Positioning a patient in a comfortable spot allows the physician to work more securely.
The CAMT actuator can be used for lateral roll, such as side-to-side movement of the table; and it can be used in longitudinal tilt. Other applications include adjustable back or footrest mechanisms, movements typically required in medical devices. Physicians can also use Ewellix control systems that offer plug-and-play, or they can incorporate these actuators into their own control systems.
In imaging equipment, actuators allow physicians to position patients more precisely. Doctors can put patients in exactly the same position they were in before to compare an older scan with a new scan.
Intelligent feedback
Medical professionals must be able to position their patients with accuracy and repeatability, which they can achieve by using Ewellix control boxes that offer four memory positions and accommodate up to four operating devices.
“The control boxes also help improve the working environment, when people of different heights are using the same device,” Hesselsweet says. “They can save their preferred position and come right back to it later. This capability makes their jobs easier to do because the device can be located in the best ergonomic position.”
The actuators contain a dual Hall-encoder system that provides accurate feedback when extending or retracting the actuators.
Compared to single Hall systems, which lose pulses with each movement, the Ewellix dual Hall systems uses pulse width modulation (PWM) to reduce the need to rehome the system. Controls maintain accurate positioning by monitoring the encoder pulses and adjusting the power to each actuator.
Original equipment manufacturers (OEMs) can incorporate Ewellix actuation systems into their own systems by using a standard control box with an RS232 communication port. If there is a need to access the control box logic, Ewellix can provide guidance in interpreting the signals, or OEMs can acquire positioning information to use with their own software.
Physicians can make adjustments using their own power supply and software. OEMs who prefer this option already have power and logic for other non-linear components, such as imaging systems.
The Integrex i-300ST configured with a milling spindle and lower turret can process first and second operations simultaneously or perform required sequential operations on a single workpiece. The machine’s main horizontal turning spindle with 10" chuck is capable of C-axis indexing in 0.0001° increments. The main turning spindle is a 40hp integral spindle motor providing up to 4,000rpm spindle speed, while the second, opposed headstock with a 10" chuck features a 35hp integral spindle motor and 4,000rpm top speed.
A 30hp, 12,000rpm integral motor milling spindle rotates in the B-axis throughout a range of 210° and -30° from vertical. The milling spindle also travels 10.24" in the Y-axis. For increased versatility, the Integrex i-300ST accommodates workpieces up to 25.9" in diameter and 59.8" in length. Tool magazine capacity ranges from 36 tools up to a maximum of 110 tools.
The machine’s lower drum turret accommodates nine tools and can work at either the main or second spindle with the same tool, enabling the turret to perform balanced cutting operations on one part working in tandem with the machine’s vertical milling spindle. An option for milling with the lower turret provides flexibility to process a workpiece’s second operation with the second spindle or perform first and second operations simultaneously.
The Integrex i-300ST uses the Mazatrol SmoothX CNC, part of Mazak’s Smooth Technology, which is a complete process-performance platform spanning part-production from programming and setup to metal removal operations, automation, monitoring, and data collection/transfer.
Medical device manufacturers must establish and follow quality systems in accordance with U.S. Food and Drug Administration (FDA) current good manufacturing practices (CGMP) to ensure that devices are safe and function as intended. The quality system regulation (QSR) doesn’t prescribe how to produce a specific device, but states manufacturers “should use good judgment when developing their quality system and apply those sections of the QSR that apply to their products and operations.”
It’s the manufacturer’s responsibility to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices meeting these requirements, which involves creating or selecting a quality management system (QMS).
Many factors can steer QMS solution decision-making. Every stakeholder should consider the entire product release process to avoid myopic decisions. Take into account siloed information and disconnected teams, so everyone has full context throughout the new product development and introduction (NPDI) process.
To help ensure broader business objectives can be met, consider these five key questions when assessing your quality needs.
1. Does the QMS manage the entire product record?
Product records for complex medical devices include documents, components, assemblies, and the entire product record – organized in a relational, multitiered bill of materials (BOM). The complete BOM needs to aggregate parts and documents, track them by controlled revisions, and link every part or document to associated quality records and processes.
Traditional document-centric QMS solutions have significant gaps in managing the entire product record and BOM comprised of vast amounts of mechanical, electrical, and software components. They focus on collections of documents. However, product-centric QMS solutions are built on the product record to provide a relational, hierarchical BOM with every component, drawing, specification, manufacturing work instruction, standard operating procedure (SOP), and training record linked together for maximum visibility and transparency. These BOM structures are organized in the same manner as upstream design systems (CAD) and downstream manufacturing systems (ERP) to enable seamless passing of controlled BOMs from design to QMS to manufacturing. This product-centric approach gives engineering, quality, operations, and supply chain teams a complete picture of all records and related processes to ensure devices can be built as designed, while complying with FDA, ISO, or other regulations.
2. Does QMS elevate the corrective and preventive action (CAPA) process?
When any issue or problem occurs, having a way to quickly identify the root cause and correct the problem is critical. Determining the cause requires thorough documentation of the issue and the ability to efficiently drill into the product design record and/or manufacturing process. Only after the what/when/why/where/how questions are answered can the corrective action be identified and executed.
To design, test, and deliver high-functioning products, a quality system should improve visibility and traceability between the product design and the CAPA process. A product-centric QMS approach is the best way to manage all related documents in context with both product and quality processes. Having a single connected system simplifies investigating and resolving quality issues.
3 . Does QMS empower disparate teams to collaborate effectively?
Proactive, real-time notification speeds collaboration. And providing historical audit trails for design, test, and approval processes is critical to prevent cross-functional team blind spots. If an organization’s QMS solution can’t easily provide access to every impacted player at every stage of the NPDI process, product development and quality issue resolution delays are more likely to occur. Failing to prevent or identify issues early in the development process or after the product has been shipped to customers can prevent a medical device company from continuing to sell into a given market.
Web-based cloud solutions such as product-centric QMS connect teams 24/7 and speed communication, eliminate design errors, and spur rapid innovation. This multidisciplinary collaboration makes it easy for every team to review information and respond immediately by reviewing product designs, associated documentation, and quality records in a single system to drive continuous improvement, increase product reliability, and enhance manufacturability.
4. Does QMS support quality processes before and after products are shipped?
The importance of quality management doesn’t diminish after initial compliance to regulations or after products are delivered to market. Medical device companies must have a fully traceable quality and design process that spans many years and many patients. Since quality issues can arise before or after devices have gone to market, having a QMS that provides a historical audit trail for everyone involved in designing, testing, delivering, and sustaining is key. This ensures the medical device manufacturer can trace the design and quality records to determine design or manufacturing issues throughout the entire product life cycle.
5. How difficult is it to validate the QMS software?
The FDA requires medical device manufacturers to validate software used in the design or delivery of devices. However, validation is often considered an overhead cost. Meeting the FDA’s validation regulations for traditional on-premises or document-centric QMS environments requires significant internal resources and an understanding of the software capabilities, and specific use cases.
Product-centric QMS solutions with multi-tenant cloud architecture eliminate traditional obstacles and alleviate resource challenges, simplifying a large portion of the validation process. Your QMS vendor should design and support validation requirements to reduce the impact to internal teams. Be sure to ask whether the QMS has standard validation services and documentation to remove the heavy lifting for installation qualification (IQ) and operational qualification (OQ) – leaving mostly customer-specific performance qualification (PQ) requirements to be executed by your internal team. Multi-tenant cloud solutions offer greater scalability of IQ and OQ validation support since they leverage the same infrastructure across all customers.
Designing, producing, and supporting complex products is challenging with distributed teams and supply chains. For medical device manufacturers, the ability to ship quality devices is more difficult due to stringent FDA and ISO regulatory compliance. To innovate and ensure compliance and positive patient health outcomes, it’s essential to have a product-centric QMS approach. These five questions will help identify whether a QMS solution can support the delivery of high-quality devices while maintaining regulatory compliance and providing better traceability throughout the entire product lifecycle.
Posted by Elizabeth Engler Modic
