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Custom EMF Measurement Solution Doubles End-of-Line Test Throughput

  • Sep 3
  • 5 min read

Medical manufacturer automated EMF device testing with dual-station NI PXI system, reducing test cycles from hours to minutes while doubling throughput.

Dual-station test system housed in ruggedized, custom cart containing NI PXI chassis enabling automation of system I/O.
Dual-station test system built on NI PXI platform


Project Summary

Medical manufacturer automated EMF device testing with dual-station NI PXI system, reducing test cycles from hours to minutes while doubling throughput.


System Features & Components

  • Dual-station automation enabling single operator to manage two test stations simultaneously

  • High-speed PXI analog I/O integrated with fluxgate magnetometers for precise electromagnetic field measurement

  • Automated firmware uploading and multi-level power testing to simulate battery conditions

  • LabVIEW user interface with automated pass/fail determination and database integration

  • Seamless integration with existing Helmholtz coil test fixtures

  • Barcode scanning and automated data logging for quality control traceability


Outcomes

  • Reduced testing time from hours to five minutes per device with automated measurement protocols

  • Doubled testing throughput through dual-station operation managed by single operator

  • Turnkey solution delivered within 8-week timeline and project budget


Technology at-a-glance

  • NI PXIe-6341 Multifunction DAQ

  • NI PXI-4110 Programmable DC Power Supply

  • NI PXI-2564 16 SPST Relay Module

  • NI LabVIEW software architecture

  • LabVIEW Database Connectivity Toolkit

  • MEDA Fluxgate Magnetometers

  • Barcode scanners

  • Dell Embedded Industrial PCs

  • Ruggedized, custom mobile cart design



Electromagnetic Compatibility

Electromagnetic field (EMF) medical devices are regularly used to support patient well-being in applications like pain management, nerve stimulation, and muscle rehabilitation. These EMF medical devices rely on precisely controlled magnetic pulses to deliver therapeutic benefits, and therefore must meet rigorous safety and performance standards to ensure therapy efficacy and patient safety.


The FDA requires EMF medical devices to comply with Electromagnetic Compatibility (EMC) standards to ensure these devices are compatible with their electromagnetic environment. Compatibility entails:

  • Immunity: medical device must not malfunction when exposed to electromagnetic interference (EMI)

  • Emissions: medical device’s own EMF emissions must not interfere with other medical devices or electronics in its environment


Due to the complexity of EMF medical devices and the high-stakes associated with patient safety and capital expenditure investments in medical equipment, the manufacturing and quality control of EMF devices has traditionally required labor-intensive, manual testing methodologies.



End-of-line Test Bottlenecks

A leading medical device manufacturer faced significant production and end-of-line test bottlenecks because of this paradigm. Production was constrained by slow, manual testing procedures which prevented them from scaling up their operations to keep up with growing market demand.


When regulatory compliance requirements and quality control standards demanded faster, more consistent testing processes, the manufacturer realized their manual approach would no longer suffice.


Our client had an industrial test fixture that incorporated a Helmholtz coil to produce a region of uniform magnetic field. When there is a change in the magnetic field of the Helmholtz coil, a current is induced because of the detected magnetic waves. This concept was incorporated into the client's design of their industrial test fixture to test their product—an electromagnetic medical device.


The greatest limitations of their existing test workflow were:

  • Manual Testing Inefficiencies: Their existing electromagnetic field measurement process was labor-intensive and time-consuming, creating quality control bottlenecks

  • Single-Station Limitations: Their current testing setup created workflow bottlenecks, with operators managing only one test station at a time


To produce a high-quality, EMC product, keep up with customer demand and protect their market position, they required:

  • Increased Testing Throughput: Growing market demand required faster, more automated testing procedures to meet delivery timelines (Leads to need for automated test)

  • High Measurement Accuracy: Precise electromagnetic field measurements were essential for regulatory compliance and ensuring therapeutic device effectiveness


The company needed an automated solution to measure and quantify the electromagnetic waves their medical devices emitted while simultaneously increasing testing throughput and maintaining high accuracy standards.


Automated, Parallel Testing

This medical device manufacturer approached Cyth Systems for help mitigating the testing bottlenecks that threatened their growth and capture of market share.


Cyth designed and built a turnkey automated solution using NI PXI hardware and LabVIEW software capable of:

  • Powering and pulsing the devices-under-test (DUTs)

  • Interfacing with the industrial test fixture to induce and read current measurements

  • Automatically acquiring and analyzing all measurements


Parallel Test System Architecture:

The system's architecture enabled a single test operator to simultaneously interface with and run two industrial test stations, dramatically increase testing efficiency and throughput. A LabVIEW user interface and software architecture provided operators with simple controls that logged acquired data directly to the client's database via Ethernet.



Custom EMF Measurement Solution:

Our engineering team designed the system to measure and quantify the electromagnetic waves the client's medical device emitted using fluxgate magnetometers that measure the direction, strength, and relative change of magnetic fields. We acquired these measurements using high-speed PXI analog inputs for maximum precision and speed.


At all times, the device's provided power was precisely controlled to measure the power consumption of the device under test (DUT). The analog output lines of the PXIe-6341 were used to generate waveforms to enable the measurement of changes in the pulsation of the device's electromagnetic field (EMF).


Operator interface of dual-test station with two sets of magnetometers, barcode scarnners, computer keyboards and mouses.
HMI for test operators using dual-station test cart

System Order of Operations:

  1. An operator loads the EMF medical device into the client's industrial test fixture, scans the barcode, and connects the required wiring

  2. The operator begins the test on the LabVIEW user interface (UI) menu

  3. Our system uploads firmware to the client's device and performs a low-level power on before testing the client's device at different power levels (to simulate battery power conditions)

  4. The device is pulsed, and our system automatically reads and acquires the electromagnetic signals using the NI PXI high-speed analog I/O, with readings measured using the fluxgate magnetometer

  5. The percentage error between control and measured magnetic field readings is calculated by LabVIEW algorithms and deems the device a pass or reject sample on the user interface

  6. The measured data is automatically uploaded by our system into the client's database via Ethernet

  7. Once the test is complete, the UI prompts the operator to load the next sample and repeat the process




Sustainable by Design


The automated parallel testing solution delivered transformative results that exceeded the medical device manufacturer's initial expectations for operational efficiency improvements, product quality improvements, and streamlined regulatory compliance:

Operational Efficiency:

  • Five-minute test cycles: Test time reduced from hours to approximately five minutes per device.

  • Dual-station capability: Single test operator enabled to manage two test stations simultaneously, parallelizing testing and doubling testing throughput.

  • Automated data management: Manual data entry errors eliminated through automated datalogging.

  • Streamlined compliance: Automated datalogging to servers ensured accurate, consistent regulatory compliance and device calibration documentation.

 

Quality and Compliance Benefits:

  • Enhanced precision: Fluxgate magnetometer measurements ensured measurement accuracy levels compliant with FDA regulations.

  • Improved repeatability: Automated testing protocols eliminated human variability and increased product quality consistency.

  • Real-time pass/fail determination: Immediate pass/fail results enabled rapid decision-making for operators and reduced bottlenecks impacting test throughput.

 

Technical Achievement:

  • 8-week delivery: System design, build and testing completed within client's aggressive, two-month timeline requirement.

  • Budget compliance: Solution delivered within the client's fixed budget.

  • Seamless integration: Final solution interfaced flawlessly with medical device manufacturer's existing industrial test fixtures and database infrastructure.

 

Market Position Impact

The automated testing solutions's impact extended beyond operational improvements by strengthening the medical device manufacturer's competitive position in the market. The high test throughput achievement enabled the company to meet growing market demand without sacrificing the quality required for medical device regulatory compliance.


The precision measurement and automated documentation capabilities of the automated testing solution became key differentiators for the medical device manufacturer, as they could now to guarantee consistent, repeatable testing results that exceeded industry standards.


The automation framework was designed with adaptability to future customer and product requirements in mind, leveraging the I/O modularity of NI PXI hardware, with the flexibility of the LabVIEW software to position the medical device manufacturer for sustainable future growth.



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