Wearable technology has emerged as a revolutionary force throughout modern healthcare, heralding a new era of proactive and personalized health management. Healthcare providers can leverage this technology to monitor patients and collect data while they live their everyday lives.
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However, these devices' intricate design and advanced capabilities present a difficult challenge. For them to operate safely and effectively, liquid and dust must be occluded in accordance with stringent IP67 certification standards without damaging the device or product in question.
Successfully mitigating the risk of liquid or dust ingress is imperative if product integrity is to be safeguarded. Patients must feel confident that their devices will remain undamaged whether they go for a bike ride or a hike in the rain.
Advances in non-destructive testing methods have made this goal more feasible than ever. Manufacturers can now offer wearables that are durable and water-resistant, affording patients reliability and peace of mind.
Uses of wearable medical devices in health, nutrition, and athletics
Adopting convenient and established designs has seen wearable devices seamlessly integrated into many facets of society. Commercially available tools, such as smartwatches, rings, and pendants, allow health-conscious individuals to easily monitor a range of useful biometrics.
Wearables marketed toward health enthusiasts make up a significant portion of the market. Alongside these devices, medical wearables have been specifically developed to meet the critical monitoring needs of patients, healthcare professionals, and high-performance athletes.
Continuous glucose monitors are widely employed tools designed to record the glucose concentrations of patients with diabetes. With this data available in real-time, photoacoustic patches can image hemoglobin, and insulin delivery systems can automatically administer medication.
The strict performance standards outlined in IP67 ensure that users can be confident in these life-saving technologies, affording them peace of mind as they enjoy their day-to-day activities.2,3,4
Understanding IP67: The standard for dust and liquid protection
Wearables must occlude liquids and dust throughout their working lives, consistently withstanding cleaning processes and use in various environments. Medical wearables must prevent the inclusion of dust or liquid into the device as this can compromise functionality and present a serious risk to the wearer.
The International Electrotechnical Commission (IEC) regulates the development and manufacture of wearable technology, defining strict product performance requirements, including robust ingress protection against liquids and dust.
International standard IEC 60529 describes the Ingress Protection (IP) code, which represents a device’s level of protection against water and dust.
For example, a device rated IP67 is considered dust-tight and submersible in one meter of water for a limited time. IP67 is, therefore, a popular standard for a range of electronic devices, including wearables such as smartwatches.5
To adhere to the IP67 standard, wearable manufacturers must design and test products to prevent or detect micron-sized holes in welds, seals, or joints.
Further challenges stem from the need to conform to the stringent regulatory standards of medical device manufacture. Tests are often destructive, meaning that a manufacturer’s ability to test on the production line itself is strictly limited.
It is generally recommended that automated, non-destructive leak tests be used in these instances, but selecting appropriate testing methods depends on various factors, such as leakage pathways, part attributes, and the likelihood of failure.
Once relevant factors are identified, manufacturers will typically employ non-destructive leak tests for ingress testing, such as pressure decay, differential pressure decay, or tracer gas sniffer/accumulation.
Challenges linked to leak testing wearable devices
Manufacturers must confirm the integrity of device seals via standardized testing procedures to ensure that electronic devices perform in line with their claimed IP ratings. However, the complex nature of wearable devices raises several challenges for traditional testing.
Restrictive testing area
The compact designs of wearables mean there is limited internal space to detect pressure changes. Therefore, it is important to minimize the volume of test circuits and fixtures to ensure measurement accuracy.
No ports to fill from inside
Wearables typically lack an internal filling port, making testing them using the standard pressure decay method impossible. Therefore, specialized knowledge in leak testing and the development of tailored testing applications is necessary when working with these devices.
Accommodating complex geometries and flexible materials
The elastic materials and irregular geometries of wearables may pose challenges to manufacturers employing testing methods designed for rigid structures with conventional shapes. Porous restrictive areas may be required while testing the product to limit the movement of this flexible area.
As wearable technologies develop and demand for these innovative and convenient devices rises, manufacturers must employ effective and reliable testing processes to address these obstacles, adhere to specification requirements, and meet production goals.
Capabilities of the Sprint mD and sealed component leak testing
The need for robust, accurate, non-destructive IP67 testing for medical wearables highlights the vital importance of solutions ensuring user safety and product integrity. Wearable technology plays a pivotal role in healthcare, so devices must adhere to stringent standards, especially IP ratings.
Uson by PAC has developed the Sprint mD Multi-Channel Leak Tester to address these challenges, equipped with sealed component functionality.
This pioneering wearable testing technology marks a noteworthy advancement in compliance, efficiency, and excellence. It effectively overcomes the limits of conventional water test methods while aligning with IP67 certification standards for performance and reliability.
Advantages of the Sprint mD and sealed component leak test
The Sprint mD boasts advanced sealed component leak test functionality, offering an array of benefits:7
- Rapid, non-destructive testing: Using compressed air rather than water, testing remains non-destructive while accelerating cycle times.
- Customized sealed component test method: The Sprint mD features Uson by PAC’s proprietary sealed component test method, allowing users to customize reference volume based on available headspace.
- Effectiveness with no internal filling ports: The sealed component leak test does not rely on internal filling ports, while ensuring a comprehensive sealing integrity assessment.
- Heightened sensitivity for small parts: The Sprint mD's minimal internal circuit volume affords it the sensitivity to detect and measure gross leaks in small wearable parts accurately.
- Operational excellence and compliance: The Sprint mD, thanks to its embedded fieldbus technology and advanced security features, offers users enhanced process insights and meets strict regulatory requirements.
Leveraging the Sprint mD's power throughout the manufacturing process enables manufacturers to confidently assess and ensure the quality and reliability of their wearable products against the risk of potential leaks.
These improved testing capabilities streamline the manufacturing process and minimize the risk of the expensive recalls or warranty claims commonly associated with defective seals or insufficient protection against environmental elements.
Uson: Guiding the future of reliable wearable testing
Advances in wearable medical technology have unlocked new routes toward truly personalized health management. Several key challenges exist in maintaining these devices' integrity and performance, most notably in meeting the strict IP67 certification standards. Non-destructive testing methods are essential in ensuring device performance.
The Sprint mD Multi-Channel Leak Tester's sealed component functionality empowers manufacturers to overcome these challenges and deliver consistently reliable, high-quality wearable devices.
This innovative solution from Uson facilitates rapid, non-destructive testing via customized sealed component test methods and offers heightened sensitivity for small parts.
By leveraging these advanced testing technologies, manufacturers can streamline their production processes effectively, maintain regulatory compliance, and ensure user confidence in the reliability and durability of wearable medical technology.
References and further reading
- Stünkel, I. (2019). [Online] Ancient Egyptian Amulets: Heilbrunn Timeline of Art History. The Met. Available at: https://www.metmuseum.org/toah/hd/egam/hd_egam.htm (Accessed on 11 December 2023).
- Yoo, J.H., et al. (2023). Advances in Continuous Glucose Monitoring and Integrated Devices for Management of Diabetes with Insulin-Based Therapy: Improvement in Glycemic Control. Diabetes & Metabolism Journal. doi.org/10.4093/dmj.2022.0271
- Gao, X., et al. (2022). A photoacoustic patch for three-dimensional imaging of hemoglobin and core temperature. Nature Communications. doi.org/10.1038/s41467-022-35455-3
- Pintavirooj, C., et al. (2021). Noninvasive Portable Hemoglobin Concentration Monitoring System Using Optical Sensor for Anemia Disease. Healthcare (Basel). doi.org/10.3390/healthcare9060647
- Uson. [Online] Sealed Component Leak Test. Available at: https://www.uson.com/sealed-component-leak-test-uson (Accessed on 11 December 2023).
- Uson. [Online] Sprint mD Multi-Channel Leak Tester. Available at: https://leaktesters.uson.com/products/sprint-md (Accessed on 11 December 2023).
About PAC
PAC is a leading global manufacturer of advanced analytical instruments for laboratories and online process applications in industries such as petrochemical, refinery, upstream, biofuels, environmental, food & beverage, lubricants, automotive and pharmaceutical.
With a product portfolio of over 200 testing instruments, PAC serves its customers with cutting-edge technology and significant research and development resources to support its core technologies: chromatography, elemental analysis, physical properties, fuels composition, and laboratory automation.
Our corporate strength is built upon the quality of our product lines, our powerful technology team, and our commitment to customer support.
We're an industry leader in standards development, and we work tirelessly to establish benchmark procedures that scientists and analysts around the world rely on every day to build better products and a cleaner environment.
PAC operates as a unit of Roper Technologies, Inc., a diversified technology company and a constituent of S&P 500, Fortune 1000, and Russell 1000 indices.
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