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1/28/2025 0 Comments

Cephasonics Minnesota Manufacturing Facility Receives 13485 Certification

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Blaine MN., October, 2024 -- Cephasonics, a leader in AI-enabled OEM ultrasound platforms and development systems, announced that it received ISO 13485:2016 certification for its new Blaine Minnesota manufacturing facility.  

This expands Cephasonics' ISO 13485 certification to include the manufacturing facility in Minnesota along with their San Jose technology center as of July 2024. The Minnesota received certification from American Systems Registrar that its quality management system for engineering and design as well as manufacturing have met the ISO13485 requirements.

(American Systems Registrar (ASR) is an ANAB accredited and IATF approved registrar.)
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Randall Whiting, Chief Operating Officer of Cephasonics, stated, “The receipt of the ISO certification for our new manufacturing facility continues to validate our strong commitment to quality through out device, manufacturing and customer support areas.  Notably, this ISO certification marks the continuation and acceleration of our commitment to providing best-in-class OEM platforms for developing next generation medical ultrasound systems that support our customers' requirements.”

ISO 13485:2016 an internationally recognized quality standard that is intended to ensure that medical devices and related services have consistent design, development, production, and sale of products that are fit for purpose as per intended use. To be certified, organizations must demonstrate that their Quality Management Systems are able to provide products and related services that consistently meet customer and applicable regulatory requirements.

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1/28/2025 0 Comments

Cephasonics USB Isolation Module

Cephasonics Unveils High-Performance USB Isolation Module for Medical and Ultrasound Applications

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Cephasonics Ultrasound, a leader in advanced OEM ultrasound technology, is excited to announce the launch of its new Lowry USB Isolation Module, designed to provide robust electrical isolation, signal integrity, and enhanced safety for medical and imaging applications.

This cutting-edge module supports USB 2.0 signaling with automatic detection of low (1.5 Mbps), full (12 Mbps), and high-speed (480 Mbps) connections, ensuring seamless data transmission while maintaining ultra-low power consumption. With bidirectional isolation for both upstream and downstream ports, the module features advanced redriving and high-speed data retiming, effectively removing input jitter and delivering an open-eye signal for superior performance.

Unmatched Protection & Compliance for Medical Applications

Engineered to meet the stringent demands of ultrasound and medical imaging systems, the Cephasonics USB Isolation Module provides ±8000V IEC 61000-4-2 ESD protection across the isolation barrier, safeguarding sensitive devices from electrostatic discharge. Additionally, the module has high common-mode transient immunity (50 kV/μs typical), ensuring stable operation even in high-noise environments.

With safety at the forefront, the module is designed to meet key international regulatory and safety standards (pending certifications):

  • UL 1577 – 5700V rms isolation for 1 minute
  • CSA Component Acceptance Notice 5A – IEC 62368-1, IEC 61010-1, and IEC 60601-1 compliance
  • VDE Certificate of Conformity (pending) – DIN V VDE V 0884-11 with VIORM = 849 VPEAK

Optimized Power Efficiency & Extreme Durability

The Cephasonics USB Isolation Module is engineered for ultra-low power standby operation, consuming just 1.7 mA (upstream) and 20 μA (downstream) in USB 2.0 suspend mode. With a 5VDC 300mW isolated power supply, the module ensures reliable power delivery while maintaining creepage >8mm and clearance >5mm, enhancing insulation and safety.

Designed for harsh environments, the module operates over an extended temperature range of -55°C to +125°C, making it ideal for demanding medical and industrial applications. Additionally, it has successfully passed CISPR32/EN55032 Class B emissions compliance, ensuring minimal electromagnetic interference.

Enabling Safer and More Reliable Medical Imaging

“The Cephasonics USB Isolation Module sets a new standard in safety, reliability, and performance for medical ultrasound and imaging systems,” said [Richard Tobias, CTO] of Cephasonics. “With its advanced isolation technology and robust compliance with international safety standards, this module provides seamless USB connectivity while protecting sensitive devices from electrical interference and high-voltage transients.”

Availability & Pricing

The Cephasonics USB Isolation Module is now available for integration into ultrasound systems, medical imaging devices, and other critical applications requiring high-reliability USB isolation.  It is priced at $395/unit single quantity orders.

For product inquiries, technical specifications, or purchasing details, click here or contact us at [email protected]

About Cephasonics Ultrasound
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Cephasonics is a leading provider of high-performance OEM ultrasound technology and ultrasound AI solutions, specializing in scalable, modular, and regulatory-compliant systems. With a focus on innovation and quality, Cephasonics delivers state-of-the-art ultrasound platforms and components that enable the next generation of medical imaging advancements.

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