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RoHS Compliant RF Isolators and Circulators for Medical Devices

Time:2025-08-14 Views:1

  RoHS Compliant RF Isolators and Circulators for Medical Devices

  In the realm of medical technology, where patient safety and diagnostic precision are paramount, RF isolators and circulators must meet dual imperatives: uncompromising signal integrity and strict environmental compliance. Our RoHS compliant RF isolators and circulators—engineered for 1MHz to 60GHz medical applications—merge lead-free, halogen-free materials with ultra-low interference performance, ensuring they excel in MRI suites, surgical theaters, and portable diagnostic tools while adhering to the strictest global environmental standards.

  Core Technologies: Where Compliance Meets Clinical Precision

  RoHS 2.0 Compliant Materials Ecosystem

  Utilizing tin-silver-copper (Sn-Ag-Cu) solder alloys and nickel-free ferrite composites, these devices eliminate all restricted substances under RoHS 2.0 (EU 2011/65/EU), with lead (Pb) and mercury (Hg) levels <1ppm—verified by SGS testing. The medical-grade PEEK housing (ISO 10993-1 certified) ensures no leachable toxins, making them safe for use in patient-contact environments such as wearable monitors.

  Ultra-Low EMI Design for Diagnostic Accuracy

  Through a proprietary helical ferrite structure, insertion loss is minimized to <0.2dB at 1.5GHz (MRI frequency bands), while isolation ≥25dB suppresses electromagnetic interference (EMI) from nearby medical equipment. This precision ensures MRI image signal-to-noise ratio (SNR) improves by 20%, reducing scan times without compromising diagnostic clarity.

  Sterilization-Resistant Construction

  The hermetically sealed (IP68) stainless steel housing withstands 100+ cycles of autoclaving (134℃ at 2bar) and chemical disinfection (70% isopropyl alcohol), maintaining electrical performance with <0.1dB insertion loss drift. This durability is critical for intraoperative RF ablation systems requiring frequent sterilization.

  Medical Device Applications

  MRI & Imaging Systems

  In 3T and 7T MRI machines, our circulators isolate transmit/receive coils, preventing RF amplifier noise from corrupting imaging data. The RoHS-compliant design eliminates ferromagnetic impurities, ensuring no image artifacts—a requirement for oncology and neurological diagnostics.

  RF Ablation & Therapy Devices

  Cancer treatment systems utilize our isolators to direct 400-500kHz RF energy precisely to tumor sites, with VSWR ≤1.1:1 minimizing energy reflection. This reduces healthy tissue damage while meeting EU Medical Device Regulation (MDR) 2017/745 for biocompatibility.

  Portable Ultrasound & Telemedicine

  Battery-powered point-of-care ultrasound devices benefit from the 30% weight reduction (vs. non-compliant alternatives) and low power consumption (<50mW), extending battery life to 8+ hours. The compact form factor (12mm×12mm) fits seamlessly into handheld probes used in remote clinics.

  Cardiac Rhythm Management

  Implantable defibrillator programmers employ our low-frequency (1MHz) isolators to safely transmit programming signals through body tissue, with isolation ≥22dB preventing interference with pacemaker function.

  Reliability & Regulatory Compliance

  Dual-Certified for Global Markets

  Compliant with RoHS 2.0 (10 substances restricted), REACH (197 SVHCs), and ISO 13485:2016 (medical device quality management). CE marked under MDR and FDA-listed (Class I) for use in medical electrical equipment.

  Biocompatibility & Safety

  Passes ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) tests, ensuring no adverse biological response in patient-contact applications.

  Long-Term Clinical Performance

  Undergoes 5,000-hour accelerated aging at 85℃/85%RH, with insertion loss degradation <0.3dB—validated for 10-year service life in critical care equipment.

  Future-Ready for Next-Gen Medical Tech

  Next-generation devices will integrate RFID tags for traceability (per FDA UDI requirements) and temperature sensors to monitor sterilization cycles. We’re also developing 60GHz variants for high-resolution endoscopic imaging, enabling 4K video transmission with zero EMI interference.

  Precision You Can Trust, Compliance You Can Verify

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