Integra LifeSciences Corporation engaged with Sunrise Labs to support the development of its next generation Ultrasonic Tissue Ablation System, called “CUSA® Clarity,” designed to help neurosurgeons remove fibrous tissue more quickly and safely than CUSA® Excel Plus.
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- Designed and developed electronics and firmware for an aspiration and irrigation real-time control subsystem, within a fast-paced timeline. Architected as a scalable platform to also support future enhancements.
- Aspiration Scroll pump required Sunrise to design and implement an innovative control system to achieve accuracy requirements, with consideration for mechanical components that degrade over their lifetimes.
- Participated in the system level hazards analysis.
- Design met industry requirements for IEC 60601-1 3rd Ed and IEC- 60601-2-2 4th edition for the safety of high frequency surgical equipment.
- CE and CSA Mark approved, the CUSA® Clarity is now on market, and exceeding sales expectations.