ThrombUS+ D6.1: Product Design Specifications

Deliverable D6.1 aims to revise the high-level regulatory, technical, and functional requirements outlined in previous deliverables (D2.2, D2.3, and D2.4) and provide detailed specifications for the ThrombUS+ system, designed for monitoring and preventing deep vein thrombosis (DVT).
A thorough analysis of the proposed conceptual architecture revealed the need for two critical external components: a dedicated Wi-Fi router for secure, reliable, and low-latency communication between modules, independent of the hospital network, and an isolating power transformer to ensure electrical safety, noise reduction, and compliance with medical standards. These additions were incorporated into the system design. The internal ThrombUS+ system modules were categorized into hardware and software components, with detailed specifications provided in standardized tables. This process involved making several key decisions, and the specifications will serve as a foundation for the development of individual modules and subsystems in the future.
The ThrombUS+ system is designed with high modularity, allowing flexible configuration and integration of different modules to support various DVT monitoring methods. The primary monitoring methods include compression duplex ultrasonography, venous occlusion plethysmography, and light reflection rheography. Each method will utilize different module sets and operate in one of three working modes: imaging, monitoring, or analysis. A separate set of modules will also focus on DVT prevention.
Finally, the deliverable identifies potential improvements to the ThrombUS+ system development process, including the adoption of embedded systems design methodologies, optimization of real-time embedded execution, risk mitigation strategies, and the possibility of extending the system to support telemonitoring.