Portfolio » RF Surgical Generator

Click on the images below to see a slideshow of the project.

Project Overview

The RF generator is used for delivering algorithm-controlled RF energy to proprietary surgical devices. The RF Generator in conjunction with surgical devices provides the physician with the capability for non-invasive volumetric tissue reduction of the palate. ZoZo Engineering worked closely with the customer’s executive staff and marketing group to identify and produce the right product for the market. ZoZo Engineering was responsible for all aspects of the product development including coordinating internal customer resources.

Product Development

Project Management

  • Customer Requirements Definition and Assessment
  • Product Requirements Documentation and Review
  • Project Proposal, Schedule, Status Reports, and Budget Updates
  • New System and Subsystems Architecture Definition
  • Lead System Engineers coordinating customer mechanical and industrial design efforts
  • System and Subsystem Design Reviews
  • ECO and Bug Report Process
  • Complete 21 CFR 820.30 Design Control Process
  • Prototype and Pilot Builds
  • Transfer to Manufacturing Package Sample BOM Page

Electronics

  • Main PC-104 RF PCB Development
  • Patented Digitally Controlled E-Class ZVS Resonant Inverter Topology RF Amplifier
  • Instantaneous RMS Power, Current, Temperature Measurements
  • Medical Device Recognition/Usage Function
  • Error EEPROM Logging
  • Temperature and Watchdog Monitoring
  • LCD T-Filter and other PCB Developments
  • Cable Design

Software

  • Embedded SMX RTOS Application
  • Multi-Stage PID RF Power Control Loop
  • Baseboard BSP Package
  • HP PCL Graphics Printer Driver
  • Custom Color LCD Graphics and Icons
  • Software Verification and Validation Plan
  • User Interface Modal Behavior Specifications
  • Software Critical Module Unit Testing

Mechanical

  • Enclosure specification
  • RF Amp Heatsink analysis and design
  • EMC Mechanical features design
  • Internal Assembly Packaging layout specification

Regulatory

  • Verification & Validation Plans
  • Requirements Traceability Matrix
  • Test Acceptance Plan and Test Reports
  • Design History File Maintenance
  • Failure Mode Effects Analysis
  • EMC Testing
  • Technical File Documentation
  • FDA and TUV Testing Support
  • FDA 510K, UL and TUV Approval