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FF Schneider

Medical Device Engineering

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Mechanical insufflation-exsufflation device

Portable airway clearance device for patients with respiratory muscle weakness. Also called cough-assist device.

Wound Assessment Device - Detailed prototype view

System Characteristics

Sensors and Measurement

  • 2 Pressure sensors (±0.5cmH2O)
  • Flow sensor (50 to 400L/min)
  • Inspiratory and Expiratory flows
  • Multiple temperature sensors

Hardware Capabilities

  • 2 large brushless DC blowers (150W)
  • Custom valves and pneumatic circuit
  • Firmware designed with a hard real-time premise
  • Lower electronic cost compared to competitors

Interface and Safety

  • 7" touchscreen interface controlled by a single 8-bit microcontroller
  • Button and Pedal for controlling insp and expiration
  • Continous operation device
  • Professional and lay operation modes

Certifications and Regulatory Compliance

IEC 60601-1

Basic Safety and Essential Performance

ISO 13485

Medical Devices - Quality management systems

ANVISA certified

under code 80488299002

IEC 60601-1-6

Medical electrical equipment: Usability

IEC 60601-1-11

Medical electrical equipment used in the home healthcare environment

Project Description

Developed between 2016 and 2018, this project aimed to provide a cost-effective, locally-produced cough assist machine for the Brazilian market.

I worked directly with patients and technical staff, employing Human-Centered Design principles to align the product with medical and user requirements while addressing market needs.

From concept to stable production, the device was completed within two years and is certified by ANVISA under code 80488299002. It remains in the market, with thousands of units sold over the years by a single small manufacturer.

Core service areas and leadership initiatives

Technical Project Leadership

  • Project owner
  • Technical specification and client meetings
  • White paper writing and technical comparison
  • EMC Compliance Plan

Hardware Development

  • Designed and specified sensing circuits
  • Plan and developed device control systems
  • Integration and EMC compatibility testing
  • Developed Verification and Validation methods
  • Custom control systems for 2 large BLDC motors

Algorithms and Software

  • Custom Algorithms for system control
  • Bare metal application for efficiency and reliability
  • Designed and validated calibration methods
  • Responsive and intuitive user interface

Regulatory Compliance

  • ANVISA and INMETRO applications
  • Field tested and approved
  • ISO 13485 preparation

Project Gallery

Front view of the respiratory monitoring system
User interface - main monitoring screen
Internal components and system circuits
System in use in hospital environment
Validation testing in laboratory
Initial prototype during development
System in use in hospital environment
Validation testing in laboratory
Initial prototype during development

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