1. ECMO Circuit Pressure Alarm PROJECT PROPOSAL
University of Pittsburgh
Senior Design - BioE1160
ECMO Circuit Pressure Alarm PROJECT PROPOSAL
Desiree Bonadonna
Apryle Craig
Laura Gilmour
ECMOre, Uninc.

2. Overview ECMO Pressure Alarm Pre-Oxygenator Post-Oxygenator
Post-Heat Exchanger
Audible and Visual Alarms
Make healthcare workers aware of high/low pressures
Dangers of high/low pressures
Healthcare Workers
Perfusionists
ECMO Technicians
Physicians
Nurses
Redesign
Analog  Digital
Programmable
Audible Alarm
Add additional pressure indicator (post heat-exchanger)

3. Project Goals Develop digital pressure alarm system
Simulink model
Build model
Submission for FDA approval
Milestones
Current technology summary
Re-assess project goals
Redesign
Add programmable inputs
Add alarm
Add sound
Deliverable

4. Features & Benefits Three inputs
Monitor pressure pre- and post-oxygenator
Monitor pressure pre- and post-heat exchanger
Digital System
Reduce interpretation errors
Clear and easy to understand
Consistency
Three read-outs
Clear display of each pressure
Three pressures can be monitored and compared at same time

5. Features & Benefits Programmable range
Adjust high and low alarm range per patient basis
Allows for variable sensitivity of system
Audible and Visual Alarms
Alert staff by audible alarm
Notify particular pressure deviance by visual alarm

6. Description: Circuit Modification

7. Description: Device Circuitry

8. Design Alternatives Types of Displays Number of Audible Alarms
Number of Visual Alarms
Alarm independence/convenience

9. Competitive Analysis Current Medically approved devices No audible
Analog
Difficult to read
Not clearly labeled
No audible
No visual alarm
Non-approved devices
Digital with visual alarm

10. ECMOre Design weaknesses
Competitive Analysis
ECMOre Design weaknesses
More expensive than analog
More tubing in an already cluttered space
Increased training time/expenses

11. Altera circuit design software SolidWorks for enclosure SimuLink
Technology
Altera circuit design software
SolidWorks for enclosure
SimuLink
Model an ECMO circuit using water
Experiment with transducer voltages
Test final product

12. Team/Resources Team Desiree Bonadonna- Design Manager
Apryle Craig- Electronics Manager
Laura Gilmour- Standards Manager
Michael Shaeffer- Project Advisor
Steven Jacobs, PhD- Circuitry Advisor
Equipment
Electronics ordered from University Vendor
Tools/signal generators available in B69

13. Team/Resources Locations Instrumentation Laboratory- B69 Benedum
Design Laboratory- B62 Benedum
Healthcare consultation- Children’s Hospital of Pittsburgh
Manufacturing
UPMC Machine Shop (Scaiffe Hall)
UPMC Electronics Shop (Scaiffe Hall)
Funding
University of Pittsburgh Department of Bioengineering

14. Schedule

15. Team Roles Name Role Tasks Desiree Bonadonna Design Manager
Oversee product design
Reassess design at appropriate times
Apryle Craig
Electronics Manager
Oversee circuitry design
Electronics ordering and production
Laura Gilmour
Standards Manager
Oversee communications
Ensure designs meet FDA standards/are eligible for approval
Steven Jacobs, PhD
Project Advisor
Electronics consultant
Provide guidance in design procedure
Michael Shaeffer
Healthcare consultant

16. Current Status Met with both advisors Visited Children’s ECMO services
HFE Analysis, FMEA
Determined regular meeting time for next semester

17. Acknowledgements University of Pittsburgh Department of Bioengineering
Mark Gartner
Michael Shaeffer
Steven Jacobs

18. Questions?