ECMO Circuit Pressure AlarmPROJECT PROPOSAL

Desiree Bonadonna

Apryle Craig

Laura Gilmour

University of PittsburghSenior Design - BioE1160

ECMOre, Uninc.

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)

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

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

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

Description: Circuit Modification

Description: Device Circuitry

Design Alternatives

• Types of Displays

• Number of Audible Alarms

• Number of Visual Alarms

• Alarm independence/convenience

Competitive Analysis

Current Medically approved devices • Analog

• Difficult to read• Not clearly labeled

• No audible • No visual alarm

Non-approved devices• Digital with visual alarm

Competitive Analysis

ECMOre Design weaknesses

• More expensive than analog

• More tubing in an already cluttered space

• Increased training time/expenses

Technology

• Altera circuit design software

• SolidWorks for enclosure

• SimuLink

• Model an ECMO circuit using water

• Experiment with transducer voltages

• Test final product

Team/ResourcesTeam

• 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

Team/ResourcesLocations

• 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

Schedule

Team RolesName 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 Project Advisor •Healthcare consultant

•Provide guidance in design procedure

Current Status

• Met with both advisors

• Visited Children’s ECMO services

• HFE Analysis, FMEA

• Determined regular meeting time for next semester

Acknowledgements

University of Pittsburgh

Department of Bioengineering

Mark Gartner

Michael Shaeffer

Steven Jacobs

Questions?