1. Marcos Esterman, Associate Professor Industrial and Systems Engineering Department Rochester Institute of Technology marcos.esterman@rit.edu Multidisciplinary Senior Design I Problem Definition Review Preparation

2. Agenda Questions to be Answered by the Problem Review Goals of the Problem Definition Review Mechanics of the Review  An Example

3. Questions to be Answered What is the current state and why is it unacceptable? What does the desired state look like? Who are the stakeholders that benefit from the desired state? What are those benefits (can be qualitative or quantitative)? What stakeholders can be negatively impacted by the desired state? What are the limits of those negative impacts (can be qualitative or quantitative)? How will your system be used by stakeholders? What are quantifiable responses (engineering requirements) that your system must produce? Do you have a project plan (objectives, key milestones, responsibilities) that your team, Guide, and Customer agree to? What are some systems that already do (or are similar to) what you want to do? How do these (similar) systems compare to the desired state? What can you learn/borrow from them? Where should they be improved?

4. Goals of the Problem Definition Review Demonstrate that your team can answer the questions posed by:  Clearly defined and agreed upon problem statement & project deliverables  Prioritized list of Customer requirements  Engineering requirements  Use scenarios  Draft of project plan Identify any gaps that exist between your ability to meet the above goal and your actual state  Be honest (Don’t try to BS)  Show your action plan to close gap by next review

5. MECHANICS OF THE REVIEW

6. Marcos Esterman, Associate Professor Industrial and Systems Engineering Department Rochester Institute of Technology marcos.esterman@rit.edu Daniel Fenton Kennedy Kong Marie Revekant David Engell Eric Welch P13026: Portable Ventilator Derek Zielinski Chris Freeman Melissa Harrison Ryan Muckel Roberto Castilla Zavala

7. Agenda Introduce Team Project Background Problem statement & project deliverables Use scenarios Prioritized list of needs (customer rqmts) Engineering requirements Draft of project plan

8. Team Introduction & Roles

9. Current Product- Mediresp III Provide positive pressure ventilation 3 modes:  CMV (constant mandatory ventilation)  Assist  CPR Manual Large and heavy 2-4 hour battery life FDA approval Patented Contains BVM backup

10. What is a PEV? A Portable Emergency Ventilator (PEV) is a device that can provide mechanical ventilation to a person who is incapable of breathing on their own  Volume controlled  Pressure controlled  Spontaneously controlled  Negative pressure controlled

11. PEV Theory of Operation Pressure controlled cycling is based on an applied positive pressure that is set by the clinician. In pressure controlled modes the total volume is variable as the ventilator is using only the pressure as a measurement for cycling.

12. P13026 Problem Statement Current State  A prototype was developed in 1990 that is too heavy, consumes to much energy and is not easy to use. Desired State  The device should not interfere with first responders’ abilities to administer life-saving measures.  A functional prototype which can be marketed to companies and ultimately be manufactured Project Goals  Analyze the current design and the patent database  Identify opportunities lighter more energy efficient easier to use more feedback and control to the user Constraints  Consistent with the intellectual property and FDA approvals

13. Additional Project Deliverables Functional prototype which can be marketed to companies and can be the basis for a product that will ultimately be manufactured Appropriate design, test, manufacturing and supply chain documentation to support transition to a manufactured product Test data verifying correct operation Designs alternatives  Other possible configurations  Other possible use environments User’s guide for operation

14. P13026 Stakeholders 14

15. Use Scenarios Considered Scenario 1: Unresponsive patient, heart beating but not breathing – PEV assist and transport to hospital Scenario 2: Unresponsive patient, heart beating but not breathing – PEV assist and administer life-saving measure X Scenario 3: Unresponsive patient, heart not beating and not breathing – PEV assist and CPR

16. Unresponsive patient, heart beating but not breathing

17. P13026 Needs List NeedPriority Have a modern look and feel 3 Is Light weight 3 Is Small 3 Is Easy to Use 9 Has Long-Lasting Portable Power 9 Low Cost Functional Prototype 3 Low UMC for Final Design 9 Alert user of the following data: XXX 9 Measure Oxygen Levels 3 Measure CO 2 Levels 3 Transfer Data Wirelessly 9 Assist Human to Breathe 9 Integrates into CPR Process 9 Does not interfere with the following life-saving measures: XXX 9 Improves air quality delivered to patient 9 Is safe 9 Is reliable 9 Needs to use principles in patents #5,211,170 and # 5,398,676 9 Needs to be consistent with FDA 510K Approval 9

18. Key Performance Metrics

19. P13026 Engineering Requirements

20. P13026 Preliminary Schedule

22. Issue & Corrective Actions Please highlight any gaps Identify action plans to close them