1. Marcos Esterman, Associate Professor Industrial and Systems Engineering Department Rochester Institute of Technology marcos.esterman@rit.edu Multidisciplinary Senior Design I Problem Definition: Module 2

2. PROBLEM STATEMENT & PROJECT DELIVERABLES

3. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes to much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market.

4. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy(?) efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Current State

5. P13026 Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Desired State

6. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Project Goals & Key Deliverables

7. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy(?) efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Key Constraints

8. HOW DID WE GET THERE?

9. Project Overview (Directly from PRP) The PEV (Portable Emergency Ventilator) is a life supporting device which quickly and efficiently provides positive pressure ventilation for a non-breathing patient. It is a contaminant free resuscitator that eliminates mouth-to-mouth procedures while permitting life saving treatment for shock, cardiac arrest, heart attack, drug overdose, drowning, smoke inhalation, and other respiratory trauma. Emergency personnel equipped with the PEV have the opportunity to vastly improve a person’s chance of survival and avoid brain damage. Additionally PEV can be used as patient’s transport ventilator for aviation and ground transportation. Currently the existing PEV utilizes analog circuitry, and the most advanced developments in airflow sensing techniques to produce an innovative, life-saving device. By replacing imprecise mouth-to-mouth resuscitation, it provides clean, filtered air and automatically regulates flow and pressure to suit a victim's critical needs. Additionally, the PEV’s unique “CPR mode” eliminates direct patient-rescuer contact, thereby reducing the chances of transmitting communicable diseases. Working prototypes were built and tested successfully thus enabling to receive FDA “Permission to Market” status. In addition to military applications, the PEV can be effectively used in hospitals, clinics, emergency and security vehicles as well as private homes. The Project is based on US patents entitled Portable Emergency Respirator #5,211,170 and # 5,398,676 authored by Roman Press and Jeff Gutterman and their FDA 510K approval to manufacture and market the device. A full working prototype of the ventilator based on now outdated technology serves as a useful example and inspiration for a revised and updated model. The product has a number of unique features including a CPR mode which allows the machine to work in synch with a person administering CPR and an integral sterilizer to provide clean air without any biological contaminations. The goal of the proposed project is the creation of light weight state-of-the-art digital electronic PEV version. This multidisciplinary project can create a positive RIT image as a new technology developer, and may potentially prove to be financially advantageous to RIT as well.

10. Portable Emergency Ventilator (PEV): Current State Current PEV Problems/ Undesired State Desired Attributes Assist Unresponsive Patient to Breathe Integrate into the CPR Process It must not interfere with the administration of life-saving measures It must be portable Out Dated Technology Take 10 minutes to identify the Desired Attributes and the Undesired States

11. Team Problem Statement (from EDGE) A Portable Emergency Ventilator (PEV) is a device that can provide positive pressure ventilation to a person who is incapable of breathing on their own. This device can eliminate the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device can also be used when transporting patients or in home use when a large ventilator is too expensive and impractical. This project focuses on improving a PEV developed in the early 1990s by Jeff Gutterman and Roman Press (shown on right below). The goal of this project is to update the model using technology available today by making it lighter, more efficient, easier to use, and provide more feedback. The expected end result is a functional prototype (shown on left below) which can be marketed to companies and be manufactured.

12. Modified Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market.

13. 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. Recap A good problem statement contains  A description of the current state  A vision of the desired state  Key goals and deliverables  Key constraints