P13026: Portable Ventilator
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Planning & Execution

Table of Contents

Project Summary

Full Project Summary

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. Reasons for this lack of ability to breath include cardiac arrest, heart attack, smoke inhalation, and many others. 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.

Many PEVs already exist and are being used by EMTs and physicians today. This project focuses on improving a PEV developed in the early 1990s by Jeff Gutterman and Roman Press. The device is patented and has been approved by the FDA to market and manufacture. The PEV device includes different modes which can be used based on different situations. These modes are Constant Mandatory Ventilation (CMV), Assist, CPR, and Manual. The mode which would be most useful to first responders is CPR. In this mode, the rescuer would perform CPR on the patient just as they normally would, using only chest compressions. The PEV would keep track of the number of compressions through a feedback network, and, based on a setting applied by the rescuer, provide clean air to the patient after a specific number of compressions were performed.

The current device has many characteristics which we plan to keep in the updated model. First, since the device has already been approved by the FDA, the general operation cannot deviate from the current design. Second, the PEV is durable so it can be dropped or used in inclement weather and yet still provide it’s life saving function. Third, the device has redundancies so that if a malfunction occurs, the patient can still be ventilated by other means. Finally, the device is easy to use with paramedics. The large knobs and audible feedback allows the PEV to be used by those wearing gloves and ensures incorrect use is not possible.

The goal of this project is to update the model using technology available today by making it lighter, more efficient, and easier to use. To make it is portable as possible, we plan on make this device less than 8 kilograms. Also, this device will run on a battery, which should have the ability to operate the device for at least 2 hours without requiring a recharge. This should provide sufficient time for the patient to be transported to a larger machine not running on battery power. Lastly, one very important aspect of this device is that it will be able to record the patient’s vitals as resuscitation is occurring. This will benefit the rescuer from this feature since he/she will no longer have to worry about writing down this information, along with the time it was taken. We expect to market our device once a final product is built and extensively tested.

This project will be completed by May 2013 with a budget of $1000. The ultimate goal is to have a working prototype. We will be guided by our customers, Jeff Gutterman and Roman Press, and our faculty mentor, Edward Hanzlik.

Intellectual Property Considerations

Customer Needs

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Specifications

Original Engineering Specs:

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Final Engineering Specs with Status:

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Functional Decomposition

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RISK Assessment

RISK Assessment Table
Risk Item Effect Cause L S I Action to minimize risk Owner Completion Date
Technical Concerns
1 over heating damaged components; total system failure electronic components; environment; mis-use; upkeep 2 3 6 basic thermal analysis; provide safety cautions Dan week 9- MSD1
2 Integration of hardware and software together non-workable prototype using devices from different companies that don't function together 2 2 4 plan and read specs on all technical components; test components compatability Derek week 9- MSD1
3 inputs do not match outputs failing to meet FDA requirements programing and calibration errors 2 1 2 quality testing of design Chris/ Kennedy MSD2
4 battery integration in system underperforming; fire hazard battery failure; not meeting engineering specs 1 2 2 check with experts on how to manage battery functionality Eric MSD2
5 Durability failure components breaking; failure of system components malfunctioning during usage 2 3 6 perform vibration testing; perform environmental testing Ryan MSD2
Project Concerns
6 Over budget cannot build a working prototype that looks like vision necessary parts more expensive than budget leaving not enough money for aesthetics 3 3 9 perform cost analysis; utilize resourcefulness; properly plan so things can be done right the first time Marie week 9- MSD1
7 uncoordinated team schedule late completetion of deliverables; lack of team unity conflicting schedules and desired meeting times 2 3 6 constant communication; survey of wekkly available time Dan
8 late delivery of parts modification to design schedule; miss deadlines lack of planning; problems with vendors 1 2 2 order parts ahead of time; expedite when necessary Melissa week 5- MSD2
9 Remaining substantially equivalent with current design design that is not capable with FDA approval changing the current design drastically beyond the FDA approved design 1 3 3 make sure any major changes to design are validated with client Chris week 9- MSD1
10 conflicts with customer more budget needed; change design schedule change in market; change in design plans; change in prospective 2 2 4 team members should maintain open communication with client; relevant market research Dave week 5- MSD1
11 product does not match consumer needs not profitable not meeting FDA requirments; not meeting trends 2 3 6 benchmarking research Roberto

Team Norms & Values

Created in MSD I, updated in MSD II or as needed

Project Plans & Schedules

MSD I

Project Schedule (MS Project)

Project Schedule Updated (PDF)

Project Schedule R1 (PDF)

Work Breakdown Structure (MS Word)

Work Breakdown Structure (PDF)

MSD II

Imagine RIT:

Team Vision for Imagine RIT 2013

MSD-2 Week 3 Demo:

Team Demonstration Proposal

MSD-2 Week 6 Demo:

Team Demonstration Vision

MSD-2 Final Presentation:

Final Project Presentation

Meeting Minutes, Notes, & Actions

MSD I Meeting Notes

Peer Reviews

MSD I & II

Project Reviews

3 Week System Review

4 Week System Review

5 Week System Design Review

Week 7 Technical Review

Week 9 Detailed Design Review

Final Project Presentation


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