Project Readiness Package
Rev 3/03/13
ADMINISTRATIVE INFORMATION:

Project Name (tentative):

Project Number, if known:

Preferred Start/End Quarter in Senior Design:
Spring 12
Fall/Spring
Winter/Spring
/Fall 13
Portable Emergency Ventilator Phase II
13027

Faculty Champion: (technical mentor: supports proposal development, anticipated technical
mentor during project execution; may also be Sponsor)
Name
Edward Hanzlik
Dept.
ME
Email
echeee@rit.edu
Phone
475-7428
For assistance identifying a Champion:

Other Support, if known: (faculty or others willing to provide expertise in areas outside the domain of the Faculty Champion)
Name
Jeffrey Gutterman PE
Roman Press Ph.D.

Dept.
Email
jsgutterman@gmail.com
rjpsch@rit.edu
Phone
585-748-2272
585-317-3595
Project “Guide” if known:
Edward C. Hanzlik


Primary Customer, if known (name, phone, email): (actual or representative user of project output; articulates needs/requirements)
Jeffrey Gutterman PE Comtech Solutions LLC, 585-748-2272, jsgutterman@gmail.com
Sponsor(s): (provider(s) of financial support)
Name/Organization
Comtech Solutions
RIT
Contact Info.
Jeffrey Gutterman
Page 1 of 9
Type & Amount of Support Committed
$1000
TBD
Project Readiness Package
Rev 3/03/13
PROJECT OVERVIEW:
RIT Multidisciplinary Student Project # 13027: 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.
This MSD project is related to Project 13026 which has been tasked with delivering a working prototype with a certain feature content. This
project is currently entering MSD2. Team 13026 has provided a useable road map of what will be accomplished by their team and what objectives
are to be accomplished by Team 13027. It is expected that teams 13026 and 13027 will have regular information exchanges. Team 13027 is
encouraged to view EDGE website for project 13026.
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 by medical first responders as a patient transport ventilator for aviation and ground transportation.
The updated design in the Phase I project is based upon digital circuitry, and advanced developments in airflow sensing techniques. The functions
and features determined in Phase I and implemented in Phase II will result in an innovative, life-saving device. By replacing imprecise mouth-tomouth resuscitation, the unit will provide clean, filtered air and automatically regulate flow and pressure to suit a victim's critical needs.
Additionally, the PEV’s unique “CPR mode” will eliminate direct patient-rescuer contact, thereby reducing the chances of transmitting
communicable diseases.
The PEV will be intended primarily for Emergency Medical Services but will eventually have models suitable for use in hospitals, clinics,
emergency and security vehicles as well as private homes. A further revision for military applications is possible in future phase.
Working prototypes were built and tested successfully thus enabling the sponsors (Gutterman, Press) to receive FDA “Permission to Market”
status. A working prototype has been supplied for reference and student use.
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 contemporary
design was completed as Phase I project #... .. The goal of the proposed project is the creation of a light weight, state-of-the-art digital electronic
PEV version suitable for emergency medical technicians and firefighters. 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.
The exceptional portability, low cost, and number of unique features including a CPR mode , leads to conclusion that commercialization of the
RIT design can be very useful as live saving device. The goal is to make the apparatus be popular and ubiquitous as portable Defibrillators.
Page 2 of 9
Project Readiness Package
Rev 3/03/13
The project shall consist of the following components:
1. Market analysis and business model creation
2. Engineering design finalization
3. Bill of Materials (BOM)
4. Samples production
5. Manufacturing plan
6. Cost Study
7. Test for Vibration, Shock, corrosion, UL
8. Test on biological objects at RGH or/and Strong Memorial
9. Collaboration with medical equipment manufacturers such Jonson & Jonson
10. Intensive testing (legal limitations) on human
11. Instructions and technical documentation
DETAILED PROJECT DESCRIPTION:
o Customer Needs and Objectives: This is incomplete; it is expected that the team will work with the faculty guide, Team 13026, and customers
to complete this list.
o
Customer
Need #
Importance
CN1
1
CN2
CN3
1
1
CN4
CN5
CN6
CN7
CN8
CN9
CN10
CN11
CN12
CN13
CN14
1
1
1
2
1
1
1
2
2
1
1
Description
The design of premarket updated version of the PEV that remains
“substantially equivalent” to the design which received FDA 510(k)
approval to manufacture and market. .
Portable based on digital electronics, preferably on microprocessor
Gives non-visual, non-Braille instructions/feedback
Operates for a minimum of 2 hours without recharging
Parts cost <$1000
Page 3 of 9
Project Readiness Package
CN15
2
CN16
3
Rev 3/03/13
o Functional Decomposition:
Insert the commercialization Diagram
Product Specification
Control Parameters
Power
Modes of operation:
Volume Control
Breathing Rate
Pick Flow
Air Assist Sensitivity
High Pressure Alarm
On/Off
1) Common mode (Automatic)
2) Air Assist
3) Manual
4) CPR
0.2 to1.2 liters
4 to 15 BPM
15 to 60 liter/min
0.5 to1.5 cm H2O
10 to 70 cm H2O
Displays and AlarmsPower On
Elapsed Time
Breath Per Minutes
Liters per Breath
CPR Counter
High Pressure
Low Battery
Light
Display
Display
Display
Display
Tone/Light
Tone/Light
Page 4 of 9
Project Readiness Package
Electrical InputDC Input
DC Internal Battery
Additional FeaturesPEEP
Elapsed Time Meter
Pump Life
O2/Air Mixer
Secondary Pressure Relief
Timed Backup BPM
DimensionsHeight
Width
Length
Weight
Rev 3/03/13
6 to 16 Volts
12 V DC
0 t0 8000 hours
2,000 hours
21 to 100% O2
75 cm H2O
TBD
TBD
TBD
<8.0 Kg
Page 5 of 9
Project Readiness Package
Rev 3/03/13
o Specifications (or Engineering/Functional Requirements): This is incomplete; it is expected that the team will work with the faculty guide,
Team 13026, and customers to complete this list. Team 13027 should review Team 13026’ EDGE webpage.
S1
S2
S3
S4
S5
S6
S7
S8
S9
S10
S11
S12
S13
S14
S15
S16
S17
S18
S19
S20
S21
S22
S23
S24
S25
S26
S27
S28
S29
Source
Function
CN4,8,11,12
System
CN4,8,11
CN14
CN4
CN9
CN9
CN10
CN1,2
CN1,2,3,7,15
CN5,16
CN1,3,5,7,
16
CN1,3,7,15,
16
CN5,11,12
CN1
CN1,2
System
System
System
System
System
System
System
System
System
System
CN1
CN1
CN11,12
CN3
CH4,12,13
CN6,7,8,10
CN6,7
CN6,7
CN7
CN8
CN3,6,9
CN3,8
System
System
System
System
System
System
System
System
System
System
System
System
System
System
Specification (metric)
Size
Unit of
Measure
inches
System
System
System
System
Page 6 of 9
Marginal
Value
Ideal
Value
<=
4x2x1
Comments/Status
Project Readiness Package
Rev 3/03/13
Constraints:
o Low weigh and physical dimensions
o Simplicity of operation
o Low cost
o Project Deliverables: Expected output, what will be “delivered” – be as specific and thorough as possible.
o
Fully operational prototype
o
Design documentation
o
Operating Instruction
o
Competitive Analysis Results
o
FMA&E
o
Market Analysis
o Budget Estimate:
$1000
o Intellectual Property (IP) considerations:
o As a privately funded project, any IP generated as a result of this project have to discussed
with RIT IP professionals
o Other Information: Describe potential benefits and liabilities, known project risks, etc.
o The device has the potential to save lives.
o Medical expenses for rehabilitation can be reduced.
o New tool for first responders, emergency medical technicians, public facilities and hospitals.
o Continuation Project Information, if appropriate: Include prior project(s) information, and how prior project(s)
relate to the proposed project.
o
o
o
o
o
Technical documentation from Phase I.
Test results protocol
Proposed project with updated digital design creates new market niche due to increased portability
Testing shock/vibration, corrosion, durability
Testing at Strong Memorial Hospital and/or other health organization
STUDENT STAFFING:

Anticipated Staffing Levels by Discipline:
Discipline
How
Many?
Anticipated Skills Needed
EE1: Sensor search, analog to digital and digital circuit interface, power
budget analysis, pump power system design, device characterization
EE
1-2
EE2: Basic analog circuit design to include voltage and current sense
circuitry, battery selection, on-board power source utilization, regulation
circuitry, and analog to digital and digital circuit interface design
Page 7 of 9
Project Readiness Package
ME
CE
2-3
1
Rev 3/03/13
ME1:Analysis and ergonomics (with ISE)design of enclosure, based on
Solid Work (manufacturing enclosure is acceptable), cables & connectors,
heat dissipation, user interface components selection, pump selection
CE1: Digital Signal Processor/Microcontroller Unit selection,
programming, algorithm implementation, memory allocation, PCB layout,
DSP/MCU development board interface and usage, troubleshooting
Biomedical analysis and test to specification parameters
Market analysis
Manufacturing
ISE
2-3
Biology test!!!
0-1
ISE1: Ergonomics, usability and human interface, packaging for
transportation, maintenance and manufacturing
OTHER RESOURCES ANTICIPATED:
Category
Description
Faculty
EE, CE consultants?
Environment
MSD Design Center
EE Senior Design lab
Machine Shop & Brinkman lab
Equipment
Emulation board for
Materials
Electronic/electrical components, mechanical components, interface devices
interface team documentation
Other
team documentation
Page 8 of 9
Resourc
e
Availab
le?
Project Readiness Package
Rev 3/03/13
Prepared by:
Date:
Page 9 of 9
03/03/2013