Project Readiness Package
ADMINISTRATIVE INFORMATION:
Rev 7/22/11

Project Name (tentative):

Project Number, if known:

Preferred Start/End Quarter in Senior Design:
Fall/Winter
Fall/Spring
Winter/Spring

Faculty Champion: (technical mentor: supports proposal development, anticipated technical mentor during project
Portable Emergency Ventilator
P13026
execution; may also be Sponsor)
Name
Dept.
Email
Phone
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.
COS
Email
jsgutterman@gmail.com
rjpsch@rit.edu
Phone
585-748-2272
585-317-3595
Project “Guide” if known:
Dr.

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 7
Type & Amount of Support Committed
$1000
TBD
Project Readiness Package
PROJECT OVERVIEW:
Rev 7/22/11
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.
The project may consist of the following components:
1. Market analysis and business model creation
2. Engineering design
3. Packaging
4. Microelectronic dedicated IC design and prototyping
5. Biomedical testing
6. IP analysis
DETAILED PROJECT DESCRIPTION:
o Customer Needs and Objectives:
Customer
Need #
Importance
CN1
1
CN2
1
Description
The design of an updated version of the PEV that remains
“substantially equivalent” to the design which received FDA 510(k)
approval to manufacture and market. .
Page 2 of 7
Project Readiness Package
Rev 7/22/11
CN3
1
.
CN4
CN5
CN6
CN7
CN8
CN9
CN10
CN11
CN12
CN13
CN14
1
1
1
2
1
1
1
2
2
1
1
Portable based on digital electronics, preferably on microprocessor
Gives non-visual, non-Braille instructions/feedback
CN15
2
CN16
3
Operates for a mimimum of 2 hours without recharging
Battery is easy to replace
Parts cost <$1000
o Functional Decomposition:
Pneumatic
Interface with
patient
Pump
Power
Source
Controller
Control Panel
Power
interface
Product Specification
Control Parameters
Power
Modes of operation:
On/Off
1) Common mode (Automatic)
2) Air Assist
3) Manual
4) CPR
Page 3 of 7
Project Readiness Package
Volume Control
Breathing Rate
Pick Flow
Air Assist Sensitivity
High Pressure Alarm
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
Electrical InputDC Input
DC Internal Battery
6 to 16 Volts
12 V DC
Additional FeaturesPEEP
Elapsed Time Meter
Pump Life
O2/Air Mixer
Secondary Pressure Relief
Timed Backup BPM
DimensionsHeight
Width
Length
Weight
Rev 7/22/11
0 t0 8000 hours
8,000 hours
21 to 100% O2
75 cm H2O
TBD
TBD
TBD
<8.0 Kg
Page 4 of 7
Project Readiness Package
Rev 7/22/11
Specifications (or Engineering/Functional Requirements):
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
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
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 5 of 7
Marginal
Value
Ideal
Value
<= 4x2x1
Comments/Status
Project Readiness Package
Rev 7/22/11
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
Prior project information is attached.
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
3
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
ME
2
ME1:Analysis and ergonomics (with ISE)design of enclosure, based on
Page 6 of 7
Project Readiness Package
Rev 7/22/11
Solid Work (manufacturing enclosure is acceptable), cables & connectors,
heat dissipation, user interface components selection, pump selection
CE
1
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
ISE
1
ISE1: Ergonomics, usability and human interface, packaging for
transportation, maintenance and manufacturing
OTHER RESOURCES ANTICIPATED:
Category
Resourc
e
Availab
le?
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
Prepared by:
Date:
Page 7 of 7
10/2012