1. P13027: Portable Ventilator
Team Leader: Megan O’Connell
Matt Burkell
Steve Digerardo
David Herdzik
Paulina Klimkiewicz
Jake Leone

2. Overview Project Scope-Background 13026 Foundation slide
Proposed redesign
Customer Needs
Engineering Specs
Risk Assessment
HOQ/QFD Diagram
System Block Diagram
Function Decomposition
Pugh Diagrams
Battery
Pressure Sensors
Circuit Board
MCU
CO2 Measurements
CAD Visuals
Usability Study at Imagine RIT
Questions?
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3. Project Scope
Project Objective: Improve the current design of P13026 Duration: 27 weeks Market Release: 2015 Budget: $1000
Customer:
Jeff Gutterman
Roman Press
Faculty Mentor:
Team:
Edward Hanzlik
4 Mechanical Engineers
2 Electrical Engineers
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4. MEDIRESP III
PEV
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5. From 13026 -> Our Foundation to Build On
Updates:
Electronic controls (decrease size/more options)
Smaller pump
Reliable and smaller battery (2+ hours)
Device ergonomics and usability
Additions:
Ability to monitor and record vitals
Pulse oximeter feedback
Signaling alerts
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6. Revision B- Proposed Redesign
Update:
Battery Size-> Reduce Size & keep same capacity
Reduce Circuit Board size-> Create custom board for all electrical connects
Phase motor driver to a transistor
Display Ergonomics
Overall Size and shape of PEV
Instruction manual
Additions:
Visual Animated Display-> Moving Vitals
Memory capabilities
USB extraction of Data
Co2 Sensor as additional Feature to PEV
Overload Condition due to Pump Malfunction
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7. Customer Needs 7 of43 Customer Need # Importance Description
Comments/Status
CN1 1
Maintain Portability
Portable based on digital electronics, preferably on microprocessor, minimize weight and size
CN2
Include Audio Feedback
Gives non-visual, non-braille instructions/feedback
CN3
Optimize Battery Life
Operates for minimum of 2 hours without recharging
CN4
Replaceable Battery
Battery easily replaced
CN5
Minimize Expenses
Parts cost < $1000
CN6
Display Relevant Data
Show information that will be necessary for the customer to operate the ventillator on the front panel
CN7 2
Measure Oxygen Levels
Add a pulse oximeter
CN8
Measure CO2 Levels
Measure CO2 levels on expiration
CN9
Optimize for mass production
CN10 3
Design Similarly
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
CN11
Record and Transfer Data
Record and transfer data
CN12
Reduce size/weight
(less than 18lbs)
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Importance: 3: Preference only 2: Nice to Have 1: Must Haves

8. Engineering Specifications
Portable Emergency Ventilator
Engineering Specifications - Revision /19/13
Specification Number
Source
Function
Specification (Metric)
Unit of Measure
Marginal Value
Ideal Value
Comments / Status S1
PRP
System
Volume Control
Liters
0.2 ± 0.2 S2
Breathing Rate
BPM, Breaths per Minute
4 -15 S3
Pick Flow
Liter/Min S4
Air Assist Senitivity
cm H20
0.5 ± 0.5 S5
High Pressure Alarm S6
DC Input
Volts
6 - 16
Due to battery, must be greater than 9V S7
DC Internal Battery 12 S8
Elasped Time Meter
Hours S9
Pump Life
4500
S10
O2 / Air mixer O2
21% %
S11
Secondary Pressure Relief 75
S12
Timed Backup BPM
S13
Weight Kg
≤ 8
S14
Robustness
Drop Height
meter 1
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9. Risk Assessment
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11. HOQ/QFD Diagram
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12. System Block Diagram
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13. Functional Decomposition
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14. Top Level Functions
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15. Provide Airflow
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16. Monitor Feedback
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17. Communicate State
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18. Manage Power
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19. Battery Selection Pugh Chart
Battery Option Selection
Option #1
Option #2
Option #3
Option #4
NiMH
NiCd
Li-Ion
Li-Ion Polymer
Selection Criteria
Score
Cost + -
Weight
Size
Physical Durability
Charge Loss
Resistance to Environmental Effects
Operating Conditions
Sum +'s 1 2 4
Sum 0's 6 3
Sum -'s
Net Score
Rank
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20. Batteries: Lithium-Ion Polymer
Very low profile - batteries resembling the profile of a credit card are feasible.
Flexible form factor - any reasonable size can be found
Lightweight - gelled electrolytes enable simplified packaging by eliminating the metal shell.
Improved safety - more resistant to overcharge; less chance for electrolyte leakage
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21. Flow Sensor Type Pugh Matrix
Selection Criteria
Option 1 (Original)
Option 2
Option 3
Mass Flow Sensor
Differential Pressure
2 Pressure Sensors
Score
Weight +
Cost
Physical Durability
Accuracy
Range
Operating Temperature
Size
Sum +'s 4
Sum 0's 8 3
Sum -'s
Net Score
Rank 1
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22. Pneumatic Schematic
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23. Differential Pressure Sensor Model
Inlet
Filter
PUMP
Exit
DP Pressure Sensor
Pressure Sensor
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24. Two Pressure Sensors Model
Inlet
Filter
PUMP
Exit
Pressure Sensor
Pressure Sensor
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25. Pressure Sensor Pugh Matrix
Selection Criteria
Option 1
Option 2
Option 3
Option 4
FreeScale MPXV7007
FreeScale MPXV7002
FreeScale MPX12
Honeywell TruStability
Score
Weight
Cost - +
Physical Durability
Compensated
Accuracy
Range
Operating Temperature
Size
Sum +'s 5 4 2 1
Sum 0's 3
Sum -'s
Net Score -2
Rank
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26. PCB Selection Pugh Chart
PCB Structure Selection
Option #1
Option #2
Option #3
Mediresp IV
Mediresp III
Custom PCB
Selection Criteria
Score
Weight - +
Cost
Size
Physical Durability
Implementation
Manufacturability
Work Required
Sum +s 2 4
Sum 0s 1
Sum -s
Net Score -2
Rank
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27. Number of Analog inputs
MCU Selection PUGH
Manufacturer
NXP
ST Micro
Freescale TI
MCU
LPC1769
STM32
K60
k70
Hercules
Architecture
ARM M3
ARM M4
ARM R4
Price
$11
$16
$20
$30
Packaging --
Ease of programming -
Cost
Performance ++ +
+++
Number of Analog inputs
PGA
Reliability
Power usage
Net Score 3 4 2
Rank 1
General Notes:
All MCU rated for
-40° to 105° C
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28. Data Transfer PUGH USB Mass Storage USB Device Bluetooth SD
Ease of Development + -
Security
Usability
Cost
Net Score 3 1 -2 2
Rank 4
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29. LCD Interface: RGB vs Parallel
Two different interfaces commonly used in LCD displays are RGB (no controller) and Parallel (built-in controller, ex. SSD1963)
RGB
Parallel (8080)
Pins required for communication
26 (8 for each color, Vsync, Hsync)
13 (8 data, Rd, Wr, R/D, CS, RST)
MCU requirements
Requires LCD peripheral
Any MCU with GPIO will work
Refresh rate
Limited to speed of MCU
Limited to speed of controller (slower)
Cost
Cost of bare LCD (~$75 for 7”)
Cost of RGB+$25 controller
(~$100 for 7”)
Status
Unimplemented
Implemented
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30. CO2 Sensor Pugh Matrix
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31. GE Sensing Telaire 6004 Co2 Sensor (~$25)
Non-Permeable Seal
NDIR Co2 Measurement
Wiring
Exhale From Patient
ASCO Pneumatic Disposable In-line Filter
Send Reading To PEV System MCU
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32. Housing Modifications
Smaller components = smaller package
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33. Housing Modifications
Old Physical Extremes:
15in long X 10in high X 7in deep
Target Weight: 17 pounds
New Physical Extremes:
11in long X 6.75in high X 7in deep
Target Weight: 10 pounds
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34. Housing Modifications
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35. Housing Modifications
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36. Housing Modifications
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37. Housing Modifications
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38. Housing Modifications
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39. Housing Modifications
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40. Housing Modifications
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41. Usability Testing At Imagine RIT
Goal: Gather data to understand the overall feasibility of the PEV user interface design and styling.
Critical Components of Design:
Overall Geometry
Knob Controls and Display
Knob Location
Screen Location
Screen Function- Vitals Display
Verbage Clarity
Color
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42. Usability Study Breakdown1 2 3
INSTRUCTIONAL INTERACTION
LIKERT SCALE RATING
COMPONENT COMPARISON
Goal:
Gain user feedback from actual interaction with device.
Gain a mass feedback on overall look and operation of the device.
Understand and Maximize usability of critical user operated components.
Guide user through medical scenario and operation.
Instruct user to operate with system inputs
Ask questions about the user/device interaction
Conversational Feedback from direct system operation
Create handout to be filled out by on-viewers
Scaled rating (1-10) of critical components of design.
Mass feedback from overall system aesthetic
Knob Board Comparison with physical examples
Overall geometry comparison (using David’s sketches)
Original MEDIRESP III to MSD hands on part comparison
Direct Feedback of liking to a specific individual component
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43. Interactive Knob Board
Value displays on screen
MEDIRESP III
MEDIRESP IV
Feedback:
Which is easiest to use?
Is there a distinction conflict in certain knob design?
Opinion of overall aesthetic?
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