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

Overview Project Summary Customer Needs Engineering Specs System Block Diagram Functional Decomposition Risk Assessment Proposed Redesign

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: Edward Hanzlik Team: 4 Mechanical Engineers 2 Electrical Engineers

Customer Needs Customer Need #ImportanceDescriptionComments/Status CN11Maintain Portability Portable based on digital electronics, preferably on microprocessor, minimize weight and size CN21Include Audio FeedbackGives non-visual, non-braille instructions/feedback CN31Optimize Battery LifeOperates for minimum of 2 hours without recharging CN41Replaceable BatteryBattery easily replaced CN51Minimize ExpensesParts cost < $1000 CN61Display Relevant Data Show information that will be necessary for the customer to operate the ventillator on the front panel CN72Measure Oxygen LevelsAdd a pulse oximeter CN82Measure CO 2 LevelsMeasure CO 2 levels on expiration CN92Optimize for mass production CN103Design 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 CN113Record and Transfer DataRecord and transfer data CN123Reduce size/weight(less than 18lbs) Importance: 3: Preference only 2: Nice to Have 1: Must Haves

Engineering Specifications Portable Emergency Ventilator Engineering Specifications - Revision /19/13 Specification Number SourceFunctionSpecification (Metric)Unit of MeasureMarginal ValueIdeal ValueComments / Status S1PRPSystemVolume ControlLiters S2PRPSystemBreathing RateBPM, Breaths per Minute4 -15 S3PRPSystemPick FlowLiter/Min S4PRPSystemAir Assist Senitivitycm H ± 0.5 S5PRPSystemHigh Pressure Alarmcm H S6PRPSystemDC InputVolts Due to battery, must be greater than 9V S7PRPSystemDC Internal BatteryVolts12 S8PRPSystemElasped Time MeterHours S9PRPSystemPump LifeHours4500 S10PRPSystemO 2 / Air mixerO2O2 21% % S11PRPSystemSecondary Pressure Reliefcm H S12PRPSystemTimed Backup BPM S13PRPSystemWeightKg≤ 8 S14 RobustnessDrop Heightmeter1

System Block Diagram

Functional Decomposition

Top Level Functions

Provide Airflow

Monitor Feedback

Communicate State

Manage Power

Risk Assessment Risk ItemEffectCause Likelihood Severity Importance Action to Minimize Risk Tech Concerns 1 Integration of hardware and software together non-workable prototype using devices from different companies that don't function together 339 plan and read specs on all technical components; test components compatibility 2 inputs do not match outputs failing to meet FDA requirements programing and calibration errors133quality testing of design 3 battery integration in system underperforming; fire hazard battery failure; not meeting engineering specs 313 check with experts on how to manage battery functionality 4Durability failure components breaking; failure of system components malfunctioning during usage 236 perform vibration testing; perform environmental testing Severity Scale:1= Not Severe 2= Moderately Severe 3=Very Severe Likelihood Scale:1= Not Likely 2= Conceivable 3=Very Likely Importance= likelihood x severity

Risk ItemEffectCause Likelihood Severity Importance Action to Minimize Risk Project Concerns 5Over budget cannot build a working prototype that looks like vision necessary parts more expensive than budget leaving not enough money for aesthetics 313 perform cost analysis; utilize resourcefulness; properly plan so things can be done right the first time 6 uncoordinated team schedule late completetion of deliverables; lack of team unity conflicting schedules and desired meeting times 224 constant communication; survey of wekkly available time 7late delivery of parts modification to design schedule; miss deadlines lack of planning; problems with vendors224 order parts ahead of time; expedite when necessary 8 Remaining substantially equivalent with current design design that is not capable with FDA approval changing the current design drastically beyond the FDA approved design 133 make sure any major changes to design are validated with client 9conflicts with customer more budget needed; change design schedule change in market; change in design plans; change in prospective 122 team members should maintain open communication with client; relevant market research 10 product does not match consumer needs not profitable not meeting FDA requirments; not meeting trends 133benchmarking research 11 team skillset doesn't match task misdistributed work loaduneven distribution of disciplines224maximize group communication Severity Scale:1= Not Severe 2= Moderately Severe 3=Very Severe Likelihood Scale:1= Not Likely 2= Conceivable 3=Very Likely Importance= likelihood x severity

From > Our Foundation to Build On Updates: 1. Electronic controls (decrease size/more options) 2. Smaller pump 3. Reliable and smaller battery (2+ hours) 4. Device ergonomics and usability Additions: 1. Ability to monitor and record vitals 2. Pulse oximeter feedback 3. Signaling alerts

Revision B- Proposed Redesign Update: 1. Battery Size-> Reduce Size & keep same capacity 2. Reduce Circuit Board size-> Create custom board for all electrical connects 3. Phase motor driver to a transistor 4. Display Ergonomics 5. Overall Size and shape of PEV 6. Instruction manual Additions: 1. Visual Animated Display-> Moving Vitals 2. Memory capabilities 3. USB extraction of Data 4. Co2 Sensor as additional Feature to PEV 5. Overload Condition due to Pump Malfunction

Batteries: Area for improvement Decrease weight Smaller size Lower price Higher power capacity

Batteries Tekkeon Tenergy 11.1V Heavy Duty Tenergy 11.1V LIPO Power Capacity 58 Wh111 Wh61 Wh Dimensions 17.4cm x 8.43cm x 2.26cm 20.5cm x 7.3cm x 2.2cm 14.8cm x 5.2cm x 2.3cm Weight452 grams726 grams333 grams Price$200$108.75$57.99

Custom PCB Solution We plan on using a custom mixed signal PCB solution Advantages: Reduce size and weight greatly reduce production costs Manufacturability Flexibility Disadvantages: High development costs A lot of work Some risks involved

Size and Weight All electronics will fit on one PCB turning a volume into an area that can fit on the side of the enclosure and take up very little space

Costs Development costs will be high but production costs will be very low

Manufacturability Having only one board will minimize assembly time since fewer connections are required Connections to be made: Battery LCD Dials/Switches Pump Air lines to sensors

Flexibility We can customize our design to work with a wider variety of products This will potentially reduce costs since we can choose the best and cheapest components

Example: LCD Display Selection of LCDs we can interface with is greatly increased This allow us to use a display like this 7” diagonal touchscreen LCD available for only $97

Risks of Custom PCB We may have trouble figuring out how to interface with some of the new features, particularly the pulse oximeter If there is a significant problem in the initial PCB ordered, another order will have to be made to fix it which will be just as expensive

Housing Modifications Smaller components = smaller package

Housing Modifications Old Physical Limits: 15in long X 10in high X 7in deep New Physical Limits: 11in long X 6.75in high X 6.5 in deep

Housing Modifications

Additional Developmental Testing 1. Vibration Testing- How will the PEV stand up to external vibration and drop conditions? I. Random Vibration Frequency Testing (From 0- 2kHz) - Understand Natural Frequency of System (Resonance) and address measures to avoid this state - Specs: TBD II. Drop Testing - Understand g-forces with respect to system mass and height to drop. Allow us to make judgment on component damage. 2. Usability Testing on Major Display Components I. Understand General Usability-> Imagine RIT surveying (designed with Marie and David) II. EMT intelligent Usability-> Survey EMT and medical practitioners

Improving Ease of Use Improving User Interface Providing Audio Feedback Supplying medical staff with patient data

Audio Feedback We plan on providing the user with limited audio feedback to guide them through using the PEV Simple Commands that cover the basic functions Not a step-by-step instruction manual Advantages: Provides assistance in hectic environments Could provide untrained personnel with guidance

User Interface Small Improvements to make the User Interface more “user- friendly” Adding small sections of display above settings/mode knobs that correspond with the user-selected settings LEDs to help guide user during operation

USB Data Extraction By implementing a USB connection on the custom board, data scripts will be able to be downloaded after using the device. Text scripts will be time-stamped ID-ing patients with a patient # Recording important information such as vitals and/or air flow/compressions administered Can be used by medical experts when needed for legal/health- related issues.

Mass Flow Analysis (Between Pump outlet and Ventilator outlet) Replacing Mass Flow Sensor with Venturi Analysis Assume incompressible flow: Constant density

Venturi Analysis compared to mass Flow Sensor Cost: Honeywell AWM2300V Mass Flow Sensor = $ Freescale MPX12 series Differential Pressure Sensor = $8.61 Number of Parts: Current design about 6 parts Proposed design about 8 parts Additional parts on the order of a few dollars (reducers) Size: Mass Flow Sensor = 1.24”x1.2”x0.61”=0.91 in 3 Differential Pressure Sensor = 1.15”x0.69”x0.43”=0.34 in 3

High Pressure Safety Improvements 1. Audio Alarm: Software triggered alarm if flow rate is out of bounds of pump inputs 2. Audio Alarm: Secondary pressure sensor records high back pressure 3. Mechanical Relief Valve: Fail safe to release system pressure if pressure exceeds a predetermined level

Bench Marking High Pressure Precautions Both AutoVent and CAREvent have double redundant ways to assure the patient never experiences too high of pressure

CO 2 Disposable Sensor Benchmarking Current Technologies: