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Team Leader: Megan OConnellMatt BurkellSteve DigerardoDavid HerdzikPaulina KlimkiewiczJake Leone

P13027: Portable VentilatorOverviewProject Scope-Background13026 Foundation slideProposed redesignCustomer NeedsEngineering SpecsRisk AssessmentHOQ/QFD DiagramSystem Block DiagramFunction DecompositionPugh DiagramsBatteryPressure SensorsCircuit BoardMCUCO2 MeasurementsCAD VisualsUsability Studyat Imagine RITQuestions?Project ScopeProject Objective: Improve the current design of P13026Duration: 27 weeksMarket Release: 2015Budget: $1000Customer:Jeff GuttermanRoman Press

Faculty Mentor:Edward Hanzlik

Team:4 Mechanical Engineers2 Electrical Engineers

MEDIRESP III13026 PEVFrom 13026 -> Our Foundation to Build OnUpdates:Electronic controls (decrease size/more options)Smaller pumpReliable and smaller battery (2+ hours)Device ergonomics and usability

Additions:Ability to monitor and record vitalsPulse oximeter feedbackSignaling alerts

Revision B- Proposed RedesignUpdate:Battery Size-> Reduce Size & keep same capacityReduce Circuit Board size-> Create custom board for all electrical connectsPhase motor driver to a transistorDisplay ErgonomicsOverall Size and shape of PEVInstruction manual

Additions:Visual Animated Display-> Moving VitalsMemory capabilitiesUSB extraction of DataCo2 Sensor as additional Feature to PEVOverload Condition due to Pump MalfunctionCustomer NeedsCustomer Need #ImportanceDescriptionComments/StatusCN11Maintain PortabilityPortable based on digital electronics, preferably on microprocessor, minimize weight and sizeCN21Include Audio FeedbackGives non-visual, non-braille instructions/feedbackCN31Optimize Battery LifeOperates for minimum of 2 hours without rechargingCN41Replaceable BatteryBattery easily replacedCN51Minimize ExpensesParts cost < $1000CN61Display Relevant DataShow information that will be necessary for the customer to operate the ventillator on the front panelCN72Measure Oxygen LevelsAdd a pulse oximeterCN82Measure CO2 LevelsMeasure CO2 levels on expirationCN92Optimize for mass productionCN103Design SimilarlyThe design of an updated version of the PEV that remains "substantially equivalent" to the design which received FDA 510(k) approval to manufacture and marketCN113Record and Transfer DataRecord and transfer dataCN123Reduce size/weight(less than 18lbs)Importance: 3: Preference only 2: Nice to Have 1: Must HavesEngineering SpecificationsPortable Emergency VentilatorEngineering Specifications - Revision 1 - 03/19/13Specification NumberSourceFunctionSpecification (Metric)Unit of MeasureMarginal ValueIdeal ValueComments / StatusS1PRPSystemVolume ControlLiters0.2 0.2S2PRPSystemBreathing RateBPM, Breaths per Minute4 -15S3PRPSystemPick FlowLiter/Min15 - 60S4PRPSystemAir Assist Senitivitycm H200.5 0.5S5PRPSystemHigh Pressure Alarmcm H2010 - 70S6PRPSystemDC InputVolts6 - 16Due to battery, must be greater than 9VS7PRPSystemDC Internal BatteryVolts12S8PRPSystemElasped Time MeterHours0 - 8000S9PRPSystemPump LifeHours4500S10PRPSystemO2 / Air mixerO221% - 100 %S11PRPSystemSecondary Pressure Reliefcm H2075S12PRPSystemTimed Backup BPMS13PRPSystemWeightKg 8S14RobustnessDrop Heightmeter1Risk Assessment

HOQ/QFD Diagram

System Block DiagramFunctional Decomposition

Top Level Functions

Provide Airflow

Monitor Feedback

Communicate State

Manage Power

Battery Selection Pugh ChartBattery Option SelectionOption #1Option #2Option #3Option #4NiMHNiCdLi-IonLi-Ion PolymerSelection CriteriaScoreScoreScoreScoreCost++--Weight0-++Size0-++Physical Durability0+--Charge Loss00++Resistance to Environmental Effects0000Operating Conditions00++Sum +'s1244Sum 0's6311Sum -'s0222Net Score1022Rank2311Batteries: Lithium-Ion PolymerVery low profile - batteries resembling the profile of a credit card are feasible.Flexible form factor - any reasonable size can be foundLightweight - gelled electrolytes enable simplified packaging by eliminating the metal shell.Improved safety - more resistant to overcharge; less chance for electrolyte leakage

Selection Criteria Option 1 (Original) Option 2 Option 3 Mass Flow SensorDifferential Pressure2 Pressure SensorsScoreScoreScoreWeight 0++Cost 0++Physical Durability 000Accuracy 000Range 000Operating Temperature 0++Size 0++Sum +'s 044Sum 0's 833Sum -'s 000Net Score 044Rank 311Flow Sensor Type Pugh Matrix

Pneumatic SchematicPUMPDP Pressure SensorPressure SensorFilterInletExitDifferential Pressure Sensor ModelPUMPPressure SensorFilterInletExitPressure SensorTwo Pressure Sensors ModelSelection Criteria Option 1 Option 2 Option 3 Option 4FreeScale MPXV7007FreeScale MPXV7002FreeScale MPX12Honeywell TruStabilityScoreScoreScoreScoreWeight 0000Cost --++Physical Durability 0000Compensated+0--Accuracy ++0-Range ++0-Operating Temperature +++0Size ++00Sum +'s 5421Sum 0's 2354Sum -'s 1113Net Score 431-2Rank 1234Pressure Sensor Pugh MatrixPCB Structure SelectionOption #1Option #2Option #3Mediresp IVMediresp IIICustom PCBSelection CriteriaScoreScoreScoreWeight--+Cost-+-Size--+Physical Durability000Implementation+-+Manufacturability--+Work Required++-Sum +s224Sum 0s111Sum -s442Net Score-2-22Rank221PCB Selection Pugh ChartManufacturerNXPST MicroFreescaleFreescaleTIMCULPC1769STM32K60k70HerculesArchitectureARM M3ARM M4ARM M4ARM M4ARM R4Price$11 $11 $16 $20 $30 Packaging000--0Ease of programming0-----Cost000---Performance0++++++++Number of Analog inputs0++++++++PGA00++++0Reliability0000++Power usage00000Net Score03423Rank42132

General Notes:All MCU rated for -40 to 105 CMCU Selection PUGHData Transfer PUGHUSB Mass StorageUSB DeviceBluetoothSDEase of Development+0-+Security0+-0Usability+-00Cost++-+Net Score31-22Rank1342LCD Interface: RGB vs ParallelTwo different interfaces commonly used in LCD displays are RGB (no controller) and Parallel (built-in controller, ex. SSD1963)

RGBParallel (8080)Pins required for communication26 (8 for each color, Vsync, Hsync)13 (8 data, Rd, Wr, R/D, CS, RST)MCU requirementsRequires LCD peripheralAny MCU with GPIO will workRefresh rateLimited to speed of MCULimited to speed of controller (slower)CostCost of bare LCD (~$75 for 7)Cost of RGB+$25 controller(~$100 for 7)StatusUnimplementedImplemented

CO2 Sensor Pugh MatrixGE Sensing Telaire 6004 Co2 Sensor (~$25)

ASCO Pneumatic Disposable In-line FilterExhale From PatientNon-Permeable SealNDIR Co2 MeasurementWiringSend Reading To PEV System MCUHousing ModificationsSmaller components = smaller package

Housing ModificationsOld Physical Extremes:15in long X 10in high X 7in deepTarget Weight: 17 pounds

New Physical Extremes:11in long X 6.75in high X 7in deepTarget Weight: 10 pounds

Housing Modifications

Housing Modifications

Housing Modifications

Housing Modifications

Housing Modifications

Housing Modifications

Housing Modifications

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 GeometryKnob Controls and DisplayKnob LocationScreen LocationScreen Function- Vitals DisplayVerbage ClarityColorUsability Study Breakdown123INSTRUCTIONAL INTERACTIONLIKERT SCALE RATINGCOMPONENT COMPARISONGoal:Gain user feedback from actual interaction with device.Goal: Gain a mass feedback on overall look and operation of the device.Goal: Understand and Maximize usability of critical user operated components.Guide user through medical scenario and operation.Instruct user to operate with system inputsAsk questions about the user/device interaction

Conversational Feedback from direct system operationCreate handout to be filled out by on-viewersScaled rating (1-10) of critical components of design.

Mass feedback from overall system aestheticKnob Board Comparison with physical examples Overall geometry comparison (using Davids sketches)Original MEDIRESP III to MSD 13026 hands on part comparison

Direct Feedback of liking to a specific individual componentInteractive Knob Board

Feedback:Which is easiest to use?Is there a distinction conflict in certain knob design?Opinion of overall aesthetic?Value displays on screenMEDIRESP IIIMEDIRESP IV