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Team Leader: Megan OConnell Matt Burkell Steve Digerardo David Herdzik Paulina Klimkiewicz Jake Leone P13027: Portable Ventilator 1 of 75

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Technical Review Overview Engineering Specs Proposed redesign Battery and Power Calculations Power: Electrical Electric Board Layout SPO2 Sensor CO2 Sensor Pneumatic Design Pressure Sensor Testing Housing Vision-Casing Structure Project Comparison System Testing BOM Risk Assessment Project Passover Questions? 2 of 75

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Engineering Specifications Portable Emergency Ventilator Engineering Specifications - Revision 1 - 03/19/13 Specification Number SourceFunctionSpecification (Metric)Unit of MeasureMarginal ValueIdeal ValueComments / Status S1PRPSystemVolume ControlLiters0.2 0.2 S2PRPSystemBreathing RateBPM, Breaths per Minute4 -15 S3PRPSystemPick FlowLiter/Min15 - 60 S4PRPSystemAir Assist Sensitivitycm H 2 00.5 0.5 S5PRPSystemHigh Pressure Alarmcm H 2 010 - 70 S6PRPSystemDC InputVolts6 - 16 Due to battery, must be greater than 9V S7PRPSystemDC Internal BatteryVolts12 S8PRPSystemElapsed Time MeterHours0 - 8000 S9PRPSystemPump LifeHours4500 S10PRPSystemO 2 / Air mixerO2O2 21% - 100 % S11PRPSystemSecondary Pressure Reliefcm H 2 075 S12PRPSystemTimed Backup BPM S13PRPSystemWeightKg 8 S14 RobustnessDrop Heightmeter1 3 of 75

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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. Reduce Electrical Drive Motor 4. Display Ergonomics 5. Reduce Size and weight 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. Mechanical Overload Condition due to Pump Malfunction 4 of 75

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Battery Choice: Tenergy Li-Ion 14.8 V 4400mAh 0.8375 lbs 7.35cm x 7.1cm x 3.75cm Rechargeable up to 500 times Price: $50.99 Bulk pricing Each cell: $3.18 = $25.44 (8 cells) $10 Protection Circuit Module ~$40 with packaging and connectors 5 of 75

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Power Calculation Current (A)Voltage (V)Power (W) Pump311.116.65 MCU + electronics0.53.31.65 LCD0.15101.5 Total3.6519.8 Battery Voltage (V)14.8 Battery Capacity (Ah)4.4 Battery Capacity (Wh)65.12 Expected Battery Life (Hrs)3.29 6 of 75

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Charger (Brick) HP AC Adapter 18.5V 3.5Amps Power: 65W Max power: 70W Price: $14.35 (Amazon) Bulk pricing: $6.48 when quantity of 1000 is bought 7 of 75

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DC-DC Boost Converter T.I. TPS55340 8 of 75

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Component Calculations Designed for Vin = 12-18V, Vout=18V, Iout= 2.5A Most components were chosen using TIs WEBENCH component selection tool Calculating R FREQ R FREQ (k ) = 57500 sw (kHz) -1.03 Calculating minimum Inductance required for CCM 9 of 75

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Voltage Regulation Input and output capacitors were chosen with regard to values on datasheets. 10 of 75

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Battery Charging Circuit Suggested Solution: 11 of 75

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Our Solution 12 of 75

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Battery Charging Circuit Many discrete components suggested by proposed solution were used Determining the values of R8 and R9: Timing Capacitors changed in order to set longer charging times for larger battery Thermistor not needed for our application, replaced with resistor. Current sense resistors set by: I FSS = 0.1V/R12 and I FSI = 0.2V/R18 Dual-channel Power MOSFET chosen for power switch rated well for our application All components chosen with safety margins in order to achieve proper operation 13 of 75

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Refer to Electrical Schematics (confidential) Electrical Schematics 14 of 75

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Revised Board Layout 15 of 75

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User InputsSensors LCD and Powerand Audio Connections to PCB 16 of 75

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Difference in Absorption between Red and Infrared is used to determine SpO2 SpO 2 Sensor 17 of 75

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Simplified Design: SpO 2 Sensor Continued 18 of 75

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SpO2 Flow Chart Source: Freescale Pulse Oximeter Fundamentals and Design 19 of 75

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CO2 Sensor 1. Original Target -> Telaire 6004 OEM Module Problem: Supplier went out of business, similar models are not being sold by GE Sensing 2. GE SENSING: Does not sell CO2 OEM Module within concentration range needed Upon Further Investigation: The average exhale returns ~ 40,000 ppm of CO2 Dollar Range for CO2 OEM Concentration Modules (using NDIR) 20 of 75

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Cheapest option: CO2 Meter- K-30 10% CO2 Sensor Cost $249 for 1 $163 for 250+ Programmable Range: 0-100,000 ppm Accuracy: 30 ppm 3 % of measured value (up to 3% CO2) Sensor Life Expectancy: > 15 years Sampling Method: Diffusion Current Consumption: 40 mA average Simple analogue output sensor transmitter signal directed to OUT1 and OUT2 21 of 75

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Electrical Bill of Materials Total Cost: For 1: $311.94 For 100:$193.43 (This includes PCB, MCU, Sensors, and LCD) Refer to Electrical BOM for complete parts list (confidential) 22 of 75

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Initial Test Plan for PCB Assembly Weeks 1 and 2: PCB Assembly First two weeks will be spent soldering PCB. 1. Check that all pads match component footprints If any component(s) do not match footprint, attempt to solder jumper wire to pins. If jumper wire is not possible or if component overlaps another component, make changes to PCB and reorder (2 week lead time +$66) 2. Solder components in CIMS using heat gun and solder paste. Larger components such as connectors will be hand- soldered 23 of 75

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Week 3: Power System I and Hello World Program Power System I: Powered from only external or only Battery 1. Apply 18V to external input power using Lab Power Supply. Set Current Limit to 500 mA to prevent damage to circuits. 2. Measure voltage on 10V, 5V and 3.3V nodes to confirm outputs are as expected. 3. Disconnect external power and connect charged battery. 4. Measure voltage on 10V, 5V and 3.3V nodes to confirm outputs are as expected. Hello World Program: 1. Plug in JTAG connector. Ensure correct orientation. 2. Test to see if JTAG Debugger has connection to MCU. 3. Download Test Program to MCU. 4. Connect LED to output pin. LED should start blinking. 24 of 75

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Week 4: Power Systems II Motor Drive Testing Power Systems II: Battery Charging and various DC inputs 1. Connect depleted battery and attach oscilloscope across battery and battery current sense resistor. 2. Apply external Power with Current Limit set to 2.5 A. 3. Observe that current stays less than or equal to 2 A and voltage on battery steadily increases up to but not over 16.8V. Monitor battery temperatures and discontinue temperatures if battery exceeds 110 F in Ambient. Motor Drive Testing: 1. Download PWM program to MCU 2. With Motor Disconnected, observe proper pulsing from MOT_PWM 3. Connect Motor 4. Test Motor from DC=.05 to DC=.66 25 of 75

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Initial Testing 26 of 75

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Initial Testing- Differential Pressure Sensor Model 27 of 75

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Differential Pressure Sensor System Architecture No Capacitor No Backpressure

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Differential Pressure Sensor Capacitor Backpressure 29 of 75

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Static Pressure Sensor System Architecture No Capacitor No Backpressure 30 of 75

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Screen Shots DP Sensor GP Sensor System Architecture 31 of 75

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Screen Shots DP Sensor GP Sensor Mechanical Capacitor 32 of 75

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Screen Shots DP Sensor Electrical RC Circuit 10 k Resistor Capacitor 100 F 33 of 75

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Screen Shots DP Sensor GP Sensor Results of temporarily resisting flow and then releasing Pressure builds Flow spikes and then quickly levels 34 of 75

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Video Proof Impact of mechanical capacitor in system Flow speed Sensor dampening Proof of flow sensor accuracy Conversion of Mechanical Flow Sensor: Cheat: 12 = 20 l/min 35 of 75

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Human Trials- Determine if sensor can observe human backpressure System Architecture No Capacitor 36 of 75

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Mechanical Relief Valve Pressure Release at 1 psi Reusable 37 of 75

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Rough Correlation to Factory Specifications System Pressure0-4.5 kPa (0-.65 psi) Patient Pressure0.5-2 kPa (.07-.29 psi) 38 of 75

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Concerns- Calibration Currently have no way of measuring pressure accurately Mechanical gauge cannot handle pulsation Uncertainty as to whether we can calibrate against another digital sensor 39 of 75

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Housing Modifications 13026 Physical Extremes: 15in long X 10in high X 7in deep Projected 13027 Physical Extremes: 12in long X 7.5in high X 7in deep Team: 13026 Team: 13027 40 of 75

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Housing Vision 41 of 75

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Housing Vision Speaker O2 Sensor port CO2 Sensor port Mask tube ports BPMFlow RatePressure Limit Mode CPR Compression # Manual Power 42 of 75

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Housing Vision 43 of 75

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Housing Vision 44 of 75

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Housing Vision 45 of 75

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Housing Vision 46 of 75

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Project Comparison GOAL: Analyze the size and weight reduction between major contributing components of MSD 13026 PEV to our projected design. 47 of 75

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Summary: 48 of 75

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Casing Assembly Goal: Create an enclosed structure for our system components. Problem: Limiting the capabilities to ability/ access vacuum molding machine to produce similar appearance result as MSD 13026 Material: Plastic, Styrene for molding with rubber soles to protect damaging case 49 of 75

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Option 1- Recruit RIT Industrial Design Major to recreate vision Option 2- Create a paneled assembly from plastic Option 3- Purchase premade casing Cons: - Visual appearance would degrade - Casing would not be seamlessly enclosed -Expense for sheet plastic (ranges from $50-$200 based on thickness) Cons: - Visual appearance would degrade -Casing would make entire device be larger & heavier than intended -Expense (~$158)

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System Testing 1. Usability Study -Imagine RIT -Medical Personnel Discussions 2. Vibration Testing 51 of 75

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123 INSTRUCTIONAL INTERACTION LIKERT SCALE RATINGCOMPONENT COMPARISON Goal: 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. 1.Guide user through medical scenario and operation. 2.Instruct user to operate with system inputs 3.Ask questions about the user/device interaction Conversational Feedback from direct system operation 1.Create handout to be filled out by on-viewers 2.Scaled rating (1-10) of critical components of design. Mass feedback from overall system aesthetic 1.Knob Board Comparison with physical examples 2.Overall geometry comparison (using Davids sketches) 3.Original MEDIRESP III to MSD 13026 hands on part comparison Direct Feedback of liking to a specific individual component 1. Usability Study Breakdown

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Likert Survey for Imagine RIT (5/4/13) FOR IMAGINE RIT 13027 will provide: 1.Survey Print Outs 2.Clip boards 3.Folder for completed forms 4. Pens 5. Knob Board 53 of 75

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2. Vibration Analysis Performed pump vibration testing with the assistance of Dr. Lam. Pump was run at 100% duty cycle at 12v. Mono-axis accelerometer used Data was collected in Labview. Data collected on 3 axes. 54 of 75

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Vibration Analysis- Part 1 Raw data in volts Volts Gs Acceleration Force Force=V*exp factor*gravity*mass of pump For worst case, maximum voltage was.1V in any direction F(N)=.1V*1G/100mV*9.81m/s^2*1.731kg Maximum Force = 1.69795 N 55 of 75

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This force then used in failure analysis. 1 st failure scenario: vertical tear-out *not to scale Vibration Analysis- Part 1 56 of 75

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Vibration Analysis-Part 1 57 of 75

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Vibration Analysis- Part 1 Fatigue Analysis Source: Characterization and Failure Analysis of Plastics, ASTM, 2003 58 of 75

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Vibration Analysis- Part 1 59 of 75

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Vibration Analysis- Part 2 2 nd failure scenario: lateral tear-out *not to scale 60 of 75

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Vibration Analysis Part 2 61 of 75

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Vibration Analysis Part 2 62 of 75

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Bill of Materials (BOM) 63 of 75 See BOM REV 5_1_13 within Confidential Folder.

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Manufacturing Cost Analysis 64 of 75

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Revised Technical Risk Assessment

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Revised Operational Risk Assessment 66 of 75

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13027 Fall Staffing Request 1. Industrial Design Major Contributions: a. Case Construction b. Create improved case vision c. Improve user interface design (based on usability study) 2. Computer Engineer Major(s) Contributions: a. Programming of PEV system functions b. Integrate hardware outputs on display for visualization c. Design further advanced logic for software components 67 of 75

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13027-Project Passover

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13028 Staffing Proposal 1. Mechanical Engineer (1-2) 2. Electrical Engineer (1-2) 3. Computer Engineer (3-4) ** 4. Industrial Engineer (1) 5. Industrial Design Major (1) 74 of 75

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