P13026: PORTABLE VENTILATOR TEAM LEADER: DANIEL FENTON KENNEDY KONG MARIE REVEKANT DAVID ENGELL ERIC WELCH DEREK ZIELINSKI CHRIS FREEMAN MELISSA HARRISON RYAN MUCKEL ROBERTO CASTILLO ZAVALA ENGINEERING SPECIFICATIONS Portable Emergency Ventilator Engineering Specifications - Revision 5 - 2/8/13 Specification Number Importance Sourc e Function S1 3 CN1 System Operation Volume Control Liters S2 3 CN1 System Operation Breathing Rate BPM, Breaths per Minute S3 3 CN1 System Operation Peak Flow Liter/Min 15 - 24 10% S4 3 CN1 System Operation Air Assist Senitivity cm H20 0.5 - 1.5 10% S5 3 CN1 System Safety High Pressure Alarm cm H20 10 - 70 10% S6 3 CN1 System Operation DC Input Volts 6 - 16 S7 3 CN1 System Operation DC Internal Battery Volts 12 S8 3 CN4 System Operation Battery Operation Time Hours 1 S9 3 PRP System Safety Elasped Time Meter Hours 0 - 2000 S10 3 PRP System Longevity Pump Life Hours 2000 S11 3 PRP System Safety Secondary Pressure Relief cm H20 75 S12 3 PRP System Safety Timed Backup BPM seconds 15 S13 2 CN8 System Operation Blood Oxygen Level % 88-100 S15 2 System Robustness Operational Temperature Degrees Celsius 0 - 40 Volume cm3 10,000 Kg <8 S16 2 CN2 System Portability Specification (Metric) S17 3 CN2 System Portability Weight Importance Weight: 3 = Must Have, 2 = Nice to Have, 1 = Preference Only Unit of Measure Target Value Accuracy 0.2 - 1.2 10% 4 -15 ±2 Comments / Status PARKER T1-1HD-121NEA Peak Flow = 32.5* LPM 12 VDC Weight = 1.5 kg Pump Life = 3500 hours 16.5 x 7 x 9.9 cm (6.5 x 2.75 x 3.91 in) PNEUMATIC SCHEMATIC TUBING HEAD LOSS ANALYSIS (BETWEEN PUMP OUTLET AND VENTILATOR OUTLET) Bernouli’s Equation Assumptions • Constant velocity, height and air density Major Head Loss: • Dependent on length of tube between ventilator and pump exit Minor Head Loss • Dependent on the expansion and contraction for two T-joints π1 π12 π1 π22 π1 − π2 + + ππ§1 − + + ππ§2 = = βππ π1 2 π2 2 π βππ πΏ π2 π22 π22 = βππ + βπ = π + 2 πΎπ + πΎπ π· 2 2 2 Δπ = πβππ = π πΏ π2 π22 π22 π + 2 πΎπ + πΎπ π· 2 2 2 = 0.0198 ππ π MASS FLOW SENSOR ANALYSIS Cross Sectional View of Mass Flow Junction Color Code • • • • • Blue = Tubing Black = T-Joint Red = Mass Flow Sensor Orange = Control Volume for Mass Flow Route Green = Control Volume for Main Route MASS FLOW SENSOR ANALYSIS Circuit Analogy i2 i R2 vi vf i1 R1 Color Code • Orange = Control Volume for Mass Flow Route • Green = Control Volume for Main Route Analogy Explanation • Current ≈ Flow Rate • Resistance ≈ Head Loss • Voltage Drop ≈ Pressure Drop → Constant through each path! i MASS FLOW SENSOR ANALYSIS Head Loss Through Main Tubing Path (Green) • Minor • • Expansion from first T-Joint to Tubing Contraction from Tubing to second T-Joint • Frictional loss along length of tubing • Major Head Loss Through Mass Flow Path (Orange) • Minor • • • • • Contraction from Original flow to first T-Joint Expansion from first T-Joint to Tubing Two curves (approximated as 90 degree angles) Contraction from Tubing to second T-Joint Expansion from second T-joint to original flow • No Major Losses (length of tubing is negligible) • Mass Flow Sensor Pressure Drop MASS FLOW SENSOR ANALYSIS Pressure Drop • Assuming constant height, density and velocity π1 π12 π1 π22 π1 − π2 + + ππ§1 − + + ππ§2 = = βππ βΉ ΔP = πβππ π1 2 π2 2 π Total Head Loss βππ = βππ + βπ Major Head Loss πΏ π2 βπ =π π· 2 Minor Head Losses • Contraction and Expansion βππ πΆ π2 = πΎπ 2 • Curves πΏπ π 2 βππ =π π· 2 βππ πΈ π2 = πΎπ 2 MASS FLOW SENSOR ANALYSIS Mass Flow Sensor Pressure Drop • Calculated by interpolating from provided table • Assumed flow would be between 200 and 400 sccm (based on educated guess) Δπππ π2 − 200 = 31 + 83 − 31 400 − 200 Final Calculations • Only unknown is Q2 • Plugged all equations into an excel sheet and changed value of Q 2 until the difference between the pressure drops in each path was negligible (8.49e-8) ππ3 π2 = 278.73 πππ HONEYWELL AWM2300V FEATURES • Bidirectional sensing capability • Actual mass air flow sensing •Low differential pressure sensing The AWM2000 Series microbridge mass airflow sensor is a passive device comprised of two Wheatstone bridges. Data is transmitted via analog. A typical application is in medical respirators and ventilators. HONEYWELL AWM2300V CONT. Performance Characteristics @ 10.01 +/- 0.01 VDC, 25°C Characteristic Value Flow Range (Full Scale) +/- 1000 sccm Accuracy 2.5% Weight 10.8g Power Consumption 30mV – 50mV Sensor Current Max. 0.6mA Response Time 1msec – 3msec Temp. Range Oper. -25°C to +85°C Storage: -40°C to +90°C Dimension 31.5mm x 54.4mm x 15.5mm NPC-1210 LOW PRESSURE SENSOR Applications: • Medical Equipment •Ventilation •Respirator monitoring Features: • High Sensitivity •High accuracy •CB mountable package •DIP package •Solid-state reliability •Individual device traceability NPC-1210 LOW PRESSURE SENSOR Characteristic Value Pressure Range (Full Scale) 1psi or 70.3cmH2O To 3psi or 155.1cmH20 Accuracy .5% Weight 2.5g Temp. Range Oper. -40°C to +125°C Storage: -55°C to +150°C Dimension 15.24mm x 15.24mm x 4.2mm Output Type Analog CONTROL SYSTEM K70 MCU Tower kit NEC 5.7” FutureTechnology TouchStone Low-Voltage, 3-Phase Motor Control Medial Development Module Pulse Oximeter Bluetooth Module K70 TOWER SYSTEM TWR-K70F120M-KIT 32-bit ARM® Cortex™-M4 • All the ARMv7E-M architecture instructions • Maximum core operating frequency of 120MHz Onboard LCD graphics control module • TouchStone • Larger screens Tamper detection Security Freescale supplies code for majority of our functionality • Reduces learning curve. 5.7” TOUCHSTONE Future Technology LCD: NL6448BC1801 TWR-PIM-41WVGA Display Kit TouchStone interface allows K70 to drive bigger screens LOW-VOLTAGE 3-PHASE MOTOR CONTROL TWR-MC-LV3PH Three-phase Brushless DC (BLDC) Permanent Magnet Synchronous Motor (PMSM) Power supply voltage input 12-24VDC, extended up to 50VDC Output current up to 8 amps MEDIAL DEVELOPMENT MODULE TWR-MCF51MM Can operate as a stand alone debugging tool Required for the MED-SPO2 BLUETOOTH CONNECTIVITY TWRPI-BLEDEMO Connects onto the K70 Board Discovery • Potential connectivity to mobile device • Potential Bluetooth pulse oximeter PULSE OXIMETER This external device will allow for an EMT to monitor a patient’s Blood Oxygen level as well as their pulse. The Pulse Oximeter chosen for this prototype will be the Nellcor DS-100A Reusable Finger Clip. This device will interface with the Freescale MED-SPO2 development board via a DB9 connection. The MED-SPO2 is a MOD that can be attached to the K-70 tower to allow the data being created by the Pulse Oximeter to be displayed on the screen of the K-70. This particular Pulse Oximeter has been chosen because there is clear documentation on how to interface it with the Freescale hardware we will be using for the control system. PULSE OXIMETER (CONT.) PULSE OXIMETER (CONT.) OTHER COMPONENTS ELAPSED TIME METER Item Hour Meter Type LCD Time Range (Hours) 0 to 99,999 Bezel Face (In.) 2.12 x 1.25 Bezel Face Type 2-Hole Rectangular Voltage 4.5 to 28VDC Display Units Hours and Tenths Depth (In.) 0.51 Length (In.) 1.22 Width (In.) 2.12 Ambient Temp. Range (F) -22 a 149 Material of Construction ABS Reset Type Remote Signal Fits 1.45"x0.95" Mounting Method Flange Terminal Type Spade OTHER COMPONENTS TUBING MATERIAL Item I.D. (in) O.D. (in) Wall Thickness (in) Minimum Bend Radius (in) Max Working Pressure (psi) Air Tubing 1/8 3/16 1/32 1/2 30 Air Tubing 3/8 5/8 1/8 1-1/8 40 POWER SYSTEM POWER FLOW TEKKEON MP3450I • • • • • • • • • • • 12V, 5V Li-Ion 60 Wh < 1 lb. 3.3" x 6.8" x 0.9" (20.2 in3) Built in charging port, prevents overcharging Comes with 90-240VAC charger, can also be charged with 9-24VDC Low battery audible alert Price: $200, inc. tax & shipping Operating temps: -10°C to 60°C Charging temps: 0°C to 45°C Capacity reduces to 70% after 300 charge/discharge cycles FEASIBILITY - POWER ANALYSIS Current (A) Voltage (V) Power (W) Pump* 3.8 12 22.8 MCU (K70P256M120SF3) 0.3 3.8 1.14 NEC 4.3" LCD (NL4827HC1905B) 0.2764 5 1.382 Total 25.322 *Assumes pump is running at 50% duty cycle Battery Voltage (V) 12 Battery Capacity (Ah) 5 Battery Capacity (Wh) 60 Expected Battery Life (Hours) 2.37 FEASIBILITY BATTERY LIFETIME Battery capacity (Wh) 60 Power draw (Wh) 25.322 Battery capacity after 300 charge cycles 70% Number of charge cycles 550 New expected battery life (Hours) 1.07 Average number of uses per week* 5 Battery lifetime (years) 2.12 *Estimated number of uses per week THERMAL ANALYSIS Goal: Ensure styrene shell won’t melt during operation Primary Thermal Loads • • • • Pump Motor (20 W) Battery (5 W) MCU (5 W) Total with FOS = 2 (60 W) Assumptions • Natural Convection (5 W/m2) • Neglect Radiation • Uniform Distribution of Heat Generation • Simplified Geometry and Removal of Accessories • 300 K Bulk Temperature RESULTS TEST PLANS FOR MCU AND MODULE Phase 1: Model View Control architecture MCU The K70 will be the Model and View. The modules are controls. • Create “test” inputs. • If a new mode is selected, it would poll the selected settings. • Passes instructions to the other modules, like the Motor controller to change the motor signal. Model: • Model should be quick to process all the information • Test Inputs should be responsible and almost instantaneous due to high risk. View: • Create display for how all the information pass through the switches and knobs. • Change in Setting during operation: • If change in setting, the display will reflect this action. • Change in mode: • If different mode was selected, it would display a set of settings specifically for the setting. SCREEN TEST PLAN Majority of the View portion of the MVC architecture. • Follow MCU tutorials to obtain basic communication with the LCD. • Create Simple GUI • Create Buttons • Create animation. Responsive stress test: • Send numerous redraw instructions to force screen to refresh as quickly as possible. If user were to spam inputs. • Calculate the average response rate. 3 PHASE MOTOR CONTROL TEST PLAN Majority of the Control portion of the MVC architecture • Test constant Voltage output. • Send constant voltage • Measure the voltage across the motor control pins over time • Test rising voltage out • Send raising voltage command • Measure the voltage across the motor control pins over time • Test pulse voltage out • Send pulse voltage command • Measure the voltage across the motor control over time • Test Sine voltage out • Send a wave of voltage command • Measure the voltage across the motor control over time • Stress test • Send series of various output patters, then quickly cut power to zero, simulating emergency cut off • Measure the voltage across the motor control over time. POWER SYSTEM TESTING Specifications Tested Test Spec Description Critical Value Nominal Value S6 Battery must be able to be charged with a range of voltages 12 to 24 V 6 to 24 V S7 Battery must output a voltage of 12V to power the pump and 5V to power the MCU 11 to 13V and 5V 12V and 5V S8 Battery must power the unit for at least 1 hour >1 hour >2 hours S15 Battery must be able to operate in all temperature situations <0° C <-20° C Tests to be run 1. Battery life - Determine how long the battery can operate the pump for before the battery shuts down at room temperature. Repeat test with temperatures of -20° C. 2. Input voltages - Ensure the battery can be charged with both 120V AC and with a range of DC voltages. 3. Output voltages - Ensure the battery can provide both 5V to the MCU and 12V to the pump for the duration of it’s life. USER INTERFACE 13 PRINCIPLES OF DISPLAY DESIGN 1. Make displays legible (or audible) 2. Avoid absolute judgment limits 3. Top-down processing 4. Redundancy gain 5. Discriminability 6. Pictorial Realism 7. Moving Part (compatibility) 8. Information access cost 9. Proximity Compatibility 10. Multiple resources 11. Predictive aiding 12. Knowledge in the world 13. Consistency Perceptual Principles Mental Model Principles Principles based on Attention Memory Principles PROBLEMS Make legible displays -readability of scales and settings Avoid absolute judgment -ranges of knobs Redundancy -usability for user Proximity Compatibility -location of user controls Top-down processing - Assimilating knob sizes with functionality NEW DESIGN PRINCIPLES Principle of pictorial realism • Battery charge displayed as symbol for battery • Heart rate indicated by heart symbol • Adding more symbols to redundantly display realism Principle of moving part • Any loaded data will mimic real movement and typical psychological movements in humans USER CONTROLSSPEAKER CUI Inc.CDMG16008-03-ND USER CONTROLSSETTINGS SWITCHES TE ConnectivitySWITCH KNOB STRGHT 0.76" W/SPIN Kilo InternationalKNOB BLK GLOSS.625"DIA.125"SHAFT Kilo InternationalKNOB BLK MATTE.50"DIA 6MM SHAFT SWITCHES Manual Switch NKK SwitchesSWITCH PUSHBUTTON DPDT 3A 125V Power Switch TE ConnectivitySWITCH ROCKER SPST 20A 125V Mode Switch Kilo InternationalKNOB BLK MATTE.50"DIA .125"SHAFT Reset Switch Grayhill Inc.SWITCH PUSH SPST-NC 1A 115V USER INTERFACE TEST PLANS Objective: how inherent it is to use; ease of use Subjects: RIT ambulance, doctors from RIT health center, ski patrollers Procedure: 1. design a mock up of user interface using actual user controls 2. design a set of tasks for the subjects to complete that simulate situation encountered while utilizing ventilator 3. record data: tasks performed correctly, general observations 3. perform statistical analysis on data collected for percentages of subjects that complete tasks correctly PLASTIC SHEETING • • • • Strong Waterproof Connections (screws, bolts, etc.) easily attached Cost Effective • Between $6-$40 for 2880 square inches. • Adjustable / Easily Worked With • When heated, becomes extremely flexible and can be bent to specified angles. (Vaccu-form, manual shaping) • When cooled, retains shape and strength. BOM Item Needed for? ELECTRICAL PARTS Li-Ion battery Powering device Car charger Charging battery in vehicle Barrel Connector (PP3-002A) Connecting battery to outside casing Barrel Connector (PJ-006AA) Connecting battery to outside casing MECHANICAL PARTS 1/8" ID Tygon Tubing (5554K11) Air Tubing 3/8" ID Tygon Tubing (5554K17) Air Tubing ENM Hour Meter Elasped Time Meter Air Pump (T1-1HD-12-1NEA) Moving Air 3/8" - 1/8" Tee Fitting (5116K401) Tube connections 3/8" 90 Fitting (2974K161) Tube connections 3/8" Straight Fitting (2974K133) Tube connections 10-24 x 1/2" Screws (90273A242) Mounting 10-24 x 1 1/2" Screws (90273A251 ) Mounting 3/8" x 12" x 24" PVC (8747K127) Baseplate 1" x 2" x 12" Delrin (8662K63) Machined Adapters SENSORS AWM2300V Mass Flow Senson Flow control NPC-1210-005-A-1-L Pressure Monitor feedback pressure Nellcor DS-100A Pulse Oximeter Measure Pulse and Blood/Oxygen Levels USER INTERFACE Speaker-CDMG16008-03-ND user interface/ warning alarms Settings Knobs user interface SWITCH KNOB STRGHT 0.76" user interface KNOB BLK user interface KNOB BLK MATTE.50"DIA 6MM Mode Switch-KNOB BLK user interface Reset button-SWITCH PUSH SPST- user interface Manual Button-SWITCH user interface Power Switch- SWITCH ROCKER user interface Manufacturer Tekkeon Tekkeon CUI Inc CUI Inc Mcmaster Mcmaster Grainger Parker Mcmaster Mcmaster Mcmaster Mcmaster Mcmaster Mcmaster Mcmaster Quantity Price/each Lead Time Status 1 1 1 1 $172.00 7-10 days $8.00 7- 10 days $1.36 5-7 days $1.49 5-7 days 1 1 1 1 1 Pack 1 Pack 1 Pack 1 Pack 1 Pack 1 1 $9.00 5-7 days $20.60 5-7 days $33.25 5-7 days $297.00 <25 days $5.57 5-7 days $6.05 5-7 days $5.53 5-7 days $6.02 5-7 days $6.89 5-7 days $23.10 5-7 days $20.65 5-7 days Honeywell GE M&C / NovaSensor Nellcor 1 1 1 $107.82 $34.33 $60.00 5-7 days on-order 5-7 days CUI Inc. 1 $2.51 5-7 days TE Connectivity Kilo Industries Kilo industries Kilo Industries Grayhill Inc. NKK Switches TE Connectivity 3 3 3 1 1 1 1 $2.96 $6.98 $6.30 $8.57 $3.21 $32.73 $3.98 5-7 days 5-7 days 5-7 days 5-7 days 5-7 days 5-7 days 5-7 days long lead time not determined not determined mechanical BOM Item LCD Screen with Touchstone TWR-K70F120M-KIT TWR-MC-LV3PH TWRPI-BLE-DEMO TWR-MCF51MM MED-SPO2 TWR-PROTO Sheets of styrene Resin bond blue foam yellow foam zippers fabric velcrow strap Needed for? COMPUTER PARTS GUI MCU Tower kit Low-Voltage, 3-Phase Motor Control Bluetooth Module Medial Development Module Pulse Oximeter ProtoBoard PACKAGING Build Housing assemble housing and models models models tote tote tote tote Manufacturer Quantity Future Technologies Freescale Freescale Freescale Freescale Freescale Freescale Curbell (RIT) TAP Plastics DOW DOW Joann Fabric Joann Fabric Joann Fabric Lowepro Price/each Lead Time Status 1 1 1 1 1 1 1 1- 4'x3' 1- 8oz. 6 sheets 15"x11"x7" 1 2 yds 1 1 Sub Total Sponsorship Total $312.23 $179.00 $159.00 $149.00 $59.00 $59.00 $14.99 $21.60 $8.00 $10.00 $70.00 $10.88 $30.00 $5.00 $15.00 $2,021.08 -$99.71 $1,921.37 5-7 days 5-7 days 5-7 days 5-7 days 5-7 days 5-7 days 5-7 days - 5-7 days Pricing Pricing Pricing Pricing Pricing Pricing Pricing RISK ASSESSMENT 2 3 4 5 6 7 8 9 10 Integration of hardware and software together inputs do not match outputs Tech Concerns electronic components; environment; mis-use; 2 3 upkeep using devices from 1 different companies that don't function together programing and calibration 2 errors 2 2 3 non-workable prototype failing to meet FDA requirements system not function; oversight on PCB not fitting in desired lack of knowledge into requirement volume how many switches need lack of space; components mountability of not coinsiding with desired components design change layout screen not compatible with downgrade screen MCU size software failure battery integration in underperforming; battery failure; not system fire hazard meeting engineering specs inaccurate readout from mass flow sensor check failure interpolation was not valid components components Durability breaking; failure of malfunctioning during failure system usage human computer interface failure operator confusion 2 2 1 1 2 2 cuttered interface 1 2 2 2 2 3 3 Importance over heating damaged components; total system failure Cause Severity 1 Effect Likelihood Risk Item Date of Completion Action to Minimize Risk Owner 6 basic thermal analysis; provide safety cautions Chris plan and read specs on all technical 2 components; test components compatability Derek Chris/ 2 quality testing of design Kennedy week 9- MSD1 week 9- MSD1 MSD2 6 schematic planning Dan MSD2-1 layout planning Melissa MSD2- 6 4 4 using a smaller screen Kennedy check with experts on 2 how to manage battery functionality Eric MSD2- 1 MSD2 2 calibrate during testing Ryan perform vibration 6 testing; perform environmental testing Ryan perform usability 6 analysis; 13 principles of display design; iterate Marie/ to next MSD group Dave MSD2- 2 MSD2 week 2- MSD2 11 Over budget 12 13 14 uncoordinated team schedule modification to design schedule; miss deadlines late delivery of parts Remaining substantially design that is not equivalent with capable with FDA current design approval 15 conflicts with customer 16 Project Concerns necessary parts more cannot build a expensive than budget 3 3 9 working prototype leaving not enough money request funding from that looks like vision for aesthetics suppliers Marie late completetion of deliverables; lack of conflicting schedules and discussion at beginning 2 3 6 of MSD2 of schedules team unity desired meeting times Dan more budget needed; change design schedule product does not match consumer needs not profitable lack of planning; problems with vendors changing the current design drastically beyond the FDA approved design change in market; change in design plans; change in prospective not meeting trends 1 1 2 3 2 2 2 3 order parts ahead of 2 time; expedite when necessary Melissa make sure any major changes to design are validated with client Chris team members should maintain open 4 communication with client; relevant market research Dave week 9- MSD1 MSD2- 1 week 5- MSD2 3 week 9- MSD1 6 benchmarking research Roberto Severity Scale: 1 = Not Severe 2 = Moderately Severe 3 = Very Severe Likelihood Scale: 1 = Not Likely 2 = Conceivable 3 = Very Likely Importance= likelihood* severity PROJECT FUTURE Features Mediresp III Worst Case volume control x BPM x peak flow x air assist x high pressure alarm x DC input 6V-16V DC internal battery x battery operation time 2-hr elapsed time meter x pump life x 2nd pressure relief x time to back-up x blood oxygen level CO2 Operation temperature dimensions 11inx13inx7in weight ~23lbs. drop height ~ 1m screen color analog b/w screen size 1in x 2.5in. 3.5in Mediresp IIII Nominal x x x x x 9V-24V x 1-hr x x x x x Best Case 0-30 deg. C >current >17lbs. color 4.3in color 6-7in 2015 x x x x x 9V-24V x 2-hr + x x x x x x wider range ~500 cubic in. 5-10lbs. 1m color >8in. Features Mediresp III Worst Case Mediresp IIII Nominal not shown cycle screen Displays Settings BPM blood oxygen level pulse pressure level mode of operation BPM setting flow CPR count charge Housing CPR Best Case 2015 all values shown with moving all values displays and shown animations shown with having option to controls and only values customize incremental shown on all on same values shown on displays screen all values shown screen screen display on default charge display on screen with graphic LED no indicator LED's via window screen monitor breaths set compressio CPR audio Audio and with dial ns instructions pictoral beat count CPAP Alarms LED and beep LED and beep shape material square metal square sheet metal Data LED and beep panel deisgn styrene message on screen form fitted w/ custom mount styrene displayed so can be recorded no storage SD or USB x audio/ visual display geometric composite internal storage w/ Bluetooth communication MEDIRESP IIII- 2015 QUESTIONS