Team Members: Jon Klein Nguyen Vu Kyle Menges Christine Lowry Chris Stein Priya Narasimhan Julie Coggshall

Pg.1 Meeting Timeline Start Time Topic of Review 10:00 Introductions, Review Agenda 10:02 Design Review 1 Action Items 10:03 System Design and BOM 10:15 Fluids Analysis – Electrical Simulation, Results 10:35 Blood Tank – Bubble Rise Time, Fluid Extraction 10:40 Water Bath – Heat Transfer 10:45 Tubing – Heat Transfer 10:50 Automated Resistance - Linear motor’s force approximation 11:00 Compliance Tank – Arterial Tank Dimensioning, Electrical Equivalent Model 11:15 Custom LVAD Connection 11:20 System Drain – Saline Flush 11:25 Pressure, Flow, and Temperature Sensors and DAQ 11:50 LabView Front Panel Concept 11:55 Wrap-up

To review the detailed design proposal to ensure design adequacy. Pg.1

1.Generate pressure and flow curves for static system (automatically adjusted) 2.Extracting fluids while running to determine damage to blood 3. Process data to generate pressure and flow curve for dynamic system (scaled model of the physiological circulatory system working with a PVS) Pg.2

Item #DescriptionResponsibleComments A001Create Quick Connect DesignIE-Jon Valve and non-valve connections A002Reservoir Calculations – Air BubblesME-Nguyen Calculated bubble rise time A003 Temperature Control – Heating Tank, find out what changes are in the human body with regards to temperature? ME-Chris Heating element, water bath A004Should we use the flow sensors Dr. Day has?EE-PriyaYes A005 Pressure Sensor Selection – are resolution, output format and frequency response appropriate? Will sensor trap blood? EE-PriyaUse Bleed port A006 Select Resistance Generation Method – research automated clamp valve ME - KyleAutomate clamp A007Compliance Tank Analysis – Do we need two tanks?EE-PriyaDo not need A008 Compliance Tanks – What are the clinical comparisons for the compliance values, what about different disease states. ME-Christine, Nguyen Ideal value ~2 mL/mm Hg, range varies for different diseases A009Blood removal - Look into self healing membrane.ME - Chris Disposable syringe, extended connection Pg.5

Engr Spec #MetricUnitsImportanceIdeal Value Lower Limit Upper LimitNotes System Properties ES1System Leakage# leak locations5002 ES2Systemic Vascular ResistanceMPa·s/m Reflects the average range for human body ES3Arterial CompliancemL/mm Hg5212.2at approximately 100 mm Hg fluid pressure ES5Blood damageg Hgb/100 ml Must be biocompatible to use and not damage blood ES6Portabilityminutes345160How long it takes to prepare and actually move ES7Drain Timeminutes ES8Fill Timeminutes ES9CostU.S. Dollars ES10Blood System Volume liters For blood testing - Approximately $100/liter of blood Fluid Properties ES11ViscosityN·s/m Water at 37 C ( ), Blood at 37 C (0.0027) ES12Densitykg/m Water at 37 C (992), Blood at 37 C (1060) Data Management ES13Pressuremm Hg Current loop pressure sensors measure ±15 psi ES14Pressure Accuracymm Hg ES15Flow Rateliters/minute56010Adult flow rate approximately 6 lpm ES16Flow Rate Accuracyliters/minute ES17Temperaturedegrees C (F)537 (98.6)21 (70)49 (120) ES18Temperature Accuracydegrees F ES19Data Processing/Outputseconds310060Time to process data into graphical representation Sample Extraction ES20Sample Extraction Timeseconds ES21Sample Extraction Sizemilliliters3425Somewhere between 2-5 ml Test Rig Physical Dimensions"Cart size" ES22Heightinches ES23Lengthinches ES24Widthinches Pg.4

Summary Likelihood (1-3) Severity (1-3) RPN Total Number of 3's23 Risk AreaRisk ItemDescription/CommentLikelihood Severity Level Risk Priority NumberMitigation Activity Cost Pressure Sensors Desired sensor accuracy not within budget123 Find suitable DAQ to achieve accuracy DAQ Dedicated DAQ system not within budget326 Investigate costs, potential for sharing existing DAQ system Physiological Simulation Compliance Tank Desired compliance value not achieved236 Early milestone in test plan to ensure enough time to fix the problem Temperature System temperature is not maintained122 Monitor fluid and VAD temperature, implement temperature control system Viscosity Viscosity variation does not simulate human blood properties224 Research and verify the proper mixture of water/glycerin is used, control/maintain temperature

Risk AreaRisk ItemDescription/CommentLikelihood Severity Level Risk Priority NumberMitigation Activity Measurement Inaccurate measurements Pressure and flow measurements are inaccurate224 Use proper instrumentation and verify proper placement. Discuss with experts prior to purchasing. DAQ Error Instrumentation and DAQ not communicating properly, DAQ does not collect or output data properly236 Debug software, document procedure for DAQ operation and troubleshooting. Discuss with experts prior to purchasing. Design Leak System or components leak causing error in measurement and/or contamination224 Early milestone in test plan to ensure enough time to fix the problem Air bubbles Air bubbles cannot be removed from system – tank sizes do not allow for bubbles to escape, or there are low points in the system122 Early milestone in test plan to ensure enough time to fix the problem. Use alternative fill method to reduce bubble formation Blood Damage Valves, sensors, connectors damage blood339 Early milestone in test plan to ensure enough time to fix the problem. Put in separate, simplified loop Resistance Flow restriction does not function properly122 Design for the implementation of a back-up, manually controlled resistance method

Severity (choose most severe) Risk Ranking Likelihood ProductProjectInjury 3 Highly Likely > 50% Complete product failure, does not functionComplete project failure Severe injury, potential death 2 Somewhat Likely 20% - 50% Meets some customer needs and specifications, product performs with less functionality than desired Moderate impact to budget schedule Treatment required 1 Rare % Performance of product is not impactedNo impact to project budget or scheduleMinor or no injury Score level to Change Color: LikelihoodSeverity RPN Red336 Yellow223 Green111

Pg. 6-7

BOM 3/4" to 1/2" Polypro reducing coupling (PVS inlet) [McMaster] 1" NPT x 1/2" Barbed threaded fitting for PVS (Nylon) [McMaster] 3/8" NPT x 1/2" Barbed threaded tank fitting [Eldon James] EW Glycerin Tank - Barbed T- connector (HDPE 1/2" x 1/2") [Cole-Parmer] Y connector [Eldon James]

Glycerine Tank - Shut-off Valve (1/2" to 1/2" barb)[Eldon James] Reducer 1 to 1/2 plastic (HDPE) into PVS/Reducer 3/4 to 1/2 plastic (HDPE) Out of PVS [Cole-Parmer] BOM

Biocompatible Non-valved [Cole-Parmer] Biocompatible Valve [Cole-Parmer] BOM

10Qt [McMaster] BOM

Sam’s Club Dimensions: 43.9”L x 25.6” x 33.3”H Weight: lbs. BOM

Pg.8 Blood Loop

Glycerin Loop Pg.9

Pg

Properties & Equations: Assumptions: The assumptions that were chosen for the fluids analysis include: Laminar Flow Incompressible Flow Steady State Summary: Using the assumptions listed above, the head losses associated with diameter changes, connections and sections of tubing were analyzed The steady-state assumption at the desired flow rate (6 L/min) for the Physiological Loop is assumed to be “worst-case” in regards to the head losses. The analysis proves that there is adequate flow and pressure within the system to allow for adjustments to be made through testing to compensate for the non-steady characteristics Pg

Blood Loop Fluids Analysis Results (Q= 6L/min) h lT = in 2 /s 2 P VAD Out = 100 mmHg (1.93 psi) P VAD In = mmHg (0.65 psi) ∆P VAD = mmHg (1.28 psi) Pg

Physiological Loop Fluids Analysis Results (Q= 6L/min) h lT = in 2 /s 2 P VAD Out = 100 mmHg (1.93 psi) P VAD In = mmHg (0.65 psi) ∆P VAD = mmHg (1.28 psi) Pg

Pg FbFb FdFd mg 2R Analysis: The bubble will reach its maximum velocity when the acceleration is zero: The distance is in meters, and the time is in seconds. We calculated for a bubble of 0.5mm in radius. All the bubble with smaller size will take more time to rise. After calculation in Maple, we found that the time and distance for that the bubble reach its maximum velocity are negligible. So we can assume that the velocity of the bubble is constant with the value V=V max =0.213m/s. As a result, the traveled distance is represented as below:

Stainless Steel [Mopec] Stainless Steel Lid [Mopec] BOM

B-D Disposable Luer-Lock 5mL Syringe[Cole Parmer] Stainless steel cannula (13 gauge luer-lock) [Cole Parmer] BOM

10 Qt: [McMaster] BOM

Pg Screw-Plug Immersion Heater 304 SS, W/Temp Control, 120 Volt, 1000 Watts, 1" NPT Submersible Pump for Water PET Plastic Housing, 1/40 hp, 115 VAC, 6' Cord Parts From: McMaster-Carr

Pg Tank Dimensions: Ø = 4.875” x 5.5” T w T b T w = 98 o F = K T b = 70 o F (room temperature) = K Attempt w/ LCM (Lumped Capacitance Method) r2r2 r1r1 TiTi q” TiTi T∞T∞

Tank Dimensions: Ø = 4.875” x 5.5” T w T b T w = 98 o F = K T b = 70 o F (room temperature) = K Attempt w/ LCM (Lumped Capacitance Method) Results: Time for the blood loop to heat less than 2 hours. Show temperature rise will be less likely to damage the blood. Pg

Tygon 1/2" ID tubing (S-50-HL Medical Grade) AAX00037 Tygon 7/8" ID tubing (S-50-HL Medical Grade BOM

Stepless ear clamps [Oetiker] Double Snap-Grip Nylon Hose and Tube Clamp[McMaster] BOM

Pg T ∞ =70 o F T i =98 o F Tm=? y x | | Pg. 498 equation 8.37 Properties and Equation from Fundamentals of Heat and Mass Transfer 6 th editions Solution Homogenous: Assume solution: Particular Solution Assume Solution: Now:

Pg

Back Up Manual Resistance Automated - linear actuator & stepper motor combination (Anaheim Automation) Parallax BASIC Stamp 2 microcontroller (to control stepper motor) Competitively priced, high resolution digital captive linear acutuators Linear force up to 22.5 lbs (100N) Linear step resolution of.001”,.002” and.004” Unipolar and bipolar coil constructions Fast, powerful and precise positioning Precision radial ball bearing design Industry standard frame size Customized designs available %20TSMCA42%20Spec%20Sheet.pdf gKits/tabid/136/CategoryID/11/List/0/SortField/0/Level/a/ProductID/294/De fault.aspx Pg. 30

Pg.31 Arterial Tank: Acrylic 7.2in tall 8in OD 7.75in ID Bottom & Top: Acrylic 9in OD thickness Bolts: Steel Hex Nut (1/4"-20, 7/16” width, 5/32" height) x8 Washer: Stainless Steel x8 Silicon O-Ring x2 Barbed Hose Fitting (Stainless - pressure regulator hook- up) (53505K72) Quick-connect Air Hose fitting (3/8" NPT threaded) Low-Pressure SS Case- Gauge +/-1% Accuracy 4" Dial, 1/4" NPT (McMaster) Cole-Parmer Pressure Regulator

Resistance Calculations V air =Volume of air in tank A tank = Cross sectional area of tank V tank =Volume of tank P fluid =absolute pressure of fluid Tank size Calculations = density of fluid g=Acceleration due to gravity C= Compliance P air =absolute pressure of air Source: University of Virginia Article, Design Initial testing of a mock human circulatory loop to test LVAD performance Source: Berne R. etal Physiology 4 th edition Mosby, St Louis 1998

Pg. 32

Saline Flush Pg. 33

Pg. 34 Sensitivity V/liter Resolution – 7.8mV Flow sensor (Transducer+board digiflow-ext1 ) SpecsModel's specs Resolution1ml/min Output format-5V to 5V Max measurement Frequency 15kHz to 18MHz (transmitter frequency) PriceDon’t need to purchase

Pg.34 Pressure Sensor (Omega PX26-005DV ) SpecsModel's specs Output 50mV Price$36.00 Sensitivity – 10mV/psi Resolution – 36.1µV

Pg. 35 Thermocouple. (Omega - KMQSS-020G-12 ) SpecsModel's specs TypeUngrounded Price$28.65 S

Pg Thermocouple DAQ (NI 9211A) SpecsModel's specs Resolution24bit (9.54nV/code) Number input pins4 Voltage range-80mV to 80mV Sampling rate15 S/s (samples per secs) Price$521 DAQ ( OMB-DAQ-54) SpecsModel's specs Resolution22 bits (4.761µV/code) Number input pins10 single ended Voltage rangePer Channel 31mV to 20V Sampling rate80 S/sec Price$649

N RISK Dedicated DAQ system not within budget 6 Instrumentation and DAQ not communicating properly, DAQ does not collect or output data properly 6 Pg.11 ?More needed ?