1. 1 P08025 – LVAD Durability Test Machine Project CARNA Scott CarlsonProject Manager Jim CezoLead Mechanical Engineer Chris DickensLead Electrical Engineer Emily BergMechanical Engineer Tim DoviMechanical Engineer Suraj JaisinghaniComputer Engineer June LeeComputer Engineer Syung LeeIndustrial Engineer Ronan MabialaElectrical Engineer Jackie SergiMechanical Engineer Sponsor – Dr. Don Olsen of the Utah Artificial Heart Institute

2. 2 LVAD (Left Ventricular Assist Device) Provides Congestive Heart Failure Patients with a high quality of life while waiting for a heart transplant (Bridge to Transplant) The LVAD-R2 is currently being developed at the Rochester Institute of Technology CARNA is a tool to gain FDA Approval for an Investigational Device Exemption (IDE), which will allow the LVAD- R2 to enter Clinical Human Trials. P08025 – LVAD Durability Test Machine Background Information

3. 3 Probability of Failure < 2% over 2 years Will run for 2 years uninterrupted with the following exceptions – Critical Signals may be lost for 24 hours (with proof of VAD normal operation) – Non-Critical Signals may be lost for 72 hours Will Allow Multi-Unit Connection and Operation (10 VAD Units) Will measure the LVADR2 Performance Will Analyze data to detect faults and early warning signs of VAD Will Safely Store VAD Data Will Provide Remote and Local Access to the Data P08025: CARNA High Level Customer Needs

4. 4 P08025: CARNA Sub-System Breakdown Data Management Center [DMC] Power Plant Pump Test Module [PTM] VAD Flow Loop Health Monitor Tank Off-Site Data Storage Center [DSC]

5. 5 Design meets all customer needs, with some caveats: – Two year continuous run time assumes a constant supply of uninterrupted power – Health monitor will not be incorporated into project at this time Detect early warning signs of pump and CARNA & alert users Design meets engineering specifications – Same caveats apply to health monitor specifications Initial project budget of $4,000 underestimated due to robustness and complexity of subsystems – Current projected cost of $12,225 Mitigations – Projects not being tackled this term (e.g. power plant, health monitor) will be spec’d out for future Senior Design work, current possibility of 3 design projects. P08025: CARNA Current State of Design

6. 6 Need two tanks to generate pressure needs – Head tank to control pressure at LVAD inlet – Sump tank to drain to atmospheric pressure Non-interrupting maintenance – Replace heater without loss in flow – Planned Maintenance of primary and secondary return flows Single fault tolerant – Primary pump fails – Level sensor detects change in tank height – Backup sump pump activated Selected Concept - TANK System

7. 7 Submersible Pump Rotary Pump Tank-less Heating Salinity Temp. Level Boolean Flow

8. 8 Project CARNA - System Layout

9. 9 Non-interrupting maintenance – Replace failed Sensors or Valves (Fail-safe Open) – Planned Maintenance [Swap and Re-Validate sensors] Interchangeable parts – Fast, easy change out Selected Concept - VAD Flow Loop System Ball Valve Globe Valve Boolean Flow TempFlowPressure

10. 10 Selected Concept - VAD Flow Loop System

11. 11 Selected Concept – Data Management Center [DMC] Two Redundant PC’s with Linux OS – Receive Data from PTM via Ethernet – Analyze and Store Data – Make Data Available Remotely In addition, the DMC will do the following: – Provide a Local User Interface Real-Time Performance and Statistics VAD Flow Loop Configuration Trouble-Shooting / Repair Procedures – Communicate with the Health Monitor

12. 12 Parallel Ethernet Switch PTM #2 RAID-1 Storage MySql Database Firewall Services PTM Comm. Node 1 Node 2 Heartbeat PTM #4 PTM #7 PTM #3 PTM #8 PTM #10 PTM #5 PTM #6 PTM #9 LUI Touch Screen Display Selected Concept - DMC PTM #1 RAID-1 Storage MySql Database Firewall Services PTM Comm. Heartbeat LUI

13. 13 PC with National Instruments RTOS and DAQ Hardware will measure all signals from the VAD and the VAD Flow Loop. In addition, PTM will do the following: – Receive control messages from the DMC – Store the data locally – Send the data to the DMC through Ethernet – Communicate with the Health Monitor – Measure adjacent VAD and VAD Flow Loops Selected Concept – Pump Test Module [PTM]

14. 14 Pump 1Loop 1 Pump 2Loop 2 Pump 3Loop 3 Pump nLoop n Pump 8Loop 8 Pump 9Loop 9 Pump 10Loop 10 PTM 1 PTM 2 PTM 3 PTM n PTM 8 PTM 9 PTM 10 Single Fault Tolerance If one PTM unit fails, ALL pump signals are still measured. If 2 non-adjacent PTM units fail, ALL pump signals are still measured. Pseudo Double Fault Tolerance Selected Concept – Pump Test Module [PTM]

15. 15 Project Size Proving Reliability Software Analog Data Acquisition P08025: CARNA Identified Risks

16. 16 Project Size Attempt to do too much Larger Budget  Bigger Failure Solution: Renegotiated customer needs Asking: Is it necessary? P08025: CARNA Identified Risks

17. 17 Proving Reliability Testing MTBF and Reliability Statistics Solution: Continuing to Research Statistical Methods Shifting Resources P08025: CARNA Identified Risks

18. 18 Software Size and Complexity National Instruments RTOS Solution: Flowcharting Software Researching RTOS Acquire Development Hardware Soon P08025: CARNA Identified Risks

19. 19 Analog Data Acquisition Noise Large Quantity of Collected Data Solution: Industry Standard – National Instruments Plan to Experiment and Optimize P08025: CARNA Identified Risks

20. 20 Dec 3: Begin Software Development Dec 10: Design finalized and all components purchased Jan 4: Completion of loop assembly Jan 5: Begin initial testing phase and incorporating electronics Feb 2: Run continuous test and continue Software Development Feb 15: Documentation finalized: technical paper, poster, design history file Feb 29: MSDII Final Design Review P08025: MSD II Project Schedule Milestones

21. 21 CREDITS Dr. Steven Day Ron Kipp Dr. Don Olsen Dr. Daniel Phillips John Wellin Bill Finch Dave Gomez Dr. Mark Kempski Dr. Ed Henzel Dr. Taylor Our Audience THANK YOU!