P08025 – LVAD Durability Test Machine

1. P08025 – LVAD Durability Test Machine Project CARNA Scott Carlson Project Manager Jim Cezo Lead Mechanical Engineer Chris Dickens Lead Electrical Engineer Emily Berg Mechanical Engineer Tim Dovi Mechanical Engineer Suraj Jaisinghani Computer Engineer June Lee Computer Engineer Syung Lee Industrial Engineer Ronan Mabiala Electrical Engineer Jackie Sergi Mechanical Engineer Sponsor – Dr. Don Olsen of the Utah Artificial Heart Institute

2. LVAD (Left Ventricular Assist Device) Provides congestive heart failure patients with a high quality of life while waiting for a heat transplant (Bridge to Transplant) The LVAD-R2 is currently being developed at RIT 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 – Background Information

3. Probability of failure < 2% over 2 years 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 Allow multi-unit connection and operation (10 VAD Units) Measure the LVADR2’s performance Safely store VAD data Provide remote and local access to the data Allow non-invasive maintenance and / or emergency repair Cycle through average human activity on a schedule P08025 – High Level Customer Needs

4. P08025 – Selected Mechanical Concepts • Dual tank design • Head tank to control pressure at LVAD inlet • Sump tank to drain to atmospheric pressure • Bypass system for non-invasive maintenance • Replace failed sensors or valves • Swap and re-validate sensors • Interchangeable parts • Mobile station / Wet dock

5. P08025 – Mechanical System

6. P08025 – Mechanical System

7. P08025 – Bypass Loop

8. P08025 – Bypass Loop

9. P08025 – Selected Electrical Concepts • Pump Test Module (PTM) • Data acquisition • Measures a pair of VAD and flow loop signals • Controls flow characteristics • Single-fault tolerant data buffer • Listens for requests/commands from the DMC • Data Management Center (DMC) • Central data storage (MySQL) • Multi-master date replication • Remote access • Double-fault tolerant data storage • Off-site data storage • System health monitoring • Power grid isolation

10. VAD 1 Loop 1 PTM 1 Network Switch Health Monitor (HM) Notify GSM Wireless Network Technician VAD 2 Loop 2 PTM 2 Phone VAD 3 Loop 3 PTM 3 SMS VAD 4 Loop 4 PTM 4 Email VAD 5 Loop 5 PTM 5 DMC Node 1 Internet Off-site Storage Node 1 VAD 6 Loop 6 PTM 6 VAD 7 Loop 7 PTM 7 VAD 8 Loop 8 PTM 8 DMC Node 2 Off-Site Storage Node 2 VAD 9 Loop 9 PTM 9 VAD 10 Loop 10 PTM 10 Power Plant Standby Generator

11. P08025 – Data Management Center

12. P08025 – Success of CARNA • Both systems validated independently • Not yet fully integrated • Computer / Electrical • Full system performance simulation • Burn-in test for computer components • Proper connection of wires • Valve control system • Mechanical • Leak test • Maximum temperature of 88ºF • 20º increase from ambient in 12 hours • Maintain constant head • Maintain head within ¼” of water under several operating conditions • Successful transition from main to bypass loops • Air bleed test

13. P08025 – CARNA Budget • Initial Budget = $9,100 • Money spent to date = $8,500

14. P08025 – Mechanical Pros and Cons • Strengths • 2 tank system • Ability to maintain necessary head pressure • Non-invasive maintenance • Redundant loop • Entire system is highly visible • Weaknesses • Interchangeable parts are mirror images • Flow directional parts • Over-the-side heater • No fail-safe for return line • No one-way valve on return line • Wet dock not easily serviceable • Need to remove bulk heads to remove tank from fixture

15. P08025 – Electrical Pros and Cons • Strengths • Fault Tolerant • Data acquisition • Control and storage • Secure • Network isolation • Encrypted transport • Privilege based remote access • Designed for Reliability • Linux / National Instruments RTOS • Simple control scripts • Weaknesses • Lack of 3rd party software support contracts • Sensitivity to environment • PC Hardware • Spindled storage • Power supply • CPU fan • RJ45 Connectors

16. P08025 – Future Improvements • Health monitoring system • User interface • Power plant • Fill size tank system with 10 modules • 2nd return pump • Fail-safe • Inline water heater

17. Salinity Temp. Tank-less Heating Level Boolean Flow Submersible Pump Rotary Pump P08025 – Future Improvements

18. P08025 Would Like to Thank: • Dr. Steven Day • Dr. Daniel Phillips • Dr. Don Olsen • Tyler Oderkirk • Wayne Berg • Dr. Mark Kempski • John Wellin • Bill Finch • Our Audience