Revolution Centrifugal Pump Performance Overview Rev 2.1

Centrifugal Pump Challenges Bearing Failures Leaks Decouple Noise & Fractured Magnets Thrombus Generation & Hemolysis Air Entrapment Vane Impeller = Blender Flow Sensor Issues Ease of Set-up This is a list of issues, past and present, with centrifugal pumps. How Revolution addresses each of these is covered in this presentation.

Designed by the experts in centrifugal pump design. Revolution was designed by a pair of engineers that have spent most of their careers designing centrifugal blood pumps. Their work is done under the name SPIN Corporation. COBE Cardiovascular, now Sorin Group, purchased the 3rd generation design from SPIN Corp. Our engineers solved a few of the technical issues with the bearing design, resulting in the present design. The result is an advanced centrifugal pump, that builds on previous designs, some of which are still in the market today. The work of SPIN Corporation can be verified by conducting an internet search under “SPIN Corporation blood pump”. From their you can learn about the history of the company and the patents they were awarded.

Unique molded magnet driver: Fills internal space Assures balanced magnet Consistent performance One of the most interesting characteristics of the Revolution pump is the magnet design. A unique material, called neodymium, is magnetic but when compounded in a specific way, moldable. Using a molded magnet allows the shape to be round for precise balance at high rotational speeds and mated to the housing to fill the internal space. The result is a stable, repeatable design that provides very consistent performance.

Simple Assembly = High Quality Pump Assembly Manufacturing Process 100% Quality Control Process Designed for manufacturability Simple assembly Minimal parts Ultrasonic weld Fewer parts means fewer assembly processes, both lead to few opportunities for a defect. Use this slide to show how the pump shaft rides inside the bearings (white and red). Simple Assembly = High Quality

Internal Features 1. Patented Curved Inlet Port 2. Patented Seal-less, Low Friction Upper Bearing 3. Patented “Spin-Inducer” 5. Ultrasonic Weld Upper & Lower Housing 4. Impeller floats while pumping There are numerous other unique features in the Revolution design that create a high performance pump that is very reliable. From top to bottom: 1. The inlet uses a patented curved design that allows the central shaft of the impeller to be positioned on the center line and delivers the inlet flow to the center as well. 2. The patented bearing design stabilizes the center shaft with no moving parts, which could create friction, and thus no seals are required. The small amount of heat that is generated by stabilizing the shaft is removed by the incoming blood. 3. The patented spin inducer is unique to centrifugal pumps. By having a small portion of the impeller spinning in the inlet region, fluid actually begins rotation upstream of the pump. Later in this presentation there is a video that illustrates this effect. The benefit is smoother transition from linear flow in the tubing to rotational flow in the pump. The impeller can move up and down along the centerline of the pump. This reduces friction in the bearings and allows the pump head to “float” during uses, with the magnetic forces pulling the impeller toward the driver offset by lifting forces from flow upward thru the wash out holes. The pump housing is sealed using an ultrasonic weld which melts the halves together. Since there are no solvents, the joint is more consistent and stronger. The next slide animates the flow path within the pump.

Flow Path Flow enters the inlet rinsing the top bearing Centrifugal force moves fluid to the outside Fluid not leaving the pump moves back to the low pressure center, rinsing the bottom bearing Recirculation is completed by fluid moving up thru the central channel As fluid moves up thru the central channel, it lifts the impeller off the bottom bearing, opposing the magnetic forces, reducing bearing load and bearing friction. The impeller literally floats.

Pump-Head Internal Surface Area Revolution’s small surface area reduces platelet activation. Testing documented in Sorin Group Engineering Report SPN0263

General Specifications data source: Manufacturers IFU Model Prime (ml) Rate Flow (lpm) Rated Press (mm Hg) Max Speed (rpm) Revolution 57 8 800 3500 Medtronic Biopump 89 900 4400 Sarns Delphin 52 9.9 700 3600 Lifestream Isoflow 65 9.99 Jostra Rotaflow 32 10 750 5000 Terumo Capiox 45 3000 General Specifications data source: Manufacturers IFU

Test Circuit 2 cc of air injected Volume collected in chamber This test injected 2 ml of air and measured how much went thru the pump. More is worse. Walk thru the test circuit. Explain how the air collection chamber allows even small volumes of air to be captured and measured. Volume collected in chamber

Computational Flow Dynamics Large changes in velocity would indicate vortexing. Note steady increases from center to end of vane tips. Computation Flow Dynamics is interesting. You don’t have to be an expert to explain it. In this plot we are looking at flow velocities. Sudden increases or decreases would indicate vortexing. Walk thru the changes at the tip of the impeller on the flow scale. Note how the changes follow the progression of the colors.

Computational Flow Dynamics Analysis featured in Dynamics magazine Click here to read the article or go to: This is a reference for our CFD work. http://www.cd-adapco.com/press_room/dynamics/18/

Click on picture to start/stop video Flow Visualization Dr. Robin Shandas Professor of Pediatric Medicine & Mechanical Engineering – University of Colorado Validates CFD: No Vane Tip Vortices Gentle acceleration from center to outer diameter This video shows the motion of particles at the vane tips, illuminated with a strobe light to “freeze” the impeller. If vortexing occurred, the particles would move in a circle. Click on picture to start/stop video

Click on picture to start/stop video Flow Visualization Unorganized flow upstream of inlet Another flow visualization using particles. Note the random motion pattern. Upstream of inlet Click on picture to start/stop video

Click on picture to start/stop video Flow Visualization Organized flow approaching inlet As flow approaches the inlet the particles move in a more straight line, organized path. Near inlet Click on picture to start/stop video

Click on picture to start/stop video Flow Visualization Smooth rotational flow at inlet due to spin-inducer Again, note the organized flow entering the inlet. Inlet Click on picture to start/stop video

Click on picture to start/stop video Flow Visualization Rotational flow created by spin-inducer This video take a little while to get to the illustration. Start it then describe the action of the cone portion of the impeller to begin rotational flow upstream of the pump. Spin-inducer Click on picture to start/stop video

Plasma Free Hemoglobin at 360 min This test compares plasma free hemoglobin after running for 360 minutes. The test was run on five of each devices. The error bars show the variation in results. The P value compares the results for each pump to the Revolution. The p value indicates the probability of the data indicating similar performance (the null hypothesis) is wrong. Typically a p value less than .05 is used to define statistically significant differences in results, in other words, rejecting the null hypothesis. Low Hemolysis Testing documented in Sorin Group Engineering Report SPN0263

Plasma Free Hemoglobin Although Revolution is located in the middle of this graph, comment that is is comparable to the best pumps out there. There are two groups in this graph. Note the large increase between Revolution and BP-80. The pumps will higher hemolysis use a old fashion bearing design. Low Hemolysis Testing documented in Sorin Group Engineering Report SPN0263

Index of Hemolysis Low Hemolysis P=.047 P=.076 P=.007 P=.464 P=.799 Index of Hemolysis is simply a standardized way of looking at plasma free hemoglobin from a hemolysis test. The test was run on five of each devices. The error bars show the variation in results. Again, note the two groups – low and high. The P value compares the results for each pump to the Revolution. The p value indicates the probability of the data indicating similar performance (the null hypothesis) is wrong. Typically a p value less than .05 is used to define statistically significant differences in results. Given these data, including variability shown in the error bars and assuming the .05 significance, the Revolution has statistically significant lower Index of Hemolysis than the BPX-80 and BP-80. Low Hemolysis Testing documented in Sorin Group Engineering Report SPN0263

Temperature at 360 min Low Heat Generation This test compares the heat generated by the bearings in a recirculation loop over a long period of time. In this case 6 hours. Temperature increase is another indication of the heat generated by the bearings. Low Heat Generation Testing documented in Sorin Group Engineering Report SPN0263

Pressure-Flow (@ Maximum RPM) This graph shows pressure at maximum RPM from 0 to 8 LPM of flow. Running at max RPM is important to underscore in this graph. Flow is reduced by occluding the outlet tubing, then pressure measured at the pump outlet. In the Revolution, as outlet flow is reduced, internal recirculation flow increases, which keeps pressures relatively flat. Note the Revolution is the only pump to moderate maximum pressure this way. Testing documented in Sorin Group Engineering Report SPN0263

Pressure generated at 5 LPM This graph shows the pressure generated at specific pump speeds for a variety of pumps. Higher efficiency pumps generate more pressure (fluid driving force) at lower RPMs. So a curve farther to the left is better. Note the pumps that use shear stress (cone designs) to generate pressure require higher RPMs. High Efficiency: Highly efficient pump reduces hemolytic heat generation. Testing documented in Sorin Group Engineering Report SPN0263

A “Friendly Reminder” … Revolution uses fluid as part of the assembly…… Never run pump-head “dry” due to bearing design Do not introduce compressed air into pump-head

Thank you for your time and attention today! Contact Us Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Toll free: 800.221.7943 www.soringroup-usa.com