Dr. Glancey Greg Hayes Brett Entrekin Miles Thackrah Steve Rendulic

1. Terumo Cardiovascular Systems Viable Lean Manufacturing Solutions for the Oxygenator Production Line Dr. Glancey Greg Hayes Brett EntrekinMiles Thackrah Steve Rendulic Lou Peticca Doug Bair Ed Bottomley Jen Egolf Mike Washko

2. Current Process Vacuum Leak Test Existing Machine • Time Duration is Too Long • Can be completed with less personnel

3. Current Process Label and Pertinent Part Optical Sensors Assembly Stand • System Satisfactory • Awkward to Use • Lots of Manual Labor

4. Design Requirements • Reduce Machine Process Time • Be Compatible with all 4 HE-OX and Reservoir Combinations • Perform Leak Test • Sense for Pertinent Parts and Labels • Aid in the Assembly of the Oxygenator • Ergonomically Friendly • Safe • Compatible with Class 100,000 Clean Room Requirements • Include PLC Motion Control

5. Final Concept Selection Dual Angled Stationary Leak Tester

6. How it Works • Demo • Reservoir is Placed into Cradle Support • HE-OX is Assembled onto Reservoir • HE-OX is Rotated into Correct Position for Shipping Purposes • Connecting Ring is Put into Place • Clamping Arm Secures Connecting Ring • Assembling the Two Units Together • Start Machine by Pressing go on Touch Screen • Actuators Block Open Ports and Vacuum Test Begins • Sensors Detect Labels and Pertinent Parts • Sensors and Actuators Retract, and Completed Unit is Removed

7. Final Design Subsystem 1 Clear Cast Acrylic Doors

8. Table Design: • ERGONOMICS • Applied science concerned with designing equipment that people use so they can work safer and more efficiently • STURDY DESIGN • Support a large amount of weight • Manufacture frame out of Steel • EASE OF USE • Display Touch Panel • Doors access leak testing machines • Shelf/Cubby for remaining HE-OX fixtures

9. Bottom Shelf Layout • This table must support the our design solution: • Fixtures • Actuators • Sensors • Leak testers • PLC/Electrical Board • Pumps • Buffers • Display panel • Shelf

10. 1016 mm Completed Table Frame: 50.8 mm x 50.8 mm (3.18 mm inner wall thickness) – 1045 Carbon Steel Table Top: 1159 mm x 1000 mm x 8 mm - 304 Stainless Steel Side Panels and Bottom Plate – 1045 Carbon Steel

11. Final Design Subsystem 1 Clear Cast Acrylic Doors

12. Reservoir and HE-OX Combinations SX 25 HE-OX SX 18 HE-OX 4 Combinations Reservoir 1 Reservoir 2 SX 10 HE-OX Reservoir 1 Reservoir 2 SX 25 HE-OX SX 18 HE-OX SX 10 HE-OX

13. Interchangeable HE-OX Support HE-OX Support HE-OX Rotation Stop Reservoir Support

14. Features • Three HE-OX Support blocks to use with the four combinations of HE-OX’s with Reservoir. • PLC Sensors sense Holes in block to know which combination is in use. • Rotation Stop ensures HE-OX is in correct orientation for shipping. • Reservoir Support ensures Reservoir is fixed in position during the workstation process. • HE-OX Support ensures correct positioning and ease of assembly during workstation process.

15. Cradle Support • Bottom Cradle • Back Bumper • Side Skids • Peg Supports

16. Bottom Cradle and Back Bumper • Cradle • Shaped for Reservoir 1 • Side Skids • Lead-in for Reservoir • Provides support from the sides • Holds the side pegs in place • Bottom Bumper • A stop for Reservoir

17. Peg Supports • Made to fit into the holes in the lid • Provides good support Holes

18. Final Design Subsystem 1 Clear Cast Acrylic Doors

19. Reservoir Plug Actuators • Required for vacuum check • Plugs needed for: • Reservoir Blood Out Port • Reservoir Vent Port • Two Ports on Venus Inlet Port

20. Sensors Required • Sensors Required for: • 3 Reservoir Labels • 2 HE-OX Plugs for Blood-In and –Out Ports • Connecting Ring between HE-OX and Reservoir

21. Concept Validation Delrin Part Changeover Check Oxygenator Fit Check Overall System Fit Check and Ergonomic Fit Check

22. Final Budget

23. Project Summary Completed: • 8 Delrin Base Plates were Designed, Machined, and Tested • 2 Delrin Cradle Supports were Designed, Machined, and Tested • All Sensors and Actuators have been Specified and Ordered • Table and Table Top have been Designed, Fabricated, and Tested • PLC Components have been Specified and Ordered Including a Detailed PLC Flowchart To Do: • Code and Debug PLC Program • Wire and Install all Actuators and Sensors • Add Touch Screen-User Interface • Perform Completed System Validation

24. Transition Plan • UD Senior Design and Terumo • Complete Machining of All Components • Begin Implementation of Actuators and Sensors • Final Table Top to Table Assembly • Recommendations for Terumo • Fine Tune PLC and Safety Mechanisms • Continue Implementation of Actuators and Sensors • Incorporate Workstation into Production

25. Acknowledgments • Dr. Glancey • Lou Peticca • Doug Bair • Ed Bottomley • Jen Egolf • Mike Washko • Jeff Bupp (Sheet Metal Fabricators) • Ted Berling (BSMW) • Steve Beard • UD Engineering Office

26. THANK YOU QUESTIONS?

27. Gantt Chart

28. Concept 1 Continuous Motion Leak Tester Station 1: Assembly Station 2: Leak and Label Testing Station 3: Removal from Station

29. Project Definition: Implement lean manufacturing techniques to streamline the cardiotomy reservoir assembly process, more specifically the leak test station, by creating a stand alone apparatus to match or exceed the necessary cycle time of the area as well as assist assembly of the device and check for the presence of relevant parts via electric sensors. Concept Selection All Concepts were compared to the wants and constraints and the best fitting concept was then selected. Concepts were then modified through discussions with the Terumo team and the final concept was selected.

30. Concept 2 Dual Pneumatic Stroke Leak Tester This concept uses two fixtures, which will move by means of pneumatics, and the two fixtures will be out of phase to cut back on lag time.

31. Proximity Sensors • 3 proximity sensors will be necessary to check which fixture is in the workstation, either the SX-10,18,25 or the reservoir only system. • PLC will take data from these sensors to activate correct sensors and actuators.

32. Other Electronics and Pneumatics Considerations • A modular PLC has been chosen that has expandability in regards to input and output modules • System will also require at least five solenoid valves to differentiate between actuators for different products • Valves will be controlled by PLC

33. Concept 3 Dual Stationary Leak Tester This Concept uses two stationary stands to hold and secure the Oxygenator during assembly and testing.

34. Concept 4 Dual Angled Stationary Leak Tester • Uses gravity to hold HE-OX into place during assembly. • Stationary stand simplifies machine during testing.

35. Time Line of Process

36. Wants and Constraints: • Needs • Unit must be safe for the operator to use • Less work for operator • Faster production cycle time • Allow for different size reservoir • Able to attach the HE-OX to the reservoir • Create a holder which will not scratch or damage the product • Assemble so parts are in correct position for packaging • Use machine parts that can be used in a clean room environment • Intuitive to use • Indicator of missing relevant parts • Perform the leak test • Accessible for maintenance work • Change over for different size reservoir time is less than five minutes • Completion of project by early December • Wants • Extremely simple to use • Appeasing to the eye • Improve evacuator machine leak test time • Comfortable to use • Thermo isolator attached before assembly of the HE-OX to the reservoir • Even smaller floor area

37. Benchmarking and Metrics

38. Concept Selection

39. Customer Wants

40. PLC Flow Chart Operator places reservoir into machine. Operator places HE-OX onto reservoir and machine Operator places connector ring onto HE-OX/Reservoir assembly Operator operates connecting ring clamp to finish assembly Operator starts machine PLC checks Safety Light Curtain for no breaks Go/No-Go PLC looks for fixture (SX-10,18,25) GO PLC activates correct sensors and actuators based on previous step NO GO: Machine Stop Actuators move correct sensors and plugs into position. Sensors check for 3 labels and 2 plugs PLC receives data from sensors and Vacuum Check PLC logic determines if oxygenator passed or failed Air is evacuated from reservoir for leak check Pass: Green light is displayed Fail: Red Light plus Fault indicator on screen Operator removes oxygenator and moves it to next process table Operator removes oxygenator and places it on product fail table

41. Adjustable Table • The table height should adjust to different sized operators. • Crank • Pneumatic Cylinders and Wedges • Adjusting Feet • Polypropylene Base Housed in Nickel-Plated Steel • Adjustable to a maximum of 6 inches • Supports the weight of the table • Our final desired working table height is 40 – 46 inches C=6

42. ERGONOMICS • Repetitive process: • 2-3 cycles/min • 8 hour work day • Occupational Safety and Health Administration guidelines: • Elbow height is the desired working height for a standing process • 5th percentile of women’s elbow height= 36 inches • 95th percentile of men’s elbow height= 49 inches

43. Venus Port Support • What if the Venus Port is out of Place? • Design to catch the port if close • If not close the reservoir will not fit Venus Port

44. Sensors • One stationary sensor embedded in the reservoir cradle that will sense for middle label. • Two 90 degree sensors on each side to check for side labels (one sensor on each side for each reservoir type) • Sensors for smaller SX-10 will be on actuators.

45. Plug Actuators • Pneumatic slide table for Reservoir Blood Out Port • Also needs two compact linear actuators to adjust between two reservoir sizes. • Combination of slide table and standard linear actuators to block off Vent Port • One standard linear actuator to block off each of the ports on the Venus Inlet.

46. Sensors Continued… • One stationary 90 Degree sensor to sense for plug on HE-OX blood-in port • One sensor to check for presence of connecting ring • Three light beam sensors to check for plugs on HE-OX blood-out port • Sensor detects plug presence if light beam is broken.

47. Path Forward • Order the necessary parts • Contract machinist to build our parts • Start the Assembly of the ordered parts • Assemble the workstation • Begin testing • Sensors • Actuators • Leak Tester • Parts Tester • PLC Programming • Frame • Completed Table

48. Testing • HE-OX and Reservoir Support Fit Test • Assure the proper fit of all units into workstation • Pneumatics and Actuator Testing • Assure no entanglement/interference between actuators/sensors and product part • Assure leak test is calibrated properly • Sensor Test • Assure sensors are properly calibrated and can detect a “bad” unit • Test Safety Feature of Workstation • Light Curtain • Ergonomic constraints • Final Testing • Assure all subsystems interact correctly • Verify all metrics are met (Operator Lag Time)