10-f2003-report - University of Delaware
Contents
1. 34 7 8 9 Hose connection Diagram with assembly notes 35 Appendix B Bill of Materials aana eaaa AGA AA AASA 37 Appendix C Electrical Drawings Ericlosure Ope eee dose Saba d wus et 38 Single Line Wire Diagram 12 VDC 39 Single Line Wire Diagram 24 VAC 2 2 40 Plumbing Diagrami APA tetas ooa te pestes PERA 41 REG Wiring Layout AA APA AA 42 Pneumatic Cylinder Diagram pp 43 Enclesure Closed 25555552 set hs es m rates fie ane 44 Appendix D Manuals Operations Manual es seen ea e ctr tan x eor Cod ner han 45 Emergancy Procedure pp 48 Maintenance einen 48 Appendix E Welding Analysis 49 2 Problem Background Terumo is a Japanese based medical supply company They asked our team to design test and build a prototype that can mass clean medical catheters medical catheter long flexible hollow plastic rod designed to fit into arteries in the human body Once inserted the interior portion of the catheter is removed leaving a pathway into the body At this point the physician can either insert a micro camera or any other type of medical tool that they see fit The current tubing dimensions range from about 18 to 41 in length The internal d2. 0 5 DEC DRAWING TITLE BILLING ACCOUNT 21 22 Drawing 2 Lower Manifold 60 250 THREAD SIZE E TETERNIET FOR 4 gt TILERANCES wo TERUMO TITLE 20 MANIFOLD FEMALE 1 XX x 020 DRAWN DATE 11 03 03 FRACTIONAL APPROVED mr 1 32 MER DERN Er 1 ANGLIA SCALD 01 25 BILLING ACCOUNT Drawing 3 Bearing Brace 10 diameter TOLERENCES PROJECT OR CLASS UNLESS senlor design OTHERWISE Team 10 NOTED DRAWING TITLE DECIMAL XXX 005 XX 010 s va BILLING ACCOUNT LNA054 ON 11 925 ALINYNO umaq AC ED LTATT 150 IAT NAYAIL quoddnsg ly LIL OT woa UBISSR 155912 1 Drawing 4 cylinder support GO y TINY F TY 050 X olo XX S00 lt T310N 3SIMHIHLO 554 SIINIYITOL 24 Drawing 5 Base plate TOLERENCES PROJECT OR CLASS MEEG401 NOTED DECIMAL XXX 005 010 X 050 DRAWN By JBlyer DATE 11 04 03 1 32 MATERIAL 4 Stainless Plate quanity 1 ANGULAR SCALE unknown DRG NO 5 05 00 surme account BILLING ACCOUNT Base Plate 26 Assembly Drawing
3. 3 8 OD x 5 16 ID PTFE tubing cut to fit 1 4 x 1 4 hose push to fit connector 1 4 OD x 3 16 ID PVC hose 3 8 compression fitting Tee 1 8 NPT x 1 4 push to connect tube air flow control valve K 7 4 way custom 3 8 Compression fitting 3 8 OD x 5 16 ID PTFE tubing cut to fit 3 8 tube compression fitting x 1 8 NPT Elbow Page 31 Assembled Drawing Front View Assembly Drawing 5 Page 33 Assembled Drawing Rear Isometric View Assembly Drawing 6 Page 34 Page 35 Connection Instructions Connections labeled with corresponding letters connected with 3 8 OD x 5 16 ID PTFE Tubing cut to fit connections are compression fittings Connections and G are connected to compressed air supply regulated to 50 PSI Connections E 3 places are pressure relief valves with exhaust tubing leading to in house exhaust Page 36 Appendix B The following is a listing of all the materials used and their sources Purchased Donated items Description Company Obtained from heck Valves Deltrol Fluid Products EC 2088 0703 Purchased from McMaster Carr 47885k91 40 42 2 14 male 75 Psi Pop Safety valves CRN0631441c Purchased from McMaster Carr 498905k15 63 19 2 P Pneumatic Cyinder smo 1 ylinder Location indicators V ponad ij Regulator Valve 40 100psi 1 8 NPT pipe schedule 80 24 5 Pu
4. a ga ae 12 Problem Solution essnee sates Res 12 Solution Description for Supply 13 The PLC OU PUB 13 TES PEC INPUTS NAG a eoe KAN 13 19 WINCHES 14 Prot type NES EE 14 OE L peratoris banane AA auctis 14 Testing of Proof of Concept 16 Fe RM craves aa a 18 5 Appendix Drawing Package 2 D Engineering Drawings 4 Upp r Manifold 21 2 Lowet Manifold maana asa 22 3 Linear Bearing Brace ppp 4 Air cylinder support wire eter p euo RE E Ida 24 b Base PTE a tbt eodd CN daten 25 3 D Assembly Drawings 1 Exploded Assembly Drawing of Lower Portion with part list 26 2 Exploded Assembly Drawing of Upper Portion with part list 28 3 Exploded Assembly Drawing of Hose connections with part list 30 4 Full Exploded Assembled Drawing front isometric view 32 5 Assembled Drawing Front 33 6 Assembled Drawing Rear isometric
5. quantify each want At this point we came up with a list of target values for each metric that our concept must fulfill Directly below is a chart Table 1 describing our most important wants with the metrics and target values in their order of importance 1 being most valued and 11 being the least valued Table 1 1 Safeylockoutdevices Wherever Possible Percentage of lubricant that will stick Length of time from start to finish of operation less than 30 seconds Lowmaintence How often the machine must be stopped for cleaning 8 Recycling of Solvent How much solvent is permissible to lose less than 1 5 gallons per week 9 Ergonomically pleasing Operator Reaching angle less than 15 degrees from horizontal 3 by 5 or smaller Page 3 1 Operator Safety The AK 225 solvent can be very harmful to the operator if the operators skin comes in contact with it For this reason the safety of the operator is the most important component of the design criteria Also if operating conditions are determined to be unsafe the machine won t be able to be used at all 2 Catheters undamaged During the loading of catheters the catheters will be bent to a certain degree If the Catheters are bent too far then they will not restore to their original straight position when relaxed The target value was given to us from Terumo 3 Cleanliness We want the catheters to be as clean
6. the front is the side on which no tubes connect to the lower Page 16 manifold total of seven trials were conducted with 2 catheters each for these trials the amount of air mixed into the outside flow and the length of cleaning was varied The air pressure used for all of these trials was 40 psi which was the same about of pressure used in the verification testing The results are summarized below in table 3 The primary goal of the cleaning process was to clean 100 of the tip and have spots smaller then 2mm in diameter elsewhere Cleaning Trial Time 1 L 20 seconds 1 20 seconds 2 20 seconds 2 R 20 seconds 3 L 20 seconds 3 20 seconds 4 L 25 seconds 4 R 25 seconds 5 L 25 seconds 5 R 25 seconds 6 L 30 seconds 6 R 30 seconds 7 L 30 seconds 7 R 30 seconds Tip Clean N N N N small spots small spots lt lt lt lt lt Table 3 Other Spots N N 2 spots 2 mm in dia N N 3 spots 2 mm in 2222 2 2 spots 1mm in N N see figure 8 for a picture of trial results 7L Other Comments about Trial AK only no air mixing on outside AK only no air mixing on outside and Air mix AK and Air mix AK and Air mix too much air AK and Air mix too much air AK and Air mix too much air cycle stopped and restated AK and Air mix too much air cycle stopped and restated AK and Air mix AK and Air mix AK and Air mix cycle stopped an
7. as possible so that the coating Will stick Our goal is to completely coat the catheter 4 Ease of Use We want our washer to be easier to use than the current method of hand washing the operator must currently makes about 5 operations Our goal was to at least match the number of operations currently done 5 Speed of use Currently hand washing takes about a minute for each catheter in order to meet throughput requirements we will have to cut this time in half 6 Low maintenance Terumo asked that the machine only need to be shut down and cleaned once a day for cleaning T Effective filtration device A good solvent filtration device is crucial to good cleanliness The solvent will be removing silicon residue as well as particulates A 10 micron filter was recommended by Terumo for removing these particles from the solvent 8 Recycling of solvent The solvent is very expensive and it is crucial that as much of it is retained as possible Currently Terumo wastes about 1 5 gallons of solvent week We would like to at least equal this amount if not lessen it 9 Ergonomically Pleasing It can be uncomfortable to repeatedly have to reach to high extremities so we want to minimize this amount After pretending to be operators for several minutes we decided that an arm angle of no higher than 15 degrees to the horizontal would be an acceptable angle 10 Low cost We wanted to spend as little money as possible however Terumo agree
8. head screws 3 8 long pf 1 4 20 Hex Bolts 2 5 long 10 00000000 14 20 Hex Nut EE N tainless Sieel type 304 tainless Sieel type 316 tainless Sieel type 316 a DILL Q 2 2 055 2 23 o 6 0 9 Appendix C Electrical Drawings VALVE GROUNDS le V BLOCK 24 V BLOCK ENCLOSURE OPEN SCALE 8A P ko 03 4 040 GO d ZTN SINGLE LINE WIRING DIAGRAM ND SCALED Page 39 o PLC DUTPUT 1000 24VAC PLC OUTPUT 41004 amp 1007 110 SIMILAR SINGLE LINE WIRING DIAGRAM NU SCALE TUBING KEY NVEYS AK FLUID NVEYS AIR PRESSURE RELIEF A SE H USE CATCH TANK PRESSURE P D PLUMBING DIAGRAM SCALE CylinderClosed 6801 CylinderOpen 6800 0 1 2 K NPUT 00x UPPER MANIFOLD 10x 11x 0 1 3 0 1 e LOWER MANIFOLD RI Ra R3 R4 5 89 87 89 89 R8 RI RIO 8A I2VDC CLOSED FINISH 1007 1101 1103 DPERATING 1102 CATCH TANK PRESSURE POD WIRING LAYOUT ND SCALE RELIEF AIR PNEUMATIC CYLINDER DIAGRAM ND SCALE Page 43 O LOAD REMOVE OUTLET EMERGENCY CLOSED STOP O O START A SENSOR 1 RESET SENSOR 2 ENLLU gt URE CCLUSE
9. the catheter surface and does not help to remove it Page 7 Proof of Concept Prototype components and explanation How the following list of materials is incorporated into the current scaled down design can be seen or in the assembly drawings in Appendix Tanks Need two sealed Pressure vessels to hold at least 1 gallons of AK fluid each The vessels must be fluid tight have an interior surface compliant with AK fluid be able to with stand 80 psi and must be contain appropriately sized and threaded holes to meet our needs See assembly drawings in appendix The reason that the each vessel needs to hold 1 gallons of fluid is because we approximated the amount of fluid to clean one catheter from the actual testing done at Terumo to be about a quarter of a gallon We set ourselves a goal to clean two catheters at once for the prototype so for every time the machine goes through its cycle about 5 gallons is used The reason for the over estimation is that there needs to be a sufficient amount of room for the air to escape by way of the relief valve therefore we factored a safety factor of two The reason that we need two vessels is that one vessel needs to pump the fluid through the system and the other vessel will have to catch the fluid during a given cycle The reason that each vessel needs to be air tight is because we intend for all of the fluid in the system to be completely contained or cont
10. turn a If lower manifold is flooded with AK 225 i Physically open pop it valve on catch tank Check gaskets for damage Check that the gaskets are sitting flat in the grove openings around each catheter in the lower manifold Page 46 Use the switch on the control panel to lower the pneumatic cylinder and close the manifold Note keep hand away from manifolds during this operation Red Load Unload light should turn off and green Closed light should turn on a If pneumatic cylinder fails to lower i Check electrical connection ii Check regulator connection b If green light fails to turn on i Re open cylinder and check that the gaskets are sitting flat in their grooves then lower the cylinder ii Check the electrical connections iii Check the regulator pressure iv If the upper and lower manifold are sealed with enough pressure then check the sensor position Close the latches on both sides of the manifold a If the latches fail to close i Re open oylinder and check that the gaskets are sitting flat in their grooves then lower the cylinder ii Check the regulator pressure Press the start button green Operating light should turn on a If start button fails to begin process i Check that blue check AK light 1 ifitis on use pop it to relieve pressure check AK level and press the reset button Check that steps 4 5 have been completed iii Check electrical connections The system will go through its tasks at this p
11. 1 parts list Description 1 4 NPT nipple hex 1 4 male x male x female 1 4 NPT male x socket weld 1 2 29 1 2 Diameter 316 SS rod 1 4 NPT female x female 316 Stainless Steel Check Valve 1 4 NPT x 3 8 tube compression fitting 1 4 NPT x 1 4 NPT Elbow 3 8 NPT Nipple hex 3 8 NPT Delrin Solenoid Valve 1 4 NPT Delrin Solenoid Valve 75Psi Pop Safety valve 3 8 OD x 5 16 ID PTFE tube cut to fit 12 square machined plate see drawing 5 190 Psi stainless steel pressure tank cut at 7 inches from bottom 1 8 NPT stainless steel coupler Air Cylinder Support see drawing 4 1 8 NPT 316 SS pipe 17 G H 4 L M Oluoz Assembly note Pressure tank N 1 8 fillet welded to 12 square plate M around exterior circumference Items D C and E are press fitted and 1 8 fillet welded to 12 plate Page 27 Assembly Drawing 2 5 16 hex head 1 4 20 10 washer Linear Block see drawing 3 SMC 150 PSI air cylinder 1 2 OD x 15 long Linear Bearing Rods 10 24 cap head screw Linear 5 Steel Clasp 2 OD x 1 5 ID 3 16 radius faucet gasket Assembly Drawing 2 Parts list Page 29 Assembly Drawing 3 Parts list Assembly Drawing 3 1 4 x 3 8 tube compression fitting 1 4 x 1 4 Ball valve 1 4 x 1 4 x 1 round nipple D 1 8 male x 1 4 female reducer
12. 84 in throat 125 lee The throat of the weld is the weakest part of the weld therefore it must be checked for strength Extruding the throat of the weld around the 9in diameter gives a surface area of e 9 2 125 7 9 3 584in 2 4 Calculating the Sheer Stress on this area 6361 725lbs 3 584in The yield stress of type 304 Stainless steel is 25000psi This gives a factor of safety to yielding of 25 000 psi 1775 342 psi 1775 342 lbs in 2 14 1 Now that s a safe weld Page 49 Page 50
13. D ND SCALE Page 44 Appendix D Operation and Maintenance Manual Operations Initial Checks to be done before operating machine 1 Visually inspect the electrical connections from the solenoid valve pneumatic cylinder and sensors to make sure none of them have come lose Plug in the external power supply 110 VAC for the control panel and 12 VDC fro the valves Then test the emergency stop button to make sure it is working properly Check AK 225 level it should be filled with 34 of a gallon at the start Note the system can run on less this is an initial level suitable for cleaning a batch of catheters Connect open the in house air allowing it to flow to the regulators When the first cycle begins inspect the gaskets between the manifolds for wear and replace as necessary B Running the Cleaning Cycle 1 45 Use the switch on the control panel to raise the pneumatic cylinder and open the manifold Red Load Unload light should turn on a If pneumatic cylinder fails to raise i Check the latches are completely open Check electrical connections iii Check regulator connection and amount of pressure b If light fails to turn on but cylinder is physically open i Check sensor connections i Check sensor positions iii Check electrical connections Once the upper manifold has come to a stop in the raised position feed the catheters into the lower manifold and twist into the luer lock using a Va
14. D x 3 16 radius faucet gasket Purchased from Sears Hardware 5 2 quare D Plug in Relay 24v 12v _ 1 Donated quare D TYPE KP Relay Terminal quare D 111 1 Donded Emergency Stop Switch United Electric Company Donated 10A DC Fuse with carrier United Electric Company IDonated 1 x HE na 53 7 quare D 2 v Push Switch 12 v indicator lights OMRON PLC Controller 12 outputs eflon Tape 10 24 cap head screws 3 8 long 1 4 20 Hex Bolts 2 5 long 10 washer 1 4 20 Hex Nut 2 Linear Bearings Purchased from McMaster Carr 6630k13 Raw Material sizes HET o 2 x 12 x 25 Base Plate 25 Diameter x 15 long Cylinder support 2 diameter x 50 long x1 x 12 Upper manifold x 2 x 8 Lower manifold Custom Nuts and washers 2 2 1 2 xc 0x 2 3 PI 2 x 1 x 1 Fiberglass Electrical Cabinet United Electric Company Donated er 1221 Portable SSPressuretank Full Port Ball Valve 2 1 8 NPT 5 16 tube Flow control vale 2 x 1 5 ID x 3 16 radius faucet gasket Emergency Stop Switch untedElectriccompany DC Fuse with carrier United Electric Company 2 x 1 x 1 Fiberglass Electrical Cabinet United Electric Company 12vPushSwitch 12v indicator lights OMRON PLC Controller 12 outputs Teflon Tape 2 10 24 cap
15. University of Delaware Senior Design Team 10 Memo Medical Corporation Deborah Grohol Bill Gregory From Jon Blyer Jim Moore Dan Muhlenforth Gwen Thorson Dr Dr Keefe Dr Wilkins Date December 12 2004 Re Phase 3 Proof of Concept Prototype Table of Contents Froblem Backgro nd 286848 odi cud ed 3 Wants Constraints Metrics T arget Values 3 ae AA NAA AA PA EE 5 Chosen NAT ANA 5 Validation of Concept ae 6 Results of Testing Concept screenshots tags 7 Proof of Concept ProtolyDO dear Guo Er etta qn kaka ka NAA AD 8 LE RC RS Dr n UH EE DEN 8 eet eria NANA ana NG Ie use aie 9 Machined Manifold Bottom Fixture 10 nanan 9 Air Regulator Valve for Bottom Fixture 10 Air Manifold for Bottom 2 2 10 Fluid Manifold for Bottom FiKture ede eris YA KAG AKALA 10 Upper Manifold Top FikKture os Cox Se hes 11 Pneumatic Cylinder pp 11 TEES 11 Pressure REQUIALOIS 12 ee 12 Electronic Components 4 EE uS Rond RP 12 Equipment
16. al Washer Figure 2 this concept removed the need for rotation by having two pairs of bemcot rollers perpendicular to one another traversing the length of the catheter cleaning the whole surface in one pass After 10 passes with the scrubbers the bemcot cloth would have to be replaced This would be an awkward and time consuming process due to the scrubber orientation thus making this design less desirable The third concept was the Power Washer Figure 3 which used an array of jets around each individual catheter these jets are held within a manifold that would move over the length of the catheter This would clean by spraying AK 225 solvent at high velocities against the surface During the spraying process some of the AK 225 would become vaporized and pose a health risk to the operator Also because of this vaporized state recapturing the AK 225 would be difficult The fourth concept was the Submerged Pressure Washer Figure 4 in which each catheter is placed in a tube and pressurized solvent is passed through this tube thus cleaning the external surface This concept provided a better solution because it removed the need for bemcot cloth kept the AK 225 completely contained and made the recirculation process easy Chosen Concept After examining each of the concepts with respect to metrics and the UDesign process it was determined that the Submerged Pressure Washer was the best design This design rated well mainly because of its la
17. bricant that needs to be applied to these catheters will not stick to this silicon so if we could successfully remove this layer of silicon then the cleaning was considered successful In order to test if the silicon was removed after cleaning and coating the catheters were submerged in Congo red dye This dye will not stick to the silicon coating After submersion in the dye any spots that are not red were not cleaned thoroughly Due to safety concerns the test was performed in a room with a smaller level of compressed air than we originally anticipated We were planning on varying the amount of pressure applied to the tank between 40 and 60 psi However the room that we were placed in only had air pressure available up to 38 psi Our Team decided to go ahead with our testing anyway to see if the Submerged Pressure Washing system would work at this lower pressure We tested cleaning the catheters in a few ways with or without back pressure the closing of the valve on the bottom of the tube mixing air with the solvent and we experimented with different time durations of each step When all was said and done 8 catheters were cleaned with a combination of these variables The chart below shows the different variable combinations that were tested and the results of each Table 2 Table 2 Submerged Pressure Wash System Tests Pressure Stepi Step2 Sieps Small spots missed Large spots missed Tip Cleaned Y N Catheter was subm
18. ck of moving parts and because it contained the solvent through every step of operation making it a safe and efficient machine We assumed that all concepts would Page 5 Figure 2 Seam ex Figure 3 Figure 4 fulfill the other metrics evenly In order for the design to be put into use it had to be slightly redesigned from the initial concept Figure 4 The redesigning was primarily due to budget constraints so the system was change to show how the process would work on a smaller scale As a result of discussion instead of cleaning 10 catheters of both the 18 and 41 variety we would clean 2 of the shorter catheter Figure 5 Also instead of using the device in the manufacturing line it will be used to further develop this new method of cleaning Validation of Concept Figure 5 The Submerged Pressure washing idea as far as we know has never been used to clean medical Figure 6 catheters In order to determine whether or not this p Fixture method would be effective in cleaning catheters a test had to be performed To test the Submerged Pressure ML a washing system we built a fixture that would clean one catheter in the same way that our prototype would clean several catheters at once We built a device much like the one shown in Figure 6 Bottom Fixture The catheter is placed within a hollow chamber and down the length of a hollow tube Solvent will be run through the system cleaning the outside o
19. d and Air Out Upper Manifold will be de energized The AK Transfer Air In Catch Tank and Pressure Relief Pressure Pod valves will be energized After 20 Seconds the AK Transfer Air In Catch Tank and Pressure Relief Pressure Pod will be de energized The Finish light will be illuminated and the Operating light will be de illuminated at this point verifying that the process has been completed 7 Once the Finish light has been illuminated remove the Safety latches 8 Remove your hands and or any other obstruction from the Upper and Lower manifolds 9 Raise the pneumatic cylinder by pressing up on the toggle switch in the direction labeled open 10 When the Load Remove light is illuminated remove the cleaned catheters 11 the AK fluid level needs to be checked the Check light will be illuminated at this point Unplug the machine and or hit the Emergency Stop Button Press the manual pressure relief button located on top of the pressure pod Remove the lid Check the AK level Add as needed Lock the lid back onto the pressure pod Re Plug in the machine and or pull out the Emergency Stop button Hit the Reset button the Check AK light should be de illuminated at this point 12 The machine is now ready for its next run Note 1 If at any point during the running of the machine the senso
20. d restarted AK and Air mix cycle stopped and restarted AK and Air mix AK and Air mix From these results it was determined that air mixed with AK 225 was necessary in order to clean the outside of the catheter Also we found that the controlling of the air mixing was necessary because too much air tended to produce spots along the catheter length or caused the tip to not be cleaned We also determined that the longer cleaning time of 30 seconds overall produced the best results Further testing will have to be done with a more accurate valve in order to determine the correct rate of mixing for the air and 225 Figure 8 After testing this system and seeing how it performed conclusion can be drawn about the performance of this system with respect to the metrics and target values we set forth at the beginning of this design process Our most important want was operator safety from this two metrics were developed amount of solvent vapor contained and safety lock out devices Page 17 This prototype contained and controlled the solvent vapor during the cleaning process and after by venting hazardous vapors to fume hood Within the PLC control system safety lockouts were included for example the cleaning process would not run if the pneumatic cylinder is in the open position Also an emergency stop button was included on the control panel itself incase the operator has to stop the process for some reason These safety lock out
21. d to give us 2 000 for the project 11 Small Size Clean room real estate is highly valuable and we wanted to minimize the amount of space that our machine takes up Terumo agreed that a 3 x 5 footprint would be acceptable The machine will have to be slightly longer than the tallest catheter our target value is to minimize this height Page 4 Initial Concepts Using these metrics and constraints we were able to develop two general categories of cleaning methods cleaners that would use a wiper in contact with the catheter to clean the outside and a method that would use pressurized solvent sprayed on the catheter to clean the outside All of these methods use a luer lock to secure the catheter These luer locks have a central tube that is used to deliver the solvent 225 to the inside of the catheter The first concept developed was the Vertical Rotating Washer Figure 1 which would hold several catheters vertically and rotate them along their axis as pairs of bemcot rollers clean the length of the catheter This rotation allows for all sides of the catheter to be cleaned with one pass With this method of cleaning there was concern that damage to the catheter would occur because of the speed that the catheter would need to rotate at while also being pinched Also after some sourcing of material it was determined that it was to complicated and expensive to purchase the fittings needed The second concept was Non Rotating Vertic
22. ectrical connections b If the cycle fails to stop with in the normal length of time Hit emergency stop and check the electrical connections Unlatch both sides of the upper manifold Use the switch on the control panel to raise the pneumatic cylinder and open the manifold Red Load Unload light should turn on a lf pneumatic cylinder fails to raise i Check the latches are completely open Check electrical connections iii Check regulator connection and amount of pressure b If light fails to turn on but cylinder is physically open i Check sensor connections 1 Check sensor positions iii Check electrical connections Once the upper manifold has come to a stop in the raised position unload the catheters from the lower manifold and twist out of the luer lock using a 1 4 turn a lf lower manifold is flooded with AK 225 i Physically open pop it valve on catch tank ii Check Gasket for damage Repeat until all catheters are clean Note When ever checking the electrical connections make sure the emergency stop is presses if working on the external connections If working inside the control box unplug the entire system Page 47 D ON Emergency Procedure If at any point during the running of the machine it looks like there may be something wrong such as abnormal vibration leakage fire structural failure and or anything that may cause concern for your well being or the well being of the people ar
23. el of solvent available Then in order to better ensure operator safety we believe that a laser curtain should be added to the device to prevent the operator from getting hurt as a result of the manifold opening and Page 18 closing The final hard ware improvement that we suggest would be a vaporized solvent recovery system that would try to reclaim some of the solvent lost in the exhaust process Page 19 Appendix Engineering Drawings Table of Contents 2 D Engineering Drawings Drawing 1 Upper Manifold Drawing 2 Lower Manifold Drawing 3 Linear Bearing Brace Drawing 4 Air cylinder support Drawing 5 Base Plate 3 D Assembly Drawings Assembly Drawing 1 Exploded Assembly Drawing of Lower Portion with part list Assembly Drawing 2 Exploded Assembly Drawing of Upper Portion with part list Assembly Drawing 3 Exploded Assembly Drawing of Hose connections with part list Assembly Drawing 4 Full Exploded Assembled Drawing front isometric view Assembly Drawing 5 Assembled Drawing Front view Assembly Drawing 6 Assembled Drawing Rear isometric view Assembly Drawing 7 8 9 Hose connection Diagram with assembly notes Page 20 Drawing 1 Upper Manifold 50 diameter 4 holes 10 32 2 i thread EE S 100 L 2 holes 20 dlameter TOLERENCES PROJECT OR CLASS 2 1 28 thread UNLESS senior design OTHERWISE Team 10 NOTED DECIMAL holes M8 x 185 XXX 005 010 ia FRACTIONAL APPROVED Br
24. erged in 1A 38 Psi seconds seconds Y Catheter was submerged in pressurized Solvent 10 Catheter was dried with 1 38 Psi seconds 10 seconds Air 10 seconds 0 40 38 Psi solvent 20 Seconds seconds 3 1 Y Solvent 10 seconds seconds 0 3 Y Y N Catheter was cleaned with Solvent and air combination 10 Catheter was dried with Air 10 7 38 Psi seconds seconds 2 0 Catheter was submerged in pressurized Solvent 10 Catheter was cleaned with solvent Catheter was dried with 8 38 Psi seconds and air combination 10 seconds 10 seconds atheter was submerged in pressurized Solvent 15 Catheter was cleaned with solvent Catheter was dried with 38 Psi seconds and air combination 15 seconds Air 10 seconds a small spot is defined as a spot less than approximately 4 mm 2 and still visible to the human eye ta large spot is defined as a spot larger than approximately 4 mm 2 1 see Catheter was submerged in pressurized Solvent 20 Catheter was cleaned with solvent Catheter was dried with 5 38 Psi seconds 10 seconds Air 10 seconds 1 3 0 PE 3 r It can be seen that trial 7 cleaned the catheter most effectively Trial 7 used a combination of air and solvent to clean the catheter without the use of back pressure From the results of testing it was concluded that back pressure was not an effective means of cleaning the catheters We theorize that the back pressure actually pushes the dirt further into
25. f the catheter as it passes by Our intended method of cleaning the outside of the catheter is to use pressurized AK fluid combined with air to disengage dirt from the surface and carry it away We also incorporated a valve atthe bottom of the hollow tube when this valve was closed the fluid would remain stagnant around the catheter Our belief was that this pressurized fluid could help the solvent break up any dirt on the surface Then for cleaning the inside of the catheter we will use the current method in the testing apparatus For this reason the catheter is not going to be cleaned on the inside for testing The test for cleaning the outside of the catheter requires two preliminary steps and then a variety of flow control variables will be applied in order to determine which combination cleans the catheter best First the catheter needs to be twisted into the leur lock that has been mounted into the top fixture The top fixture and bottom fixture have been threaded to fit together After wrapping the top fixture in Teflon tape the operator will screw the two pieces together Once these two setup steps are complete the operator may clean the catheter Page 6 Results of Testing Concept On October 14 2003 our team visited the Terumo Medical Corporation to test the submerged pressure washing system had prepared a number of catheters with a thin layer of silicon on the bottom 5 centimeters The lu
26. hat the pressure going into the system is controlled at all times Also need another pressure regulator to connect the in house to the cylinder to regulate the pressure in it at all times Tubing We approximate that we needed 6 feet of 1 8 tubing and 25 feet of 5 8 tubing These estimates are based on the number of tubes and pipes that run between the tanks and the various fixtures and there respective length are estimated to be 3 4 feet long if the tubing is going to the bottom fixture and 5 6 feet long if the tubing is going to the top fixture Electronic Components Equipment list Located within the electrical enclosure see appendix C is One 1 PLC ten 10 Relays three 3 Bridges five 5 lights One 1 Emergency Stop Switch One 1 Toggle switch and two 2 Mushroom Switches Problem Solution Due to our limited budget we were only able to purchase solenoids that operate on a 12V 1 5 Amp current However our PLC operates on a 24V DC 5 amp source The solution we chose to take was to incorporate ten 10 separate relays that are activated by a 24V DC 5 Amp source but will pass a 12V DC 4 Amp current Page 12 Solution Description for Supplying Power plug caring 120 V AC current will first enter the enclosure and connect to the Emergency Stop button Exiting the stop button the current will branch into two separate wires One wire will to power the Toggle switch for the pneumatic cylinde
27. he sealed enclosure Secondly the machined manifold must be compliant with the air regulator valve attached to the air distributing manifold The third function that the machined manifold must have to be compliant with the manifold for distributing the AK fluid Next the machined manifold must be shaped so that the tip of the catheter is not damaged during loading Finally it must be able to fit and seal with the top fixture so that no fluid leaks from the system during operation All of these reasons govern the design of our machined manifold Appendix A Air Regulator Valve for Bottom Fixture Page 9 We need an air regulator valve in order to control the size of the air bubbles going into each 1 8 NPT pipe so as to ensure consistency in the cleaning of the catheters in the system The reason that we need a regulator valve to control the air flow into each catheter containing tube is that we need to control the air to AK fluid ratio used for the cleaning of each catheter The reason that the regulator valves are used instead of just opening a ball valve to allow the air to mix with the fluid is that the regulator valve allows more precise control of the size of the air bubbles that are induced into the fluid flow The air bubbles are what create or regulate the amount of turbulence in the flow so to just open a relatively large valve i e ball valve to let air mix in with a flow of AK fluid is a process that is difficult to contro
28. iameters range from about 02 to 01 and the external diameters range from 07 to 124 At the end of each catheter is a generic fitting used for securing in a luer lock Currently the catheters are washed internally by flushing the inside with AK 225 solvent for several seconds The exterior of the catheters are cleaned manually by a trained operator who soaks a Bemcot lint free cotton cloth in 225 solvent This operator must scrub the length of each individual catheter performing a very tedious and time consuming operation It would be advantageous to incorporate a machine that could clean the catheters minimizing the amount of work that the operator would have to do Ideally the operator would be able to perform a completely separate task simultaneously maximizing the amount of work out of this individual and saving Terumo money on hiring a separate employee to perform the other task Also this change to an automated system will provide an ergonomic improvement by reducing repetitive motion standardize the cleaning method and increase throughput Wants Constraints Metrics Target Values We have compiled a list of wants and constraints from talking to personnel at Terumo Medical from observing the current cleaning process and from a list of requirements given to us from the Terumo Medical Corporation Using the UDesign process we were able to decide what our most important wants were We then came up with a list of metrics to
29. ic cylinder is in the open position Verify that the Load Remove light is illuminated Load the catheters into their designated positions by inserting the thick end of the catheters into the lure locks and giving them a quarter turn Remove your hands and or any other obstruction from the Upper and Lower manifold Lower the pneumatic cylinder by pressing down on the toggle switch in the direction labeled close When the Closed light is illuminated lock the two safety latches located on the sides of the Lower manifold Press the Start button a Now the PLC program has been activated and the Operating light is illuminated Page 14 The Air In Pressure Pod and Pressure Relief Catch Tank valve is energized This will allow the pressure pod to build up pressure before running After five 5 seconds the AK Out and Air Out Lower Manifold valves are energized This will send AK to both the Upper and Lower manifolds there by cleaning both the inside and outside of the catheter Air is also being sent to the Lower manifold to insure a turbulent flow After fifteen 15 seconds the AK Out valve is de energized and the Air Out Upper Manifold valve is energized This will stop the flow of AK and only run air through both the inside and outside of the catheter After five 5 seconds the Air in Pressure Pod Pressure Relief Catch Tank Air Out Lower Manifol
30. l This will cause a lot of inconsistency in the mixed fluid flow along the lengths of the pipes Also if we find that the size of the air bubbles must be changed throughout the cycle then we will be able to do so with these valves Air manifold for Bottom Fixture To connect all of the air valves to the pressure source by way of piping or tubing would be extremely inefficient For this reason a manifold to distribute the air to all of the air regulator valves will be used to connect the air flow from the pressure source using only one tube So we need manifold to distribute the air with two 1 8 pipe fittings and 5 8 tube fitting Because our prototype only cleans two catheters we could simply use T joint as the manifold For mechanical drawings refer to appendix The reason for the two 1 4 pipe to tube fittings is to attach the regulator valve to the manifold The reason for using a 5 8 tube fitting to input the air from the pressure source is to minimize head loss between the pressure vessels and the regulator valves Keeping the cross sectional area between the flow coming into the manifold close to the cross sectional area of the flow going out of the manifold should help to minimize this problem Also all of the tubing is already 5 8 so it is just easier Fluid Manifold for Bottom fixture We need a manifold to distribute the fluid from the pressure source The fluid distributing manifold mu
31. ments First of all with the process improvements during both the tests we only had air pressure of approximately 40 psi available to us Therefore we would like to experiment with higher pressures 50 60 and 70 psi to see if there is a change in the effectiveness of the cleaning and a reduction of the amount of time the catheters need to spend in the cleaning process Second as mentioned above refine the air mixing system so that there is more control on the amount of air being mixed More accurate valves and then further testing on different combinations of air and AK 225 can do this Once these process improvements have taken place and the cleaning process proven out by further testing a full scale device can be build to clean 10 catheters at a time and of both lengths Then there is the second category of hardware improvements Most of these improvements were not included in our device due to budgetary constraints but should be considered in future versions of this device The addition of a 10 micron filter with in the line that transfers AK 225 from the catch tank back to the pressure vessel would allow particles be removed This would ensure that they are not re deposited on another catheter in a future cycle Also in the current configuration a counter with in the PLC determines when the solvent level should be checked Instead of this system a fluid level indicator could be added to one of the two tanks giving a more accurate reading of the lev
32. n See assembly drawings in appendix A The reason that 2 pipes are needed is because as designated earlier in the design process 2 catheters per cycle would be an effective solution to our problem of making a prototype to demonstrate how we intend our larger system to work There are a few reasons why we decided that the pipes should be 2 feet long The longest catheter that must be cleaned is 1 5 feet and we don t want the end of the longest catheter to be near the end of the pipe because the flow conditions close to the end of the pipe are radically different than those along its length We would like to assume close to constant pressures and velocities across the surfaces that must be cleaned so as to maintain control over the variables that govern the cleaning of the catheter Also because the most crucial section of the catheter that must be cleaned is at the end or tip we would like to have particularly good control of the flow at that section of the pipe The reason that we would like to use 1 8 NPT pipe with a 215 inner diameter is that this size pipe worked during the testing phase and we couldn t think of a reason to input another variable into deciding which conditions diameter of pipe velocity pressure etc clean the catheters best Machined Manifold Bottom Fixture The machined manifold must serve 5 separate functions It must first make it possible for the top part of the catheter with 72 width to fit into t
33. nd as low as 0 ft The piston needs to provide enough force to seal the top and bottom fixtures fluid tight The piston must have a 1 5 foot range because this is the distance the top fixture must travel per cycle And the amount of room required for loading and unloading the catheters The pneumatic cylinder was not long enough to breach the gap between the upper manifold and the base plate Therefore a cylinder support extension was created For mechanical drawings see appendix A Valves Two check valves to connect 1 8 NPT pipe to catch tank and cut off flow if necessary Three valves to connect 5 8 tubing to tanks and cut off flow or allow flow when necessary to both top and bottom fixtures One solenoid for fluid going to both top Page 11 and bottom fixtures and each of the fixtures has its own input controlled by a solenoid valve on the pressure tank One valve to open or close the tubing connection between vessels to control the direction of pressurized air from the pressure source between the two different vessels Two relief valves for each of the tanks so that pressure can be released from the system incase something were to go wrong Two solenoids to determine when in house air is allowed to pressurize each tank by sealing off the tank being pressurized and creating atmospheric conditions in the other tank so flow occurs Pressure Regulators Need a pressure regulator to connect to in house air so t
34. oint If any problems occur the system will stop abruptly and an indicator light s will illuminate displaying an error message Also if the operator notices anything odd occurring then the emergency stop button can be pressed to halt the process Note if the manifold needs to be opened in order to correct the problem the cleaning process will start over from the beginning a If closed light turns off i Check the regulator pressure ii Check the electrical connection iii Check the sensor position b If check AK light turns on i Physically open the pop it valve to relive pressure ii Check the AK level ii Press the reset button v If the light fails to turn off hit emergency stop and check wiring v Ifthe light does turn off then hit the start button c If the Load Unload light comes on 10 11 12 Hit the emergency stop and check wiring d the AK does not seem to be flowing into the lower manifold i Adjust the ball valve so that it is less open i Check the AK level iii Check electrical conections e the AK fails to flow into the upper manifold or out of the catch tank Check the electrical connections ii Check the AK level iii Check the solenoid valves iv Check the check valves When the system is done the red finish light will turn on telling the operator that the catheters can be removed and another operation can be run a If the finish light fails to turn on after the cycle is obviously done i Check the el
35. ound you do the following Immediately hit the Emergency Stop button located in the top left hand corner of the enclosure Press the Manual Pressure Relief buttons located on the top of both the Catch Tank and Pressure Pod Unplug the Car Battery Charger and the Machine Alert your supervisor and the floor Engineer to the problem Before starting back up verify that the Pressure Pod s lid is on securely With the permission of the floor Engineer plug the machine and Car Battery Charger back into the wall socket Pull out the Emergency Stop switch The Machine is now ready to run again Maintenance Valves All valves within the system should be removed an air tested to ensure proper functionality after at least every500 runs gt Hoses All hoses should be replaced after at least every 500 runs Sensors 1 The operator should run a quick diagnostic system check after every start up of the machine a If any sensors fail the test they must be removed and replaced before the next run D Frame The system s frame must be checked for sturdiness by the maintenance department after at least every 500 runs Page 48 Appendix E Weld Analysis of main weld on pressure pot to steel plate Calculating the equivalent force on the plate due to the pressure Pressure 1005 in 2 Area 63 62 Force Pr essure Area 100 25 63 62in 6361 725lbs in 1 8 weld has a 08
36. r 2 is de activated symbolizing that the cylinder is being opened the machine will come to an abrupt stop If this occurs press the Manual Pressure Relief Valve buttons located on the top of both the Pressure Pod and the Catch Tank Correct the problem and press the Start button to continue the process from the beginning Note 2 If the cylinder is in the open position and the start button is pressed the machine will not start Note 3 If the machine has already gone through its cleaning process it cannot start up again until the Cylinder is raised again and the catheters are removed Page 15 Figure 7 Upper Manifold Lower Manifold r dir Bottom Manifold In Houes Air Pressure Tank AK Transfer Testing of Proof of Concept Prototype Initial testing had been done early on to make sure the submerged pressure washing method would work After assembling the proof of concept prototype and pressure testing it for safety we had a device with more accurate timing controls So we conducted the same dye test as we used before except this time using the prototype During the testing we noticed that the flow of AK 225 to the 2 catheters being clean was different therefore each of the test specimens was labeled with its trial number and the letter L or R signifying left or right This left or right orientation is determined by the point of view with respect to the front of the prototype
37. r and the other will go to power the The Toggle s neutral line will connect to the PLC s neutral We are delivering a 12V DC 1 5 Amp source via a typical automotive car charger The Car charger converts 120V AC current into 12V DC current The positive cable of the car charger in ran through the enclosure and connected to a 10 Amp fuse The fuse is then connected to a bridge that will distribute the 12V DC current to each of the 1 inputs of the ten 10 relays Each of the Relay s 3 inputs will be connected to it s designated solenoid solenoids and lights Each of the solenoid s grounds will be ran back into the enclosure and connected to a bridge The bridge is then connected to the negative output of the car battery charger there by completing the circuit The PLC Outputs For PLC Code Refer to Appendix C The PLC outputs 1000 1004 amp 1007 1103 will exit the PLC and connect to each of the corresponding Relays in the 2 position input The PLC will be passing 24V DC 5 Amps to each Relay Since the PLC outputs act as a ground the Relay s 7 inputs will be connected to the 24V DC Bridge which is being powered by the PLC s 24V DC output The PLC Inputs For PLC Code Refer to Appendix C The PLC input 0000 is connected to sensor 1 Sensor 1 detects weather or not the cylinder is open using a magnetic switching mechanism Input 0001 is connected to sensor 2 Sensor 2 detects weather or not the cylinder is closed using a magne
38. rchasedfrom McMaster Carr 468045k11 466 2 Delrin Solenoid Valve 1 4 NPT 5 Purchased from McMaster 7876k58 3438 7 YOR LOK Compression Tee tubex tube x male for 3 8 tubeOD 14 jpurchasedfromMcMasterCar 51828187 2206 5 1 4 NPT x 1 8 NPT nipple Purchased from McMaster 51205k191 0581 2 1 4 NPT 1 4 NPT hex nipple 5 0 Purchased from McMaster Carr 51205k132 4824 4 YOR LOK Straight Compression fitting for 3 8 tube OD 1 4 NPT mae Purchased from McMaster Carr 5182kt19 7 18 PTFE tubing 3 8 OD x 5 16 ID CE Purchased from McMaster Carr 51805K73 1 94 foot 30 feet Luer lock tube fittings Male Leur x 1 4 28 male thread Purchased from McMaster Carr 5194k13 10 26 2 YOR LOK Straight Compression fitting for 3 8 tube OD 1 8NPTmale A A Purchased from McMaster Carr 5182k811 646 3 High Pressure fitting 1 4 NPT female x 1 8 Male Purchased from McMaster Carr 51205k187 1024 3 One end threaded nipple 14 NPT X Purchased from McMaster Carr 9157k21 107 2 1 8 NPT Coupler 1 McMaster Carr 4452k441 1 87 1 Portable SS Pressure tank p Purchased from McMaster Carr 41705k39 200 2 ull Port Ball Valve Purchased from McMaster 46495k58 2182 1 1 8 NPT x 5 16 tube Flow control valve 1 1 Purchased from McMaster Carr 4816k13 15 89 1 2 OD x 1 5 I
39. rolled at all times Also we intend to use pressurized air in order to move the solvent through the system Both tanks required welding in order to be air tight See appendix E for analysis of weld size and the engineering drawing of the base plate in appendix A The interior surface of the vessel needs to be compliant with the AK fluid because if the AK fluid destroys the material the vessel could be destroyed or leak Also contaminants could break off of the vessel and flow across the catheter The reason that each vessel must be able to withstand 80 psi of pressure is because that is the guaranteed pressure given by the in house air and ideally we d like to try as many combinations as possible with pressure as a variable to determine the most effective fluid flow to clean the catheter Also for safety purposes if the system is only designed to withstand 50 psi if the regulator valve breaks and 80 psi is introduced to the system we wouldn t want a catastrophic failure to occur The reason that we need the certain threaded holes to be imbedded into the vessel is that we need fluid to flow through it and be sealed to designed or Page 8 purchased outlet fixtures This could also be accomplished by drilling into the vessel and welding on appropriate fixtures See appendix A assembly drawings Pipes Need 2 different 2 foot long 1 8 NPT threaded pipes with an inner diameter of 215 to contain catheters during operatio
40. s are good but more should be added for increased operator protection see future plans for listing The second most important want was that the catheters must be undamaged at the end of the process From this we derived the metric target value of radius of curvature greater then 20 If the radius is smaller then this value the catheter will be permanently bent and un useable In the developed prototype the radius of curvature used to load and unload the catheters is about 30 Then the next most important want is cleanliness the target value for this is that the tip is coated and there are no spots larger then 2mm in diameter along the length The cleanliness results are summarized in table 3 further testing with higher pressure and a more precise air mixture is necessary in order better determine the exact specifications of the washing process Then there is the ease of use which is measured by the number of operations that an operator must perform in order to get the process started our target value for this was 5 or less operations The system we developed has exactly 5 operations load open close cylinder open close latches hit start button and unload The rest of the metrics developed involve taking measurement and long term use of a full scale device Thus they are not applicable to our scaled down system Future Plans The future plans for development of this system fall into two categories process improvements and hardware improve
41. st have 2 1 4 NPT pipe fittings and a 5 8 tube fitting Again because our prototype only cleans two catheters we could simply use a T joint to act as a manifold For mechanical drawings refer to appendix A Page 10 Note Understanding fluid flow specifically the mixture of air which is usually compressible and liquid AK liquid fluids like water are usually incompressible is extremely difficult to grasp quantitatively even for experts in the field so minimizing the variable to control this flow is of the utmost importance to us in order to utilize this technique as a cleaning mechanism Upper Manifold Top Fixture We need a manifold for the top fixture to have 2 luer lock fittings and 4 1 4 NPT pipe to tube fitting The top manifold must also be able to be fixed securely to an air cylinder to ensure controlled motion and forces applied to the manifold For mechanical drawings refer to appendix A The reason that the manifold must have 2 luer lock fittings is because the tops of the catheters are designed to fit an ISO 495 luer fitting which ensure that the fluid that flows through them is completely contained The reason that the manifold must have an opening to fit four 1 4 NPT pipe sized fittings to 5 8 tube fittings is that these are the sized fixtures used throughout the system Pneumatic Cylinder Need an air cylinder to control the motion of the top fixture The piston must reach as high as 1 5 ft a
42. tic switching mechanism Input 0002 is connected to the start switch and input 0003 is connected to the reset button Solenoids There are a total of eight 8 normally closed solenoid valves All valves are composed of a Delrin enclosure with Teflon washers A 12V DC 1 5 Amp current powers each valve Six 6 valves have a 4 diameter hole and two 2 have a 77 hole Page 13 Switches The Start switch is red in color and is normally closed The Reset button is black in color and is normally open The Emergency Stop button is red and black in color and is set up to be normally closed Prototype Cost The following is general listing of the cost of the materials used For a more complete listing see Appendix B Pressure Tanks 2 200 x 2 400 Solenoid Valves 9 34 38 x 9 309 42 SS 1 8 NPT Pipes 2 23 30 x 2 46 60 Check Valves 2 40 42 x 2 80 84 Pop it Relief Valves 2 63 19 x 2 126 38 Pressure Regulators Free in house 0 Upper Lower Manifold Free material in house machining in house 0 Fittings 300 Air Cylinder Free in house 0 Pressure Regulator 0 SS Stock Free in house 0 Tubing 25 ft 3 83 x 25 95 75 Electrical Donation 0 Miscellaneous Parts 5940 Total 52000 Order of Operations Note For a complete user manual and maintenance manual see Appendix D and for reference of parts see Figure 7 Note Process is started when the pneumat
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