Catheter Tube Assembly Process
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Transcript of Catheter Tube Assembly Process
Catheter Tube Catheter Tube Assembly ProcessAssembly Process
Team Members: Darren Brown Art Chandler
Brian Tuchband
Project IntroductionProject Introduction
Mission Statement: Mission Statement:
Design a device to streamline the assembly process of the Design a device to streamline the assembly process of the tube, TBV valve, and three-way valve.tube, TBV valve, and three-way valve.
3-Way Valve
TBV Valve
Tube
Assembled Catheter Tube
Current ProcessCurrent Process
Current ProcessCurrent Process
Current Assembly ProblemsCurrent Assembly Problems
• Operators at multiple stations required for assemblyOperators at multiple stations required for assembly
• Incomplete assembly leads to product waste and loss of moneyIncomplete assembly leads to product waste and loss of money
• Repetitive motion injuries experienced by operatorsRepetitive motion injuries experienced by operators
Carpal Tunnel Syndrome
Benefits of AutomationBenefits of Automation
• Cost Savings
→ Fewer operators are needed to assemble the product
• Ergonomics
→ Repetitive motion injuries are significantly reduced through the use of automation
• Productivity
→ Higher success rate leads to virtually no failed parts that need to be thrown away
Wants and MetricsWants and Metrics
17%
17%
12%12%
9%
8%
7%
6%
6%6%
Safeguards
Success Rate
Price
Cycle Time
Setup Time
Number of Parts
Size
Material
Life
Dust Level
Wants:
Metrics:
40%
19%
18%
13%7% 3% Safety
QualityCostPerformanceSimplicityManufacturability
Workstation OverviewWorkstation Overview
Positioning ActuatorsPositioning ActuatorsTube ClampTube ClampInsertion ActuatorsInsertion ActuatorsTBV JigTBV Jig3-Way Jig3-Way JigOptical SensorsOptical Sensors80/20 Frame80/20 FrameHand Tie-Down ButtonsHand Tie-Down ButtonsEmergency Stop ButtonsEmergency Stop ButtonsCautionary Indicator LightsCautionary Indicator LightsPneumatic ValvesPneumatic ValvesMain Circuit BreakerMain Circuit Breaker
Step 13: Machine resets to the original position
Process DescriptionProcess Description
Step 1: Insert the tube into the clampStep 2: Insert the TBV valve into its jigStep 3: Insert the 3-way valve into its jigStep 8: Clamp closes on the tubeStep 9: Insertion actuator inserts the TBV valve into the tube
Step 7: Positioning actuator moves 3-way valve forward until sensor picks up the tube
Step 6: Positioning actuator moves TBV valve forward until sensor picks up the tube
Step 5: Place hands on hand tie-down buttons and press firmly to activate the machine
Step 4: Apply primer to both ends of the tube using a brushStep 10: Insertion actuator inserts the 3-way valve into the tube
Step 11: Clamp opens to release the finished assemblyStep 12: Remove the finished assembly
Machine DemonstrationMachine Demonstration
Success!Success!
Description Qty. Part Number OriginPLC 1 C200H-MR431 Teurmo
Insertion Actuators 2 MXS12-30AS TerumoClamp 1 MHQ2-20D Terumo
Spring Return Valves 3 VZ3143 TerumoFilter/Regulator 1 AF300-02D TerumoExhaust Filter 1 AMC320-038D Terumo Linear Guides 2 SR15W TerumoThree-way Jig 1 N/A TerumoRolling Table 1 N/A Terumo
Bracket - Indicator Lights 1 Drawings Sr. DesignBracket - Position Act. To Frame 2 Drawings Sr. Design
Bracket - Position Act. to Insertion Act. 2 Drawings Sr. DesignBracket - Insertion to Linear Guide 2 Drawings Sr. Design
Bracket - Three-way Jig 1 Drawings Sr. DesignBracket - TBV Jig 1 Drawings Sr. Design
TBV Jig 1 Drawings Sr. DesignTube Clamp 1 Drawings Sr. Design
Bracket - Sensors 2 Drawings Sr. DesignPosition Actuators 2 CLJ2D16-75-E SMC
Three Position Valves 4 SYJ3333-5L0 SMCManifold 1 SS5YJ3-32-05-N3T SMC
Optical Sensors 2 Fu-37 KeyenceSensor Switches 2 FS-V21R Keyence
8020 Frame 6m 25-2525 80208020 Brackets 10 25-4119 80208020 Screws 28 75-4304 8020
Equipment List
Prototype DevelopmentPrototype Development
Prototype DevelopmentPrototype Development
Full Automation vs. Semi-Automation• High cost and intricacy of a fully automated system such
as a robot would not be worth the minor advantages it offers over a semi-automated approach
• With our semi-automated system, we can achieve ergonomic and productivity benefits at a much lower cost
• Remaining non-automated tasks do not pose any risk to operator safety
Level of AutomationLevel of Automation
System ValidationSystem Validation
Want Metric Target Value Actual Value Outcome
Simplicity Setup Time 20 seconds 11 seconds Exceeds
Cycle Time 50 seconds 23 seconds Exceeds
Success Rate 98% ~ 93% Needs Improvement
Cost Price $5,000 - $10,000 $7,900 Meets
Safety Safeguards 4 5 Exceeds
Performance
Setup Time ValidationSetup Time Validation
Setup Time: The amount of time the operator interfaces with the machine before the automated process begins.
• Using a stop watch, we measured the actual time needed to complete the following steps:
• Procedure→ Insert TBV valve and 3-way valve into
their respective jigs.→ Insert the tube into the tube clamp.→ Apply primer to both ends of the tube
using a brush.→ Place both hands on hand tie-down
buttons and press down.
Setup Time ValidationSetup Time Validation
Average Setup Time = 11 seconds
Exceeds Target Value
Sample Size = 30
Cycle Time ValidationCycle Time Validation
Cycle Time: The time required to make one unit of product.
• Using a stop watch, we determined the cycle time of the machine assembly process.
Cycle Time ValidationCycle Time Validation
0
10
20
30
40
50
60
1 6 11 16 21 26
Samples
Raw Data
Average
3rd Upper Standard Deviation
Target Value
Average Cycle Time = 23 seconds
Sample Size = 30T
ime
(Sec
onds
)
Exceeds Target Value
Success Rate ValidationSuccess Rate Validation
Success Rate: The percentage of assembled products that pass the specifications of Terumo Medical (within 1mm of valve socket)
Using 40 samples, we determined how many products passed.
FAIL PASS
2mm Gap Between Tube End and Socket
Buckling Point
Tube reached all the way to end of Socket
Success Rate ValidationSuccess Rate Validation
82.5%91.2%93.9%
Overall Success RateSystem Pressure Correct
System Pressure Correct and No Operator Errors
Success Rate Testing Results
Fails to meet Target Value: 98%
Sample Size = 40
Success Rate = x 100%# of successful assemblies
total # of assemblies
Mode of Failure: Tube Insertion Depth Not Sufficient
Price ValidationPrice Validation
Price: The amount of money it takes to build a production machine.
• Final cost is calculated from the actual cost of the prototype in addition to the estimated costs of the hand-off components:
→ Glue Dispenser→ Air Blow-Off
Project BudgetProject BudgetPart Quantity Cost/Unit ($) Total Cost ($) Prototype Cost ($)
Positioning Actuators 2 195.50 391.00 391.00
Insertion Actuators 2 120.00 240.00 0.00
TBV Jig 1 15.00 15.00 15.00
Three-way Valve Jig 1 25.00 25.00 0.00
Clamp 1 230.00 230.00 0.00
Clamp Grippers 2 10.00 20.00 20.00
Optical Proximity Sensors 2 160.00 320.00 320.00
Sensor Switches 2 80.00 160.00 160.00
Pneumatic Solenoid Valves 5 65.00 325.00 325.00
Manifold 1 60.00 60.00 60.00
Regulator and Filter 1 40.00 40.00 0.00
On/Off Safety Buttons 2 40.00 80.00 0.00
Pneumatic Fittings 20 1.00 20.00 0.00
Pneumatic Hose 1 (50 ft roll) 100.00 100.00 0.00
Frame 1 126.00 126.00 126.00
Glue Dispensers 2 2,700.00 5,400.00 0.00
PLC 1 200.00 200.00 0.00
E-Stop 2 40.00 80.00 0.00
Fasteners (Screws, Bolts) estimate estimate 30.00 30.00
Brackets estimate estimate 60.00 60.00
TOTAL: 7,922.00 1,507.00
= Acquired from Terumo Medical
Meets Target Value
Safeguards ValidationSafeguards Validation
Safeguards: The number of devices incorporated into the design of the machine to protect the operator.
Safeguards Included:• 2 Locking Emergency Stop Buttons• 2 Hand Tie-Down Buttons• Cautionary Indicator Lights
Exceeds Target Value
Path ForwardPath Forward
• Success Rate Deficiency Correction
• System Fabrication→ Air Blow-Off→ Glue Dispensing
• In-House Qualification Testing→ Installation Qualification→ Operation Qualification→ Process Qualification
• Operator Training
• Place System into Production
Success Rate DeficiencySuccess Rate Deficiency
Possible causes for failure:
Not enough insertion force
Clamp does not grip well enough
Insufficient primer application
Suggestions to improve success rate:
Use higher pressure air system
Optimize PLC code
Automate primer application process
Optimize flow control fittings
Redesign clamp (silicon coating, split-clamp design)
The Next StepThe Next Step• Air Blow-Off Process
→ Air will be sent into the three-way valve at a high velocity to remove excess primer
→ Implemented through the addition of small pneumatic hose and spring-return valve
→ Controlled by the PLC→ Estimated cost: $80
• Glue Dispensing Process
→ Precision Dispensing System for Cyanoacrylate Adhesives → Developed and sold by EFD, Inc.→ Precise material deposition improves bond strength by
applying the correct amount of material to parts→ Rejects are reduced and product appearance is improved→ Controlled by the PLC→ Estimated cost: $5,400
QuestionsQuestions