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