Catheter Tube
Assembly Process
Team Members:
Darren Brown
Art Chandler
Brian Tuchband
Project Introduction
3-Way Valve
Assembled Catheter Tube
Tube
Mission Statement:
Design a device to streamline the assembly process of the
tube, TBV valve, and three-way valve.
TBV Valve
Current Process
Current Process
Current Assembly Problems
• Operators at multiple stations required for assembly
• Incomplete assembly leads to product waste and loss of money
• Repetitive motion injuries experienced by operators
Carpal Tunnel Syndrome
Benefits 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 Metrics
7%
3%
13%
Safety
Quality
Cost
Performance
Simplicity
Manufacturability
40%
Wants:
18%
19%
Safeguards
6%
6%
Success Rate
17%
Price
6%
Metrics:
Cycle Time
7%
17%
Setup Time
Number of Parts
Size
8%
9%
12%
12%
Material
Life
Dust Level
Workstation Overview
Cautionary
Emergency
Hand
Positioning
Insertion
Main
Pneumatic
Optical
Tube
Tie-Down
Circuit
3-Way
TBV
Indicator
Clamp
Stop
Actuators
Sensors
Actuators
Jig
Buttons
Valves
Jig
Breaker
Buttons
Lights
80/20
Frame
Process Description
Step
Step
Step
Step
Step
4:
Step
Step
Step
11:
Apply
9:
Step
5:
Step
10:
Step
Clamp
7:
13:
Insertion
6:
Place
Step
Insertion
Positioning
primer
Positioning
3:
12:
Machine
1:
2:Insert
opens
8:
hands
Insert
Remove
Clamp
actuator
toactuator
the
both
resets
the
to
on
actuator
actuator
3-way
release
the
closes
hand
tube
ends
TBV
inserts
to
finished
inserts
the
into
valve
tie-down
moves
of
on
moves
the
the
the
original
the
the
finished
into
assembly
tube
TBV
3-way
clamp
tube
TBV
3-way
buttons
itsposition
using
valve
jig
valve
assembly
valve
valve
and
ainto
brush
forward
press firmly
until into
sensor
tothe
activate
the
tube
picks
tubethe
upmachine
the tube
Machine Demonstration
Success!
Prototype Development
Equipment List
Description
Qty.
Part Number
PLC
1
C200H-MR431
Insertion Actuators
2
MXS12-30AS
Clamp
1
MHQ2-20D
Spring Return Valves
3
VZ3143
Filter/Regulator
1
AF300-02D
Exhaust Filter
1
AMC320-038D
Linear Guides
2
SR15W
Three-way Jig
1
N/A
Rolling Table
1
N/A
Bracket - Indicator Lights
1
Drawings
Bracket - Position Act. To Frame
2
Drawings
Bracket - Position Act. to Insertion Act. 2
Drawings
Bracket - Insertion to Linear Guide
2
Drawings
Bracket - Three-way Jig
1
Drawings
Bracket - TBV Jig
1
Drawings
TBV Jig
1
Drawings
Tube Clamp
1
Drawings
Bracket - Sensors
2
Drawings
Position Actuators
2
CLJ2D16-75-E
Three Position Valves
4
SYJ3333-5L0
Manifold
1 SS5YJ3-32-05-N3T
Optical Sensors
2
Fu-37
Sensor Switches
2
FS-V21R
8020 Frame
6m
25-2525
8020 Brackets
10
25-4119
8020 Screws
28
75-4304
Origin
Teurmo
Terumo
Terumo
Terumo
Terumo
Terumo
Terumo
Terumo
Terumo
Sr. Design
Sr. Design
Sr. Design
Sr. Design
Sr. Design
Sr. Design
Sr. Design
Sr. Design
Sr. Design
SMC
SMC
SMC
Keyence
Keyence
8020
8020
8020
Prototype Development
Level of Automation
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
System 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 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 Validation
Sample Size = 30
25
20
Time (seconds)
Average Setup Time = 11 seconds
15
10
Raw Data
Average
3rd Upper Standard Deviation
Target Value
5
0
1
6
11
16
21
26
Samples
Exceeds Target Value
Cycle 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 Validation
Sample Size = 30
60
50
Time (Seconds)
40
Average Cycle Time = 23 seconds
30
20
Raw Data
Average
3rd Upper Standard Deviation
Target Value
10
0
1
6
11
16
21
26
Samples
Exceeds Target Value
Success 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
Buckling Point
2mm Gap Between Tube End and Socket
Tube reached all the way to end of Socket
Success Rate Validation
Success Rate =
# of successful assemblies
x 100%
total # of assemblies
Success Rate Testing Results
Overall Success Rate
System Pressure Correct
System Pressure Correct and No Operator Errors
82.5%
91.2%
93.9%
Sample Size = 40
Mode of Failure: Tube Insertion Depth Not Sufficient
Fails to meet Target Value: 98%
Price 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 Budget
Part
Positioning Actuators
Insertion Actuators
TBV Jig
Three-way Valve Jig
Clamp
Clamp Grippers
Optical Proximity Sensors
Sensor Switches
Pneumatic Solenoid Valves
Manifold
Regulator and Filter
On/Off Safety Buttons
Pneumatic Fittings
Pneumatic Hose
Frame
Glue Dispensers
PLC
E-Stop
Fasteners (Screws, Bolts)
Brackets
Quantity
2
2
1
1
1
2
2
2
5
1
1
2
20
1 (50 ft roll)
1
2
1
2
estimate
estimate
Cost/Unit ($) Total Cost ($) Prototype Cost ($)
195.50
391.00
391.00
120.00
240.00
0.00
15.00
15.00
15.00
25.00
25.00
0.00
230.00
230.00
0.00
10.00
20.00
20.00
160.00
320.00
320.00
80.00
160.00
160.00
65.00
325.00
325.00
60.00
60.00
60.00
40.00
40.00
0.00
40.00
80.00
0.00
1.00
20.00
0.00
100.00
100.00
0.00
126.00
126.00
126.00
2,700.00
5,400.00
0.00
200.00
200.00
0.00
40.00
80.00
0.00
estimate
30.00
30.00
estimate
60.00
60.00
TOTAL:
7,922.00
1,507.00
= Acquired from Terumo Medical
Meets Target Value
Safeguards 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 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
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 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
Questions