Rees Group Senior Design Report

SPITFIRE:
Separation of Prosthetic In Timely

Fashion Incorporating Resistive Electronics

Group Members:
Aaron Fineout
Blair Caston
Caroline Tulloh
Carly Sproule
Daniel Rees

Faculty Advisor:
Daniel Hayes, Ph.D
Louisiana State University
Department of Biological and Agricultural Engineering

Student Advisor:
Nick Totaro
Louisiana State University
Department of Biological and Agricultural Engineering

Acknowledgements
First and foremost, we would like to thank Dr. Hayes for sponsoring our project and
acting as our faculty advisor. Many thanks go to Nick Totaro, our graduate student advisor. We
would also like to thanks Dr. Vinod Dasa at Oschner Hospital for his support and collaboration
in our project. Our project success is due to the support of these three people.
We would like to thank the LSU Biological Engineering Department for contributing the
experienced faculty, research facilities, and extensive energy and resources into supporting
student design projects like ours.

Table of Contents
1. Introduction......1
1.1.Knee Replacement Surgical Procedure.1
1.2.Bone Cement Properties1
1.3.Standard Knee Revision Surgical Procedure.2
1.4.Experimental Knee Revision Surgical Procedure.4
1.5.Principles of Electrosurgury..4
1.6.Theories of Mechanism of Action.5
1.7.Design Objectives.6
2. Constraints...7
3. Concept Generation........7
3.1.General Conceptual Design.7
3.2.Heating Element...8
3.3.Attachment Mechanism...8
3.4.Power Source...9
4. Concept Evaluation and Selection10
4.1.General Conceptual Design....10
4.2.Heating Element.10
4.3.Attachment Mechanism.11
4.4.Power Source.11
4.5.Feedback Control System..12
5. Design Description.13
5.1.Current Prototype...13
5.2.Procedural Description...13
5.3.Functional Decomposition.14
5.4.Morphological Chart..15
5.5.Physical Decomposition16
5.6.Material Selection..17
5.7.Manufacturing and Assembly17
6. Refined Engineering Analysis...17
6.1.Validation Simulation17
6.2.Thermal and Stress Simulations18
6.3.Heating Element....20
6.4.Failure Mode and Effect Analysis.21
7. Testing Procedures and Results21
7.1.Differential Scanning Calorimetry....21
7.2.Thermogravimetric Analysis.....23
7.3.Thermal Expansion Tensile Test...23
7.4.Heating Element Transient Heating..24
7.5.Proposed Evaluation.25

List of Appendixes
Appendix A: Budget
Appendix B: Gantt Chart
Appendix C: Technical Specifications
C.1: Omega Silicon Rubber Heater Specifications
C.2: Staco Variable Voltage Controller Specifications
Appendix D: Component Selection Information
D.1: General Conceptual Design Decision Matrix
D.2: Heating Element Decision Matrix
D.3: Attachment Mechanism Decision Matrix
D.4: Power Source Decision Matrix
Appendix E: Testing Procedure and Results
E.1: Differential Scanning Calorimetry
E.2: Thermogravimetric Analysis
E.3: Thermal Expansion Tensile Test
Appendix F: Refined Engineering Analysis
F.1: Simulation Reports
F.2: Failure Mode and Analysis
Appendix G: References
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1. Introduction

1.1. Knee Replacement Surgical Procedure

Total knee replacement surgery
is usually done to patients 50 years
of age or older, and most implants
are designed to last 15-20 years.
However, with the wear of the
implant, potential for infection, its
chance of initial failure in a person,
and the implant installation may
need to be revised. (HSS) There are
two common current surgical
methods that are used to revise total
knee replacement surgery; total
knee arthroscopy and revision
arthroplasty. Both forms of surgery
have a potential to exasperate the
bone tissue within the knee, can lead
to infection, cause blood clotting,
and require the patient be sedated.

1.2. Bone Cement Properties

During total knee replacement and knee revision surgeries, a thermoplastic,
biocompatible material known commonly as acrylic bone cement is used to attach
the new prosthesis to the femur and tibia. For our design, we focused on one type of
bone cement, poly-methyl methacrylate (PMMA). This polymer is currently utilized
in a two-part form, a PMMA powder that is mixed with a liquid methyl
methacrylate combined with a benzoyl peroxide initiator that produces a dough-like
material following a free radical polymerization of the monomer. This mixture
hardens into a hardened, glass-like state within minutes depending on the
concentrations of the two parts of the mixtures; however set time can be slightly
tailored to help a surgeon safely apply the cement in enough time to both the bone
and the prosthesis. German chemists Fittig and Paul discovered the polymerization
process in 1877 that made it possible to turn methyl methacrylate in poly methyl
methacrylate, and PLEXIGLAS was soon patented in 1933 by Otto Rhm as the
first commercial instance of the use of this polymer. (Panchbhavi) PMMA was used
industrially during the Second World War until 1959 when Sir Charnley used
PMMA during a hip replacement. (Biomet) Soon after this in the 1970s, bone
cement was mixed with gentamicin to create antibiotic-infused bone cement by
Figure 1: Exploded view of the implant
installation structure
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Buchholz, and Merck began to market PMMA as bone cement for orthopedic use.
(Biomet)

1.3. Standard Knee Revision Surgical Procedure

Arthroscopy revision surgery is a procedure where the surgeon inserts a tube
with a fiber-optic camera into a small incision in the knee to see inside the joint.
From there, the surgeon can use miniaturized instruments to remove/repair any
damaged tissue, drain fluid, or check for infection. This cannot be used to treat
infections in the implant unless they are caught early enough, but have been known
to decrease stiffness and increase the range of motion of the patient. (Surgery
Encyclopedia) Surgeons recommend having a total knee arthroplasty revision
instead of an arthroscopy as it can treat infections as well remove damaged tissue,
drain fluids, and repair or replace the implant.
Knee revision surgery, or revision total knee arthroplasty, is the procedure by
which a surgeon removes a previously installed prosthesis and replaces it.
Approximately 45,000 of these procedures occur every year in the United States, and
this is the most common knee revision surgery in practice today.(Smith and Nephew)
A knee revision procedure requires the anesthetized patient to undergo a three hour
surgery, in ideal conditions, that can be traumatic to the patient. The surgery is
typically performed by opening up the knee joint, cutting through the joint capsule,
and then removing the prosthesis. This is done by sawing through the bone cement
and then chiseling it off, or using a newer apparatus to suction the metal plates of the
implant off the cement after sawing into the bone cement layer to loosen the
prosthetic.
Figure 2: Poly (methyl methacrylate)
http://en.wikipedia.org/wiki/Poly(methyl_methacrylate)#Medic
al_technologies_and_implants

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Current total knee arthroplasty revision surgeries require the surgeons to remove
the implant using a combination of bone saws and applied force with either a chisel
or suction device. The surgeon must first saw underneath the implant to break the
layer of bone cement. If the surgeon cuts too deep some bone loss may occur. This is
due to the lack of clarity of where the bone cement and bone interface is. Colored
bone cements are used to help the surgeon distinguish between bone and bone
cement, but during the sawing process visibility is limited as it must be applied
underneath the implant cap. Once this is complete, the surgeon grasps the implant
and chisels it away or uses a suction device to remove the implant from the
remaining bone cement. This removal process is done to both the femoral and tibial
implant, and then the installation screw is removed. Often, the screw can be difficult
to remove depending on how it lodged into the bone. The removal process can
involve grasping the screw and attempting to hammer it out of the bone, or by
attempting to unscrew it out. The size and difficulty of removing the screw lead to
delays in the revision procedure.
Figure 3: Schematic of knee implant
http://www.wecareindia.com/images/inner/orthopedic/revision-knee-replacement.jpg

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1.4. Experimental Knee Revision Surgical Procedure

A new method employed by Dr. Dasa involves using an electrocautery pen to
heat up the interface between the bone cement and the metal implant to a high
temperature. He inserts the tip of the pen underneath the implant, and rotates it
around or places it in a few strategic locations on the prosthesis to loosen it. He
then wedges the chisel under the prosthesis and lifts the device from the bone
cement. His procedure is faster and gentler than the standard removal of the metal
implant.

1.5. Principles of Electrosurgury

Electrosurgery uses alternating current by using a generator as the power source to
send current to the active electrode. From the active electrode, energy is created
using the resistance in the air with the electricity admitted by the active electrode to
cause cutting to proceed. The current used in this process is then transmitted through
the patient to the return electrode and cycles back to the generator. The patient return
electrode is located near from the incision site on the patient. It has a large area and
must be securely in place to prevent electrical burns. Current is follows the path of
least resistance, so potential grounding objects such as the operating room table,
Figure 4: Current Knee Revision Surgery Removal
http://healthpages.org/wp-content/uploads/2010/06/knee-replacement-surgery.jpg

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equipment, or even staff members must be taken into consideration when using
electrosurgery. The patients tissue acts as the impedance or an obstacle to flow
current through so it is also important that the patient electrode be near the operating
site to allow for the smallest possible path for the current that travels through the
patient ("Principles of Electrosurgery").
Standard electrical current alternates at a frequency of 60 Hertz.
Electrosurgical systems operating at this frequency would cause excessive
neuromuscular stimulation and electrocution. Nerve and muscle stimulation ceases at
100 kHz. The generator takes a 60 Hz current input and increases the frequency to
over 200 kHz. By doing so there is less risk of adverse effects from the alternating
current.
When applying the active electrode to begin cutting the patients tissue, two
main tissue effects can be present. The most efficient is electrosurgical cutting which
divides the tissue with electric sparks that focuses intense heat at the surgical site. The
sparking created by the cutting instrument produces the maximum current
concentration on the surgical site. By holding the active electrode away from the
patient, it produces the greatest amount of heat over a short period of time resulting in
vaporization of tissue. The second tissue effect is desiccation. Desiccation is where
the active electrode is in direct contact with the patients tissue causing less heat to be
produced and no cutting action to occur. Coagulation instead of vaporization is the
effect on the patients tissue. The heat generated from the cutting instrument radiates
through the tissue and dissipates at the surface. The danger with desiccation is that
damage to the inside healthy tissue is prevalent. Dr. Dasa uses both electrosurgical
cutting and desiccation in his current knee revision surgery procedure. Our device
will change this procedure and prevent healthy tissue from being damaged by surface
heating of the implant ("Principles of Electrosurgery").

1.6. Theories of Mechanism of Action

The exact mechanism that creates the metal to bone cement separation in the
experimental surgical procedure is currently unknown. It is suspected that the
application of heat to the metal-polymer interface causes the material to expand at
different rates, thus breaking the bonds between them, resulting in an easier
separation of the two materials. However, the electrocautery pen may cause a
piezoelectric effect that is affecting the release of the bone cement from the
prosthesis. Dr. Dasa has shown that is procedure results in a clean removal with
minimal bone cement residue on the implant. The main drawback of this
procedure is the lack of consistency in removing the bone cement from the
prosthetic. Dr. Dasa uses a cauterizing iron to heat different areas of the implant to
an unknown temperature before removal. This is inefficient with respect to time
and risks damaging surrounding tissue.
The general conceptual design for the device was developed based on the
mechanisms of Dr. Dasas experimental surgical procedure. It is believed that his
method operates by a thermal phenomenon, a piezo-electric effect, or a
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combination of the two. The thermal phenomenon is based on the law of thermal
expansion. The metal implant heats and expands more than the PMMA layer, thus
inducing thermal stresses at the interface and breaking the adhesive bonds.
Likewise, the piezo-electric phenomenon is based on the observation that bone has
been shown to have piezo-electric properties, therefore, a high frequency current
passing through the bone may induce high frequency oscillating stresses that
transmit through the PMMA layer to the metal polymer interface. Additionally,
PMMA with certain additives has been shown to exhibit piezo-electric properties
that could enhance this effect.

1.7. Design Objectives

We have modified Dr. Dasas experimental surgery to create a novel procedure
that will utilize our proposed device design. The procedure and device are designed to
exploit the same mechanism of action of the experimental surgery, but reduce the
time, inconsistency, and danger of the operation. The device will heat from the
surface of the femur implant down. We are in the process of designing a procedure
that will apply the device, heat the femur prosthetic for less than 15 minutes, remove
the device, and then use a standard implant removal device currently to remove the
implant from the bone cement.
Measurable Objectives
Procedure time under 15 minutes
Avoid heating bone above 45C
Do not exceed heater temperature of 200C
Since SPITFIRE is a medical device that is to be used to aid in the removal of
knee prosthetics, medical manufacturing companies such as Stryker, DRE, and
WelchAllyn could purchase the intellectual property from Louisiana State
University to develop their own unique device that fitted especially to their
prosthetics. However, if SPITFIRE were to be produced by an independent source to
where it fit various manufacturers prosthetics, hospitals, or the doctors themselves,
could purchase this device. If this design were to be taken further, it could be adapted
for prosthetics other than the femur head which would greatly increase its
marketability.

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2. Constraints

Must be small enough to fit in an open knee
Performance of device must be predictable such that a standard procedure can be
developed for its use
Shape must fit prosthesis of all sizes, or shape must be scalable to fit specific sizes
Whole system must fit next to the operating table without overcrowding the
doctor
Components must be sterile and disposable
Whole system must be built within budget
Voltage regulator must deliver an electrical current with known voltage and
current to the surface heater
Be able to monitor temperature output of the surface heater
Must comply with FDA standards

3. Concept Generation

3.1. General Conceptual Design

4 general conceptual designs were generated based on the 2 potential mechanisms
of action, and the means of application in a localized pen design, or a distributed
surface design. Resulting in an electrical pen, thermal pen, electrical surface, and
thermal surface application.
The electrical pen design would operate similar to the procedure Dr. Dasa is
currently preforming. The design could interface with the Force FX Electrosurgical
Generator and Covidien Electrosurgical Pen currently in use in many hospitals across
the country. The improvements would primarily be in the reinforcement of the
disposable electrode insert to withstand the rigorous procedure. However, no solution
was seen to reduce the sparking or flaming observed in procedure.
The thermal pen design would operate similar to a soldering iron. Instead of
delivering electrical current, the pen tip would be heated to deliver a thermal load.
Localized heating is perhaps an inefficient heating process, and presents increased
potential for burns.
The electrical surface design would attach wide electrodes across the surface of
the implant, and a return electrode at the base of the exposed bone. A high frequency,
high voltage current would be applied through the implant interface and potentially
disrupt the adhesive bonding of the PMMA to the metal. However, the equipment
8

needed to operate and test this design was far outside of budget and presented great
risk for any potential lenders of the necessary equipment.
The thermal surface application design uses a flexible resistive heater to apply a
distributed thermal load to the implants exposed surface. The heat diffuses through
the implant to the PMMA layer. This will induce thermal stresses in the interface that
are potentially great enough to disrupt the adhesive bonds of the polymer to the metal
surface and drastically reduce the force needed for removal. This phenomenon was
simulated in Solidworks (Section 6.1-6.2) and an experiment was designed to test this
theory (Section 7.3).

3.2. Heating Element

The heating element is a critical component of the design as it is the mechanism
of operation of the device. The design required that the component be flexible to
conform to the curvature of the implant surface, inexpensive as it will be disposed of
after contact with the patient, durable enough to withstand handling and installation,
and customizable in shape to fit the implant surface precisely.
Several heating elements were considered, including silicon rubber, polyamide,
and resistive metal wire elements.

3.3. Attachment Mechanism

To provide the heat generated from SPITFIRE to the prosthetic itself, a securing
mechanism is required. The properties in Figure 5 were used to determine the best
mechanism. With these properties in mind, adhesive tapes, clamps, heat resistant
pastes, and gloves were initially considered as suitable attachment features.

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3.4. Power Source

When determining the power source for our device, our team examined a number
of different options. The power source was dependent upon the chosen heating
element, as to ensure it was rated for the correct voltage output.

Property Significance
Clinical
Relevance
Potential use in the operating room, small and easy to integrate
into an already complex workspace.
Size With respect to the limited amount of space available in an
operating room, source must be small and unobtrusive.
Cost Source cost must be within budget constraints.
Accessibility Source must be easy to operate and maintain, and kept sterile.

Property Significance
Time Required to
Secure
The attachment feature needs to be secured in a short
amount of time to reduce the overall time to remove the
prosthetic.
Cost

Must be within budget constraint
Operating
Temperature
The securing mechanism must withstand temperatures
up to 300C.
Clinical
Effectiveness
This mechanism must not impede the dexterity of the
surgeon.
Removability The attachment device will need to be separated from
the prosthetic, so the prosthetic can be properly
disposed of.
Figure 5: Design considerations for attachment mechanism

Figure 6: Design considerations for power source

10

Five power sources were considered during our selection process. The
first was the pre-existing Force FX machine currently in use within the
operating room, allowing a wide range of voltages and a high frequency but
was not readily accessible for testing. The device could plug directly into a
wall outlet with an adapter, offering a low cost option with no control over
current delivered. California Instruments P Series compact AC power source.
The programmable electronic load, CS13710A from Circuit Specialists offers
the ability to program the voltage to decrease over time but is a DC source.
The Staco 3PN1010B variable voltage controller offers a durable design,
necessary voltage range, and easy operation.
The functional requirements considered in our weighted decision matrix
when evaluating each power source during the selection process were as
follows:
Variability of voltage
Able to operate at frequencies above 150 kHz
Able to operate above 100 V, alternating current
Easy to interface with chosen heating element
Ease of operation, accessibility
Cost

4. Concept Evaluation and Selection

4.1. General Conceptual Design

Thermal surface application was chosen as the general conceptual design. This
design was determined to be safer, less expensive, more user friendly, and more
effective than the other designs considered. A weighted decision matrix can be found
in Appendix D.1.


The OMEGA silicon rubber heating element was chosen due to its low cost and
potential for customization. A 3 in diameter circular element was purchased, but
future designs may have the component shaped to fit the surface of the implant
precisely. This design will allow for the most efficient heating process.
The element operates at a maximum voltage of 120 V ac, and a maximum
temperature of 232C. The model selected produces 10 W/in
2
which is the output
that the manufacturer suggests is best for a rapid heating process. The manufacturer
notes that when operating at 120 V ac, the element will exceed the maximum
11

operating temperature. Thus, the design will operate at 120 V ac to rapidly heat to a
given temperature, and lower voltage to maintain that temperature.
A weighted decision matrix for this component can be found in Appendix D.2.

4.3. Attachment Mechanism

A weighted matrix, as seen in Appendix D.3, was used to determine the
attachment feature. A clamp was chosen as the securing mechanism to be used. This
clamp would be designed in the spring semester and subsequently built to aid in the
testing of SPITFIRE. This clamp would be secured only to the prosthetic so no tissue
is damaged and have a heat protective coating where the surgeon would secure
SPITFIRE; however, suggestions were made by various faculty members regarding
this aspect of our design. Further discussion is needed to determine whether a clamp
is the most suitable way to proceed.

4.4. Power Source

The Staco 3PN1010B variable voltage controller from Cole-Parmer was
chosen for the design due to its compact size, ease of use, low cost, and ability to
operate within 0 to 140 V alternating current. High frequency operation became
irrelevant once a thermal system was chosen.
The voltage controller receives an input of 120 V ac from a wall outlet, and
outputs between 0 to 140 V ac. The maximum amp output is 10, and the device
operates between 50 and 60 Hz. The total net weight of the source is 10.25 pounds,
and the device dimensions are shown below.

Figure 7: Dimensions of Staco VariableVoltage Controller

12

Research was done to determine the best and most cost effective option for
providing reliable power to the device. Once we had determined what heating
element we were going to use, we searched online to find several different options
for providing alternating current power at high frequencies.
The Staco Variable Voltage controller was that while it does not operate at
high frequencies, but cost of obtaining a high frequency power source was far
outside of budget, or the source did not provide the power we needed. The chosen
power sources acts as a variable transformer from a standard wall outlet, which is a
convenient and relatively reliable source of power, which will allow us to
potentially heat the device up faster by providing excess voltage, then lower the
voltage to stabilize the temperature.
The Force FX generator was not used due to high cost and high liability. The
generator exceeded budget constraints considerably, and would have required
special adapters be manufactured to interface a device with it. Also, borrowing one
from the hospital, presented liability issues to any potential damage caused by
connecting an unknown device to such an expensive piece of equipment, and may
have had to buy a new one if damaged during testing.
Appendix D.4 shows the decision matrix for the power source

4.5. Feedback Control System

A thermocouple sensor measures the temperature of the implant and interface
then relays it back to the controller. The controller compares this temperature with the
desired temperature setting. The data logger intercepts this data and relays it to the
program LabView to track and organize the data. If this temperature is not at the
desired setting, an alert will be implemented to raise or lower the voltage from the
power supply. The power supply dial will have to be turned up or down by hand by a
nurse or assistant in the surgery room. This process will cycle until the desired
temperature is met.

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5. Design Description

5.1. Current Prototype

The current prototype of the design consists of a variable voltage controller
(Staco) to supply a controllable current to a 3 inch diameter silicon rubber heating
element (Omega). The heating element lead wires are connected the power supply
with a wall outlet replacement plug. A feedback system consisting of a type K
thermocouple connected to a data logger and lab computer can monitor the
temperature of the heating element.

Several components need to be added to complete the prototype, including an
attachment mechanism. The type K thermocouple will likely be changed to a type T,
and the computer and DAQ are subject to change as well.

5.2. Procedural Description

After initial incisions have been made to open the knee, the heating element will
be secured with the attachment feature to the prosthetic. The voltage controller will
then be turned to a predetermined voltage output, so the heating element can heat the
Figure 8: SPITFIRE prototype

14

prosthetic to the desired temperature. The feedback loop system will ensure that the
heat generated will not damage the surrounding tissue. After the device has heated the
prosthetic, the attachment feature and the prosthetic will be removed.

5.3. Functional Decomposition

Electricity travels through the SPITFIRE device, generating heat in the heating
element. The feedback loop system will display the temperature of various interfaces
to ensure little to no tissue is damaged due to the device. A force is then applied with
a removal device to remove the prosthetic from the head of the femur. This process is
shown below in Figure 9.

Materials
Energy

SPITFIRE
Prosthetic
Electricity
Heat
Removal Device
Force
Removed
Prosthetic
Figure 9: SPITFIRE functional decomposition

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5.4. Morphological Chart

The morphological chart (Figure 10 below) shows various criteria that the design
must meet, and potential components or techniques to meet those criteria.

Morphological Chart
Heat Delivery to
Interface Heating Method Casing Power Source
Feedback
Controls
Microwaves Induction Pen Force FX LabView
Heating Tip Resistance Gun Battery
Programmable
chip
Surface Heating Fire heating Glove Wall Outlet Force FX
Heating Tip Filament
Flexible Heating
Element
Hydroelectric
Hot Air Electrodes Geothermal
Convection gun

Figure 10: SPITFIRE morphological chart

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5.5. Physical Decomposition

The SPITFIRE device can be broken down into four main components; all of
these are connected to the heating element. The applicator/adhesive, which we have
not yet determined at this stage, will be connecting the heating element to the
prosthetic to ensure maximum heat transfer to the implant. The feedback control look
is a safety measure, put in place to ensure the temperature of the heating element does
not reach an unsafe level for use during surgery. The voltage regular is connected to
the power source, and has controls that allow it to regulate the amount of energy
flowing through the outlet to the heating element, and thus can alter the temperature
emitted by the heating element. This is manually done, but will be adjusted based on
the results of the feedback loop.

Figure 11: SPITFIRE physical decomposition

Heating Element
Applicator/Adhesive Surface Heating
Feedback Control
Display
Thermocouple
Processor LabView
Data Logger
Voltage Regulator
Internal Circuitry
Wall Outlet
Casing
Pending Component

Developed Component
17

5.6. Material Selection

The medical application of the device makes final material selection a complex
process. The silicon rubber in the heating element is regarded as generally
biologically safe, however material choice will be subject to approval by the FDA.
The device prototype uses a commercial silicon rubber encased heating element.
These elements have been quoted at prices as low as $8 per unit in bulk. A
production prototype will likely require that the material be subjected to a more
controlled and refined manufacturing process to eliminate impurities in the material,
increasing the cost.

5.7. Manufacturing and Assembly

Manufacturing and Assembly will need to be done in an FDA approved
environment and process. The heating element component will need to be sterilized
and packaged in a sterile container. This seal must remain intact until the moment of
use. The rest of the components of the device will be subject to less stringent
regulation as they do not contact the patients body.

6. Refined Engineering Analysis

Prior to constructing testing apparatus, models and simulations are used to predict results
of the test. These models save money and time by avoiding physical experimentation, but the
validity of the model must be confirmed before their results can be considered reliable. A
simplified test can be developed and modeled for this purpose. If the results of the simulation
and test differ dramatically, the model must be altered to reliably predict the results of the
complex test.

6.1. Validation Simulations

Initial testing helped validate
simulation results produced by
SolidWorks. In the test, we wanted to
make sure the PMMA did not reach its
melting temperature, 110C (Appendix
E.1). As the polymer begins to melt,
there is potential it may flow into and
cause damage to the patients tissue. The
simulation uses a simplified model of the
Figure 12: Validation model
18

initial test (Figure 12) to predict the time it takes the metal to reach a temperature at
which shearing stresses will decompose the PMMA bonds. From the data, we were
able to determine whether or not the polymer will melt.
These samples will be fabricated in a manner discussed in Section 7.3.1 and run in
conjunction with the thermal expansion tensile test (Section 7.3).
Thermal Simulation
In the temperature simulation, two stainless steel bars were bonded by PMMA
with one of the bars in direct contact to a hot plate. Some assumptions made include:
the convective heat transfer coefficient is 10W/m
2
K, the temperature of the hot plate
is 110C and does not fluctuate with time, and the ambient temperature is 21C . Error
may arise due to the fact that the bar is considered to be perfectly bonded to the hot
plate, but the effects are considered negligible. The simulation was ran for one minute
under fine mesh parameters with a time step of .6 seconds. Simulation results
(Appendix F.1.1) predict the PMMA reaching a temperature of 109.35C after 18
seconds. Results at this time step are imported into a stress simulation.
Stress Simulation
The stress simulation shows how stresses due to thermal expansion build up in
the assembly. The target stress value is the ultimate shearing strength of PMMA, 12
MPa (Stone, et. al.). Some assumptions made in the stress simulation include: all
parts are bonded, effects due to friction are negligible, and the model is reinforced by
soft springs. The simulation is ran at the 18 second time step under fine mesh
parameters. Simulation results (Appendix F.1.2) predict maximum stresses
experienced at the polymer-metal interface are approximately 16 MPa. If this is true,
the test subjects should come apart under little to no force.

6.2. Thermal and Stress Simulations

Validation of a simplified model allows us to reliably predict results of the
complex test. In the complex test model, a femoral knee prosthesis is bound to a
femur by a 2mm thick PMMA layer. Heat flow through the prosthesis is predicted by
running a thermal simulation on this model. A goal of the simulation is to limit
temperatures experienced by the patient to a safe value. Exposure to scalding
temperatures ranging from 45C to 90C for one minute will cause necrosis in bone
tissue (Berman AT, et. al.) Bertman explains damage incurred by temperatures
exceeding 70C for one minute is replaced by scar tissue under the implant. Scar
tissue formation at the prosthetic-bone interface causes poor adhesion and may result
in a failed replacement surgery. He goes on to suggest limiting temperature exposure
to 70C. Necrosis at temperatures lower than this limit may be acceptable since
evidence suggests the tissue till be repaired (Bertman); however, we would like to
minimize damage done during the removal process and limit temperature exposures
to about 45C. If stresses at this temperature are not large enough to shear the
adhesive bonds, the heating time and temperature to reach the necessary stress will be
evaluated.
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6.2.1. Thermal (bone temperature does not exceed 45C)
A constant heat flux of 15,500
W/m^2 is applied to the entire femoral
surface exposed during surgery. This
case is considered ideal because,
realistically, we will not be able to
cover the entire surface; however, the
model gives us insight into how long
the prosthetic should be heated. The
simulation assumes the surface heater
provides a heat flux at its rated
capacity, the heat flux does not vary
with time, all parts are bonded, and the
initial temperature of all components in
the assembly is 37C (approximate body
temperature). The simulation predicts
the patients bone will reach a
maximum of 49C after 2 seconds
(Appendix F.1.3). If stress concentrations are not large enough in the PMMA
layer at 49C, we assume they will not be large enough at 45C.

6.2.2. Stress (bone temperature does not exceed 45C)
Results from the thermal
simulation are imported into the
stress simulation. All parts are
assumed to be bonded and are
reinforced by soft springs. At this
temperature, maximum stresses
experienced by the PMMA layer
are approximately 5.2 MPa, and
stresses experienced by the
patients bone are approximately
6.7 MPa (Appendix F.1.4).
According to the University of
Wisconsin-Madison, the ultimate
shearing strength of the femur is
65-71 MPa, so this value is well
within the allowable range. Stress
concentrations within the PMMA
layer do not exceed the shearing
strength of PMMA (12 MPa), so
the time it takes to exceed this
value and corresponding temperatures were evaluated
Figure 14: Thermal stresses max
temperature at bone is 49
C.
Figure 13: Heat distribution through the
implant assembly.
20

6.2.3. Thermal (shortest heating time to reach 12 MPa)
Assumptions made in the
thermal simulation assuming
bone temperature does not exceed
47C are identical to those in
this simulation. The simulation
predicts the PMMA layer
reaching a max of 92C and the
bone reaching a maximum of
85C after 8 seconds (Appendix
F.1.5). At this time step, the
PMMA layer will not begin to
melt; however, some of patients
bone will become damaged
beyond reliable repair. Figure n
shows isolated portions of the
bone whose temperature exceeds
70C. This small, but significant
volume of bone will form scar tissue and may need to be removed before
replacing the prosthesis. Cooling the bone before applying the surface heater may
reduce the max temperature experienced by the bone. Corresponding stresses at
this temperature are evaluated in the stress simulation.

6.2.4. Stress (shortest heating time to reach 12 MPa)
Assumptions made in the stress simulation assuming bone temperature
does not exceed 45C are identical to those in this simulation. Stress
concentrations at 8 seconds are 12.6 MPa in the PMMA layer and 17.5 MPa in the
bone (Appendix F.1.5). We assume at this time, the PMMA bond will shear and
the patients bone will not suffer from shearing stresses.
Our simulation results suggest in order to shear the bonds holding the
prosthesis to the bone, a constant heat flux of 15,500 W/m
2
. must be applied to the
prosthetic for 8 seconds.


The prototype heating element is a 3 inch diameter circle with etched foil resistive
heating elements embedded in silicon rubber. The maximum operating temperature is
232 degrees Celcius. The maximum operating voltage is 120 V ac. When operating
at maximum voltage, the power density is 10 W/in
2
and the element will exceed the
maximum operating temperature.

Figure 15: Isolated portions of assembly
exceeding 70C.
21

6.4. Failure Mode and Effect Analysis

A failure mode and effects analysis (FMEA) was developed to assess problems
that may arise from malfunctions within the system (Appendix F.2). The FMEA
identifies modes of failure for each component and determines the effect of each
failure on the system. The analysis was used to establish steps that can be taken to
prevent the failure. A risk priority number (RPN) was calculated for each failure
mode based on the severity of the effect, occurrence of the failure mode, and the
chance of detection. The RPN was used to determine which failure mode was most
severe and required immediate attention. RPN was calculated using the formula:
=
Severity, occurrence, and detection are quantified based on criteria determined in
Engineering Design, Fourth Edition.
Failure modes for our device have a relatively low risk priority number. Most of
the failure modes can be corrected by disposing the surface heater and using another
or by monitoring the temperature of the surface heater. A critical failure mode that we
have little control over is sterility failure. Sterility failure takes place when a
prepackaged component is not properly sterilized and is used during surgery.
Detection of a sterility failure is nearly impossible. It does not hinder the functionality
of our device, but the implications of sterility failure can be life-threatening to the
patient. We suggest reducing the occurrence of this failure mode by sterilizing the
surface heater using ethylene oxide and purchasing pre-sterilized thermal paste from a
reliable vendor.
The full FMEA report can be found in Appendix F.2.

7. Testing Procedures and Results

7.1. Differential Scanning Calorimetry

Differential Scanning Calorimetry (DSC) is a measure of the difference in heat
flow rate between a sample and inert reference as a function of time and temperature.
For our samples, we had an endothermic heat flow, where heat flowed into the sample
so we could determine the melting temperature of our PMMA bone cement. The heat
flow measured is the temperature of the pan, not the temperature of the actual sample.
This heat flow is based on the DSC heat flow equation, shown in Eqn XX below. In
this equation, the DSC heat flow signal (dH/dt) is equal to the sample heat capacity
Equation 1: Risk Priority Number Equation
22

time the heating rate plus the heat flow that is a function of time at an absolute
temperature.

= (
) + (, )
When we ran our sample, the PMMA bone cement, through DSC, we ran
it twice. This was done because PMMA is a wet-based polymer, and to ensure we
had reached the correct melting temperature of our polymer, we wanted to ensure
all the liquid had been evaporated from the solution. We know from the fact that
PMMA is a thermoplastic material that DSC would give us the melting point of
our polymer, and this would help us determine a maximum temperature for
breaking down the polymer-prosthesis interface when designing our thermal and
stress modeling, and when we designed our Instron tests.
The results obtained from the second heating of the first run and the first
heating of the second run were used in our calculations. This was done as they
showed the consistency we would expect for when the melting point of our
polymer was reached, and the liquid had been evaporated from the PMMA
compound. We did not use the second heating of the second run due to this being
after the melting point was achieved. The graphs found in Appendix E.1 show the
melting points of the first heating second run and second heating first run, as well
as the two together. From this data the melting temperature is determined to be
about 110C.
Graphs and tests were run with the assistance of the LSU Chemistry
Department, and Dr. Rafael Cueto.
Figure 16: Basic Setup of Sample in DSC
http://www4.ncsu.edu/~lalucia/courses/WPS-595B-BIOMATERIALS-CHARACTERIZATION/DSC.pdf

Equation 2: DSC Heat Flow Equation

23

7.2. Thermogravimetric Analysis

Thermogravimetric Analysis (TGA) is a technique used to determine a materials
thermal stability and fraction of volatile components, by monitoring its weight change
that occurs as a sample is heated. The measurement is usually carried out in air or an
inert atmosphere, and weight is recorded as a function of increasing temperature.
TGA can reveal second-order phase transition data about a material, such as
vaporization, sublimation, and adsorption, as well as chemical phenomena such as
decomposition and chemisorption.
TGA analysis gave the glass transition point of PMMA. Glass transition is a
reversible point in a reaction where an amorphous material changes from a hard and
brittle state to one that is molten or rubber like. The results show the glass transition
of PMMA to occur at 358C
Graphs and tests were run with the assistance of the LSU Chemistry Department,
and Dr. Rafael Cueto. TGA results are found in Appendix E.2.

7.3. Thermal Expansion Tensile Test

An experiment was designed to determine the effect of thermal expansion on the
metal-polymer interface.

7.3.1. Sample Preparation
Sample bars used in initial testing are
made of 316L stainless steel. 316LVM is
one of the metals the femoral knee
prosthesis is made of; however, our budget
limits us to purchasing 316L and assuming
material properties are similar enough to
produce reliable test results. Test bars were
cut to 1x.25x2.75 in. so they would fit in
the tensile grips. Contaminants are
removed from the bars surface by
whipping them down with ethanol, and
gloves are used while handling the bars.
The bars are placed in a mold and are ready
to be bonded together.
The mold used in preparing test samples is made of wood. The wood is
sprayed with a lubricant to prevent adhesion of the PMMA to the wood. A test bar
is placed in the mold and spacers are placed on top of the bar. PMMA is placed in
a void created due to the spacers and a second bar is placed on top of the spacers.
Figure 17: Exploded view of the mold used in
sample preparation.
24

A constant force is applied to the top of the second bar for 4 minutes while the
polymer hardens. An exploded view of the whole setup is found in Figure 17.
PMMA used in the test sample is prepared according to the manufactures
instructions. 8g of the solid were mixed with 3.92 mL of liquid using an automatic
mixer for 30 seconds. After a one minute standing period, the PMMA is put in the
mold. Samples are allowed to set for 24 hours before tests are ran on them.

7.3.2. Instron Test Procedure
Grip Design
Grips were designed to interface with the Instron Materials
Characterization System. The grips were designed to produce a tensile
force on the sample, while minimizing shear forces. Several prototype
grips were made, leading to the final design created from a 2 hollow steel
rectangles with a face partially cut-out. Steel brackets serve to connect the
grip and the instron system.
Diagrams and images of the test setup are found in Appendix E.3.
Testing Protocol
Bluehill software was used to control the instron interface. The
specially design grips were attached to the instron using the standard
tensile grips. Samples were inserted into the setup, and the grips were
moved apart at a rate of 1mm/s. The tensile force exerted on the load cell
increases as the grips separate. A sharp drop in the force detected
indicates that the sample has been broken. Using the maximum force
before breaking, and the measured area of the interface, the ultimate
tensile strength can be calculated.

7.4. Heating Element Transient Heating

The heating element was placed between two nonconducting surfaces and
subjected to 110 V ac. Temperature was recorded using a type K thermocouple and a
Pico instruments data acquisition terminal. Picologger software displayed the
temperature over time.
The heating element took about 30 seconds to heat to 100C, but testing was
halted when smoke was noticed from the heated element. The manufacturer claimed
the component was defective and sent a replacement that has yet to be evaluated.
It should be noted that while this experiment is performed in between two
insulating surfaces, the application of the device will be between an insulating and a
conducting surface thus increasing the transient heating time.

25

7.5. Proposed Evaluation

The testing that we will be conducting for our final testing will be to mount a
cadaver bone onto a board or flat surface stabilizing the bone. Next, a knee implant
will be attached to the bone with bone cement to simulate realistic conditions. Type T
thermocouples will be attached on the knee implant, the bone cement interface, and
the bone itself. These thermocouples will relay temperature as our heating device is
applied to the knee implant for the set temperature and time. The knee implant will
then need to be removed and the force quantified to do so. Our group members will
all be certified to handle cadaver bones to do initial testing but for final testing we
will have Dr. Dasa perform the removal. By doing so, the time it takes to remove
them implant can be estimated effectively due to using a trained and well versed knee
revision surgeon.

Appendix A: Budget
PreliminaryExperimentation $148
DevicePrototype $625
Evaluation $475
Unrestricted $552

Preliminary
Experimentation Quantity Cost
ATSMF208312 1 $41
316LSteelBar(1"X0.25") 12ft $32
PMMA $75
Subtotal $148

DevicePrototype Quantity Cost
PowerSupply 1 $400
HeatingElement 1 $150
Wires 1 $25
ControlSystem 1 $25
SensorSystem 1 $25
Subtotal $625

Evaluation Quantity Cost
PMMA $75
TestingInstrumentation 1 $400
Subtotal $475

Unrestricted Cost

Preliminary
Experimentation,
$148
DevicePrototype,
$625
Evaluation,$475
Unrestricted,$552
Budget
Appendix B: Gantt Chart

CanttProject Report
Project : SenIor DesIgn FaII 2013
Start : 3]10]13
End : 12]8]13
OrganIzatIon : 8AE
Web LInk : http:]]
DescrIptIon :
Date : Nov 19, 2013 1:07:28 PM
SenIor DesIgn FaII 2013
3]10]13-12]8]13
Page 1
Tasks LIst
Name
8egIn date
End date
Resources
nItIaI Project Research 3]10]13 5]8]13
Observe New SurgIcaI Procedure 3]17]13 4]15]13
Research Knee RevIsIon Surgery 3]10]13 5]8]13
MaterIaI CharacterIzatIon 8]18]13 9]7]13
TCA]DSC AnaIysIs oI PMMA 8]18]13 8]24]13
CharacterIze and Render ProthesIs 8]18]13 9]7]13
ModeIIng 9]8]13 11]30]13
ThermaI SImuIatIon oI PMMA and ProthesIs 9]8]13 9]28]13
Stress SImuIatIon oI PMMA and ProthesIs 9]29]13 10]28]13
Heat FIux SImuIatIon through ProthesIs 10]29]13 11]30]13
ConceptuaI DesIgn 9]1]13 11]30]13
PotentIaI Heat]EIectrIc DeIIvery Methods RevIew 9]1]13 10]12]13
Research PIezoeIectrIc]ThermaI EIIects 9]8]13 9]22]13
RevIew Power Sources 10]27]13 11]16]13
Research SecurIng MechanIsms 11]10]13 11]30]13
TestIng 8]25]13 12]1]13
Adapt and Purchase ASTM Standards 8]25]13 9]10]13
PerIorm Necessary ModeIIng 9]8]13 10]27]13
Research and Order TestIng MaterIaIs 9]22]13 10]5]13
8egIn AssembIIng Test EquIpment and nstron TestIng 10]13]13 12]1]13
Project Research 3]10]13 12]7]13
3]10]13-12]8]13
Page 2
Resources LIst
Name
DeIauIt roIe
DanIeI Rees project manager
CarIy SprouIe undeIIned
Aaron FIneout undeIIned
8IaIr Caston undeIIned
CaroIIne TuIIoh undeIIned
3]10]13-12]8]13
Page 3
Cantt Chart
3]10]13-12]8]13
Page 4
Resources Chart
3]10]13-12]8]13
Page 5
Appendix C: Technical Data
C.1. Omega silicon rubber heater specs

9
To Order, Call or Shop Online at omega.com
SM
FLEXIBLE SILICONE RUBBER
FIBERGLASS INSULATED HEATERS
exceed 305 mm (12") use the wire-
wound element design. Effect of
power density: gentle warming is
best done with 2.5 W/in
2
.

A good all
purpose unit is the 5 W/in
2
. Rapid
Comes complete with operators manual
*
Insert watt density: 2 for 2.5 W/in
2
, 5 for 5 W/in
2
or 10 for 10 W/in
2
.
**
Most sizes available in 230V. Contact Engineering.
Heaters with pressure sensitive adhesive: max operating temperature is 149C (300F).
Ordering Examples: SRFR-3/10, 7.6 cm (3") diameter heater with a watt density of 10 W/in
2
and 70 watts of total power.
SRFR-11/10, 28 cm (11") diameter heater with a 10 W/in
2
, 949 watts.
warm-up and high temperature
are achieved with the 10 W/in
2
;
however, temperature must be
controlled as the safe maximum
operating temperature limit of
232C (450F) may be exceeded.
Round Silicone Rubber Heaters
To Order Visit omega.com/srfr_srfg for Pricing and Details
Diameter Total Wattage for Watt Density Without PSA With PSA

cm (inch) 2.5 W/in
2
5 W/in
2
10 W/in
2
Model No. Model No.
7.6 (3) 17.5 35 70 SRFR-3/* SRFR-3/*-P
10 (4) 31.4 62.8 125.6 SRFR-4/* SRFR-4/*-P
13 (5) 49.0 98.15 196.3 SRFR-5/* SRFR-5/*-P
15 (6) 70.67 141.3 282.7 SRFR-6/* SRFR-6/*-P
18 (7) 96.2 192.4 384.8 SRFR-7/* SRFR-7/*-P
20 (8) 125.65 251.3 502.6 SRFR-8/* SRFR-8/*-P
23 (9) 157.9 315.8 631.7 SRFR-9/* SRFR-9/*-P
25 (10) 196.25 392.5 785 SRFR-10/* SRFR-10/*-P
28 (11) 237.45 474.9 949.8 SRFR-11/* SRFR-11/*-P
30 (12) 376.8 753.6 1507.2 SRFR-12/* SRFR-12/*-P
SRF Series
SRF Series shown
smaller than actual size.
OMEGALUX
silicone rubber
berglass insulated exible heaters
can improve heat transfer and speed
warm-ups where controlled heating
is required in conned areas. Two
circuit designs are available: etched
foil or wire wound. Heaters with
etched foil designed elements are
available where the length or width
dimension is less than 305 mm
(12"). All other heaters where both
the length and the width dimensions
U Lightweight Thin, Flexible
U Available in 2.5, 5 and
10 W/in
2
U -56 to 232C (-70 to 450F)
Operating Temperature
U Etched Foil and Wire
Wound Design
U Round or Rectangular Shapes
U Available in
115 or 230** Vac
U Optional Pressure Sensitive
Adhesive (PSA)
10
SM
CAUTION AND WARNING!
Fire and electrical shock may result if products are
used improperly or installed or used by non-qualied
personnel. See inside back cover for additional warning.
Total Wattage for Watt Density
Without PSA With PSA
Width, cm (") Length, cm (")

2.5 W/in
2
5 W/in
2
10 W/in
2
Model No. Model No.
2.5 (1) 2.5 (1) 10 SRFG-101/10 SRFG-101/10-P
2.5 (1) 5 (2) 5 10 SRFG-102/* SRFG-102/*-P
2.5 (1) 7.6 (3) 7.5 15 30 SRFG-103/* SRFG-103/*-P
2.5 (1) 10 (4) 10 20 40 SRFG-104/* SRFG-104/*-P
2.5 (1) 13 (5) 12.5 25 50 SRFG-105/* SRFG-105/*-P
2.5 (1) 15 (6) 15 30 60 SRFG-106/* SRFG-106/*-P
2.5 (1) 18 (7) 17.5 35 70 SRFG-107/* SRFG-107/*-P
2.5 (1) 20 (8) 20 40 80 SRFG-108/* SRFG-108/*-P
2.5 (1) 23 (9) 22.5 45 90 SRFG-109/* SRFG-109/*-P
2.5 (1) 25 (10) 25 50 100 SRFG-110/* SRFG-110/*-P
2.5 (1) 28 (11) 27.5 55 110 SRFG-111/* SRFG-111/*-P
2.5 (1) 30 (12) 30 60 120 SRFG-112/* SRFG-112/*-P
2.5 (1) 46 (18) 45 90 180 SRFG-118/* SRFG-118/*-P
2.5 (1) 61 (24) 60 120 240 SRFG-124/* SRFG-124/*-P
2.5 (1) 76 (30) 75 150 300 SRFG-130/* SRFG-130/*-P
2.5 (1) 91 (36) 90 180 360 SRFG-136/* SRFG-136/*-P
2.5 (1) 107 (42) 105 210 420 SRFG-142/* SRFG-142/*-P
2.5 (1) 122 (48) 120 240 480 SRFG-148/* SRFG-148/*-P
5 (2) 5 (2) 10 20 40 SRFG-202/* SRFG-202/*-P
5 (2) 7.6 (3) 15 30 60 SRFG-203/* SRFG-203/*-P
5 (2) 10 (4) 20 40 80 SRFG-204/* SRFG-204/*-P
5 (2) 13 (5) 25 50 100 SRFG-205/* SRFG-205/*-P
5 (2) 15 (6) 30 60 120 SRFG-206/* SRFG-206/*-P
5 (2) 18 (7) 35 70 140 SRFG-207/* SRFG-207/*-P
5 (2) 20 (8) 40 80 160 SRFG-208/* SRFG-208/*-P
5 (2) 23 (9) 45 90 180 SRFG-209/* SRFG-209/*-P
5 (2) 25 (10) 50 100 200 SRFG-210/* SRFG-210/*-P
5 (2) 28 (11) 55 110 220 SRFG-211/* SRFG-211/*-P
5 (2) 30 (12) 60 120 240 SRFG-212/* SRFG-212/*-P
5 (2) 46 (18) 90 180 360 SRFG-218/* SRFG-218/*-P
5 (2) 61 (24) 120 240 480 SRFG-224/* SRFG-224/*-P
5 (2) 76 (30) 150 300 600 SRFG-230/* SRFG-230/*-P
5 (2) 91 (36) 180 360 720 SRFG-236/* SRFG-236/*-P
5 (2) 107 (42) 210 420 840 SRFG-242/* SRFG-242/*-P
5 (2) 122 (48) 240 480 960 SRFG-248/* SRFG-248/*-P
7.6 (3) 7.6 (3) 22.5 45 90 SRFG-303/* SRFG-303/*-P
7.6 (3) 10 (4) 30 60 120 SRFG-304/* SRFG-304/*-P
7.6 (3) 13 (5) 37.5 75 150 SRFG-305/* SRFG-305/*-P
7.6 (3) 15 (6) 45 90 180 SRFG-306/* SRFG-306/*-P
7.6 (3) 18 (7) 52.5 105 210 SRFG-307/* SRFG-307/*-P
7.6 (3) 20 (8) 60 120 240 SRFG-308/* SRFG-308/*-P
7.6 (3) 23 (9) 67.5 135 270 SRFG-309/* SRFG-309/*-P
7.6 (3) 25 (10) 75 150 300 SRFG-310/* SRFG-310/*-P
7.6 (3) 28 (11) 82.5 165 330 SRFG-311/* SRFG-311/*-P
7.6 (3) 30 (12) 90 180 360 SRFG-312/* SRFG-312/*-P
Rectangular Silicone Rubber Heaters
Comes complete with operators manual
*
2
, 5 for 5 W/in
2
or 10 for 10W/in
2
.
**
Most sizes available in 230V. Consult heater sales and engineering.
Ordering Examples: SRFG-208/5-P, 5 x 20 cm (2 x 8") heater with a watt density of 5 W/in
2
, total rated wattage output of 80 watts,
with optional pressure sensitive adhesive.
SRFG-208/10, 10 W/in
2
, 160 watts.
Note: Heaters are available in only the watt densities where total wattage is shown. Heaters with pressure sensitive adhesive: max operating
temperature is 149C (300F).
11
SM
Comes complete with operators manual.
*
2
, 5 for 5 W/in
2
or 10 for 10W/in
2
.
**
Most sizes available in 230V. Consult heater sales and engineering.
Ordering Examples: SRFG-404/5-P, 10 x 10 cm (4 x 4") heater with a watt density of 5 W/in
2
, total rated wattage output of 80 watts,
with optional pressure sensitive adhesive.
SRFG-318/5, 5 W/in
2
, 270 watts.
Note: Heaters are available in only the watt densities where total wattage is shown.
Heaters with pressure sensitive adhesive: max operating temperature is 149C (300F).

2.5 W/in
2
5 W/in
2
10 W/in
2
Model No. Model No.
7.6 (3) 46 (18) 135 270 540 SRFG-318/* SRFG-318/*-P
7.6 (3) 61 (24) 180 360 720 SRFG-324/* SRFG-324/*-P
7.6 (3)) 76 (30) 225 450 900 SRFG-330/* SRFG-330/*-P
7.6 (3) 91 (36) 270 540 1080 SRFG-336/* SRFG-336/*-P
7.6 (3) 107 (42) 315 630 1260 SRFG-342/* SRFG-342/*-P
7.6 (3) 122 (48) 360 720 1440 SRFG-348/* SRFG-348/*-P
10 (4) 10 (4) 40 80 160 SRFG-404/* SRFG-404/*-P
10 (4) 13 (5) 50 100 200 SRFG-405/* SRFG-405/*-P
10 (4) 15 (6) 60 120 240 SRFG-406/* SRFG-406/*-P
10 (4) 18 (7) 70 140 280 SRFG-407/* SRFG-407/*-P
10 (4) 20 (8) 80 160 320 SRFG-408/* SRFG-408/*-P
10 (4) 23 (9) 90 180 360 SRFG-409/* SRFG-409/*-P
10 (4) 25 (10) 100 200 400 SRFG-410/* SRFG-410/*-P
10 (4) 28 (11) 110 220 440 SRFG-411/* SRFG-411/*-P
10 (4) 30 (12) 120 240 480 SRFG-412/* SRFG-412/*-P
10 (4) 46 (18) 180 360 720 SRFG-418/* SRFG-418/*-P
10 (4) 61 (24) 240 480 960 SRFG-424/* SRFG-424/*-P
10 (4) 76 (30) 300 600 1200 SRFG-430/* SRFG-430/*-P
10 (4) 91 (36) 360 720 1440 SRFG-436/* SRFG-436/*-P
10 (4) 107 (42) 420 840 1680 SRFG-442/* SRFG-442/*-P
10 (4) 122 (48) 480 960 SRFG-448/* SRFG-448/*-P
13 (5) 13 (5) 62.5 125 250 SRFG-505/* SRFG-505/*-P
13 (5) 15 (6) 75 150 300 SRFG-506/* SRFG-506/*-P
13 (5) 18 (7) 87.5 175 350 SRFG-507/* SRFG-507/*-P
13 (5) 20 (8) 100 200 400 SRFG-508/* SRFG-508/*-P
13 (5) 23 (9) 112.5 225 450 SRFG-509/* SRFG-509/*-P
13 (5) 25 (10) 125 250 500 SRFG-510/* SRFG-510/*-P
13 (5) 28 (11) 137.5 275 550 SRFG-511/* SRFG-511/*-P
13 (5) 30 (12) 150 300 600 SRFG-512/* SRFG-512/*-P
15 (6) 15 (6) 90 180 360 SRFG-606/* SRFG-606/*-P
15 (6) 18 (7) 105 210 420 SRFG-607/* SRFG-607/*-P
15 (6) 20 (8) 120 240 480 SRFG-608/* SRFG-608/*-P
15 (6) 23 (9) 135 270 540 SRFG-609/* SRFG-609/*-P
15 (6) 25 (10) 150 300 600 SRFG-610/* SRFG-610/*-P
15 (6) 28 (11) 165 330 660 SRFG-611/* SRFG-611/*-P
15 (6) 30 (12) 180 360 720 SRFG-612/* SRFG-612/*-P
15 (6) 46 (18) 270 540 1080 SRFG-618/* SRFG-618/*-P
15 (6) 61 (24) 360 720 1440 SRFG-624/* SRFG-624/*-P
15 (6) 76 (30) 450 900 SRFG-630/* SRFG-630/*-P
15 (6) 91 (36) 540 1080 SRFG-636/* SRFG-636/*-P
15 (6) 107 (42) 630 1260 SRFG-642/* SRFG-642/*-P
15 (6) 122 (48) 720 1440 SRFG-648/* SRFG-648/*-P
18 (7) 18 (7) 122.5 245 490 SRFG-707/* SRFG-707/*-P
18 (7) 20 (8) 140 280 560 SRFG-708/* SRFG-708/*-P
18 (7) 23 (9) 157.5 315 630 SRFG-709/* SRFG-709/*-P
12
SM
Comes complete with operators manual.
* Insert watt density: 2 for 2.5 W/in
2
, 5 for 5 W/in
2
or 10 for 10W/in
2
.
** Most sizes available in 230V. Consult heater sales and engineering.
Ordering Example: SRFG-712/5-P,18 x 30 cm (7 x 12") heater with a watt density of 5 W/in
2
, total rated wattage output of 420 watts, with
optional pressure sensitive adhesive.
Note: Heaters are available in only the watt densities where total wattage is shown. Heaters with pressure sensitive adhesive: max operating
temperature is 149C (300F).
APPLICATIONS
U Freeze Protection
U Low Temperature Ovens
U Heat Tracing Systems
U Viscosity Control
U Dehumidication of Motors
and Control Devices
SPECIFICATIONS
Wattage: 5 to 1440 Watts
Power: 115 or 230** Vac
Watt Density: 2.5, 5 and 10 W/in
2
Lead Wire:
305 mm (12") PFA

insulated
Thickness: 0.030 to 0.070",
except at lead wire exit
Dielectric Strength: 1250 Vac
Maximum Temperature: heaters
without pressure sensitive adhesive,
232C (450F); heaters with
pressure sensitive adhesive, 149C
(300F)
Minimum Temperature:
-56C (-70F)

2.5 W/in
2
5 W/in
2
10 W/in
2
Model No. Model No.
18 (7) 25 (10) 175 350 700 SRFG-710/* SRFG-710/*-P
18 (7) 28 (11) 192.5 385 770 SRFG-711/* SRFG-711/*-P
18 (7) 30 (12) 210 420 840 SRFG-712/* SRFG-712/*-P
20 (8) 20 (8) 160 320 640 SRFG-808/* SRFG-808/*-P
20 (8) 23 (9) 180 360 720 SRFG-809/* SRFG-809/*-P
20 (8) 25 (10) 200 400 800 SRFG-810/* SRFG-810/*-P
20 (8) 28 (11) 220 440 880 SRFG-811/* SRFG-811/*-P
20 (8) 30 (12) 240 480 960 SRFG-812/* SRFG-812/*-P
20 (8) 46 (18) 360 720 1440 SRFG-818/* SRFG-818/*-P
20 (8) 61 (24) 480 960 SRFG-824/* SRFG-824/*-P
20 (8) 76 (30) 600 1200 SRFG-830/* SRFG-830/*-P
20 (8) 91 (36) 720 1440 SRFG-836/* SRFG-836/*-P
20 (8) 107 (42) 840 1680 SRFG-842/* SRFG-842/*-P
20 (8) 122 (48) 960 1920 SRFG-848/* SRFG-848/*-P
23 (9) 23 (9) 202.5 405 810 SRFG-909/* SRFG-909/*-P
23 (9) 25 (10) 225 450 900 SRFG-910/* SRFG-910/*-P
23 (9) 28 (11) 247.5 965 990 SRFG-911/* SRFG-911/*-P
23 (9) 30 (12) 270 540 1080 SRFG-912/* SRFG-912/*-P
25 (10) 25 (10) 250 500 1000 SRFG-1010/* SRFG-1010/*-P
25 (10) 28 (11) 275 550 1100 SRFG-1011/* SRFG-1011/*-P
25 (10) 30 (12) 300 600 1200 SRFG-1012/* SRFG-1012/*-P
25 (10) 46 (18) 450 900 SRFG-1018/* SRFG-1018/*-P
25 (10) 61 (24) 600 1200 SRFG-1024/* SRFG-1024/*-P
25 (10) 76 (30) 750 1500 SRFG-1030/* SRFG-1030/*-P
25 (10) 91 (36) 900 1800 SRFG-1036/* SRFG-1036/*-P
25 (10) 122 (48) 1200 SRFG-1048/* SRFG-1048/*-P
28 (11) 28 (11) 302.5 605 1210 SRFG-1111/* SRFG-1111/*-P
28 (11) 30 (12) 330 660 1320 SRFG-1112/* SRFG-1112/*-P
30 (12) 30 (12) 360 720 SRFG-1212/* SRFG-1212/*-P
30 (12) 46 (18) 540 1080 SRFG-1218/* SRFG-1218/*-P
30 (12) 61 (24) 720 1440 SRFG-1224/* SRFG-1224/*-P
30 (12) 76 (30) 900 SRFG-1230/* SRFG-1230/*-P
30 (12) 91 (36) 1080 SRFG-1236/* SRFG-1236/*-P
30 (12) 107 (42) 1260 SRFG-1242/* SRFG-1242/*-P
30 (12) 122 (48) 1440 SRFG-1248/* SRFG-1248/*-P
C.2. Staco variable voltage controller specifications

Variable Transformers
Cord & Plug Series
l l
2.5 to 22.0 Amperes

3PN221B, 3PN501B
The cased plug-in models feature a ventilated steel case,
input line cord and plug, fused NEMA rated output receptacle,
and an illuminated on/off switch. They are connected for out-
put voltage increase with a clockwise rotation, and the dials
are graduated from 0-100% of the voltage setting.
For application flexibility, two field modification kits have been
added. The 3PN-MK kit allows either the 3PN221B or
3PN501B to be wall, bench top, or machine mounted. The
3PN-SK kit provides an adjustable voltage stop for either the
3PN1000, 3PN1200, or 3PN1500 series.
Cased plug-in models are also available with a pivot and jewel
AC voltmeter or ammeter (with 5% full scale accuracy) con-
veniently located atop the enclosure for easy readout.
Enclosed Cord and Plug Series
3PN1010BV & 3PNJ201BV, A Cord and Plug
3PN-MK-Kit
3PN-SK-Kit
3PN1010B
3PN221B,
3PN501B
3PN Series
3PN1000B
3PN1500B 3PN2210B
3PN1200B
3PNJ401B Series 3PN2520B
3PNJ201B Series
L 6.96 (176.8 mm) 9.35 (237.4 mm) 10.85 (275.6 mm)
H 5.50 (139.7 mm) 6.00 (152.4 mm) 6.31 (160.3 mm)
W1 4.62 (117.4 mm) 6.24 (158.4 mm) 7.95 (202.1 mm)
W2 3.18 (180.8 mm) 4.31 (109.6 mm) 4.31 (109.6 mm)
K 1.06 (27.0 mm) 1.00 (25.4 mm) 1.65 (41.8 mm)
B 4.38 (111.1 mm) 5.50 (139.7 mm) 7.13 (181.0 mm)
M1 3.75 (95.3 mm) 4.75 (120.7 mm) 6.38 (161.9 mm)
M2 3.50 (88.9 mm) 5.88 (149.2 mm)
F 0.28 (7.1 mm) 0.32 (8.1 mm) 0.32 (8.1 mm)
MH 0.29 (7.4 mm) 0.31 (7.9 mm) 0.38 (9.5 mm)
INPUT OUTPUT
CONSTANT CONSTANT
VOLTS PART NO.
CURRENT IMPEDANCE SCHE-
NET
HERTZ VOLTS
LOAD LOAD MATIC
WT
.
MAX MAX MAX MAX
(Pg.
LBS
AMPS KVA AMPS KVA
8 & 9)
3PN221B 60 0-132 2.50 0.33 3 3
3PN501B 50/60 0-140 5.0 0.70 3 7 3/4
3PN1010B 50/60 0-140 10 1.4 3 10 1/4
3PN1010BA
50/60 0-140 10 1.4
w/Ammeter
9 10 1/4
120
3PN1010BV w/Voltmeter
3PN1210B 60 0-120 12 1.44 15 1.80 11 10 1/4
3PN1510B 50/60 0-140 15 2.10 3 18
3PN1510BA
50/60 0-140 15 2.10
w/Ammeter
9 18
3PN2210B 50/60 0-140 22 3.08 3 24 1/4
3PN1020B 50/60 0-280 3.5 0.98 3 10 1/4
3PN1020BA
50/60 0-280 3.5 0.98
w/Ammeter
9 10 1/4
240 3PN1220B 60 0-240 5.0 1.20 7.0 1.68 11 10 1/4
3PN1520B 50/60 0-280 9.5 2.66 3 22
3PN2520B 50/60 0-280 10 2.80 3 24 1/4
Unit is fused for the constant current rating at the factory.
Enclosed Cord and Plug Series
OUTPUT DIMENSIONS
MODEL LINE
VOLTAGE CURRENT HEIGHT WIDTH DEPTH
WEIGHT
NUMBER* VOLTAGE (LBS.)
L221 0-132 1.75 6.31 [160.4] 5.00 [127.0] 4.25 [108.0] 3.5
L501
120
4.5 7.75 [197.0] 5.38 [136.5] 5.62 [142.9] 7.25
L1010 0-140 10.0 9.41 [238.9] 6.50 [165.1] 6.25 [158.8] 12.25
L1010VA 10.0 12.38 [314.3] 10.75 [273.0] 6.25 [158.8] 17.75
* All models 50/60 Hz operation except L221, which is 60 Hz only.
3PN1010BV
These fully enclosed variable voltage controls provide protec-
tion from physical abuse, chemical spills, and other hazards.
They are ideal for about every laboratory application including
control of electric heating elements, lighting, electric motor
speed or power, and electrical testing. Output voltage is con-
trolled with a large slip resistant knob which increases the volt-
age linearly as it is turned clockwise.
In addition to portable use, the rugged, flat-topped enclosure
has a slot at top rear for wall mounting. All models include line
cord and plug, receptacle, switch, pilot lamp and fuse (the
metered unit includes a circuit breaker). A voltmeter and
ammeter are included in the L1010VA. The meter accuracy is
3%, and a meter range selector is used to increase reading
resolution.
3PN1510B
3PN2210B
3PN (120) 3PN (240)
L Series
Appendix D: Component Selection
Information
D.1. Conceptual design decision matrix
Weight
Thermal
Surface
Electric
Surface
Thermal
Pen
Electric
Pen
Manufacturability 0.1 10 10 7 7
Consistency 0.2 8 8 4 4
Safety 0.4 7 7 5 5
Cost 0.3 8 1 6 10
Total 7.8 5.7 5.3 6.5

D.2. Heating element decision matrix
Weight
Silicon
Rubber Polyamide
Resistive
Wire Strips
Maximum
Temperature 0.2 6 6 10
Operating
Voltage 0.1 7 7 10
Size/Shape 0.1 10 5 5
Safety 0.3 7 7 3
Cost 0.3 10 7 3
Total 8 6.6 5.3

D.3. Attachment mechanism decision matrix
Weight Adhesive Clamp
Thermal
Paste
Thermal
Glove
Installation Time 0.3 2 4 2 5
Cost 0.3 3 5 2 5
Ease of Removal 0.2 4 5 4 5
Effective
Temperature 0.2 4 5 4 4
Clinical
Effectiveness 0.1 2 5 2 1
Total 3.1 4.8 2.8 4.3

D.4. Power source decision matrix

Weight
Force
FX
Wall
Outlet
CA
Instruments
P Series
CSI3710A
Staco
3PN1010B
Variable
Voltage
0.15 5 1 4 4 5
Operates
above
150kHz
0.05 5 1 5 1 1
Operates
above
100V AC
0.1 5 5 5 1 5
Easy to
Interface
0.2 4 2 4 2 4
Ease of
Operation
0.1 4 5 4 4 4
Cost 0.4 1 5 1 4 3
Total 3.1 3.6 2.95 3.15 3.7

Appendix E: Experimental Data
E.1.1 DSC- Comparison of 1
st
Run Second Heating and 2
nd
Run First Heating

C
o
m
p
a
r
e

2
n
d

h
e
t
i
n
g

f
i
r
s
t

r
u
n

w
i
t
h

1
s
t

h
e
a
t
i
n
g

2
n
d

r
u
n
-
0
.
0
0
3
-
0
.
0
0
2
-
0
.
0
0
1
0
.
0
0
0
Deriv. H eat F low (W /(gC ))
-
0
.
4
0
-
0
.
3
5
-
0
.
3
0
-
0
.
2
5
-
0
.
2
0
H eat F low (W /g)
2
0
4
0
6
0
8
0
1
0
0
1
2
0
1
4
0
1
6
0
1
8
0
2
0
0
T
e
m
p
e
r
a
t
u
r
e

(
C
)

B
A
E
_
0
8
2
9
1
3
_
D
S
C
1
.
D
S
C

B
A
E
_
0
8
2
9
1
3
_
D
S
C
2
.
D
S
C
E
x
o

U
p
U
n
i
v
e
r
s
a
l

V
4
.
2
E

T
A

I
n
s
t
r
u
m
e
n
t
s
E.1.2 DSC- Run of second heating first run

1
0
8
.
0
1
C
(
I
)
1
0
0
.
3
2
C
1
1
4
.
4
5
C
T
g

c
a
l
c
u
l
a
t
i
o
n

a
t

2
n
d

h
e
a
t
i
n
g

o
f

1
s
t

r
u
n
-
0
.
0
0
3
-
0
.
0
0
2
-
0
.
0
0
1
0
.
0
0
0
Deriv. Heat Flow (W/(gC))
-
0
.
4
0
-
0
.
3
5
-
0
.
3
0
-
0
.
2
5
-
0
.
2
0
Heat Flow (W/g)
2
0
4
0
6
0
8
0
1
0
0
1
2
0
1
4
0
1
6
0
1
8
0
2
0
0
T
e
m
p
e
r
a
t
u
r
e

(
C
)
S
a
m
p
l
e
:

B
A
E

0
8
2
9
1
3

B
o
n
e

C
e
m
e
n
t
S
i
z
e
:

8
.
0
0
0
0

m
g
M
e
t
h
o
d
:

H
e
a
t
/
C
o
o
l
/
H
e
a
t
C
o
m
m
e
n
t
:

H
M
I
M
_
T
P
B
D
S
C
F
i
l
e
:

C
:
\
U
S
E
R
S
_
D
A
T
A
\
B
A
E
\
B
A
E
_
0
8
2
9
1
3
_
D
S
C
1
.
D
S
O
p
e
r
a
t
o
r
:

R
C
R
u
n

D
a
t
e
:

3
0
-
A
u
g
-
2
0
1
3

0
8
:
3
5
I
n
s
t
r
u
m
e
n
t
:

2
9
2
0

M
D
S
C

V
2
.
6
A
E
x
o

U
p
U
n
i
v
e
r
s
a
l

V
4
.
2
E

T
A

I
n
s
t
r
u
m
e
n
t
s
E.1.3. DSC Run of first heating second run

1
0
9
.
2
7
C
(
I
)
9
9
.
5
9
C
1
1
6
.
4
9
C
T
g

c
a
l
c
u
l
a
t
i
o
n

a
t

1
s
t

h
e
a
t
i
n
g

o
f

2
n
d

r
u
n
-
0
.
0
0
2
5
-
0
.
0
0
2
0
-
0
.
0
0
1
5
-
0
.
0
0
1
0
-
0
.
0
0
0
5
0
.
0
0
0
0
Deriv. Heat Flow (W/(gC))
-
0
.
4
0
-
0
.
3
8
-
0
.
3
6
-
0
.
3
4
-
0
.
3
2
-
0
.
3
0
-
0
.
2
8
-
0
.
2
6
-
0
.
2
4
Heat Flow (W/g)
2
0
4
0
6
0
8
0
1
0
0
1
2
0
1
4
0
1
6
0
1
8
0
2
0
0
T
e
m
p
e
r
a
t
u
r
e

(
C
)
S
a
m
p
l
e
:

B
A
E

0
8
2
9
1
3

B
o
n
e

C
e
m
e
n
t
S
i
z
e
:

8
.
0
0
0
0

m
g
M
e
t
h
o
d
:

H
e
a
t
/
C
o
o
l
/
H
e
a
t
C
o
m
m
e
n
t
:

H
M
I
M
_
T
P
B

r
e
r
u
n

o
f

s
a
m
p
l
e

1
D
S
C
F
i
l
e
:

C
:
\
U
S
E
R
S
_
D
A
T
A
\
B
A
E
\
B
A
E
_
0
8
2
9
1
3
_
D
S
C
2
.
D
S
O
p
e
r
a
t
o
r
:

R
C
R
u
n

D
a
t
e
:

3
0
-
A
u
g
-
2
0
1
3

1
0
:
3
2
I
n
s
t
r
u
m
e
n
t
:

2
9
2
0

M
D
S
C

V
2
.
6
A
E
x
o

U
p
U
n
i
v
e
r
s
a
l

V
4
.
2
E

T
A

I
n
s
t
r
u
m
e
n
t
s
E.2. TGA Results for PMMA polymer

1
.
3
6
6
%
2
3
0
.
3
9
C
2
8
0
.
1
0
C
3
5
8
.
3
9
C
-
0
.
5
0
.
0
0
.
5
1
.
0
1
.
5
2
.
0
Deriv. Weight (%/C)
0
2
0
4
0
6
0
8
0
1
0
0
1
2
0
Weight (%)
0
1
0
0
2
0
0
3
0
0
4
0
0
5
0
0
6
0
0
T
e
m
p
e
r
a
t
u
r
e

(
C
)
S
a
m
p
l
e
:

0
8
2
9
1
3
S
i
z
e
:

8
.
4
2
2
0

m
g
M
e
t
h
o
d
:

S
t
a
n
d
a
r
d

T
G
A
T
G
A
F
i
l
e
:

C
:
\
U
S
E
R
S
_
D
A
T
A
\
B
A
E
\
0
8
2
9
1
3
_
T
G
A
1
.
T
G
A
O
p
e
r
a
t
o
r
:

R
C
R
u
n

D
a
t
e
:

2
9
-
A
u
g
-
2
0
1
3

1
6
:
1
7
I
n
s
t
r
u
m
e
n
t
:

2
9
5
0

T
G
A

H
R

V
6
.
1
A
U
n
i
v
e
r
s
a
l

V
4
.
2
E

T
A

I
n
s
t
r
u
m
e
n
t
s
E.3. Thermal Expansion Tensile Test

Appendix F: Refined Engineering
Analysis
F.1. Solidworks Simulation Reports

Analyzed with SolidWorks Simulation Simulation of test bars 1

F.1.1. Validation Thermal Simulation

Simulation of test
bars

Date: Thursday, November 28, 2013
Designer: Solidworks
Study name: hot plate 110
Analysis type: Thermal(Transient)
Table of Contents
Description ........................................... 1
Assumptions ..... Error! Bookmark not defined.
Model Information ......... Error! Bookmark not
defined.
Study Properties ..................................... 2
Units ................................................... 2
Material Properties ................................. 3
Thermal Loads ....................................... 4
Contact Information ................................ 4
Mesh Information .................................... 5
Sensor Details ... Error! Bookmark not defined.
Study Results ......................................... 6
Conclusion ....... Error! Bookmark not defined.

Description
No Data


Study Properties
Study name hot plate 110
Analysis type Thermal(Transient)
Mesh type Solid Mesh
Solver type FFEPlus
Solution type Transient
Total time 60 Seconds
Time increment 0.6 Seconds
Contact resistance defined? No
Result folder

Units
Unit system: SI (MKS)
Length/Displacement mm
Temperature Kelvin
Angular velocity Rad/sec
Pressure/Stress N/m^2


Material Properties
Model Reference Properties Components

Name: AISI 1020
Model type: Linear Elastic Isotropic
Default failure
criterion:
Unknown
Thermal
conductivity:
47 W/(m.K)
Specific heat: 420 J/(kg.K)
Mass density: 7900 kg/m^3
SolidBody 1(Boss-
Extrude1)(Part1^test bars-1)
Curve Data:N/A

Name: 316lvm
Default failure
criterion:
Unknown
Thermal
conductivity:
14.6 W/(m.K)
SolidBody 1(Split
Line1)(Part3^test bars-1),
SolidBody 1(Split
Line1)(Part3^test bars-2)
Curve Data:N/A

Name: PMMA def
Default failure
criterion:
Unknown
Thermal
conductivity:
0.18 W/(m.K)
SolidBody 1(Boss-
Curve Data:N/A


Thermal Loads

Load name Load Image Load Details
Temperature-
1

Entities: 4 component(s)
Initial temperature: 21 Celsius
Temperature-
2

Entities: 1 face(s)
Temperature: 110 Celsius
Convection-1

Entities: 16 face(s)
Convection Coefficient: 10 W/(m^2K)
Time variation: Off
Temperature variation: Off
Bulk Ambient Temperature: 294 Kelvin
Time variation: Off

Contact Information

Contact Contact Image Contact Properties
Global Contact

Type: Bonded
Components: 1 component(s)
Options: Compatible
mesh


Mesh Information
Mesher Used: Standard mesh
Automatic Transition: Off
Include Mesh Auto Loops: Off
Jacobian points 4 Points
Element Size 1.57111 mm
Tolerance 0.0785557 mm
Mesh Quality High


Study Results

Name Type Min Max
Thermal1 TEMP: Temperature at Step No:
3(1.8 Seconds)
20.9972 Celsius
Node: 57960
110 Celsius
Node: 1

test bars-hot plate 110-Thermal-Thermal1

Name Type Min Max
Thermal2 TEMP: Temperature at Step No:
30(18 Seconds)
21.8377 Celsius
Node: 58153
110 Celsius
Node: 1


test bars-hot plate 110-Thermal-Thermal2


F.1.2. Validation Stress Simulation

Simulation of test
bars

Date: Thursday, November 28, 2013
Study name: stress 110
Analysis type: Static
Table of Contents
Description ............................................ 1
Model InformationError! Bookmark not defined.
Units ................................................... 2
Material Properties .................................. 3
Loads and FixturesError! Bookmark not defined.
Connector DefinitionsError! Bookmark not defined.
Contact Information ................................. 4
Resultant Forces Error! Bookmark not defined.
Beams ............. Error! Bookmark not defined.
Study Results ......................................... 6

Description
No Data


Study Properties
Study name stress 110
Analysis type Static
Thermal Effect: On
Thermal option From thermal study
Input thermal study: hot plate 110
Time Step 30
Zero strain temperature 21 Celsius
Include fluid pressure effects from SolidWorks
Flow Simulation
Off
Solver type FFEPlus
Inplane Effect: Off
Soft Spring: On
Inertial Relief: Off
Incompatible bonding options Automatic
Large displacement Off
Compute free body forces On
Friction Off
Use Adaptive Method: Off
Result folder SolidWorks document

Units
Temperature Kelvin


Material Properties

Name: AISI 1020
Default failure
criterion:
Unknown
Yield strength: 3.51571e+008 N/m^2
Tensile strength: 4.20507e+008 N/m^2
Elastic modulus: 2e+011 N/m^2
Poisson's ratio: 0.29
Shear modulus: 7.7e+010 N/m^2
Thermal expansion
coefficient:
1.5e-005 /Kelvin

SolidBody 1(Boss-
Curve Data:N/A

Name: 316lvm
Default failure
criterion:
Unknown
Tensile strength: 3e+007 N/m^2
Thermal expansion
coefficient:
1.8e-005 /Kelvin

SolidBody 1(Split
Line1)(Part3^test bars-1),
SolidBody 1(Split
Line1)(Part3^test bars-2)
Curve Data:N/A

Name: PMMA def
Default failure
criterion:
Unknown
Yield strength: 3e+007 N/m^2
Compressive
strength:
1.05e+008 N/m^2
Thermal expansion
coefficient:
7.3e-005 /Kelvin

SolidBody 1(Boss-
Curve Data:N/A


Contact Information

Global Contact

Type: Bonded
Options: Compatible
mesh

Mesh Information
Mesh Quality High
Remesh failed parts with incompatible mesh Off

Mesh Information - Details
Total Nodes 93453
Total Elements 57983
Maximum Aspect Ratio 11.093
% of elements with Aspect Ratio < 3 97.6
% of elements with Aspect Ratio > 10 0.00345
% of distorted elements(Jacobian) 0
Time to complete mesh(hh;mm;ss): 00:00:08
Computer name:



Study Results

Name Type Min Max
Stress1 VON: von Mises Stress 3124.05 N/m^2
Node: 23417
2.78767e+007 N/m^2
Node: 22253

test bars-stress 110-Stress-Stress1

Name Type Min Max
Displacement1 URES: Resultant Displacement 0.00285832 mm
Node: 31930
0.158783 mm
Node: 728


test bars-stress 110-Displacement-Displacement1

Name Type Min Max
Strain1 ESTRN: Equivalent Strain 6.02141e-009
Element: 187
0.00730779
Element: 50118

test bars-stress 110-Strain-Strain1

Analyzed with SolidWorks Simulation Simulation of Assem2 1

F.1.3. Thermal Simulation (bone under 45C)

Simulation of Assem2

Date: Saturday, November 30, 2013
Study name: 15500
Analysis type: Thermal(Transient)
Table of Contents
Description ............................................ 1
Units ................................................... 2
Thermal Loads ........................................ 3
Study Results ......................................... 6
Conclusion ............................................ 7

Description
No Data


Study Properties
Study name 15500
Analysis type Thermal(Transient)
Solver type FFEPlus
Solution type Transient
Total time 10 Seconds
Time increment 0.1 Seconds
Contact resistance defined? No

Units
Temperature Kelvin


Material Properties

Name: PMMA def
Default failure
criterion:
Unknown
Thermal
conductivity:
0.18 W/(m.K)
SolidBody
7(SurfaceCut16)(Femur-1),
SolidBody
4(SurfaceCut8)(PMMA^Assem
2-1)
Curve Data:N/A

Name: 316lvm
Default failure
criterion:
Unknown
Thermal
conductivity:
14.6 W/(m.K)
SolidBody
3(SurfaceCut9)(rough-1)
Curve Data:N/A

Thermal Loads

Load name Load Image Load Details
Temperature-
1

Entities: 3 component(s)
Initial temperature: 37 Celsius
Heat Flux-1

Entities: 7 face(s)
Heat Flux Value: 15500 W/m^2


Contact Information

Global Contact

Type: Bonded
Options: Compatible
mesh

Mesh Information
Element Size 3 mm
Tolerance 0.15 mm
Mesh Quality High

Total Nodes 84711
Computer name:



Study Results

Name Type Min Max
10s TEMP: Temperature at Step No:
100(10 Seconds)
37.013 Celsius
Node: 1258
105.511 Celsius
Node: 66924

Assem2-15500-Thermal-10s

Name Type Min Max
2s Femur 49.8C TEMP: Temperature at Step No: 20(2
Seconds)
37 Celsius
Node: 491
54.4661 Celsius
Node: 66924


Assem2-15500-Thermal-2s Femur 49.8C

Conclusion


F.1.4. Stress Simulation (bone under 45C)


Date: Friday, November 29, 2013
Study name: static 15500
Table of Contents
Description ............................................ 1
Units ................................................... 2
Contact InformationError! Bookmark not defined.
Study Results ......................................... 6

Description
No Data


Study Properties
Study name static 15500
Thermal Effect: On
Input thermal study: 15500
Time Step 20
Flow Simulation
Off
Solver type FFEPlus
Inplane Effect: Off
Soft Spring: On
Friction Off
Result folder

Units
Temperature Kelvin


Material Properties

Name: PMMA def
Default failure
criterion:
Unknown
Compressive
strength:
1.05e+008 N/m^2
Thermal expansion
coefficient:
7.3e-005 /Kelvin

SolidBody
SolidBody
2-1)
Curve Data:N/A

Name: 316lvm
Default failure
criterion:
Unknown
Thermal expansion
coefficient:
1.8e-005 /Kelvin

SolidBody
Curve Data:N/A


Mesh Information
Mesh Quality High

Total Nodes 83424
Computer name:



Study Results

Name Type Min Max
Node: 50319
6.78036e+006 N/m^2
Node: 58531

Assem2-static 15500-Stress-Stress1

Name Type Min Max
Node: 2420
0.117115 mm
Node: 65674


Assem2-static 15500-Displacement-Displacement1

Name Type Min Max
Element: 16258
0.00228799
Element: 263

Assem2-static 15500-Strain-Strain1


F.1.5. Stress Simulation (to reach 12 MPa)


Date: Saturday, November 30, 2013
Study name: Study 1
Table of Contents
Description ............................................ 1
Units ................................................... 2
Study Results ......................................... 6

Description
No Data


Study Properties
Study name Study 1
Thermal Effect: On
Input thermal study: 15500
Time Step 80
Flow Simulation
Off
Solver type FFEPlus
Inplane Effect: Off
Soft Spring: On
Friction Off

Units
Temperature Kelvin


Material Properties

Name: PMMA def
Default failure
criterion:
Unknown
Compressive
strength:
1.05e+008 N/m^2
Thermal expansion
coefficient:
7.3e-005 /Kelvin

SolidBody
SolidBody
2-1)
Curve Data:N/A

Name: 316lvm
Default failure
criterion:
Unknown
Thermal expansion
coefficient:
1.8e-005 /Kelvin

SolidBody
Curve Data:N/A


Contact Information

Global Contact

Type: Bonded
Options: Compatible
mesh

Mesh Information
Element Size 3 mm
Tolerance 0.15 mm
Mesh Quality High

Total Nodes 84711
Computer name:



Study Results

Name Type Min Max
Node: 52725
1.75109e+007 N/m^2
Node: 59205

Assem2-Study 1-Stress-Stress1

Name Type Min Max
Node: 42095
0.250112 mm
Node: 66527


Assem2-Study 1-Displacement-Displacement1

Name Type Min Max
Element: 23334
0.00574085
Element: 43399

Assem2-Study 1-Strain-Strain1

F.2. Failure Mode and Effect Analysis

Preparedby:
Productname:SPITFIRE
Productcode: Partno.:
Function Failuremode Effectsoffailure Causesoffailure Detection Severity Occurrence Detection
Riskpriority
number
Recommended
correctiveaction
1.Heaterdelivers
heatfluxto
prosthesis
Contactfailure
Heaterdoesnot
heatup
Wiresnotproperly
bonded
Visual
inspection
3 3 1 9 Noactionrequired
Defective
product
Heaterdoesnot
heatupproperly
Manufacturedefect
Surfaceheater
smoking
5 4 1 20
Purchasesurface
heaterfromreliable
vendor
Electrical
Overstress
Heaterbecomes
toohot
Voltageregulator
failure
Thermocouple
feedbackloop
7 4 1 28
Removesurfaceheater
whenthermocouple
indicatestemperature
istoohigh
Sterilityfailure
Increasedchance
ofinfection
Impropersanitation
duringpackaging
none 8 1 10 80
Ethyleneoxide
sterilization
2.Voltage
regulatorprovides
powertothe
surfaceheater
Controlfailure
Heaterbecomes
toohot
Wear
Thermocouple
feedbackloop
7 2 1 14 Replacecontrolunit
Controlfailure
Heaterdoesnot
heatup
Wear
Thermocouple
feedbackloop
3 2 1 6 Replacecontrolunit
Semiconductor
failure
Heaterdoesnot
heatup
Impropercircuit
design
Visual
inspection
6 1 1 6
Ensureproperdesign
ofhardwareand
software
Electrical
Overstress
heaterdoesnot
heatup
Impropercircuit
design
Visual
inspection
6 1 1 6
Ensureproperdesign
ofhardwareand
software
3.Thermocouple
actsinafeedback
looptoregulate
temperature
Stressrupture
heaterbecomes
toohot
Internalorexternal
stressesbreak
junctionbetween
metals
Visual
inspection
8 1 1 8 Protectthermocouple
Bondingfailure
heaterbecomes
toohot
Manufacturedefect
Visual
inspection
8 1 1 8
Checkeach
thermocouplebefore
installing
DesignDeadline:
FailureModesandEffectAnalysis SheetNo.___of___
Partname:SPITFIRE Primarydesignresponsibility:Heatprosthesis
Appendix G: References
Berman AT, Reid J S, Yanicko DR J r, Sih GC, Zimmerman MR. Thermally induced bone
necrosis in rabbits. Relation to implant failure in humans. Clin Orthop Relat Res. 1984
J un;(186):284-92. PubMed PMID: 6723155.

"Elastic Anisotropy of Bone." University of Wisconsin-Madison, n.d. Web. 01 Dec. 2013.
<http://silver.neep.wisc.edu/~lakes/BoneAniso.html>.

Schmidt, Linda C. "Failure Mode and Effects Analysis." Engineering Design. By George E.
Dieter. 4th ed. New York: McGraw-Hill, 2009. 707-12. Print.

Staff, Mayo Clinic. "Definition." Mayo Clinic. Mayo Foundation for Medical Education and
Research, 28 Aug. 2012. Web. 11 Mar. 2013.

Stone, Martin H., Rosemary Wilkinson, and Ian G. Stother. "SOME FACFORS AFFECTING
THE STRENGTH OF THE CEMENT-METAL INTERFACE." The J ournal Of Bone
And J oint Surgery 71-B.2 (1989): 217-20. Print.

"Knee Revision Surgery." Surgery Encyclopedia. N.p., n.d. Web. 11 Mar. 2013.

"Revision Total Knee Replacement: Frequently Asked Questions (FAQs)." Hospital for Special
Surgery. N.p., n.d. Web. 14 Mar. 2013.

"LEGION." LEGION Total Knee System. N.p., n.d. Web. 27 Nov. 2013.

Panchbhavi, Vinod K., Dr. "Bone Cement ." Bone Cement. N.p., 21 Feb. 2012. Web. 27 Nov.
2013.

http://www.ncbi.nlm.nih.gov/pubmed/18288697

http://www.stryker.com/en-us/products/Orthopaedics/BoneCementSubstitutes/005885

http://www.bonecement.com/cementing-techniques/bonecement/history?cookieAccept=true

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SPITFIRE:

Separation of Prosthetic In Timely

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