i
ULTRASOUND DEVICE TESTER
MURNI NORESTRI BINTI MOHD NORDIN
A project report submitted in fulfillment of the
requirements for the award of the degree
of Master of Science (Information Technology Entrepreneurship)
Faculty of Computer Science and Information Systems
Universiti Teknologi Malaysia
OCTOBER 2009
iii
To my beloved mother and father
iv
ACKNOWLEDGEMENT
In preparing this thesis, I was in contact with many people, researchers,
academicians,
and
practitioners.
They
have
contributed
towards
my
understanding and thoughts. In particular, I wish to express my sincere
appreciation to my Faculty of Computer Science and Information System
(FSKSM) thesis supervisor, Dr. Mohd Zaidi Abd Rozan and Faculty of
Management and Human Resource Development (FPPSM) thesis supervisor,
En. Ahamad Zaidi Bahari for encouragement, guidance, critics and friendship. I
am also very thankful to my co-supervisor Associate Professor Ir. Dr. Ing. Eko
Supriyanto for his guidance, advices and motivation. Without their continued
support and interest, this thesis would not have been the same as presented here.
I am also indebted to Majlis Amanah Rakyat (MARA) for funding my
Master study. Librarians at Universiti Teknologi Malaysia (UTM), and other
lecturers also deserve special thanks for their assistance in supplying the relevant
literatures. My fellow postgraduate students should also be recognized for their
support. My sincere appreciation also extends to all my colleagues and others who
have provided assistance at various occasions. Their views and tips are useful
indeed. Unfortunately, it is not possible to list all of them in this limited space. I
am grateful to all my family members.
v
ABSTRAK
Pada masa ini, teknologi ultrabunyi telah digunakan secara meluas untuk
tujuan perubatan, industri, keselamatan, automotif dan pendidikan.
Dalam
kebanyakan applikasi seperti terapi perubatan, diagnostik perubatan dan pengujian
kerosakan, kuasa yang tepat yang dijanakan oleh transduser ultrabunyi amatlah
penting. Jika kuasa yang dijanakan itu tidak tepat untuk applikasi tersebut, masalah
yang timbul menyebabkan bahaya kepada pesakit. Satu kajian menunjukkan lebih
kurang 10,000 mesin ultrabunyi di United Kingdom gagal menjanakan kuasa
sekurang- kurangnya 30 % daripada kuasa yang tepat. Untuk mengurangkan risiko
ini, mesin ultrasound haruslah diuji secara berkala dan kerap. Salah satu cara untuk
menguji mesin ini ialah dengan menggunakan meter kuasa ultrasound.
Dalam
projek ini, satu prototaip Penguji Alat Ultrabunyi akan dibangunkan di mana ia
adalah alat untuk mengukur kuasa ultrabunyi yang dijanakan oleh mesin ultrabunyi
diagnostik dan terapi. Ia terdiri daripada bahagian perkakasan dan perisian. Ia
menggunakan Rajah Kes Guna untuk membangunkan bahagian perisian dan
pengesan polimer sebagai teknologi pengukuran. Beberapa ujian telah dilakukan
untuk melihat sama ada prototaip ini berfungsi dengan baik atau tidak dan ia selamat
digunakan.
Kesimpulannya, prototaip ini telah berjaya dibangunkan.
Untuk
menjayakan projek ini, jumlah pembiayaan yang diperlukan ialah sebanyak RM 0.5
juta.
RM 0.15 juta diperlukan untuk pembangunan prototaip dan permulaan
perniagaan.
Lebihan pembiayaan tersebut diperlukan untuk permohonan harta
intelek, menjalankan pengujian professional permohonan pensijilan tempatan dan
antarabangsa serta pra- komersialan.
vi
ABSTRACT
Nowadays, ultrasound technology is widely used for medical, industry,
security, automotive and education purposes. For many application such as medical
therapy, medical diagnostic and non destructive testing, accurate value of power
generated by ultrasound transducer is very crucial. If the power generated is not
accurate for those applications, problems which cause danger to patients might
occur. A research shows that most of the 10,000 ultrasound machines in the United
Kingdom fail to deliver within 30% of the correct power. To reduce the risk the
ultrasound machine must be tested periodically and frequent. One of the approaches
to test the machine is using ultrasound power meter. In this project, an Ultrasound
Device Tester prototype is developed whereby it is a device to measure ultrasound
power generated by ultrasound diagnostic and therapeutic machines. It consists of
hardware and software part. Use case model is used to create the software part and
polymer sensor is used as the measurement tool. Testing has been done to see
whether the prototype is working properly or not and safe to use. As a conclusion,
the prototype has been successfully developed. In order to embark on this project, a
total funding RM 0.5 million is required. RM 0.15 million of the funding is required
which for prototype development and business incorporation.
Balance of the
funding required is for intellectual property application, perform professional testing,
local and international certifications application and pre- commercialization.
vii
TABLE OF CONTENTS
CHAPTER
TITLE
PAGE
DECLARATION
ii
DEDICATION
iii
ACKNOWLEDGEMENTS
iv
ABSTRAK
v
ABSTRACT
vi
TABLE OF CONTENTS
vii
LIST OF TABLES
xi
LIST OF FIGURES
xii
LIST OF ABBREVIATIONS
xv
LIST OF SYMBOLS
xvii
LIST OF APPENDICES
xix
1
PROJECT OVERVIEW
1
1.1
Introduction
1
1.2
Problem Statement
3
1.3
Background of Study
3
viii
1.4
Objective
4
1.5
Scopes of Project
5
1.6
Thesis Outline
5
2
3
LITERATURE REVIEW
7
2.1
Ultrasound
7
2.2
Transducer Field (Far and Near Field)
8
2.3
Scattering
10
2.4
Reflection
11
2.5
Absorption
12
2.6
Attenuation
12
2.7
Piezoelectric Devices
13
2.8
PVDF Sensor
15
2.9
PVDF Sensor Parameters
17
2.10
Attaching Electrodes to PVDF
19
2.11
Specification of the Intensity
21
2.12
Spatial and Temporal Measurements
22
2.13
Conducting Ultrasound Intensity Measurement
24
METHODOLOGY
25
3.1
Flow Process Diagram
25
3.2
Work Breakdown Structure
27
3.3
System Requirement Analysis
29
3.3.1 Hardware Justification
29
3.3.2 Software Justification
31
ix
3.4
4
Project Schedule
DESIGN IMPLEMENTATION
33
4.1
Description of the System
33
4.2
Product Design
35
4.2.1
Conceptual Diagram
35
4.2.1.1 Hardware Block Diagram
35
4.2.1.2 Flowchart of the Process in FPGA
36
4.2.1.3 System Architecture Diagram
37
4.2.1.4 Use Case Diagram
38
4.2.1.5 Flowchart of Smart Measurement
39
Logical Design
40
4.2.2.1 Database Table
40
4.2.2.2 User Interface
41
4.2.2
5
31
4.2.3 Physical Design
42
4.2.3.1 Electronic Unit
42
4.2.3.2 Mechanical Unit
44
4.2.3.3 Software Unit
46
RESULT AND DISCUSSION
49
5.1
Experiment
49
5.1.1
49
Signal of PVDF Sensor
5.2
Complete Product
51
5.3
Product Testing
62
5.3.2
62
Electromagnetic Compatibility Testing
x
5.4
6
5.3.2 Stability Testing
63
Market Study Analysis
64
CONCLUSION AND RECOMMENDATION
75
6.1
Conclusion
75
6.2
Recommendation
76
REFERENCES
BUSINESS PLAN
APPENDIX A-F
77
1 - 30
xi
LIST OF TABLES
TABLE NO.
TITLE
PAGE
2.1
The reflectivity for different medium
11
2.2
Comparison of piezoelectric material
17
3.1
Hardware justification
30
4.1
Database table
40
4.2
Electronic component specification
42
5.1
Frequency response
50
xii
LIST OF FIGURES
FIGURE NO.
TITLE
PAGE
2.1
Far field and near field
9
2.2
Scattering affect
10
2.3
PVDF sensor electrodes attached
20
2.4
TA, TP,PA related to time
21
2.5
SP and SA diagram
22
3.1
Process flow diagram
26
3.2
Work breakdown structure
27
3.3
Project schedule
32
4.1
Measurement configuration
34
4.2
Hardware block diagram
35
4.3
Flowchart of the process in FPGA
36
4.4
Architecture diagram
37
4.5
Use case diagram of Smart Measurement
38
4.6
Flowchart of Smart Measurement
39
4.7
Window flow diagram
41
4.8
Water tank unit
44
4.9
Detail view of water tank unit
45
xiii
4.10
Ultrasound device tester
46
4.11
Main page
47
4.12
Login page
47
4.13
Report page
47
4.14
Information page
48
4.15
Testing page
48
5.1
Signal of PVDF sensor
50
5.2
Temperature effect
51
5.3
Ultrasound device tester prototype
52
5.4
Main page
52
5.5
Information page
53
5.6
Testing page
54
5.7
Testing page displaying result and status
55
5.8
Data insert message box
56
5.9
Log in page
56
5.10
Report page by selected date
57
5.11
Report of selected date
58
5.12
Report page by selected date with status
59
5.13
Report of selected date with PASS status
59
5.14
Report of selected date with FAIL status
60
5.15
Report page by selected date with selected result range
60
5.16
Report of selected date with selected result range
61
5.17
Printed report
62
5.18
Electromagnetic compatibility testing
63
5.19
Stability testing
64
5.20
Knowledge in ultrasound
65
5.21
Experience in ultrasound field
65
xiv
5.22
Number of ultrasound machine in workplace
66
5.23
Awareness about high ultrasound power effects
67
5.24
Awareness about the limit ultrasound power
67
5.25
Alert about coming Malaysian Standard
68
5.26
Maintenance of ultrasound machine
69
5.27
Frequency of calibrating the ultrasound machine
69
5.28
Expenses per year for calibrating the ultrasound machine
70
5.29
Opinion to test ultrasound machine weekly
71
5.30
Aware about new ultrasound device tester
71
5.31
Interest to learn about ultrasound
72
5.32
Best time to learn about ultrasound
73
5.33
Need assistant device to learn ultrasound
73
5.34
Willing to buy ultrasound device tester
74
xv
LIST OF ABBREVIATIONS
ADC
-
Analog to Digital Converter
DOS
-
Density of States
DSO
-
Digital Signal Oscilloscope
EMI
-
Electromagnetic Interference
IEC
-
International Electrotechnical Commission
LCD
-
Liquid Crystal Display
PA
-
Pulse Average
PVDF
-
Polyvinylidene Difluoride
SA
-
Spatial Average
SATA
-
Spatial Average Temporal Average
SATP
-
Global System for Mobile Communications
SPTA
-
Spatial Peak Temporal Average
TA
-
Temporal Average
TGC
-
Time Gain Control
TP
-
Temporal Peak
FPGA
-
Field Programmable Gate Array
UDevT
-
Ultrasound Device Tester
UTest
-
Ultrasound Tester
SMeas
-
Smart Measurement
xvi
VB
-
Visual Basic
USB
-
Universal Serial Bus
SRAM
-
Static Random Access Memory
RFI
-
Radio Frequency Interference
FDA
-
Food and Drug Administration
PC
-
Personnel Computer
µC
-
Microcontroller
.exe
-
Executable File
API
-
Application Programming Interface
JTAG
-
Joint Test Action Group
AS
-
Active Serial
RS-232
-
Recommended Standard 232
HLI
-
Higher Learning Institution
HCI
-
Healthcare Institution
MOH
-
Ministry of Health
UK
-
United Kingdom
US
-
United States
MDB
-
Medical Device Bureau
xvii
LIST OF SYMBOLS
W
-
Watt
V
-
Volt
W/cm2
-
Watt per centimeter per centimeter
cm
-
Centimeter
mm
-
Millimeter
g
-
Gram
kg
-
Kilogram
MHz
-
Megahertz
Hz
-
Hertz
kHz
-
Kilohertz
Z
-
Acoustic Impedance
m
-
Mass
v
-
Velocity
f
-
frequency
t
-
time
dB
-
Decibel
+/-
-
Plus Minus Range
>
-
Greater Than
<
-
Lower Than
xviii
d
-
Transmission Coefficient
g
-
Reception Coefficient
k
-
Coupling Coefficient
Q
-
Mechanical Coefficient
ºC
-
Degree Celcius
nm
-
Nanometer
s
-
Second
ms
-
Millisecond
µs
-
Microsecond
Vp-p
Peak to Peak Voltage
Vin
Input Voltage
Vout
Output Voltage
xix
LIST OF APPENDICES
APPENDIX
TITLE
A
Projected first year cash flow
B
Projected second year cash flow
C
Projected third year cash flow
D
Datasheet of PVDF sensor
E
Microchip PIC16F877A Microcontroller Features
F
Questionnaire
CHAPTER 1
PROJECT OVERVIEW
1.1
Introduction
Ultrasound therapeutic device is used to generate the ultrasound mainly used in the
treatment of soft tissue injuries for the acceleration of wound healing.
Therapeutic
ultrasound can be divided into two classes; at low spatial peak temporal average (SPTA)
intensities around 0.125 to 3.0 W/cm2 at frequency 0.5 to 3.0 MHz. The aim is to produce
non- destructive heating or non thermal effect for accelerating normal physiological
response to injury. Besides, at higher intensities above 5 W/cm2, the aim is rather to
produce controlled selective destruction of tissues.
The first category includes the
majority usage for physiotherapeutic whereas beam surgery falls into the second category.
The thermal energy from the treatment head will transfer to the exposure tissues with a
depth for the treatment of soft tissues injuries, wound healing and treatment of bone and
joint injuries.
The ultrasound power meter is a device used to measure and calibrate the output
power and intensity of the ultrasound machine. The measurement of the ultrasound power 2
meter is aimed to ensure the output generated by the ultrasound machine is under the
safety condition according to the International Electrotechnical Commission (IEC)
standard. The ultrasound power meter used the piezoelectric devices to detect the
ultrasound field. The piezoelectric devices have the nature ability to convert the
mechanical energy or heat to the electrical energy. Meanwhile, there is variety
methods used to construct the ultrasound power meter. The approaches are the
radiation force method, calorimetry and hydrophone with polyvinilidene difluoride
(PVDF) sensor.
Ultrasound power meters which are currently available mostly rely on
radiation force balance method. It is balancing the radiation force exerted by and
ultrasound wave on a reflector with a restoring force. The restoring force may be
provided by an electronic feedback system. The main concept is using the reflecting
rather than absorbing targets. The power meter is measuring the entire of the beam
ultrasound and the quantity pressure is the main concern parameter to carry out the
measurement for the power meter. Then the mostly of the detector sensor using for
this power meter is ceramic piezoelectric device.
The calorimetry type of ultrasound power meter is measuring the total beam
power and carried out with direct reference to fundamental physical quantities. The
calorimetry measurement of the total acoustic power output of a transducer under
conditions where the complete beam can be directed into the calorimetry.
Measurement of local values of intensities by calorimetry method is rather a
different approach and one that is additionally of interest in the assessment of the
pattern of temperature rise that occur in tissues exposed to therapeutic sources of
ultrasound. Thermocouple is the sensor used in the calorimetry method for the
absorption of the heat produced by the ultrasound beam. The measurement is due to
the temperature as reference set value.
The development of Ultrasound Device Tester (UDevT) for medical
application have been reached the point of formal international agreement on
3
recommended method to measure the power and intensity for the ultrasound
machine. It consists of hardware part called Ultrasound Tester (UTest) and software
part called Smart Measurement (SMeas). The hydrophone is a water tank and used
the water as the propagation medium for the ultrasound sources with the sensor.
Then a piezoelectric polymer sensor place inside the water tank to measure the
intensity of the sources of the ultrasound. The absorption of the heat of the PVDF
sensor will convert to the electrical energy for measurement. The hydrophone power
meter with PVDF sensor can utilize for wideband frequencies which is suitable for
most of the medical application.
1.2
Problem Statement
Published surveys of ultrasound therapy generators in hospital use have
revealed that the calibration supplied by the machine manufacturers may be grossly
inaccurate.
The machine may exceed the safety regulation and may cause the
biological negative effect to the patients. Some researches have been done and the
problems have been identified are:
i.
37 devices use in the Ottawa area that were tested, the acoustic output varied
from +/ 250 % of the meter reading, with 72 % of the devices giving less than
the set value.
ii.
Most of the 10,000 ultrasound machines in United Kingdom (UK) fail to
deliver within 30 % of the correct power.
iii.
37 treatment head, the ultrasound beam non-uniformity ratio was normally
found to be in the range 3 to 7 W/cm2, but 8 heads had values above 8 W/cm2.
4
1.3
Background of Study
Ultrasound is one of the most popular and productive non-invasive
therapeutic and diagnostic tools in medicine. Ultrasound with frequencies 1 to 10
MHz for diagnostic usage is most frequently used, as high frequency allows good
resolution to be obtained. For the ultrasound therapeutic devices, the safety intensity
emission is 3 W/cm2 and the frequency response is 1.5 to 3.5 MHz. Increases in
transmitted ultrasound power improve the signal to noise ratio of the image and the
biomedical usage. However ultrasound absorption in the body causes heating which
may be harmful in excess. Therefore, it is important to keep the overall power to a
minimum but sufficient to produce the desired information.
Due to the significance of the ultrasound devices to generate safety acoustic
wave for medical usage, there are currently available products which are able to
measure it accurately to ensure the correct operation and safe use of ultrasound for
specify application. Monitoring of output power levels also provides a means of
monitoring the performance of the equipment. The products are the ultrasound
power meter. It comes with different features and sensor used as detection. The
features of these products vary from low cost to high cost with different
specifications. Meanwhile, the power meter’s measurement methods used are the
radiation force measurement and hydrophone with PVDF sensor in membrane probe
and needle.
5
1.4
Objective
The objectives of this project are:
i.
To complete market survey through literature, questionnaire distribution and
interviews.
ii.
To study basic principal of ultrasound and characteristics of the PVDF sensor
through literature.
iii.
To create programme codes for data management in processors.
iv.
To integrate analogue part and digital part in the UTest.
v.
To develop prototype of the UDevT.
1.5
Scope of Project
Scope will be used to bind this project to a certain limit. So, the writer has to
concentrate on what really important and related to this project. There are three
main scopes that should be covered and it will determine the effectiveness of this
project. The scopes are:
i.
Design and develop the prototype of UTest.
ii.
Design and develop the prototype of SMeas.
iii.
UDevT is developed for testing the ultrasound diagnostic and therapeutic
machines.
6
1.6
Thesis Outline
The thesis consists of seven chapters. Each chapter is described follows.
Chapter 1 serves as an introduction to the report. It includes an overview of
ultrasound power meter applications and description, literature review, project
objective and scopes of the project.
Chapter 2 discusses the literature review which is relevant for focusing on the
basic concept of ultrasound and comparison between several ultrasound power
meters available in the market. Then, advantages’ using the PVDF sensor rather
than ceramic is discussed.
Chapter 3 will describes the methodology taken to complete the entire
project. It included the flow diagram and the work breakdown structure about the
every process taken to construct the project.
Chapter 4 will guides to the system designed implementation and the
description for the hardware and software part of the project.
Chapter 5 shows the result and testing for the project.
Chapter 6 describes the shortcomings experienced and suggestions solution
and the conclusion. The recommendation of the project will also be discussed.
At the end of this thesis, a business plan for this project will be presented.
CHAPTER 2
LITERATURE REVIEW
This chapter presents the fundamental of ultrasound and the principle used to
construct the ultrasound device tester. The underlying principles of ultrasound need to be
established before designing the power meter.
This chapter will be described the
ultrasound wave propagation, energy lost effect during propagation, piezoelectric device,
the advantage using the PVDF sensor, the spatial peak and spatial average of ultrasound
intensity and other relevant fundamentals.
2.1
Ultrasound
Ultrasound can be defined as high-frequencies mechanical waves that human
cannot hear, that is, mechanical waves having frequencies greater than 20 KHz. The
general wave equation is A=A0 sin (2πft) (David et al., 1985). The waves divided into 2
basic groups: Longitudinal and transverse.
Longitudinal waves are those for which
8
particle motion is along the direction of propagation of the wave energy. The
molecules vibrate back and forward in the same direction in which the wave is
travelling. Sound waves are longitudinal. Besides, transverse waves are those in
which the motion of the particle is perpendicular to the direction of propagation of
the wave energy. The ultrasound always needs a propagation medium to transfer the
ultrasound to the target.
Anyway, there are lost of ultrasound energy during
propagation due to attenuation, reflection and other effects.
Acoustic energy may be transformed into several other forms of energy,
which may exist at the same time within any given medium (Lawrence, 1982). The
mechanisms of transformation into these other forms of energy are conventionally
subdivided into three major categories comprising a thermal mechanism, a
cavitational mechanism, and other mechanisms including streaming motions. When
ultrasound is absorbed by matter, it is converted into heat producing a temperature
rise in the exposed subject.
An ultrasound wave produces alternate areas of
compression and rarefaction in the medium and the pressure changes produced can
result in cavitations. Streaming motions and shearing stresses can occur within the
exposed system through stable cavitations; twisting motions (radiation torque) have
also been observed in biological systems exposed to ultrasound.
2.2
Transducer Field (Far Field and Near Field)
The ultrasonic beam shows two zones: the near field (Fresnel region) and the
far field (Fraunhofer region) (Figure 2.1) (Lawrence, 1982). In the near field all the
components of the beam propagate in parallel. In the far field the beam diverges.
An acoustic lens can be placed in front of the transducer, so that in the near field the
beam is convergent before a focus zone, after which it becomes divergent in the far
9
field (Lawrence, 1982). This allows a greater range of useful beam into the body
before it becomes divergent and so loses resolution.
The beam is diffracted,
scattered and absorbed by the tissue. A small proportion is reflected back by each
structure in the tissue and is used to form the image, knowing the time for the round
trip from the transducer, out to the point of reflection and back to the transducer.
Thus the signal loses strength roughly exponentially with distance (or time). To
compensate for this and ensure the image has an even brightness, the amplifier of the
received signal has a gain that increases exponentially with time from the instant of
pulse transmission by the transducer.
The attenuation of the beam sets a practical limitation on the depth into the
body that can be imaged. As a rough rule of thumb, the beam can form images to a
depth of 200 wave lengths (Lawrence, 1982). Thus lower frequency beams can
penetrate to a greater depth than higher frequencies. However the lower frequency
beam has a lower spatial resolution than the higher frequencies. Generally most
machines have a number of transducers operating at different frequencies. The one
that is used in any given situation is the highest frequency transducer that can
achieve the desired depth of penetration.
treatment head
treatment head
Figure 2.1 Far field and near field (Lawrence, 1982)
The focusing limits the useful of the near field depth, since the beam will
diverge very rapidly beyond the focus zone (Lawrence, 1982). The focal zone is
defined as the region in which the intensity corresponds to within 3 db of the
10
maximum intensity along the transducer axis (Lawrence, 1982). The degree of
focusing can be change by increasing the radius of curvature of the crystal or by
increasing the curvature of the acoustic lens or mirror. The focal zone for weak
focusing or long focus is 7 to 19 cm (Lawrence, 1982). Meanwhile the strong
focusing is 1 to 4cm (Lawrence, 1982).
2.3
Scattering
The scattering occurs because the interface is smaller than the diameter of the
sound beam (C. R. Hill et al., 2004). This is known as non-specula reflection. The
scattering effect is dependent most with the frequency.
It is useful for the
characterizing the tissue. The scattering effect will decrease the intensity of the
beam incident and below is the formula for the scatter power and the scattering
effect (Figure 2.2) (C. R. Hill et al., 2004).
Figure 2.2 Scattering affect (C. R. Hill et al., 2004)
11
2.4
Reflection
The reflection of sound is defined as a sound beam is directed at a right angle
to a large interface; the beam will be reflected back toward the sound source. The
percentage of the reflectivity is concern with the acoustic impedance Z = ρv
(Lawrence, 1982). The acoustic impedance Z is analogue with the momentum (p =
mv) (Lawrence, 1982). Meanwhile this is a measure of the resistance to sound
passing though the medium and similar with the electrical resistance.
The
impedance mismatch is use to calculate the percentage of the reflectivity between
two different medium and the formula of the reflectivity according to the acoustics
impedance (Lawrence, 1982). All interaction that decreases the intensity of the
beam except for reflection is included in the attenuation process. Table 2.1 shows
the reflectivity of the ultrasound in different medium.
Table 2.1: The reflectivity for different medium (Lawrence, 1982)
Tissue at Interface
Reflectivity
Brain – skull bone
0.66
Fat – bone
0.69
Fat – blood
0.08
Fat – kidney
0.08
Fat – muscle
0.10
Fat – liver
0.09
Lens – aqueous humor
0.10
Lens – vitreous humor
0.09
Muscle – blood
0.03
Muscle – kidney
0.03
12
2.5
Muscle – liver
0.01
Soft tissue (mean) water
0.05
Soft tissue – air
0.9995
Soft tissue – piezoelectric crystal
0.89
Absorption
The absorption is the only process whereby sound energy is dissipated in a
medium. Absorption is tee process in which the ultrasound energy is transformed
into other energy, exclusively heat (Lawrence, 1982). This is the principle used in
the therapeutic ultrasound. The absorption is related to the frequency of the beam,
viscosity and the relaxation time of the medium. The relaxation time is the rate of
the molecules return to their original position after being displaced by a force. The
viscosity of the medium describes the ability of the molecules to move past one
another medium. The fictional force must be overcome by vibrating molecules and
the heat is produced. Then, the frequency is increase, the molecule will moving fast
thus generating more heat.
The absorption of the ultrasound beam follow an
exponential function which is A=A0exp (-αx) (Lawrence, 1982).
2.6
Attenuation
The intensity used to describe the amount of energy flowing though units
cross section area each second. The intensity of the ultrasound is proportional to the
13
square of the pressure amplitude, particle-displacement or velocity amplitude. The
power defined as the measure the total energy transmitted per unit time multiplied
with the entire cross-sectioned area of the beam which is P = intensity x area (C. R.
Hill et al., 2004). Meanwhile the absolute value of the power and the intensity
ultrasound beam are very difficult to measure. So, the useful method is used to
determine the resections of the power and intensity of the beam by making the
relative measurement that compare the quantities with one reference point to that
interest point in the beam (C. R. Hill et al., 2004).
db = 10 log I/Io
I = the intensity at the point of interest
I0 = the reference intensity
The attenuation of an ultrasound beam is a measure of the decrease of the
power or the intensity as the beam traverse a medium.
Since all type of the
interaction will cause a decrease in the beam intensity and results as attenuation. But
the interaction absorption of the beam is only the result on energy loss to the tissue.
The decrease in intensity is directly proportional to both the depth of penetration and
the frequency of the ultrasound beam.
High-frequency sound waves will be
attenuated faster than low-frequency sound wave, thus, there is less penetration in
tissue with higher frequencies. The greater of the depth of penetration will cause the
greater attenuation of the signal in which the signals decrease as the depth increase.
2.7
Piezoelectric Devices
Piezoelectricity is the ability of some materials (notably crystals and certain
ceramics) to generate an electric charge in response to applied mechanical stress (C.
14
R. Hill et al., 2004). If the material is not short-circuited, the applied charge induces
a voltage across the material. The word is derived from the Greek piezein, which
means to squeeze or press (C. R. Hill et al., 2004). The piezoelectric effect is
reversible in that materials exhibiting the direct piezoelectric effect (the production
of electricity when stress is applied) also exhibit the converse piezoelectric effect
(the production of stress and/ or strain when an electric field is applied) (C. R. Hill et
al., 2004). For example, lead zirconate titanate crystals will exhibit a maximum
shape change of about 0.1 % of the original dimension (C. R. Hill et al., 2004). The
effect finds useful applications such as the production and detection of sound,
generation of high voltages, electronic frequency generation, microbalances, and
ultra fine focusing of optical assemblies. Ceramic phonograph cartridges simplified
player design, were cheap and accurate, and made record players cheaper to maintain
and easier to build.
The principle of operation of a piezoelectric sensor is that a physical
dimension, transformed into a force, acts on two opposing faces of the sensing
element (C. R. Hill et al., 2004). Depending on the design of a sensor, different
"modes" to load the piezoelectric element can be used: longitudinal, transversal and
shear. For many sensing techniques, the sensor can act as both a sensor and an
actuator -often the term transducer is preferred when the device acts in this dual
capacity, but most piezo devices have this property of reversibility whether it is used
or not. Ultrasonic transducers, for example, can inject ultrasound waves into the
body, receive the returned wave, and convert it to an electrical signal (a voltage).
Most medical ultrasound transducers are piezoelectric.
15
2.8
PVDF Sensor
By the 1960's, researchers had discovered a weak piezoelectric effect in
whale bone and tendon (Alan and Peter, 2000). This began an intense search for
other organic materials that might exhibit piezoelectricity. In 1969, Kawai found
very high piezo-activity in the polarized fluoropolymer, polyvinylidene difluoride
(PVDF) (Alan and Peter, 2000). While other materials, like nylon and PVC exhibit
the effect, none are as highly piezoelectric as PVDF and its copolymers. Like some
other ferroelectric materials, PVDF is also piezoelectric, producing electrical charge
in response to a change in temperature (Alan and Peter, 2000). PVDF strongly
absorbs infrared energy in the 7 to 20 cm wavelengths, covering the same wave
length spectrum as heat from the human body (Alan and Peter, 2000). Accordingly,
PVDF makes a useful human motion sensor as well as piezoelectric sensor for more
sophisticated applications like video cameras for night vision and laser beam
profiling sensors. A dense infrared array has been recently introduced that identifies
one’s fingerprint pattern using the piezo-effect of piezo polymer (Alan and Peter,
2000).
Polyvinylidene difluoride (PVDF) exhibits piezoelectricity several times
larger than quartz (Alan and Peter, 2000).
Unlike ceramics, where the crystal
structure of the material creates the piezoelectric effect, in polymers the intertwined
long-chain molecules attract each and repel other when an electric field is applied.
New copolymers of PVDF, developed over the last few years, have expanded the
applications of piezoelectric polymer sensors.
These copolymers permit use at
higher temperatures (135 ºC) and offer desirable new sensor shapes, like cylinders
and hemispheres (Alan and Peter, 2000). Thickness extremes are possible with
copolymer that cannot be readily attained with PVDF. These include ultra thin (200
Å) spin-cast coatings that enable new sensor-on-silicon applications, and cylinders
with wall thicknesses in excess of 1200 µm for sonar (Alan and Peter, 2000). Piezo
cable is also produced using copolymer (Alan and Peter, 2000).
16
Piezo PVDF film is a flexible, lightweight, tough engineering plastic
available in a wide variety of thicknesses and large areas.
Its properties as a
transducer include (Alan and Peter, 2000):
i.
Wide frequency range - 0.001 Hz to 109 Hz.
ii.
Vast dynamic range.
iii.
Low acoustic impedance – close match to water, human tissue and adhesive
systems.
iv.
High elastic compliance
v.
High voltage output – 10 times higher than piezo ceramics for the same
force input.
vi.
High dielectric strength – with standing strong fields (75 V/m) where most
piezo ceramics depolarize.
vii.
High mechanical strength and impact resistance (109 - 1010 Pascal modulus).
viii.
High stability – resisting moisture (< 0.02 % moisture absorption), most
chemicals, oxidants, and intense ultraviolet and nuclear radiation.
ix.
Can be fabricated into unusual designs.
x.
Can be glued with commercial adhesives.
One major advantage of piezo film over piezo ceramic is its low acoustic
impedance which is closer to that of water, human tissue and other organic materials.
For example, the acoustic impedance (Z = ρυ) of piezo film is only 2.6 times that of
water, whereas piezo ceramics are typically 11 times greater (Alan and Peter, 2000).
A close impedance match permits more efficient transduction of acoustic signals in
water and tissue. Piezo film does have some limitations for certain applications. It
makes a relatively weak electromechanical transmitter when compared to ceramics,
particularly at resonance and in low frequency applications. The copolymer film has
maximum operating or storage temperatures as high as 135 ºC, while PVDF is not
recommended for use or storage above 100 ºC (Alan and Peter, 2000). Also, if the
electrodes on the film are exposed, the sensor can be sensitive to electromagnetic
radiation.
Good shielding techniques are available for high electromagnetic
interference (EMI) or radio frequency interference (RFI) environments (Alan and
Peter, 2000). Table 2.2 provides a comparison of the piezoelectric properties of
17
PVDF polymer and two popular piezoelectric ceramic materials (Alan and Peter,
2000).
Table 2.2 Comparison of piezoelectric material (Alan and Peter, 2000)
Property
Units
PVDF Film
PZT
BaTiO3
Density
103 kg/m3
1.78
7.5
5.7
Relative Permittivity
/
12
1,200
1,700
d31 Constant
(10-12) C/N
23
110
78
g31 Constant
(10-3) Vm/N
216
10
5
k31 Constant
% at 1 KHz
12
30
21
Acoustic Impedance
(106) kg/m2-sec
2.7
30
30
Piezo film has low density and excellent sensitivity, and is mechanically
tough. The compliance of piezo film is 10 times greater than the compliance of
ceramics (Alan and Peter, 2000).
When extruded into thin film, piezoelectric
polymers can be directly attached to a structure without disturbing its mechanical
motion. Piezo film is well suited to strain sensing applications requiring very wide
bandwidth and high sensitivity (Alan and Peter, 2000). As an actuator, the polymer's
low acoustic impedance permits the efficient transfer of a broadband of energy into
air and other gases. So this sensor is suitable for become the sensor for ultrasound
power meter to measure the therapy ultrasound.
2.9 PVDF Sensor Parameters
There are several factors or parameters we need to concern for the PVDF
sensors. These parameter are the electromechanical coupling coefficient, k, the
18
transmission coefficient, d, the reception coefficient, g, the dielectric constant, ε, the
acoustics impedance, Z, and the mechanical coefficient, Q (Alan and Peter, 2000).
The sensitivity of the sensor is influenced by all these factors.
The electromechanical coupling coefficient, k, describes how efficiently the
sensor converts both the electrical of the unit into ultrasound energy as well as the
ultrasound energy into the electrical signals (Alan and Peter, 2000).
The
transmission coefficient, d, indicates the fraction of the electrical energy that is
converted into the acoustic energy (Alan and Peter, 2000). The fraction of the
returning acoustic energy that is converted into the electrical energy is given by the
reception coefficient, g (Alan and Peter, 2000).
The multiplication of the
transmission coefficient and the reception coefficient yields the electromechanical
coupling coefficient (Alan and Peter, 2000).
The mechanical and electrical properties of the sensor are partially
characterized by the dielectric constant, ε, which is also related to the coefficient
mentioned before (Alan and Peter, 2000). The dielectric constant is important for
electrical and mechanical matching of the transducer to the rest of the ultrasound
unit. The acoustic impedance, Z, as the product of the velocity times density (Alan
and Peter, 2000). The Z value is important in matching the interface of the sensor
and the propagation medium (Alan and Peter, 2000). The mechanical coefficient Q
characterizes the frequency response of the sensor (Alan and Peter, 2000). The Q
value is a point of major consideration when selecting a sensor for a particular
application (Alan and Peter, 2000).
19
2.10
Attaching Electrodes to PVDF
Electrodes can be attached to PVDF in one of two ways: conducting adhesive
or mechanical contact. Soldering to PVDF film is not an option for two reasons: 1)
The heat of the soldering iron is likely to melt the film; 2) long before it melts the
film the heat will have caused permanent and irreversible damage to the
piezoelectric nature of the film (Alan and Peter, 2000).
There is a wide range of commercially available conduct adhesives, most of
which are based upon an epoxy that has been loaded with conductive particulates,
with the intention of getting a continuous electrical pathway across adjacent,
touching, particulates (Alan and Peter, 2000).
Often these adhesives are very
heavily loaded with either silver or carbon powders, leading to very low resistances
when cured. Unfortunately the adhesive strength of these products is often poor
(many of the standard conductive epoxies available from RS Component or Farnell
fall into this category).
However the United States (US) chemical company
Emerson and Cuming make a range of very good conductive adhesives that both
bond well and have low resistance; particular recommendations are Eccobond 56c
and Eccobond 64c for respectively silver and carbon loaded epoxies (Alan and Peter,
2000). These can be obtained in the UK from Hitek Electronic Materials.
An alternative solution is to form a temporary bond between wire and PVDF
film with a cyano-acrylate (Superglue) adhesive and then use silver loaded paint (RS
own brand is just fine) over the ends of the wire on the film to make an electrical
connection. Once the paint is dry, check the connection with a resistance meter and
then re-enforce the connection by applying a small quantity of standard two part
clear non-conductive epoxy over the connection.
20
Figure 2.3 PVDF sensor electrodes attached (Alan and Peter, 2000)
For the project, the PVDF sensor is made by using the thin wire as electrode
and epoxy gel to glue the wire on two opposite side of the film. The area of the film
is 1cm x 1cm. Here are some guidelines to use the PVDF film (Alan and Peter,
2000):
i.
PVDF is pre shrunk prior to the deposition of electrodes and further
“shrinking” is not required
ii.
Exposure to temperatures above 80 ºC will start to irreversibly degrade the
performance of PVDF
iii.
Do not solder onto PVDF as this can cause local depolarization
iv.
To make a connection to the metallised PVDF consider the use of: 1)
Mechanical connection via a crimp or fold, 2) Adhesive connection using
silver loaded epoxy
v.
To bond PVDF to a substrate use a low viscosity epoxy or nitrile contact
adhesive. In either case make sure sufficient pressure is applied during cure.
vi.
To cut PVDF use a sharp scalpel
21
2.11
Specification of the Intensity
The density of states (DOS) must be known to calculate the actual intensity
generated from the transducer to avoid negative biological effect (Joseph and Barry,
1982). DOS is the quantity of energy absorbed per unit mass of absorbing medium.
The maximum intensity in the pulse is defines as temporal peak (TP) (Joseph and
Barry, 1982). The intensity averaged over the duration of a single pulse corresponds
to the pulse average (PA) (Joseph and Barry, 1982). Meanwhile, the averaging over
the longer time interval of the pulse repetition period yields the temporal average
(TA) (Joseph and Barry, 1982). All this illustrated in Figure 2.4. The temporal
average intensity is related to the pulse average intensity by the duty factor, such that
TA = Duty Factor x PA (Joseph and Barry, 1982). Example if the pulse duration is 1
µs and the repetition is 1 ms, the duty factor is 0.001 (Joseph and Barry, 1982).
Figure 2.4 TA, TP,PA related to time (Joseph and Barry, 1982)
If the TP, PA and TA are related to the function of position, the beam profile
is created. The maximum intensity is the beam profile is designated as the spatial
peak (SP) (Joseph and Barry, 1982). The spatial averaging (SA) over the cross
sectional area of the beam for one of the temporal intensities could be specified
(Joseph and Barry, 1982). A cut off point of 0.25 times the spatial peak intensity has
been establish to limit the area over the in which the intensity averaged (Joseph and
22
Barry, 1982). Figure 2.6 shows the SP and SA related to the position and the beam
profile.
Figure 2.6 SP and SA diagram (Joseph and Barry, 1982)
From the description of the SA and the SP, we can found 3 of the common
intensity measurement method which is spatial peak temporal average (SPTA)
intensity, spatial average, temporal peak (SATP) intensity and SATA. The most
commonly use is the SPTA, which can be approximately as the ratio of ultrasound
power to the beam cross section area (Joseph and Barry, 1982).
2.12
Spatial and Temporal Measurements
Ideally, to measure the spatial and temporal characteristics of ultrasound, a
detector is needed that is small compared with the wavelength of the ultrasound field
and has a response function (i.e., the quotient of the electric output signal and the
acoustic input signal) that is flat over the frequency of interest, combined with high
sensitivity, low noise, and a wide acceptance angle (Jasjit et al., 2008). Miniature
23
piezoelectric hydrophones, though not ideal, are used extensively to determine the
spatial distributions and temporal pressure waveforms and, when properly calibrated
against an appropriate standard, can provide a satisfactory measurement method
(Jasjit et al., 2008). Devices of this type respond to the instantaneous local value of
the acoustic pressure in the field.
However, not all commercially available
hydrophones are frequency independent in their sensitivity, and this presents a major
problem. The frequency responses of several hydrophones have been reported in the
literature.
The International Electrotechnical Commission (IEC) (IEC, 1981) and the
American Institute for Ultrasound in Medicine/National Electrical Manufacturers
Association joint task group have both recommended the use of hydrophones for the
measurement of spatial and temporal exposure parameters for diagnostic ultrasound
equipment (IEC, 1981). Comparison of the reciprocity technique for the calibration
of ultrasonic hydrophones with that of planar scanning in a field of known acoustic
power has shown that both methods yield consistent results (IEC, 1981). The choice
of method depends on convenience and the interest and background of the user.
Most conventional probes have resonances in the frequency range of interest
but distort the ultrasonic pulses being observed. Only if the frequency characteristics
of the probe are known, can appropriate corrections be made. Another limitation in
the use of hydrophones is their directional sensitivity, for which correction must be
made.
The use of the piezoelectric polymer polyvinylidene difluoride as an
ultrasonic hydrophone has been described. Compared with ceramic, this material
has an acoustic impedance much closer to that of water and, because it is available in
sheets that have thickness resonances greater than 20 MHz, it promises to be useful
as a broad-band, acoustically transparent receiver (IEC, 1981). Hydrophones made
with piezoelectric polymer are commercially available.
24
2.13
Conducting Ultrasound Intensity Measurement
The approach used to conduct the ultrasound intensity measurement from the
hydrophone is complicated and practical. The Acoustic Precision had provided a
simple guideline for reference due to the ordered PVDF sensor from them. But this
method exist some problem due to the hydrophone sensitivity parameter. This
parameter is needed to calculate the intensity according to the raw output voltage
from the hydrophone. Anyway, this guideline can be a useful reference to conduct
this project.
According to the guideline, here is the discussion about it. First, the signal
consideration from the output of the hydrophone (Alan and Peter, 2000). It is
assumed that you have set up the hydrophone as recommended in the instruction
leaflet, and that both the transducer and hydrophone are correctly aligned in the
water tank, with the output of the hydrophone being displayed the screen of the
oscilloscope (Alan and Peter, 2000).
CHAPTER 3
METHODOLOGY
This chapter presents the flow diagram, system requirement analysis and project
schedule. The work breakdown structure (WBS) chart used to describe the methodology
to complete this project.
3.1
Flow Process Diagram
The flow diagram as shown in Figure 3.1 shows the process flow of the project.
All the process mentioned are important in completing the project. First, some market
surveys have been done include searching information through literature, interviews and
distribute questionnaires for qualitative and quantitative information. At the same time,
basic principles of ultrasound have been studied.
26
Then, the concept of the ultrasound power meter and PVDF sensor are
analyzed. Next, the specifications are verified, the conceptual designs are drawn, the
product is designed and the design is implemented. Lastly, the prototype testing
must be done to ensure the project is successful and meets the requirements.
Figure 3.1 Process flow diagram
27
3.2
Work Breakdown Structure
Figure 3.2 Work breakdown structure
The WBS chart is shown at Figure 3.2. The main processes in completing
the project are basically study, design and implementation. Study is the process that
is continuous throughout the project, from beginning till the end. At the beginning
of the project, a lot study has been done to gather knowledge and understanding
about the concept of the ultrasound power meter. First, the principle of ultrasound
therapy and diagnostic has been studied. This includes study on the ultrasound wave
28
propagation theory, the intensity measurement and the safety regulation for the
ultrasound purposed.
In the study phase, the concept of the functionality of the ultrasound power
meter also learned by exploring to article or journal done by other researchers.
Then, the characteristics of the PVDF sensor such as acoustic impedance,
electromechanical coupling, dissipation factor and more have elaborated in the
literature review. Next, programming language of verilog, VB.net and C have been
study. The verilog programming language is implemented in field programmable
gate array (FPGA) for data management and calculation.
Then, the VB.net
programming language is used to implement the SMeas and C programming
language is implemented in microcontroller to display data.
At the same time, some market surveys have been performed to get
information and feedback about this product. Information about existing ultrasound
power meter has been searched through internet. Then, specification of the entire
existing ultrasound power meter have been analysed. Next, some interviews with
medical device distributors, doctors and testing engineers have been conducted.
Most of them give good feedback about the product and they also give some
suggestion for further improvement of the product.
Meanwhile in the design phase, the product will be developed according to
the conceptual diagram, logical diagram and also physical diagram. First, hardware
block diagram is designed based on the requirements. Then, flowchart of
programming process in the FPGA is designed and logical design for the software
analyser also been designed. Next, the circuit design is plan based on the hardware
block diagram. Lastly, mechanical design for casing has been discussed and drew.
In the implementation phase, the product will be implemented with the
hardware and software approaches.
The hardware approach is using the entire
29
prepared component to build the product. Then, for the software approach is use the
programming abilities to implement data calculation in the FPGA, programmed the
microcontroller and develop the SMeas. After the hardware and software part is
completed, integrating between them is completed and some customisation is done.
Lastly, analysis and testing were performed on the overall prototype to
ensure the product is functioning. Then, the improvements of the system were done
to enhance the performance and the accuracy of the system. Testing were be done
are functional testing and safety testing.
3.3
System Requirement Analysis
3.3.1
Hardware Justification
There are two part of hardware for the UTest which are power meter box and
water tank. Power meter box contains the processor and performs the following
services:
i.
Capture sensor output (analog) signal, amplify the signal, filter noise and
convert to digital signal.
ii.
Process the digital signal, do calculation using unique formula and save to
memory in the processor.
iii.
Display the result on the Graphical Liquid Crystal Display (LCD).
iv.
Sent the data from the memory to Personnel Computer (PC).
30
Meanwhile sensors will be placed in this unit. It will capture the ultrasound
wave signal and sent to the Power Meter Box. Table 3.1 specifies the hardware
justification of the UDevT in sufficient detail to enable designers to design the
product.
Table 3.1 Hardware justification
Hardware Components
Graphical Liquid Crystal Display
Descriptions
Display results from the processor
Process the digital signal, calculate the
Field Programmable Gate Array
data, save the data and sent to PC and
microcontroller
Microprocessor
Process the data from FPGA to display
result on the graphical LCD
Recommended Standard 232 (RS-
Provided (ingoing only) for connection
232)
between power meter box and water tank
Analog Circuit
Captured signal from the sensors will be
amplified and filtered by this circuit
Convert the analog signal to digital
Analog to Digital Converter (ADC)
signal and sent to the FPGA to be
processed
Fan
Cooler in the Power Meter Box
Button
Button for ON and OFF
Universal Serial Bus (USB)
Rechargeable Battery and Charging
Port
Clamp (Holder)
Absorber
Provided (outgoing only) for connection
between power meter box and PC
Supply power to the power meter box
and it can be charged through charging
port
Hold ultrasound transducer that is going
to be tested
Cover the water tank wall
31
Polymer sensor and a temperature sensor
Sensor
will be placed in the water tank to sense
the ultrasound wave and compensate
temperature of the water
3.3.2
Software Justification
SMeas will use VB.net platform and it will be running in .exe file. Thus, it
compatible running by most operating system environment. However, it requires
driver for RS 232 to USB converter for interfacing between UTest and SMeas.
3.4
Project Schedule
The project schedule is illustrated in Figure 3.3. This project takes about 15
months starting from July 2008 until October 2009. It includes the entire work
breakdown as mentioned in Section 3.2.
32
Figure 3.3 Project schedule
CHAPTER 4
DESIGN IMPLEMENTATION
This chapter described the design for the UTest and SMeas. The design will be
described according to the conceptual design of the hardware and software.
4.1
Description of the System
The UDevT consist of hardware and software called SMeas. The hardware has
two parts which are power meter box and water tank. Transducer is going to be tested is
hold by the clamp and put inside the water tank. The PVDF sensor and temperature
sensor were placed inside the water tank to sense the ultrasound wave and compensate
temperature of the water. Then, the captured signals from the sensors are sent to power
meter box through RS-232. The signals will be processed by the analogue circuit before it
sent to digital circuit.
34 Next, the signals are converted to digital signals by the ADC and sent to
FPGA. FPGA will process the signals, do some calculation and save to the memory
before it sent to the graphical LCD and PC. The graphical LCD will display the
result. For further analysis, the result from the memory is sent to the PC through the
USB connector. The SMeas is use to do the further analysis. The SMeas can
display the result, view and print the report of the testing done. Figure 4.1 shows
the measurement configuration of the product.
Figure 4.1 Measurement configuration
35 4.2
Product Design
4.2.1
Conceptual Diagram
4.2.1.1 Hardware Block Diagram
Figure 4.2 Hardware block diagram
Figure 4.2 shows the hardware block diagram of UTest. The ultrasound
transducer will generate the ultrasound signal. This ultrasound will be emitted by a
treatment head in which connected to the machine with a probe. The treatment head
will put inside the water tank immersed in the water. The treatment head emitted the
ultrasound by using the water as propagation medium to transmit energy. The PVDF
sensor placed inside the water tank will detect the ultrasound energy. The heat
explore on the surface of the PVDF sensor will transform to the electrical energy.
Besides, the temperature of the water also is transformed to the electrical energy.
Then the signals will be amplified by using amplifier circuit because the output
signals are small.
36 Then, the signals will be converted into digital signal by the ADC and sent to
FPGA for the further process. In the FPGA, the signals will be calculated using
formula to determine the result of ultrasound intensity. Next, the result will be
displayed on the graphical LCD and save to the memory. The saved result can be
analyse using PC and sent to the PC through USB connector.
4.2.1.2 Flowchart of the Process in FPGA
In the FPGA, the signals being process is in term of digital code (binary
code). This code is converted by the ADC from the raw analogue signals amplified
by the analogue circuit. Then, the digital code is buffering before it been calculate
using formula. After the calculation, the digital code consists of the output result
will be rearranged in a form, then will be displayed and save in the memory. Figure
4.3 shows the flowchart of the process in the FPGA.
Figure 4.3 Flowchart of the process in FPGA
37 4.2.1.3 System Architecture Diagram
Figure 4.4 Architecture diagram
Figure 4.4 shows the whole system architecture diagram of the UDevT.
38 4.2.1.4 Use Case Diagram
System
<<extend>>
Get Result
Test Machine
User
<<extend>>
Save Result
Print Report
<<extend>>
Select Query
View Report
Admin
Figure 4.5 Use case diagram of SMeas
Figure 4.5 shows the use case diagram of SMeas. There are two actors
which are admin and user. User can only test the machine while admin can do both
machine testing and viewing report. When testing is done, the result will be saved
and all the saved result can be view later by admin. Then, the report can be printed
for further actions.
39 4.2.1.5 Flowchart of Smart Measurement
Figure 4.6 Flowchart of Smart Measurement
Figure 4.6 shows the flow process of SMeas. In the main page, there are
three option buttons which are testing, report and exit. In the testing page, there are
40 several information required and need to fill up. Then, the result will appear when
measure button is clicked. Lastly, the result will be saved in database.
Besides, all the result of the testing done can be view or print. In the report
page, there are option dates of testing can be selected. So, when the view or print
button is selected, all the result of testing done on the date selected will appear. By
the way, to enter the report page, a login page will appear to ensure only certain
respective people can view the report.
4.2.2 Logical Design
4.2.2.1 Database Table
Table 4.1 shows the description of database table. There are six information
that important in a testing. The report will show all the information according to the
database table.
Table 4.1 Database table
Testing
Description
Attributes Name
Name
Represents information of the testing
Logical
Description
Data Type
Text
The name of the person who did the
testing
41 Transducer_Type
Text
The transducer type that been tested
Transducer_Model
Text
The transducer type that been tested
Result
Text
The testing result
Status
Text
Date_and_Time
Datetime
The safety status of ultrasound machine
that been tested
The date and time of the testing done
4.2.2.2 User Interface
Figure 4.7 Window flow diagram
Figure 4.7 shows the window flow diagram of SMeas. It contains five
windows and button is used to connect the windows. In the information page, tester
needs to key in some information required. Meanwhile, to view the report login is
required to ensure the report can be viewed by certain people to secure quality of the
42 report.
4.2.3
Physical Design
4.2.3.1 Electronic Unit
The system uses PVDF sensor that able to convert the ultrasound wave to
electrical signal from 20 kHz until 10 MHz. Moreover, it also uses temperature
sensor to compensate temperature of the water inside the water tank as the
measurement medium. The signals are amplified using wideband amplifier before
the signals are passed to ADC. Then, digital signal from ADC will be passed to the
FPGA. In order to store the data, the signal from FPGA will be transferred and
stored in SRAM. The use of SRAM is to store the temporary measurement result.
Finally, the result will be displayed on LCD and the data is sent to PC for further
analysis. Table 4.2 shows the specification of electronic component use in this
project.
Table 4.2 Electronic component specification
Component
Specification
Material: Piezoelectric polymer PVDF
Density: 1780 kg/m3
Ultrasound
sensor
Longitudinal acoustic velocity: 2260 m/s
Melting temperature: 175 - 180 ºC
Curie temperature: None observed but extrapolates to 205 ºC
Maximum operating temperature: 70 ºC
43 Metallisation: Approximately 250 nm gold on top of 40 nm
chrome
Film orientation: Uni-axially oriented film
Poling method: Poled as continuous roll via corona discharge
Poling uniformity: Some small scale local variation
Approx. piezo coefficients: d31 = -5 to -6, d32 = -4 to -5, d33 = 28 to -32
Dielectric constant (relative permittivity): 10-12
18,752 Logic elements
512-KByte SRAM
USB-Blaster controller chip set for programming and user API
FPGA
control, supporting both Joint Test Action Group (JTAG) and
Active Serial (AS) programming modes.
Two 40- pin expansion headers with resistor protection.
50 MHz, 27 MHz, and 24 MHz oscillators for clock sources.
7.5 V Direct current (DC) adapter or a (USB) for power.
Resolution: 12 bit
ADC
Sample Rate: 105 SMPS
Output: Parallel
USB
Power
Battery
LCD
USB 1.1
Voltage: 12 V
Capacity: 2.3 Ah
Size: 176 mm x 33 mm x 60 mm
128 x 64 graphic LCD display
Blue backlight
Type: Operational amplifier
Amplifier
Bandwidth: 350 MHz
Voltage supply: 2.7 – 5.5 V
Temperature, operating range: -40 °C to +85 °C
44 4.2.3.2 Mechanical Unit
The mechanical hardware consists of two main parts which is water tank unit
and power meter box unit. Figure 4.8 shows the water tank unit and Figure 4.10
shows the ultrasound device tester. The water tank unit uses PVDF sensor and a
temperature sensor with the dimension of 15 mm x 15 mm each.
Absorber
Clamp
Stainless
Steel
Figure 4.8: Water tank unit
Figure 4.8 shows the outlook of water tank unit and it is build separately
from the power meter box unit. On top of it, there is an adjustable clamp use to hold
the ultrasound transducer. The water tank unit is connected to the power meter box
unit (electronic circuit) using the RS 232 connector. The outer part of the water tank
unit is built using stainless steel and the inner part is ‘softlatex’. The ‘softlatex’ is
used to absorb the ultrasonic signal.
45 (a)
(b)
(c)
(d)
Figure 4.9 Detail view of water tank unit (all measurement in millimeters)
(a) Top view (b) 3D view (c) Front view (d) Side view
Figure 4.10 shows the prototype of UTest. The power meter box is built
using stainless steel. The buttons to control the device is placed sides the power
meter box. There is also an additional fan as a cooling system. Heat inside the
device will be transfer outside through this fan. The water tank unit and power
meter box is connected using RS 232 port.
46
Reeset Button
US
SB
Clamp
RS-232
connectorr
Fan
Poweer
Buttoon
Stainnless
Steell
Battery
y
LCD Disp
play
Figure 4.10
4 Ultraso
ound devicee tester
4.2.3.3 Sooftware Un
nit
Thhe user inteerfaces for SMeas hav
ve five pagges. The ssnapshot deesign for
every winndows are illlustrated inn Figure 4.1
12 to Figuree 4.16
47 Figure 4.11 Main page
Figure 4.12 Login page
Figure 4.13 Report page
48 Smart Measurement
Name
:
Transducer Type :
Transducer Model :
Date and Time
:
Back
Figure 4.14 Information page
Figure 4.15 Testing page
Next
CHAPTER 5
RESULT AND DISCUSSION
This chapter will be discussing the result of the design product and market study
analysis. A questionnaire has been distributed in order to do some market survey.
5.1
Experiment
5.1.1
Signal of PVDF Sensor
The Figure 5.1 illustrates the signal of the PVDF sensor. The sensor detects the
signal emitted from the transducer head. Meanwhile the actual input signal is generated
from the function generator with a square wave. As a result the amplitude signal detected
by the sensor is very small. The range is within 20 mV to 80 mV with the input signal
from the function generator is 1 V peak to peak voltage (Vp-p). So, it definitely needs an
50 amplifier circuit to amplify the signal to get original value. Several testing have
been done to verify the characteristic of the ultrasound signal sensed by the PDVF
sensor.
Figure 5.1 Signal of PVDF sensor
Table 5.1 Frequency response
Frequency (Hz)
Vout (mV)
100k
35
1M
50
3M
35
5M
30
10M
29
Table 5.1 shows the result of the output voltage from the PVDF sensor due
to frequency response.
In this testing, it verifies the output voltage (Vout) is
dependent to frequency of the transducer. When the frequency is changed, the Vout
will change. Here, the input voltage (Vin) is constant and the value is 1 V.
51 180
160
140
Vp-p (mV)
120
100
80
Vp-p
60
Vp-p1
40
20
0
1
1.2
1.4
1.6
1.8
2
2.2
2.4
2.6
2.8
3
Frequency (MHz)
Figure 5.2 Temperature effect
Figure 5.2 shows Vp-p pattern with different frequency and temperature of
the water.
Vp-p represents voltage when the temperature is 27.5 ºC and Vp-p1
represents the voltage when the temperature is 28.8ºC.
It verifies that the
temperature of the water affects the ultrasound signal. Thus, temperature sensor is
used to compensate this effect.
5.2
Complete Product
After implement all the design of the product, the result is illustrated in
Figure 5.3 and Figure 5.17.
52 Figure 5.3 Ultrasound Device Tester prototype
Figure 5.3 shows the UDevT prototype that has been successfully developed.
It consists of the power meter box and the water tank. The results displayed on the
LCD are SPTA intensity and temperature.
Figure 5.4 shows the main page of SMeas. If the user wants to perform
testing, then click Testing button. If admin want to view report, then click Report
button. Otherwise, click Cancel button to quit.
Figure 5.4 Main page
53 If the user chooses to perform testing, they need to key in some information
in the information page. All the information will save in the database for reporting
purposes. After completing key in the information, click the Next button to perform
the testing. Figure 5.5 shows the information page.
Figure 5.5 Information page
Figure 5.6 shows the testing page of SMeas. Click Measure button to get the
result.
54 Figure 5.6 Testing page
The result of SPTA intensity and temperature will display in the result
textbox. At the same time, status of the ultrasound machine also will display based
on the comparison between the result and benchmark value. For the diagnostic
application, the benchmark value is 0.72 W/cm2 and for therapeutic is 3 W/cm2. If
the result is over the benchmark value, the status will display FAIL, otherwise is
PASS. The result need to be saved for reporting and further inspection. Figure 5.7
shows the result and status displayed after the Measure button is clicked.
55 Figure 5.7 Testing page displaying result and status
When the result is successfully saved, a data insert message box will appear.
Figure 5.8 shows the data insert message box.
56 Figure 5.8 Data insert message box
Figure 5.9 Log in page
57 Admin can view the report by clicking Report button in the main page. To
view the report, log in is needed to secure the originality of the report. Figure 5.9
shows the log in page.
The report can be viewing by selected date only, by selected date and with
status FAIL or PASS or by selected date and selected result range. Figure 5.10
shows the report page with date selected and Figure 5.11 shows the viewing report
of the selected date.
Figure 5.10 Report page by selected date
58 Figure 5.11 Report of selected date
Figure 5.12 shows the report page with date selected and with status. Figure
5.13 shows the viewing report of the selected date with PASS status and Figure 5.14
shows the viewing report of the selected date with FAIL status.
.
59 Figure 5.13 Report page by selected date with status
Figure 5.13 Report of selected date with PASS status
60 Figure 5.14 Report of selected date with FAIL status
Figure 5.15 Report page by selected date with selected result range
61 Figure 5.15 shows the report page with date selected and selected result
range and Figure 5.16 shows the viewing report of the selected date with selected
result range of 2.5 to 3.5 W/cm2.
Figure 5.16 Report of selected date with selected result range
Besides viewing the report, the report also can be printed by clicking the
Print button in the report page. Figure 5.17 shows the printed report.
62 Figure 5.17 Printed report
5.3
Product Testing
5.3.1 Electromagnetic Compatibility Testing
The objective for this testing is to see whether the product is safe to use and
comply with international standard (IEC 60601-1-1, 60601-2-5 and 60601-2-37) or
63 not. Figure 5.18 shows the result of the testing and it verifies that the product is
comply with the standards.
Power Intensity (W/cm2)
2.5
2.4
2.3
2.2
2.1
2
1.9
100
1k
100k 1M 25M 50M 100M 500M 1G 2.4G 5.6G 10G
Frequency (Hz)
Power Intensity (Before)
Power Intensity (After)
Figure 5.18 Electromagnetic compatibility testing
5.3.2 Stability Testing
Figure 5.19 shows the result of the testing it verifies that the product is
stable. The objective for this testing is to see whether the product is stable or not
when it was turn on for certain duration and when temperature is changing.
64 Power Intensity (W/cm2)
2.5
2.4
2.3
2.2
2.1
2
1.9
1.8
1.7
1.6
1.5
0
20
40
60
80
100
120
Time (minutes)
Figure 5.19 Stability testing
5.4
Market Study Analysis
A questionnaire has been distributed to 120 respondents and about 108
respondents replied the questionnaire. The analysis of the questionnaire is based on
the replied questionnaires only. The questionnaire can be referred in Appendix F.
Figure 5.20 to Figure 5.34 illustrates the results.
65 93
14
Yes
No
Figure 5.20
5 Knowledge in ultrrasound
ge about
Fiigure 5.20 show that 86.9 % off the responndents havee knowledg
ultrasoundd.
From this response, conclu
usion that can be m
made is no
owadays,
ultrasoundd technologgy has beeen widely used
u
in maany applicaations especcially in
medical sector.
58
49
Yes
No
Figure 5.21 Experiencce in ultrasoound field
66 Fiigure 5.21 illustrate thhat 54.2 % of the resppondents haaving experrience in
ultrasoundd field.
This show
ws that the respondennts are com
me from medical,
manufactuuring or eduucation secttor.
34
17
5
2
1 to 10
11 to 20
> 20
None
Figuree 5.22 Numbber of ultrassound machhine in workkplace
Fiigure 5.22 demonstraate that 96.6 % of thhe responddents workiing with
ultrasoundd machines currently. This explaiins that the respondents
r
s are workin
ng either
in health care
c instituttions, universities, calib
bration com
mpanies.
67 34
24
Yes
No
Figure 5.23
5 Awarenness about high
h
ultrasoound power effects
Fiigure 5.23 express thhat 58.6 % of the respondentss know ab
bout the
ultrasoundd effects. This probleem is havin
ng attentionn till FDA has announ
nced the
safety lim
mit power off ultrasoundd for treatmeent.
31
27
Yes
No
Figuree 5.24 Awarreness abou
ut the limit ultrasound
u
ppower
68 Fiigure 5.24 state
s
that 533.4 % of thee respondennts know abbout the saffety limit
of ultrasoound powerr for treatm
ment. Howeever, still most
m
of theem just ignored the
standard set
s by the FD
DA.
56
2
Yes
No
Figu
ure 5.25 Aleert about co
oming Malayysian Standdard
Fiigure 5.25 show that 96.6 % off the responndents do nnot know ab
bout the
coming Malaysian
M
Standard. Thhe standard
d compellingg the ultrasoound machiine must
be tested periodically
p
y and more frequent to ensure the machine
m
safe to be useed.
Fiigure 5.26 illustrate thhat 56.9 % of the resppondents sennd to calibrration to
ensure thee machine is safe to use. Besides,, ultrasoundd power metter has been
n used to
calibrate the
t ultrasouund machinee.
69 33
16
9
Send to callibration
Used power meter
Othher
Figgure 5.26 Maintenance
M
e of ultrasouund machinne
33
23
1
Weekly
W
- Monnthly
1
Quarteely - Yearly More
M
than one year
once
Never
Figure 5.27
5 Frequenncy of calib
brating the ultrasound
u
m
machine
Fiigure 5.27 demonstrate
d
e that 56.9 % of the reespondents ccalibrate ulttrasound
machine once
o
a yearr. The ultraasound machine might be in bad ccondition an
nd is not
safe to usse. Thus, thhe ultrasounnd must bee tested morre frequent to ensure it
i safe to
use.
70 Fiigure 5.28 show that 84.5 % off the responndents’ exppense less th
hen RM
10,000 foor calibratess the ultrassound mach
hine in theiir workplacce. If they need to
calibrate the ultrasouund more frequent,
f
th
he expensess will increease and giv
ve some
burden to them. Thuus, they need other alteernative to reduce or maintain theirr current
expenses for calibratiion the ultraasound macchine.
499
9
0
< RM10000
RM10001 - RM20000
>RM220000
Fiigure 5.28 Expenses
E
peer year for calibrating
c
t ultrasouund machinee
the
Fiigure 5.29 illustrate thhat 82.8 % of the resppondents aggree to calib
brate the
ultrasoundd machine weekly
w
in order
o
to enssure the ulttrasound maachine is saafe to be
used.
H
However,
thhere needs an alternattive to enssure it willl not burdeen them
especiallyy in financiaal aspect.
71 48
10
Agree
Not agree
Figure 5.29 Opinnion to test ultrasound
u
m
machine
weeekly
53
4
Yes
No
Figurre 5.30 Awaare about neew ultrasounnd device teester
Fiigure 5.30 demonstrate
d
e that 91.4 % of the reespondents ddid not kno
ow about
new ultraasound devvice tester that can help
h
them solve theirr problem.
If the
ultrasoundd device tesster have been commeercialise, it can help thhem to calib
brate the
72 ultrasoundd machine more
m
frequeent with cheeap expensees.
35
14
Yes
No
F
Figure
5.31 Interest to learn about ultrasound
Fiigure 5.31 show that 71.4
7
% of the responddents intereested to learrn about
ultrasoundd. They didd not know
w about ultraasound but since ultrassound techn
nology is
widely used now, thuus they interrested to kn
now about ultrasound.
u
Fiigure 5.32 illustrate thhat 79.6 % of the resppondents suuggest that the best
time to leearn about ultrasoundd is in high
her learningg level incllude matricu
ulations,
polytechnnics and unniversities. However, some of the
t responddents suggeest some
basic knoowledge abbout ultrasoound is inccluded in secondary
s
sschool subjject like
physics.
73 2
21
18
8
10
Secondary school
M
Matriculation/
/ polytechnic
Univversity
Figgure 5.32 Best
B Time to
o learn abouut ultrasounnd
7
% of the
t responddents proposse there mu
ust be an
Fiigure 5.33 show that 75.5
assistant device
d
in orrder to learnn about ultrrasound. Thus, it can attract more people
to learn abbout ultrasoound especiaally secondary school student.
s
37
12
Yes
No
Figure 5.33 Neeed assistant device to leearn ultrasoound
74 90
17
Yes
No
Figure 5.34 Willling to buy Ultrasoundd Device Teester
Laastly, Figurre 5.34 illuustrate that 84.1 % of the responddents are willing
w
to
buy the new
n
ultrasoound device.
The deevice can help
h
them test the ulttrasound
machine and
a also cann help them
m to learn ab
bout ultrasoound easier.. From thiss survey,
it can be conclude
c
thaat this devicce has big potential
p
to be
b commerccialised soo
on.
CHAPTER 6
CONCLUSION AND RECOMMENDATION
6.1
Conclusion
The UDevT has been successfully developed. It consists of hardware part called
UTest and software part called SMeas. The UTest is use to test the ultrasound machines.
It will display power output result of the ultrasound machines tested. From the result, user
can user can know whether it safe to use or not. For further analysis, user can use the
SMeas. It will display the result and save as a report. User can view report of ultrasound
machines passed or failed the testing and range of result selected regarding to date
selected.
The full business plan for the project also has been successfully written. The
business plan written based on the MARA template and including the company’s
background, summary of business activities, marketing strategies and expected income.
Thus, it can be used to apply further funding for mass production and precommercialization activities.
76
6.2
Recommendation
For the further plan, some improvements should be done.
Some
recommendations have been identified and the recommendations are:
i.
The casing design needs to modify and using plastic material, hence it more
sophisticated and light.
ii.
For capturing ultrasound signal, at least three PVDF sensors need to use rather
than a single PVDF sensor used in this prototype.
iii.
More reporting should be manipulated from the SMeas, thus it will be very
precious.
iv.
Professional testing will be done to get safety certificates from professional
bodies like IEC 60601.
v.
Intellectual property (IP) for this product will be registered later to secure the
originality of the product.
vi.
Further funding will be applied to improve the prototype, IP application,
perform professional testing and pre- commercialization activities.
As a conclusion, is hoping that this product will bring significant value to the
user in the future.
77
REFERENCES
Alan Selfridge and Peter A.Lewin (2000). Wideband Spherically Focused PVDF
Acoustic Sources for Calibration of Ultrasound Hydrophone. IEEE Transaction on
Ultrasonic, Ferroelectrics and Frequency Control. November. Vol 47, No.6, 13721376.
C.R.Hill, J.C.Bamber and G.R.ter Haar (2004). Medical Ultrasonics. (2nd ed). England:
Wiley.
David Hykes, Wayne R.Hedrick and Dale E.Starchman.Ultrasound (1985). Physics and
Instrumentation. New York: Churchill Livingstone.
IEC 60601 Particular requirement for the safety of ultrasonic physiotherapy equipment.
IEC Switzerland
Jasjit S. Suri, Chirinjeev Khaturia, Kuey- Feng Chang, Filippo Molinari and Aaron
Fenster (2008). Advances in Diagnostic and Therapeutic, Ultrasound Imaging.
United States: Artech House, Inc.
Joseph L.Rose and Barry B. Goldberg (1982). Basic Physics in Diagnostic Ultrasound.
United States: Wiley & Sons, Inc.
Lawrence E. Kinsler (1982). Fundamentals of Acoustics. United States. Wiley & Sons,
Inc.
“Products”. Precision Acoustic Ltd. http://www.precisionacoustic.com, Retrieved July
28, 2008.
BUSINESS PLAN
i
TABLE OF CONTENT
1.0
2.0
Executive Summary
1
1.1 Objectives
2
1.2
2
Mission
1.3 Keys to Success
3
Management and Organization
3
2.1
3
Company Background
2.2 Owner Background Information
2.2.1
3.0
4.0
First Owner
5
5
2.2.2 Second Owner
6
2.3 Organization Structure
7
2.4
7
Summary of Key Personnel
Products
8
3.1 Product Description
9
3.2
Competitive Comparison
9
3.3
Future Products
9
Market Analysis Summary
10
4.1
Market Segmentation
11
4.2
Target Market Segment Strategy
11
4.3
Industry Analysis
12
4.3.1 Industry Participants
14
4.3.2
14
Competition and Buying Patterns
ii
4.4.3 Main Competitors
5.0
Strategy and Implementation Summary
15
5.1
Marketing Strategy
16
5.1.1
Place and Positioning Strategy
16
5.1.2
Pricing Strategy
17
5.1.3
Promotion Strategy
17
5.1.4
Product Strategy
18
5.1.5
Marketing Programs
18
5.2
6.0
7.0
15
Sales Strategy
19
5.2.1 Sales Forecast
20
Operation Plan
21
6.1 Business Activities
21
6.2
22
Product Requirements
6.3 Business and Revenue Model
24
Financial Plan
24
7.1
Projected Profit and Loss
24
7.2
Projected Cash Flow
26
7.3
Projected Balance Sheet
27
1 1.0
Executive Summary
Emend Solution Enterprise is running a manufacturing business based on medical
equipment. Three values become the pillars and guiding philosophies of our business
delivering our products and services; unique proprietary technologies and platform,
unique and ergonomic design and high quality and flexibility. Our company is in the
process of developing the UDevT which is expected to make its debut in the market by
August 2010. The UDevT is unique in several aspects compare to its competitors. Based
on this uniqueness we adopt the business to business (B2B) and business to consumer
(B2C) business model to deliver our product to our customers, that is, a multiple
distribution channel, virtual as well as conventional. The chosen model is based on the
nature of our product which is offered to our customers inclusive of calibration and
maintenance services, hence, our main revenue model is selling the product.
The electronics and medical equipment has big potential market because
nowadays, medical practitioners need better and more reliable and accurately calibrated
equipment to help saving life and give better health care services. Therefore, our major
target group is health care institution including clinics and hospitals providing ultrasound
diagnostic and therapeutic services.
The potential to market locally as well as
internationally is huge due to the number of health care institutions which are ever
increasing.
To capture the market, we have designed our promotional strategies
appropriately with a handsome amount of budget to ensure that our product would be
able to capture the target market share.
In order to embark on this project, a total funding RM 0.5 million is required.
RM 0.15 million of the funding is required which for prototype development and
business incorporation. Balance of the funding required is for IP application, perform
professional testing, local and international certifications application and precommercialization. Based on our estimation, after large investment, is expected to yield
2 an annual return on investment of 30% within the first five years of mass production and
commercialization with annual sales growth of 30% after year 5.
1.1
Objectives
The main existence of this company is to:
i.
manufacture the first product to be named UDevT.
ii.
commercialize the product in Malaysian market during first year and expand the
business worldwide in the subsequent years.
iii.
plan appropriately strategies marketing efforts and sufficiently allocates funds
for such purpose of set up company and develop prototype.
iv.
1.2
build strong brand based on the business philosophy.
Mission
The mission of Emend Solution Enterprise is to strive to become the best
manufacturer and distributor of electronic and medical equipment to ensure that people
have better quality of life through good health.
3 1.3
Keys to Success
In order to succeed, we will strive to achieve the following goals:
i.
To position the product in Malaysian and worldwide market.
ii.
To build strong market position within the market served.
iii.
To build strong synergistic relationships with suppliers and customers.
iv.
To maintain sound financial management of the venture.
2.0
Management and Organization
Even though the company is newly set up and having a simple management
structure, the quality of the people in terms of technical expertise and entrepreneurial
drives are high. Currently, the main activity of the company is to develop the prototype
and pre- production planning, hence focusing more on technical know how, rather than
people know how.
2.1
Company Background
Emend Solution Enterprise manufactures electronic and medical devices as it core
business while offering calibration and maintenance services of medical devices as it
secondary business activity. The company currently at its pre- operational set up and
developing its product called UDevT which is expected to debut in the market by August
2010. Below is the company background information.
4 Company Name
: Emend Solution Enterprise
Office Address
: Kompleks Usahawan Teknologi Mara,
Technovation Park, 81300 Skudai,
Johor Darul Takzim.
Phone (Office)
: 07-5537567
Fax (Office)
: 07-5216488
Company Registration Number
: IP0292352-V
Registration Date
: 10 December 2008
Business Activity
: i) Manufacture Medical/ Electronic Device
ii) ICT Service
Type of Business
: Partnership
Owner Name 1
: Murni Norestri bt. Mohd Nordin
I/C
: 850216-08-6052
Owner Name 2
: Hajariah bt. Jamhari
I/C
: 811001-01-5968
5 2.2
Owner Background Information
2.2.1
First Owner
Name
: Murni Norestri bt. Mohd Nordin
Position
: General Manager
Home Address
: 11, Jalan Harmoni 6, Taman Desa Skudai,
81300 Skudai, Johor Darul Takzim
H/P
: 013-7440552
I/C
: 850216-08-6052
D.O.B
: 16 February 1985
Race/ Religion
: Malay/Islam
Status
: Single
Academic Qualification
: Bachelor of Electric- Electronic Engineering
Table 2.1 Working experience (first owner)
Year
Position
Employer
2003
Production Operator
BenQ Corporation
2006
Trainee Engineer
Finisar Malaysia Sdn. Bhd.
6 2.2.2
Second Owner
Name
: Hajariah Binti Jamhari
Position
: Project Manager
Home Address
: 83, Jalan Besar, Tongkang Pechah,
83010 Batu Pahat, Johor
H/P
: 019-7485881
I/C
: 811001-01-5968
D.O.B
: 1 October 1981
Race/ Religion
: Malay/Islam
Status
: Single
Academic Qualification
: Bachelor of Computer Science (Software
Development)
Table 2.2 Working experience (second owner)
Year
Position
2003
Trainee Data Administrator
2005
Clerk
2007
Maintenance Clerk
Employer
MCSB (M) Data System
Berhad
Sykt. RENAFIKA Sdn
Bhd
Munchy’s Food Industries
Berhad
7 2
2.3
Orgganization Structure
S
Genneral
Mannager
P
Project
Manager
M
Finance annd
A
Admin
Assisstant
T
Technical
Engineer
Technician (2
persson)
Programmeer
nization struucture
Figuree 2.1: Organ
2
2.4
Sum
mmary of Key
K Personn
nel
From
m the orgaanization strructure, thrree positionns have beeen fulfilled
d. For thee
t
technical
e
engineer,
thhe position will be fulfilled
fu
later.
w is the su
ummary off
Below
p
personnel.
Tablee 2.3 Summ
mary of persoonnel
Posiition
Name
Qualificattion
Bach.
B
Eng. (Hons)
Genneral
Murni Noreestri
Electrical and
Mannager
Mohd Norrdin
Electronic,
E
M
Master
Scc. IT Enterppreneur
Responsibility
C
Company ow
wner,
marketin
ng
m
manager, hu
uman
reesource man
nager,
ffinance man
nager
8 Bach. (Hons)
Project
Manager
Computer Science
Project leader,
(Software
Software engineer,
Development),
marketing
Master Sc. IT
personnel
Hajariah Jamhari
Enterpreneur
Sijil Pelajaran
Finance and
Admin
Zakri Kamaruddin
Malaysia, Certificate
Assistant
Technical
Management
human resource
personnel,
marketing
personnel
Engineer
Will be hired later
-
Programmer
Will be hired later
-
Programmer
Technician
Will be hired later
-
Technical assistant
Engineer
3.0
of Office
Finance personnel,
personnel
Product
The first company’s product is called UDevT which is a device to test ultrasound
machines. All the processes to develop the product is done at the company’s site. Once
completed, the product be registered by the company to the Intellectual Property
Corporation of Malaysia (MyIPO). The company also offer calibration and maintenance
services to complement its primary product.
9 3.1
Product Description
The first product is the UDevT which is a device to accurately measure and
calibrate ultrasound power generated by ultrasound machines. It can monitor the safety
status of the machines and provides accurate reading of the ultrasound signal. It is
specifically designed to be used on ultrasound diagnostic and therapeutic machines. The
UDevT consists of hardware part called Ultrasound Tester (UTest) to test the machines
and software part called Smart Measurement (SMeas) to help customers identify and
analyze the ultrasound signal.
3.2
Competitive Advantage
By using distinct trademark, the UDevT has competitive advantage over existing
products. The competitive edge includes the measurement method, frequency range,
output power range and resolution. It has more value added features compare to existing
product.
3.3
Future Products
In the future, a three dimensional (3D) UDevT will be developed and planing to
develop other electronic and medical equipment to fulfil the market needs. Currently,
focus our research is on research and development (R&D) of the UDevT.
100 4
4.0
Marrket Analysis Summaary
We will focus on developing new eleectronic devvices. Currrently, the R&D
R
of thee
U
UDevT
is sttill in progrress. Currenntly, most of
o the existinng ultrasounnd power meter
m
can bee
u
used
only for
f one appllication eithher for diag
gnostic or thherapeutic. Most of th
hem are forr
t therapeutic machinne. We havve distributted a questiionnaire to 120 respo
the
ondents andd
a
about
108 replied the questionnair
q
re.
58 of them have experieence with ultrasound field and have back
kground ass
r
researchers,
, calibrator, engineers and docto
ors. Most of the resppondents ag
gree to testt
u
ultrasound
m
machines
inn their workkplace perio
odically andd frequent. Then, they are willingg
t buy the product
to
p
in order to helpp them test the
t ultrasouund machinees.
4
4.1
Marrket Segmeentation
Currrently, theree are three big
b players servicing thhe market; O
Ohmic Instrrument Co.,
P
Precision
A
Acoustic
Ltdd. and Neteech Corporration. Thee market shhares of pow
wer meterss
b
before
and after
a
UDevT
T is commeercialized arre illustratedd as below.
Precious
P
Acoustic Ltd.
35%
Ohmic
Instrument
50%
Netech
C
Corporation
n
15%
Figure 4.1
4 Market share
s
beforee commerciialization off UDevT
11 END
EME
SOLU
UTION
ENTER
RPRISE
100%
Preciision
Acou
ustic
10%
Neteech Corp
30%
Ohmic
Innstrument
50%
Figure 4.2 Market share after commerciaalization of UDevT
Afteer commerccialization of
o the UDeevT, we targget about 110% of the worldwidee
m
market
sharre within 3 years.
y
4
4.2
Tarrget Markett Segment Strategy
We plan to agggressively sell the UDevT
UD
in Malaysia
M
duuring the fiirst year off
o
operation.
The target customers include
i
priv
vate and pubblic healthccare institutiions (HCI),
p
private
andd public hiigher learning instituttions (HLI)), beauty ccentres, hig
gh schools,,
u
ultrasound
m
manufactur
ring compannies and callibration com
mpanies. T
The proportion of eachh
s
segment
of the target market
m
can be
b explained
d as followss:
122 Public/Privvate HCI
Public/Priivate IHL
Beauty Centre
C
Ettc
10%
20%
50%
%
20%
Figuree 4.3 Targett market seggment
Oncce the Malaaysian markket share is successfullly secured, the next strrategy is too
m
move
to reegional outllet includinng Singaporre, Indonesia, Thailannd and the Philippiness
b
before
going to the gloobal market.
4
4.3
Indu
ustry Analyysis
In a weakenedd economyy, the mediical-device industry hhas manageed to draw
w
s
strength
froom increassing globall demand for high-qquality heallth care.
Seeminglyy
i
impervious
to such prroblems, thhis vibrant industry's future
f
success is ensu
ured by thee
w
world's
everr-increasingg demand foor the pioneeering, diverrse products it designs to prevent,
d
diagnose,
annd treat diseease.
According to a report writtten on 1st May
M 2003, the industrry in the Un
nited Statess
c
clearly
reignns as the gllobal leaderr in innovatiion, and is the
t biggest producer an
nd exporterr
o medical devices. Little wondder, then, that
of
t
the woorld's largesst medical--technologyy
a
association,
, AdvaMed is headquaartered in Am
merica. Thhis Washinggton, D.C. based
b
groupp
h
helps
tell thhe sector's success
s
storry. Its 1,10
00-plus mem
mbers manuufacture 90
0 percent off
13 the $ 71 billion of healthcare technology purchased annually in the United States, and
more than 50 % of the $ 169 billion purchased worldwide each year. The nation's capital
also is home to the Medical Device Manufacturers Association, a national trade group
representing more than 160 independent industry manufacturers.
In Malaysia, the medical devices sector is one of the priority sectors identified for
promotion and further development, given the growing demand for medical products.
There is a strong presence of established supporting industries ranging from sterilization
services, sterile medical packaging, precision engineering and tool and die making to
contract moulding and assembly and machinery fabrication in Malaysia. The availability
of the supporting industries positions Malaysia as an ideal location for the manufacture of
medical devices with the potential to be developed into a medical device hub in Asia.
The vast majority of `high-end' medical equipment are imported from abroad, and
the government hopes to encourage production of more advanced devices in the
following areas :i.
Electromedical equipment
ii.
Cardiovascular products
iii.
Orthopaedic products
iv.
In-vitro diagnostic devices
v.
Wound care products
vi.
Ophthalmic products
vii.
Home care products
14 4.3.1
Industry Participants
The medical equipment industry currently has many key players especially
overseas company like Siemens, Toshiba and General Electric (GE). In Malaysia, there
are many manufacturing company of medical glove and surgical equipment but there are
no manufacturing company of medical equipment. So, we must compete with the giant
companies that have been mentioned before.
4.3.2
Competition and Buying Patterns
The medical equipment has big market because it helps to increase the health
quality. Normally, medical equipment industry offers unique technology of the medical
equipment, function and application of the medical equipment and also the market needs.
So, we will ensure that our product has unique technology and follows the market needs.
Buying patterns of the medical equipment industry is based on branding and
price. Although price is concern, many organization especially health care institutions
always rely on branding of the medical equipment because they trust the brand equipment
has high quality. Then, they also set their mind that low cost equipment has low quality.
Furthermore, they will share information and experiences among themselves about the
good quality of medical equipment and as a result, reputation and branding of the medical
equipment will be primary competitive factor of buying patterns.
15 4.3.3
`Main Competitors
Currently, there are three big players have manufactured ultrasound power meter
in the market.
The main competitors include the Ohmic Instrument Co, NeTech
Corporation and Precision Acoustic Ltd. The following are strength and weaknesses of
each of them.
i.
Ohmic Instrument Co.
¾ Strengths: It has manufactured many types of ultrasound power meters. The
products also can be used with diagnostic and therapeutic applications.
¾ Weaknesses: The products are heavy, high cost and complicated to use.
ii.
Netech Corporation
¾ Strengths: It has a very good quality ultrasound power meter.
¾ Weaknesses: The product can be used only for diagnostic application, low
resolution, very expensive and complicated to use.
iii.
Precision Acoustic Ltd.
¾ Strengths: The ultrasound power meter has very reasonable price.
¾ Weaknesses:
5.0
The product can be used only for therapeutic application.
Strategy and Implementation Summary
We commit to produce the best ultrasound power meter.
As a production
operation of UDevT, we also will concentrate on R&D of new version of ultrasound
power meter and other new product that going beyond other manufacturer. With the right
exposure, we believe that our product will have big market all over the Malaysia and our
product will be the famous choices among customers.
16 Furthermore, we will make sure our government will support our company by
promoting our product worldwide. Then, we will make promotion like give discounts to
the new distributor or resellers and give special maintenance services. Thus, we can cater
more market in the future.
5.1
Marketing Strategy
We will emphasize on 4Ps marketing concepts; product, place, promotion and
price to create an image of offering the best quality and unique products. As we cater
new customers, we will also make good relationship with suppliers because they are our
assets.
The UDevT will enter the Malaysian market only for the first year and the market
will be expanded in the next coming year.
Customers will be reached through
advertisements in medical magazines and website. A strong distributorship network will
be developed while at the same time using viral marketing.
5.1.1
Place and Positioning Strategy
Distribution of our products will be through our resellers, distributors and website
only. At initial stage, a pilot test will be run after prototype is developed. The pilot test
will be done in Cleaner Laboratory, Faculty of Biomedical Engineering and Health
Science and Klinik Kesihatan UTM.
17 Product demonstration will then be aggressively conducted to related associations
to create awareness on using correct power for treatment. As well as to other target
customers like health care institutions, higher learning institutions and beauty centre.
5.1.2
Pricing Strategy
There are two price packages; with software analyzer and without software
analyzer. We plan to sell the UDevT for a price range of RM4000 to RM5000. Then, we
will give 5% to 10% discounts to other new customers especially for resellers and
distributors.
A special marketing program will also incorporate offering special price and
discounts for the new resellers and distributors. Then, we will give free training to use
the product, one year warranty and 2 times free calibration. Lastly, marketing personnel
will be hired later to cater new customers.
5.1.3
Promotion Strategy
We will promote our product to customers through:
i.
Direct sales to resellers and distributors.
ii.
Special discount for selected resellers and distributors.
iii.
Promotion through medical magazines and journals.
iv.
Promotion through advertisements board.
18 v.
Free training to use the UTest and SMeas.
vi.
Promotion through internet and brochure
vii.
2 times free calibration and maintenance services.
viii.
1 year warranty.
5.1.4
Product Strategy
We plan to do R&D of new version of ultrasound power meter after we successful
market the UDevT. Besides, we also plan to execute R&D with new medical and
electronic product.
5.1.5
Marketing Programs
Since our company is electronic and medical equipments collaboration with
Medical Device Bureau (MDB) under the Ministry of Health (MOH) for
commercialization is vital. We will use direct sales through company’s website and viral
marketing to sell the UDevT. Besides, we also will advertise the product in international
medical journals and magazines to promote the product inn the international market.
Apart from that, the company also plan to develop strong distribution network
with 4U- Tech Corporation to market the UDevT. It is one of medical equipment
distributor in Malaysia and it has been appointed as one of MDB consultant. Thus, we
will use it strong network to distribute the product in local and international market. We
also will hire marketing personnel in the future to build strong marketing activities in
19 order to cater more market.
We use ‘Tools For Health’ as our company’s motto and sales tag line because our
product is intended to help people sustain their health with good treatment using reliable
and properly calibrated high technology devices.
Total funds allocated to run our
marketing program is RM 40,000 to RM 60,000 per year.
5.2
Sales Strategy
For the first initial year, we plan to focus in local market and expand the market in
the next subsequent years to Asean market. Below is the sales strategy of the UDevT:
Table 5.1 Sales strategy
Year 1
Customer
Public Healthcare
Institutions
Private Healthcare
Institutions
Beauty Centres
Higher Learning
Institutions
Year 2
Year 3
Local
Asean
Local
Asean
Local
Asean
40
-
50
5
60
10
20
-
30
5
40
5
10
-
15
-
15
2
10
-
15
5
15
5
8
-
10
-
15
5
Testing and
Calibration
Companies
20 Manufacturing
companies
(Ultrasound
12
-
10
5
10
3
-
-
-
-
5
-
100
-
130
20
170
30
diagnostic and
therapeutic machine
High Schools
TOTAL
5.2.1
Sales Forecast
Sales estimation is based on 100 units in first year and 150 units in second year
and 200 units in the third year of the UDevT. The sale is forecasted at 100 % of total
allowable for the both years. Cost of sales per unit including operational cost, indirect
material and labour is about RM 2,499 and sales price per unit is estimated about RM
4999. The total company sales including other income is RM 588,860 for the first year,
RM 831,790 for the second year and RM 1,070,740 for the third year.
Expenses including general and administrative and sales and marketing expenses
for the first year is about RM 354,356, RM 376,806, for the second year and RM
405,287.70 for the third year. Table 5.2 shows the sales forecast and expected gross
profit for the first three years.
21 Table 5.2 Sales forecast
6.0
Year 1
Year 2
Year 3
RM
RM
RM
Sales
588,860.00
831,790.00
1,070,740.00
Cost of Sales
229,908.00
379,848.00
499,800.00
Gross Profit
358,952.00
451,942.00
570,940.00
Operation Plan
For the start- up, our company need about only five personnel. The workers will
be added later and based on needs. Currently, we still work on finalize the design of the
UDevT.
6.1
Business Activities
We will be manufacturing and selling medical equipment. Apart from that, we
also creating and selling software analyzer for new and existing medical equipment.
Then, we also provide maintenance and calibration services of the company’s product for
the customers.
Currently, health industry is potentially growth because there are a lot of patients
nowadays. Thus, the industry should provide the facilities to help the treatment activities.
All the devices are used high technology platform to fulfil the market needed. Existing
manufacturers of the medical devices are from overseas which high cost. So, we use this
opportunity to produce a new brand product with new technologies platform and
22 innovation such as different measurement tools and specification with better functions.
6.2
Product Requirements
The UDevT is consists of hardware and software part. Software that will be used
for hardware are Quartus for Field Programmable Gate Array (FPGA) and C language for
microcontroller while the SMeas will be created using Visual Basic platform. The
specifications and functional block diagram of the UDevT are illustrated as below.
Table 6.1 Product features
Specification
Value
Output power
0 – 30 W
Resolution
30 mW
Frequency
0.02 – 10 MHz
Temperature
8 – 60 °C
Measurement Method
Polymer sensor (PVDF)
Interface
Universal serial bus (USB)
Display
Liquid crystal display (LCD)
23 Figure 6.1 Block diagram
Figure 6.2 GUI snapshot
24 6.3
Business and Revenue Model
We use B2C and B2B business model whereby the distribution channels of the
product include website and viral. Moreover, revenue is mostly from sales of the product
to the customers and resellers, calibration and maintenance of the product after sales
services charges.
7.0
Financial Plan
Emend Solution Enterprise requires about RM 0.45 million to start- up the company,
spend for promotion activities and production activities. We plan to apply loan or grants
or funding from banks or any venture capitals.
7.1
Profit and Loss
The projected profit and loss for the initial three years can be referred in Table
7.1.
25 Table 7.1 Projected profit and loss
YEAR
YEAR 1
YEAR 2
YEAR 3
588,860.00
831,790.00
1,070,740.00
229,908.00
379,848.00
499,800.00
358,952.00
451,942.00
570,940.00
Director's Allowance
48,000.00
48,000.00
48,000.00
Salary
135,600.00
135,600.00
142,380.00
Rental
6,000.00
6,000.00
6,000.00
Utilities
12,000.00
12,000.00
12,000.00
Telephone & Internet
12,000.00
12,000.00
12,000.00
6,000.00
6,000.00
6,000.00
Transportation
7,000.00
6,000.00
8,400.00
KWSP
18,306.00
18,306.00
18,407.70
Marketing Expenses
40,450.00
50,400.00
60,000.00
Others
12,000.00
24,000.00
30,000.00
Licenses
10,000.00
2,800.00
2,800.00
Maintenance
4,500.00
12,000.00
18,000.00
Depreciation
33,500.00
33,500.00
33,500.00
Interest
10,500.00
11,900.00
9,100.00
TOTAL OPERATING COST
355,856.00
378,506.00
406,587.70
3,096.00
73,436.00
164,352.30
0.00
3,096.00
76,532.00
3,096.00
76,532.00
240,884.30
SALES
(-)
Cost of Sales
GROSS PROFIT
-)
OPERATING COST
Stationary & Office
Equipment
RETAINED PROFIT/ LOSS FOR
THE YEAR
RETAINED PROFIT/ LOSS B/FWD
RETAINED PROFIT/ LOSS
C/FWD
26 7.7.2
Cash Flow
Table 7.2 shows the projected cash flow for the three years. Besides, detail
projected monthly cash flow for the three years can be referred in Appendix A to C.
Table 7.2 Projected cash flow
Year 1
Year 2
Year 3
Other Income
81,000.00
70,000.00
59,000.00
UDevT
499,900.00
749,850.00
999,800.00
SMeas
7,960.00
11,940.00
11,940.00
-
-
-
2,502.00
-
-
Pre- Seed Funding
150,000.00
-
-
Loan
350,000.00
1,041,362.00
831,790.00
1,070,740.00
229,908.00
379,848.00
499,800.00
Early Expenses
3,950.00
-
-
Asset Purchasing
278,300.00
-
-
Maintenance
4,500.00
12,000.00
18,000.00
Local Testing & certification
25,000.00
Cash In Flow
Credit Income
Share
Cash Out Flow
Manufacturing Cost
International Testing &
certification
75,000.00
Operational Cost
Directors' Allowance
48,000.00
48,000.00
48,000.00
Salary
135,600.00
135,600.00
142,380.00
Rental
6,000.00
6,000.00
6,000.00
27 7.3
Utilities
12,000.00
12,000.00
12,000.00
Telephone & Internet
12,000.00
12,000.00
12,000.00
Stationary & Office Equipment
6,000.00
6,000.00
6,000.00
Transportation
7,000.00
6,000.00
8,400.00
KWSP and Perkeso
18,306.00
18,306.00
18,407.70
Marketing Expenses
40,450.00
50,400.00
60,000.00
Others
12,000.00
24,000.00
30,000.00
Licenses
10,000.00
2,800.00
2,800.00
Payback Loan
52,500.00
70,000.00
70,000.00
Interest
10,500.00
11,900.00
9,100.00
Total Cash Out Flow
987,014.00
794,854.00
942,887.70
Profit / Loss
104,348.00
36,936.00
127,852.30
B/Fwd
-
104,348.00
141,284.00
C/Fwd
104,348.00
141,284.00
269,136.30
Balance Sheet
The projected balance sheet for the three years can be referred in Table 7.3 to
Table 7.5.
Table 7.3 Projected first year balance sheet
ASSETS
Cost
Machine & Equipment 146,700.00
Depreciation
Net Value
29,340.00
117,360.00
Furniture
6,600.00
660.00
5,940.00
Renovation
35,000.00
3,500.00
31,500.00
188,300.00
33,500.00
154,800.00
28 OTHER ASSETS
Testing & certification 100,000.00
Intellectual Property
90,000.00
190,000.00
CURRENT ASSETS
Stock
-
Deposit
3,950.00
Cash in Hand
104,348.00
Total Current Assets
108,298.00
CURRENT LIABILITY
Net Current Assets
108,298.00
TOTAL NET ASSETS
453,098.00
Financing by:Shares
2,502.00
Retained Profit/ Loss
3,096.00
Pre- Seed Funding
150,000.00
Loan
297,500.00
453,098.00
Table 7.4 Projected second year balance sheet
ASSETS
Cost
Depreciation
Net Value
Machine & Equipment 146,700.00
58,680.00
88,020.00
Furniture
6,600.00
1,320.00
5,280.00
Renovation
35,000.00
7,000.00
28,000.00
-
-
-
188,300.00
67,000.00
121,300.00
OTHER ASSETS
Testing & certification 100,000.00
29 Intellectual Property
90,000.00
190,000.00
CURRENT ASSETS
Stock
-
Deposit
3,950.00
Cash in Hand
141,284.00
Total Current Assets
145,234.00
CURRENT LIABILITY
Net Current Assets
145,234.00
TOTAL NET ASSETS
456,534.00
Financing by:Shares
2,502.00
Retained Profit/ Loss
76,532.00
Pre- Seed Funding
150,000.00
Loan
227,500.00
456,534.00
Table 7.5 Projected third year balance sheet
ASSETS
Cost
Depreciation
Net Value
Machine & Equipment 146,700.00
88,020.00
58,680.00
Furniture
6,600.00
1,980.00
4,620.00
Renovation
35,000.00
10,500.00
24,500.00
-
-
-
188,300.00
100,500.00
87,800.00
OTHER ASSETS
Testing & certification 100,000.00
Intellectual Property
90,000.00
190,000.00
CURRENT ASSETS
Stock
-
30 Deposit
Cash in Hand
Total Current Assets
3,950.00
269,136.30
273,086.30
CURRENT LIABILITY
Net Current Assets
273,086.30
TOTAL NET ASSETS
550,886.30
Financing by:Shares
2,502.00
Retained Profit/ Loss
240,884.30
Pre- Seed Funding
150,000.00
Loan
157,500.00
550,886.30
APPENDIX D
Datasheet Of PVDF Sensor
APPENDIX E
Microchip PIC16F877A Microcontroller Features
APPENDIX F
Questionnaire