Bauer Labs Physical Examination Tool
Instrument Mockup and Prototype
Final Report
Tylee Cairns
Lea Cavestany
Konstantin Brainich
2012–13
Project Sponsor: Bauer Labs
IE 497/8
Project Number: 101
Faculty Advisor: Dr. Ken Funk
Sponsor Mentor: Silvina de Brum
Instructor: Javier Calvo- Amodio
i
DISCLAIMER
Students prepared this report as part of a university course requirement. While considerable effort has
been put into the project, it is not the work of licensed engineers and has not undergone the extensive
verification that is common in the profession. The information, data, conclusions, and content of this
report should not be relied on or utilized without thorough, independent testing and verification.
University faculty members may have been associated with this project as advisors, sponsors, or course
instructors, but as such they are not responsible for the accuracy of results or conclusions.
ii
EXECUTIVE SUMMARY
Dr. James Bauer of Bauer labs conceived the idea of the Healthcare Toolkit. It combines wireless devices
with an information management system. The Healthcare Toolkit is a case containing the following:
physical examination sub system (“Physical Examination Tool”), screen, hard drive, and computer
software. The Bauer Labs Physical Examination Tool (PET) is a novel concept for improving the
effectiveness and efficiency of medical examination processes.
The Bauer Labs Physical Examination Tool combines a wireless device with multiple examination
components. In 2011, a two-dimensional mockup of the PET was designed by a group of students from
Oregon State. In order to further advance the PET, this year, Bauer Labs commissioned MIME Capstone
Team 101 to produce a functional prototype. The tool’s desired functions included capturing images and
videos of the eyes and ears; measuring body temperature; and recording heart, lung, voice sounds; and
sending data to other computers using a wireless platform. The team was given a budget of $1000 for this
project.
Research was conducted on possible data capture devices and wireless platforms. This led to the selection
of the following PET components: ophthalmoscope, otoscope, stethoscope, and infrared thermometer.
These PET components allowed the functional prototype to capture the data needed. Many platforms
were also researched, but the iPod Touch was selected because of the availability and compatibility with
desired components.
A case was consequently designed to hold the iPod Touch and other PET components. The PET
functional prototype is configured as follows. The case covered the iPod Touch and holds the selected
components. The ophthalmoscope and otoscope are combined and placed in front of the rear-facing
camera. Combining these components magnified images of the eye and eliminated the need to switch
components. A rechargeable battery, placed under the ophthalmoscope and otoscope combination, served
as a power source for the light within the ophthalmoscope. The stethoscope and thermometer were placed
below the iPod Touch for use with the dock connector and headset jack, respectively. The thermometer is
attached to a dock extender that allowed the headphone jack to be used by the microphone in the
stethoscope. The stethoscope was placed on the backside of the thermometer for easy access.
The iPod Touch paired with these tools allowed the prototype to demonstrate functionality of the PET.
The captured images and videos of the eyes and ears were adequate for the requirements of the project
scope; and were able to be sent through email. Body temperature, heart, lung, and voice sounds were also
captured and sent through email. The prototype allowed physicians to capture and send the different types
of patient data with a single device.
Further enhancements in imagery and data transfer are needed to improve on the current PET functional
prototype. While the images of the eyes and ears are adequate, designing custom optics are necessary to
create medical quality images. The optics must be created for use with a camera, instead of the human
eye. Currently, the iPod Touch’s camera software cannot accurately define exposure inside the ear.
Software to adjust the camera’s exposure issue is needed for image improvement. The data sent through
email is sufficient, but could be vastly improved by automation. Software must be created to automate
data transfer and streamline the switching of components.
iii
ACKNOWLEDGEMENTS
The Physical Examination Tool project had an incredible amount of help from several people for different
portions of the project. The people include Dr. Funk, Dr. Calvo, Silvina DeBrum, Dr. Egar, Drew
Shepherdson and Daniel Brooks. Silvina DeBrum assisted Team 101 by providing the mockup design for
the PET. She also helped the team understand the exact objectives for the project. Dr. Funk assisted and
monitored the team’s efforts from beginning to end. He assisted the team in understanding the research
needed to create the functional prototype; provided the formats for the usability survey and error rate test;
and connected the team to Dr. Egar. Dr. Egar provided insight for the team in relation to the functions a
doctor would desire for the PET. Dr. Calvo also assisted in monitoring the team towards success. He
regularly verified that the team was on track to completing the project timely for final evaluations. Drew
Shepherd allowed Team 101 to use his personal 3D printer to print the case. Daniel Brooks permitted the
team to use his UK Apple ID account to buy the VitaDock app for the ThermoDock. The team is grateful
for the assistance of all these people. It may not have been a success without the people mentioned.
iv
Table of Contents
DISCLAIMER............................................................................................................................. ii
EXECUTIVE SUMMARY ...........................................................................................................iii
ACKNOWLEDGEMENTS ..........................................................................................................iv
1 BACKGROUND FOR THE PHYSICAL EXAMINATION TOOL .............................................. 2
1.1 Introduction of the Physical Examination Tool .................................................................. 2
1.2 Project Description for the Physical Examination Tool ...................................................... 2
1.3 Original System of the Physical Examination Tool ............................................................ 3
1.3.1 Original System Structure of the Physical Examination Tool ...................................... 3
1.3.2 Original System Operation of the Physical Examination Tool ..................................... 4
1.3.3 Original System Performance of the Physical Examination Tool ................................ 4
1.3.4 Original System Deficiencies of the Physical Examination Tool.................................. 4
2 REQUIREMENTS FOR THE PHYSICAL EXAMINATION TOOL ........................................... 5
2.1 Customer Requirements (CRs) for Physical Examination Tool ......................................... 5
2.1.1 Discussion.................................................................................................................. 6
2.2 Engineering Requirements (ERs) for Physical Examination Tool ...................................... 7
2.2.1 Discussion.................................................................................................................. 8
2.3 Testing Procedures (TPs) for Physical Examination Tool ................................................. 9
2.4 Design Links (DLs) for Physical Examination Tool ...........................................................10
2.5 House of Quality (HOQ)...................................................................................................12
3 EXISTING DESIGNS FOR PHYSICAL EXAMINATION TOOL..............................................13
3.1 Design Research for Physical Examination Tool..............................................................13
3.2 System Level Designs for the Physical Examination Tool ................................................15
3.2.1 Existing Design #1 for the Physical Examination Tool: Welch Allyn 42NTB- E1 Blood
Pressure Pulse Oximeter ...................................................................................................15
3.2.2 Existing Design #2 for the Physical Examination Tool: Welch Allyn Spot Vital Signs
LXi .....................................................................................................................................15
3.2.3 Existing Design #3 for the Physical Examination Tool: Midmark IQ Vital Signs Monitor
..........................................................................................................................................16
3.3 Subsystem Level for the Physical Examination Tool ........................................................16
3.3.1 Subsystem #1 – Data Collection for the Physical Examination Tool ..........................16
3.3.1.1 Existing Design #1 for Data Collection: Smart Otoscope ................................................... 17
3.3.1.2 Existing Design #2 for Data Collection: Smart Dermoscope .............................................. 17
3.3.1.3 Existing Design #3 for Data Collection: StethoMic ............................................................. 17
3.3.2 Subsystem #2- Data Storage for the Physical Examination Tool ...............................17
3.3.2.1 Existing Design #1 for Data Storage: iPhone ..................................................................... 17
3.3.2.2 Existing Design #2 for Data Storage: iPod Touch .............................................................. 17
3.3.2.3 Existing Design #3 for Data Storage: Smartphone ............................................................. 17
3.3.3 Subsystem #3- Data transmission for the Physical Examination Tool........................17
3.3.3.1 Existing Design #1 for Data Transmission: iPhone ............................................................. 18
3.3.3.2 Existing Design #2 for Data Transmission: iPod Touch ...................................................... 18
0
3.3.3.3 Existing Design #3 for Data Transmission: Smartphones .................................................. 18
4 DESIGNS CONSIDERED FOR FUNCTIONAL PROTOTYPE ...............................................19
4.1
Design #1 for the Functional Prototype .......................................................................20
4.2 Design #2 for the Functional Prototype ............................................................................23
4.3 Design #3 for the Functional Prototype ............................................................................25
5 DESIGN SELECTED FOR FUNCTIONAL PROTOTYPE ......................................................27
5.1 Rationale for Design Selection of Functional Prototype ...................................................27
5.2 Design Description ..........................................................................................................27
6 IMPLEMENTATION ...............................................................................................................30
7 TESTING ...............................................................................................................................33
8 CONCLUSIONS AND RECOMMENDATIONS ......................................................................36
9 REFERENCES ......................................................................................................................38
APPENDICES...........................................................................................................................39
Appendix A: Original Handheld Device with Details ...............................................................39
Appendix B: IDEF0 Model for Physical Examination Process ................................................41
Appendix C: Failure mode analysis for Physical Examination Tool [1] ...................................48
Appendix D: Usability questionnaire for Testing Procedure 12 ..............................................52
Appendix E: Final Assembly of Physical Exam Tool ..............................................................54
Appendix F: Petitions.............................................................................................................55
Appendix G: User Error Rate .................................................................................................57
Appendix H: Usability Surveys ...............................................................................................63
1
1 BACKGROUND FOR THE PHYSICAL EXAMINATION TOOL
1.1 Introduction of the Physical Examination Tool
Bauer Labs joined the College of Engineering at Oregon State University to create a project that produced
a functional prototype of the physical examination subsystem. It is a subsystem of the Bauer Labs
Healthcare Toolkit. This subsystem is called the Physical Examination Tool (PET). The objective of the
project was to improve on the existing designs developed by previous Oregon State University students. It
also included delivering a 3D mockup and functional prototype. The 3D mockup used a design made by a
previous project. It features raised portions to demonstrate the location of the buttons. The design of the
prototype did not have to be the same size or shape as the mockup. The functional prototype demonstrates
the functionality and usability of the device within the medical field. It did not need to deliver clinic
quality data, it merely needed to show the device has the potential. The completion of the PET prototype
will allow Bauer to make further decisions about the advancements of the Healthcare Toolkit.
The PET is a multi-instrument system built around a small tablet computer that will improve patient
diagnosis by creating an improved method of collecting and examining patient data [15]. The device
seeks to decrease the number of errors made from traditional methods of examinations, and improve its
efficiency. The PET aims to put Bauer Labs in the forefront of the latest medical technology.
1.2 Project Description for the Physical Examination Tool
Previous Oregon State University student projects for the PET inspired interest in a functional prototype.
Therefore, Bauer Labs and Oregon State University created Project 101. The objective of the project was
to design and build a functional prototype, demonstrate its usefulness and usability, and build a 3D
mockup. The PET’s captured data did not need to be adequate for clinical use. The design of the
functional prototype was created using data capturing components with a wireless device as the platform.
The design of the previous project was used to create the 3D mockup.
The following is the original project description provided by the sponsor:
“When a patient sees a doctor for an ailment, the physician typically assesses the patient's
condition with his or her direct senses, supplemented with traditional instruments such as
stethoscope, otoscope, ophthalmoscope, and thermometer. Information collected in this way,
along with patient medical records and information given verbally by the patient, is used to make
diagnoses and to prescribe treatment.
Simple cases are dealt with quickly and accurately by traditional methods, but more challenging
conditions may require information and expertise that the physician does not have readily at hand.
As a result, delays may be incurred or incorrect decisions may be made. If the patient's condition
is serious and/or urgent, dangerous complications may result. But with the advent of compact
sensor technology, wireless networks, and cellular coverage, a door has been opened for a vastly
improved method of collecting data from patients, examining them, and coming to appropriate
diagnostic and treatment decisions.
To address this opportunity, Dr. James Bauer, physician and president of Bauer Labs, Inc.
conceived the idea of the Healthcare Toolkit (HT), an integrated, multi-instrument system built
around a small tablet computer (e.g., an iPad) that utilizes these capabilities to meet the clinical
needs yet fits well within the human interactions and conversations that form the basis of
healthcare. Several OSU student projects have been conducted to advance the HT, including a
thesis to model the physician-patient encounter and several HT prototypes.
2
Two such projects explored the design of a wireless instrument ensemble to work with the HT's
tablet computer, consisting of a stethoscope, otoscope, ophthalmoscope, thermometer, and
dermatological camera for the capture of physical examination data. These projects yielded a
crude physical mockup of the instrument ensemble and drawings of several alternative designs.
Bauer Labs needs more realistic models of the instrument ensemble for physicians to assess the
functionality and usability of this conceptual device.
The objectives of this project are to refine the existing designs and build a full-scale physical
mockup of the instrument ensemble and to design and build a functional prototype as well. The
functional prototype need not be the actual size and shape of the ensemble, nor need its
instruments be of quality adequate for real clinical use – it merely needs to work well enough for
15icians to judge its usefulness and usability. To achieve these objectives, the Capstone team will
work with Dr. Bauer and OSU students who did the earlier projects to develop customer and
engineering requirements, research similar medical instrument systems, research off-the-shelf
components from which the mockup and prototype can be built, implement the mockup and
prototype, demonstrate that the products are satisfactory for evaluation purposes, and document
their findings. Deliverables will include the mockup, functional prototype, and a final report
describing the products, findings, and recommendations.”
1.3 Original System of the Physical Examination Tool
Oregon State University graduate students developed the PET prototype [1]. It was created in spring term
of 2012 as a project for IE 546, a human machine systems engineering course. The students were asked to
“apply the Human-Machine Systems Engineering processes and principles to the development and the
prototyping of a physical examination kit subsystem as part of a comprehensive health care toolkit [1].”
The original system was a device mockup, which is a multi-functional device. It is portable and can be
easily handled. The concept of the mockup is to wirelessly send patient information to an iPad software
interface. The iPad software interface is an application developed for iOS, a mobile operating system that
runs on Apple devices. Recorded data from the multi-functional device will be used on the iOS interface
for physicians to analyze data and determine diagnosis.
1.3.1 Original System Structure of the Physical Examination Tool
The original handheld device is shown in Figure 1.3.1.1 below. The device is 170 mm tall, 46 mm wide,
and 25mm thick. It contains the following features: power switch, mode buttons (to switch between
tools), USB port, headphone jack, record button, stop button, stethoscope, viewfinder and camera. See
Appendix A for additional prototype details and views, including the rear-mounted housing containing the
otoscope and ophthalmoscope. The desired scope can be selected by rotation to the proper orientation.
3
Figure 1.3 - Features of the multi-instrument mockup [1]
1.3.2 Original System Operation of the Physical Examination Tool
The original system’s operation is conceptual because it lacks functionality. The concept, found in [1, pg.
6], explains how the system should function within the medical field. The PET will capture real time
patient data with the use of its medical tools (i.e. stethoscope, otoscope, and ophthalmoscope). A button
on the front of the mockup is pressed based on the tool needed by the physician. The illuminated light
indicates the tool is ready for use. The physician will also press the record button to ensure the data is
recorded. The data will be sent wirelessly to an iPad platform. The platform is designed for use with the
electronic medical records. Physicians will have the ability to compare the real time data with previously
recorded data for more accurate diagnostics. The IDEF0 model explaining the detailed operation for an
exam is found in Appendix B. An IDEF0 model is a tool used to show decisions, actions, and outputs of a
system. It provides a better understanding of how the system should function. A Failure Mode Analysis in
conjunction with the IDEF0 model identifies and prevents system problems. It enhances safety and
increases customer satisfaction. The Failure Mode Analysis table can be found in Appendix C.
1.3.3 Original System Performance of the Physical Examination Tool
The original system is not functional. Therefore, the system will have many deficiencies if current
customer requirements are applied.
1.3.4 Original System Deficiencies of the Physical Examination Tool
The original system has many deficiencies in performance if current customer requirements were to be
applied. The customer desired a prototype that would display its capabilities for use in the medical field.
The original system did not meet this requirement due to its complete lack of functionality. It cannot
physically record voice notes, capture data, or photos of the eyes, ears, or skin. However, these are the
conceptual functions for the device. It also could not physically send photos wirelessly to another device.
4
2 REQUIREMENTS FOR THE PHYSICAL EXAMINATION TOOL
Customer and engineering requirements were created to guide the design of the physical prototype and
3D mockup. There was a cascading effect that occurred with the formation of requirements. The
customer requirements were developed as defined by the customer's needs for the PET. Engineering
requirements were built upon the customer requirements. They were further defined with targets and
tolerances. Testing procedures were consequently generated. Finally, design links were generated to
confirm that the design met all customer requirements. Both customer and engineering requirements were
revised several times as conversations with the customer, research, and design developed. Sections 2.1 to
2.4 further discuss customer requirements, engineering requirements, targets, tolerances, testing
procedures, and design links.
2.1 Customer Requirements (CRs) for Physical Examination Tool
Customer requirements describe the needs and desires of the customer. Weight indicates how important
each requirement is to the customer; larger weight values indicate greater importance. Requirements that
are essential but easily achievable are given low technical effort (LTE) weights. The customer
requirements and weights for the Healthcare Toolkit project are shown in Table 2.1.
Table 2.1 - Customer Requirements and Weights
Customer Requirement
The system shall provide means to send files containing patient exam
1 data wirelessly to another computer.
The system should provide means to view and capture images and videos
2 of the eyes.
The system shall provide means to view and capture images and videos
3 of the ears.
4 The system shall provide means to capture dermatologic images.
5
6
7
8
9
10
11
12
13
14
15
The system shall provide means to listen to heart and lung sounds.
The system should provide means to measure body temperature.
The system shall provide means to record voice notes.
The system shall be efficient
The system shall minimize errors
The system shall be learnable
The system shall be satisfying to the user
The system shall be small
The system shall be lightweight
The system shall be safe for patient and user
A full scale mockup shall be provided
Total Weight
Weight
LTE
5
30
LTE
40
5
15
15
10
20
10
10
10
30
50
250
5
2.1.1 Discussion
Customer requirement 1 referred to the customer’s desire for patient exam data to be shared with other
physicians via a wireless network. This requirement was assigned a low technical effort because the iPod
Touch has the ability to send data wirelessly.
Customer requirement 2 referred to the customer’s desire of capturing images and videos of the eyes. The
images and videos did not need to possess quality for clinic use. They only needed to demonstrate the
prototypes usability. The requirement was given a weight of five because the customer did not consider it
necessary for the prototype. However, it was still desired by the customer because it was possible to
implement.
Customer requirement 3 referred to the customer’s desire of capturing images and videos of the ears. The
images and videos did not need to possess quality for clinic use. They only needed to demonstrate the
prototypes usability. The requirement was given a weight of 30 because the customer considered this
function necessary for the prototype.
Customer requirement 4 referred to the customer’s desire of capturing images of the skin. The images did
not need to possess quality for clinical use. The images only needed to demonstrate the prototypes
usability. The requirement was given a low technical effort because the iPod Touch has the ability to
capture images.
Customer requirement 5 referred to the customer’s desire to listen to heart and lung sounds. This was the
most important function described by the customer. Physicians considered it necessary to hear the sounds
of a patient’s heart and lungs in real time. It allows the physician to know the location of the sound for
proper assessment. Consequently, the requirement was given a weight of 40.
Customer requirement 6 referred to the customer’s desire to measure the patient’s body temperature. The
customer did not need the prototype to measure body temperature. However, it was still desired by the
customer if it was possible. Consequently, the requirement was given a weight of 5.
Customer requirement 7 referred to the customer’s desire to record voice notes. This allows the physician
to quickly record data vocally. The requirement was given a weight of 15 because the customer wanted
the option of recording voice notes. However, it was not as important as the examination tools (i.e.
capturing heart and lung sounds, temperature, etc.).
Customer requirements 8-11 defined the customer’s desire of usability for the prototype. Efficiency and
error reduction refer to the operation of the prototype. It was designed in a way that flows with the
examination process. User satisfaction and learnability referred to the user’s satisfaction with the
prototype. User satisfaction referred to the user’s opinion towards prototypes operation. Learnability
referred to the user’s rapid comprehension of the operation. These requirements were given a weight
between 10 and 20 because of their importance for the operation of the prototype. However, they were not
as necessary as the examination tools (i.e. stethoscope, capturing of images and videos, etc.)
Customer requirements 12 and 13 referred to the customer’s desire for a small and lightweight design.
The prototype needed to be a size that the physician will have the ability to easily transport it. However,
there were limits to its size because it was built around an iPod Touch. These requirements were given a
6
weight of 10 because they had importance, however the size could not be smaller or lighter than an iPod
Touch.
Customer requirement 14 referred to the customer’s desire for a device that is safe to the user and the
patient. The main concern with safety was the light used for looking into the eyes of the patient. The light
needed to be approved for medical use. It was given a weight of 30 because of the great risk of injury to
the eyes.
Customer requirement 15 referred to the customer’s desire of a 3D mockup of which the actual device
was designed. Parts of the mockup were raised to demonstrate the location of a button. It was given a
weight of 50 because there was difficulty in building the mockup with the interface features and feasible
size.
2.2 Engineering Requirements (ERs) for Physical Examination Tool
Engineering requirements were developed from the customer requirements listed in Table 2.1. Each
engineering requirement satisfied at least one of the customer requirements and defined the objectives of
the prototype. The targets and tolerances further specified the requirements. They consequently acted as a
guide for the design of the prototype. They provided specific goals for the design to meet the needs of the
customer. Table 2.3 below lists the engineering requirements, targets, tolerances, and the numbers of the
customer requirements it satisfies.
Table 2.2- Engineering Requirements with Targets, Tolerances, and Satisfied CR
Target
Tolerances
Related
customer
requirement
1
The system shall provide means to send
files containing patient exam data
wirelessly to another computer
Yes
None
1
2
The system shall have a photo camera
Yes
None
2,3,4
3
The system shall have a video camera
Yes
None
2,3,4
4
The system shall have a light for viewing
and capturing images and videos of the ears
and eyes
Yes
None
2,3,14
5
The system shall provide means to listen to
heart and lung sounds
Yes
None
5
6
The system should have a medical
thermometer
Yes
None
6
7
The system shall have a microphone
Yes
None
7
Engineering requirement
7
8
The system shall take less than 45 sec to
switch between tools
30 sec
Less than
45 seconds
8
90 sec
Less than
120 sec
8
25%
Less than
30%
9
10
The system shall take less than 120 seconds
to send each recording of patient data
wirelessly
The user error rate shall be less than 25%
11
The system shall come with an instruction
manual
Yes
None
10
12
The system shall score more than 75% on
usability questionnaire adapted from
document provided by Dr. Ken Funk
80%
More than
75%
11
13
The system shall fit into 230mm by 102mm
m by 77mm volume
Yes
None
12
14
The system shall weigh less than 1 kg.
.75kg.
Less than 1
kg.
13
15
A full scale mock shall be provided which
confirms to sponsor mentors concept
Yes
None
15
9
2.2.1 Discussion
Engineering requirement 1 required captured patient exam data to be sent to another computer through the
use of a wireless network such as Wi- Fi, Bluetooth, or cellular network. It did not need or possess a scale
to determine its performance. The requirement was also not a physical component that could be displayed
by the prototype. It could only be demonstrated by functionality. The prototype had to send files to
another computer to prove it was operative.
Engineering requirements 2-7 are the tools needed to capture patient exam data. These were physical
components that were required on the prototype. They demonstrated the functional purposes of the
prototype. The purposes include: capturing images and videos of the eyes and ears; providing a safe lights
for capturing images and videos; capturing heart and lung sounds; measuring body temperature; and
recording voice notes.
Engineering requirement 8 improved the efficiency of capturing patient exam data. Efficiency was
determined by time. Therefore, the target and tolerances had an established time limit. The time to switch
between tools was to be less than 45 seconds. The target of switching between tools was 30 seconds.
Physicians statistically have a direct contact time of 17.5 minutes with a patient [2]. It is assumed the
physician has six objectives during the examination. Examine the eyes, ears, heart, lungs, and
temperature; and record the data. The average time objective is 3 minutes. One of the three minutes will
be designated towards the switching of tools. Efficiency was further improved by meeting the target of 30
seconds.
Engineering requirement 9 also improved the efficiency of capturing patient exam data. It pertained to the
user finding the desired file, recipient, and sending the data. The prototype was based on an iPod touch
and multiple applications. Consequently, the switching of applications was accounted for with the time to
send data. Finding and sending a file should not take more than 120 seconds. For maximum efficiency,
8
the prototype targeted 90 seconds for sending patient exam data.
Engineering requirement 10 and 12 referred to the prototypes usability, specifically its accuracy and user
satisfaction. The prototype allowed the customer an average accuracy and satisfaction rate of 70% to
consider the prototype usable.
Engineering requirement 11 referred to the user’s rapid comprehension of the prototypes operation. An
instructional manual assisted this requirement. The manual was created with an application on the iPod
Touch. It provided the user with instruction on each operation of the prototype.
Engineering requirement 13 referred to the customer’s desire for a small system. The prototype could not
be bigger than an iPod Touch because it was the platform. The data capturing components used with the
iPod Touch fit within a 230- mm by 102-mm by 77-mm volume. The prototype is easily transported.
Engineering requirement 14 referred to the customer’s desire for a lightweight system. The prototype’s
platform is the iPod Touch. Therefore, the system should not have weighed less. The iPad is a large device
of .65 kg, which is considered lightweight. The team decided that the prototype with its attached tools
should weigh less than the iPad.
Engineering requirement 15 will be displayed for the audience. No testing was involved. The team
demonstrated a mockup with the feasible size, weight, and interface features.
2.3 Testing Procedures (TPs) for Physical Examination Tool
Testing procedures provided the means to verify that the engineering requirements were addressed. There
are five type of testing procedures: Test, Demonstrate, Expert Consensus, Analysis, and Inspection.
Demonstration was a recurring test for the purposes’ of this prototype. Many of the requirements only
showed functionality. Table 2.3 below presents the testing procedure number, the related engineering
requirement, and the procedure.
Table 2.3- Testing Procedure and Number with Related Engineering Requirement
Engineering Requirement
The system shall provide means
to send files containing patient
exam data wirelessly to another
computer
The system shall have a photo
camera
The system shall have a video
camera
The system shall have a light
for viewing and capturing
images and videos of the ears
and eyes
The system shall provide means
to listen to heart and lung
sounds
The system should have a
medical thermometer
The system shall have a
microphone
Test
Procedure
#
1
2
3
4
Testing Procedure
Demonstrate: The system will send collected patient data
wirelessly to another computer
Demonstrate: The system will capture an image and
display it on the system’s screen
Demonstrate: The system will capture a video clip and
play it on the system’s screen
Demonstrate: The lights built into the ophthalmoscope
and otoscope will be turned on. The lights will be visible
to the user
5
Demonstrate: The user of the system will listen to heart
and lung sounds live.
6
Demonstrate: The system will capture and display body
temperature
Demonstrate: The system will record and play back
voice notes
7
9
The system shall take less than
45 sec to switch between tools
The system shall take less than
120 seconds to send each
recording of patient data
wirelessly
8
The user error rate shall be less
than 25%
10
The system shall come with an
instruction manual
The system shall score more
than 75% on usability
questionnaire adapted from
document provided by Dr. Ken
Funk
The system shall fit into 230mm
by 102mm by 77mm case
The system shall weigh less
than 1 kg.
A full scale mock shall be
provided which confirms to
sponsor mentors concept
11
9
12
13
Test: A timed switch between any two combination of
tools will be performed
Test: A timed set-up to wirelessly transfer collected
patient data will be performed. The timer will start after
the data is collected and will stop when the data is sent.
The actual time to for the data to be wirelessly transferred
to another computer will not be timed.
Test: 5 -6 participants will perform an operator error rate
test. The test will consist of step-by-step instructions to
operate each instrument. The scores will be averaged and
presented. The instructions will be written when the
functional prototype is operational.
Demonstrate: Instruction manual for the system will be
presented. It will cover how to operate each tool.
Expert Consensus: A usability survey will be issued to 10
participants. The scores will be averaged and presented.
The usability survey can be found in Appendix D
14
Test: The system will fit in a box with inside dimensions
of 230mm by 102mm by 77mm box
Test: The system will be weighed on a scale
15
Demonstration: A full-scale mockup will be provided.
2.4 Design Links (DLs) for Physical Examination Tool
As stated previously, requirements had a cascading effect. The design links are connected to an
engineering requirement. Clarification of design specifications is described in order to validate
satisfaction of the engineering requirement. Table 2.4 below presents the design link number in the House
of Quality, description of the design, and the engineering requirement satisfied.
Table 2.4- Design Links with Related Customer Requirement
Design
Link #
Description of design
Engineering Requirement Satisfied
The platform is an iPod Touch with wireless
capabilities.
The system shall provide means to
send files containing patient exam
data wirelessly to another
computer
The platform is an iPod touch with a photo camera
The system shall have a photo
camera
The platform is an iPod touch with a video camera
The system shall have a video
camera
1
2
3
10
4
5
Ophthalmoscope and otoscope have medical approved
lights
The system shall have a light for
viewing and capturing images and
videos of the ears and eyes
The system will have a microphone built into the
stethoscope
The system shall provide means to
listen to heart and lung sounds
The system will use a ThermoDock
The system should have a medical
thermometer
The stethoscope will also be used as a microphone
The system shall have a
microphone
The rotating arm will allow for quick switching of the
ophthalmoscope and otoscope; ThermoDock will be
attached to the dock connector; the stethoscope/
microphone will be attached to the headphone jack
The platform is an iPod touch with wireless connection
The system shall take less than 45
sec to switch between tools
6
7
8
10
A user manual will be created as part of the system to
teach the user how the device is operated
The system shall take less than 120
seconds to send each recording of
patient data wirelessly
The user error rate shall be less
than 25%
11
A user manual will be created as part of the system to
teach the user how the device is operated
The system shall come with an
instruction manual
12
The easy rotation between the ophthalmoscope and
otoscope; the attachment of the dock connector with the
stethoscope flipping on top of the infrared light
The system shall score more than
75% on usability questionnaire
adapted from document provided
by Dr. Ken Funk
13
The components are arranged in a way to fit the
dimensions described
The system shall fit into 230mm
by 102mm m by 77mm volume
14
All the components including the iPod touch weighs
less than 1kg
The system shall weigh less than 1
kg.
A 3D mock- up will be provided
A full scale mock shall be
provided which confirms to
sponsor mentors concept
9
15
11
2.5 House of Quality (HOQ)
House of Quality is a diagram that is used for defining the relationship between customer and engineering
requirements. It utilizes a matrix to relate the customer requirements to how the final product will meet
those wants and needs. The house of quality for the Healthcare Toolkit project is shown below in table 2.5
12
3 EXISTING DESIGNS FOR PHYSICAL EXAMINATION TOOL
Background research was conducted in order to create designs for the functional prototype of the PET.
Important research included general knowledge of how the PET linked to the Healthcare Toolkit; data
capturing components in the market; and understanding the design and functions of data capturing
devices. Therefore, the necessary knowledge was obtained to create designs that would produce a
functional prototype.
3.1 Design Research for Physical Examination Tool
The background research for this project was tailored to understanding the Bauer PET, its connection to
the Healthcare Toolkit, data capturing devices, and data capturing device designs. It was important to
understand Dr. James Bauer’s ideas and plans to assist in the design of the functional prototype. Dr. Bauer
was not an easily accessible source; therefore the Healthcare Toolkit website became an alternate source
of information. The team also needed to gain knowledge of the current data capturing devices that were
currently in the market for use with cellular devices, since the platform was assumed to be an iPod Touch
or cellular device. Comprehension of the ophthalmoscope’s and otoscope’s structure and function was
also important. The team needed to understand how each item operated in order for it to operate alongside
the platform.
Dr. Bauer devised the concept of the PET to improve efficiency and increase the value of healthcare
provided to the patient [16]. It is a multi-instrument system that includes a stethoscope, otoscope,
thermometer, ophthalmoscope, and dermatological camera. It will be built around a small tablet computer
with wireless capabilities, which will allow access to limitless information. This portable system has the
ability to send and access data collected from physical examinations [16].
Project objectives were broken down into two categories, physical mockup objectives and functional
prototype objectives. The mockup objectives consisted of building a physical mockup. The physical
mockup did not need to be functional. It also needed to feature the interface designed by the previous
group. The project was mainly focused on a functional prototype, which is the PET. It did not need to
mimic the mockup’s shape or size. It also did not need to deliver data for clinical use. The objective was
to demonstrate its usefulness and usability in the healthcare industry.
The first data-capturing component researched was an otoscope attachment for the iPhone. The otoscope
allowed images to be taken of the eardrum. A depiction of this attachment from Cellscope [3] can be seen
in Figure 3.1.1. Cellscope also offers a dermascope attachment for the iPhone. The dermascope
attachment allows high-magnification images to be taken of the skin. A depiction of this attachment can
be seen in Figure 3.1.2. Cellscope’s attachments are still in beta and publically unavailable.
13
Figure 3.1.1- Otoscope attachment for iPhone by
Cellscope [2]
Figure 3.1.2- Dermascope attachment for iPhone by
Cellscope [2]
The next data-capturing component researched is a stethoscope by Thinklabs [4]. This digital stethoscope
connects to Apple devices and displays waveforms and spectrograms via the supplied app. The digital
stethoscope from Thinklabs can be seen in Figure 3.1.3.
Figure 3.1.3 - Digital Stethoscope from Thinklabs [3]
The final data-capturing component researched is a thermometer by Medisana [5]. This infrared
thermometer connects to Apple devices and displays temperature of the human body via the supplied app.
The infrared thermometer can be seen in Figure 3.1.4.
14
Figure 3.1.4 - Infrared Thermometer for iPhone by Medisana [4]
The design of the otoscope and ophthalmoscope needed to be researched in order to create the PET.
Understanding of the design allowed the team to create designs appropriate for functionality of the two
data capturing components with the platform. The ophthalmoscope possess’ two lenses. It also uses
incandescent lamps that are about 1/8 inch in diameter [6]. Lens one converges the light rays. Lens two
focuses the lamp filament on the mirror, thus changing the light origination to the mirror. The lights rays
diverge, and enter the patient’s eye into the retina. It is reflected into a set of lens’ and mirrors that dim it
as it approaches the retina. An otoscope, on the other hand, possesses a “magnifying glass on the eye
piece” alongside a speculum to allow the medical professional to view the tympanic membrane [7]. The
speculum allows the medical professional to place his or her eye a specific distance from the patient’s
tympanic membrane. The magnifying glass, therefore, enables the medical professional to view the
tympanic membrane from that distance. The iPod camera used does not have the necessary magnification
for viewing within the ear; therefore an additional lens was originally needed for implementation
alongside the otoscope created for the device.
3.2 System Level Designs for the Physical Examination Tool
The PET is a system containing functions not currently available in a single, portable device, but devices
and systems do exist that are similar in their multi-functionality. Three devices were found that measure
blood pressure, temperature, pulse, and oximetry: Welch Allyn 42NTB- E1 Blood Pressure Pulse
Oximeter Temperature device, Welch Allyn Spot Vital Signs LXi, and Midmark IQ Vital Signs Monitor
are discussed in this section. Each of these systems contains a functionality that is similar to the PET.
3.2.1 Existing Design #1 for the Physical Examination Tool: Welch Allyn 42NTBE1 Blood Pressure Pulse Oximeter
The Welch Allyn 42NTB- E1 Blood Pressure Pulse Oximeter Temperature device is a multi-instrument
tool similar to the PET. It measures blood pressure, temperature, pulse, and oximetry [8]. The data is
captured through the oscillometric method where a cuff is placed on the finger and the arterial pressure
pulses are recorded. The data captured is thus displayed on a LCD screen. The tool is portable and easy to
use. However, it does not send or wirelessly transmit data. Welch Allyn Spot Vital Signs LXi is much
similar to this device.
3.2.2 Existing Design #2 for the Physical Examination Tool: Welch Allyn Spot Vital
Signs LXi
The Welch Allyn Spot Vital Signs LXi is another device that is portable and easy to use with multiple
15
functions similar to the PET. It measures blood pressure, temperature, pulse, body mass index, and
temperature. The pulse is measured through the oximitry; blood pressure is measured with SureBP
technology; the body mass index is found through inputted and calculated weight, height, respiration rate,
and pain level; and temperature is measured through the ear. The data captured is thus displayed on a
LCD screen [9]. It can, consequently, be transmitted wirelessly to the hospital EHR.
3.2.3 Existing Design #3 for the Physical Examination Tool: Midmark IQ Vital
Signs Monitor
Midmark IQ Vital Signs Monitor is the most similar device to the PET. It is another multi-functional
device that can capture blood pressure, temperature, SPO2, and pulse. The data is captured automatically
by Windows software. It is consequently displayed on a touchscreen. The captured data can also be
connected to EHR directly or with the software created- iQmanager [10]. The Midmark IQ Vital Signs
Monitor is also much smaller, thus more portable, than the other two devices previously mentioned.
3.3 Subsystem Level for the Physical Examination Tool
The functional decomposition for the PET is depicted in Figure 3.2. The subsystems included data
collection, data storage, and data transmission. Data collection is further described by the various
functions i.e. captures images and videos of the eyes, ears, and skin; capture audio of voice, heart, and
lungs; and measure body temperature.
Physical
Examination
Tool
Data
collection
Capture
images and
video
Of eyes
Of skin
Data
transmission
Data storage
Capture
audio
Of ears
Of voice
notes
Measure
body
temperature
Wireless
Of heart and
lung sounds
Figure 3.2- Functional Decomposition for Physical Examination Tool
The team did not need to produce the prototype with data storage or transmission, because they were
integrated in the choices for the platform. The platform chosen was based largely on the data capturing
devices that were available in the market.
3.3.1 Subsystem #1 – Data Collection for the Physical Examination Tool
Data collection included capturing images and videos of the eyes, ears, and skin; capturing audio of the
heart, lungs, and voice; and the measurement of body temperature. Research of available data capturing
components was necessary to create the functions on the prototype with minor modifications. The data
captured by the device was intended to be accurate and efficient for assessments by the physician. The
captured data was stored on the platform for later use as described by subsystem #2- data storage.
16
3.3.1.1 Existing Design #1 for Data Collection: Smart Otoscope
Existing data capturing components for the ears were researched. The smart otoscope by CellScope is an
attachment for the iPhone that captures images of the ear [3]. The attachment is placed over the iPhone’s
internal camera. CellScope is currently in development and not commercially available.
3.3.1.2 Existing Design #2 for Data Collection: Smart Dermoscope
Existing data capturing components for the skin were researched. Smart Dermascope by CellScope is an
attachment for the iPhone that captures images of the skin. The attachment is placed over the iPhone’s
internal camera. It allows the user to capture high-magnification, diagnostic-quality images of the skin
[3]. CellScope is currently in development and not commercially available.
3.3.1.3 Existing Design #3 for Data Collection: StethoMic
Existing data capturing components for the heart and lungs were researched. The StethoMic by
Stethocloud is an attachment for Windows phones that captures heart and lung sounds [11]. The
attachment plugs into a 3.5 mm headphone jack. The attachment is used in combination with the
StethoCloud application. This application is currently unavailable on iOS, but in development.
3.3.2 Subsystem #2- Data Storage for the Physical Examination Tool
The PET was intended to improve physician diagnostics through side-by-side analysis of previous and
current data. Therefore, the data was needed to be stored for immediate use. The platform for the PET
uses a smartphone or the iPod touch. These platforms were chosen because most of the data capturing
devices worked alongside the cellular devices below. The stored data was transferred using wireless
capabilities as described by subsystem #3- data transmission.
3.3.2.1 Existing Design #1 for Data Storage: iPhone
Existing Apple cellular devices were researched, since the device has data storage capabilities. The
iPhone is a smartphone with data storage capabilities. It can capture photos and videos with the built in
camera. Audio is captured with the built in microphone. The captured data can be stored on the iPhone.
Capacities range from 16 Gigabytes (GB) to 64 GB [12]. The stored images and videos can be viewed
through the iPhone’s touchscreen. Audio clips can be played through the built in speaker.
3.3.2.2 Existing Design #2 for Data Storage: iPod Touch
Existing Apple devices were also researched, since the devices have data storage capabilities. The iPod
Touch is a MP3 player with data storage capabilities. It can capture photos and videos with the built-in
camera. Audio is captured with the built in microphone. The captured data can be stored on the iPod.
Capacities range from 8GB to 64 GB [13]. The stored images and video can be viewed through the iPod’s
touchscreen. Audio clips can be played through the built-in speaker.
3.3.2.3 Existing Design #3 for Data Storage: Smartphone
Existing smartphones were also researched since the devices have data storage capabilities. Companies
including HTC, Samsung, and LG produce smartphones. Many of their smartphones use Android
software, a mobile operating system from Google. Most android phones can capture photos, videos, and
audio. The captured data can be stored on the smartphones memory. Memory options range from 512
Megabytes (MB) of internal storage, while others support additional storage up to 32 GB [14]. The stored
images and video can be viewed through the smartphone’s screen; while audio clips can be played
through the built-in speaker.
3.3.3 Subsystem #3- Data transmission for the Physical Examination Tool
The data captured and stored must be sent to a computer using wireless capabilities. The immediate
transmission of the data permits physicians to share the information with other physicians effortlessly.
17
The supplementary analysis can improve physician diagnostics of the patient.
3.3.3.1 Existing Design #1 for Data Transmission: iPhone
The iPhone was considered an existing design for data transmission because it has texting, calling, and
wireless connectivity. The iPhone is a smartphone by Apple Inc. [12]. The data captured and stored by the
device can be transmitted using text, Bluetooth, Wi- Fi, or “Cloud” application service. These capabilities
conceivably permit physicians to share the data for improved diagnostics. Additional software, more
commonly called apps, is available for the iPhone. These apps extend and may assist the iPhone’s
functionality.
3.3.3.2 Existing Design #2 for Data Transmission: iPod Touch
The iPod touch was considered an existing design for data transmission because it has wireless
connectivity [13]. The data captured and stored by the device can be transmitted using Bluetooth or WiFi. These feasibly allow physicians to improve diagnostics by sharing the data with other physicians. The
iPod Touch also has the ability to use apps that assist the device’s functionality.
3.3.3.3 Existing Design #3 for Data Transmission: Smartphones
Smartphones were also considered existing designs because they are capable of transmitting data through
cellular or wireless transmission. Companies including HTC, Samsung, and LG produce Android
smartphones [14]. The data captured and stored on the smartphone can be transferred through text,
Bluetooth, Wi-Fi, or a “Cloud” application service. These capabilities conceivably permit physicians to
share the data for improved diagnostics. These phones can only attain and use applications on the Google
Marketplace using the wireless network [14]. These apps extend and may assist the smartphone’s
functionality.
18
4 DESIGNS CONSIDERED FOR FUNCTIONAL PROTOTYPE
Designs for our functional prototype are presented below. The designs were created using a
morphological matrix. A morphological matrix is a technique that uses the functions identified to foster
ideas. There were three steps to this technique. The first step was to list the decomposed functions
presented in Figure 3.2. The second step was to find possible concepts that fulfill each function. The third
was to combine the individual concepts, one for each sub function, to meet all the functional
requirements. A morphological matrix with each function and possible concepts is shown in Table 4.1.
Table 4.1 Morphological Matrix
Sub function
Concept 1
Concept 2
Concept 3
Macro Lens with Pen Lite
Ophthalmoscope
Camera with available
light
Macro Lens with ring light
Front facing camera
Camera with available
light
Telephoto Lens with ring light
Otoscope
Macro Lens with
Speculum
External Microphone
Stethoscope
Internal Microphone
1. Capture
images &
video of eyes
2. Capture
images &
video of skin
3. Capture
images &
video of ears
4. Record
voice notes
19
ThinkLabs Stethoscope
External microphone in
Stethoscope
Internal Microphone
using iStethoscope Pro
ThermoDock (infrared
thermometer)
iCelsius Temperature
Sensor
-
Wi-Fi
Bluetooth
-
5. Listen &
record heart
& lung
sounds
6. Measure
body
temperature
7. Wireless
The PET will use an iPod Touch as a platform. It was chosen for two reasons. First, Dr. Funk offered an
iPod Touch for use at no cost. This ultimately allowed the team’s budget to be allotted toward other
necessary tools. Secondly, the iPod Touch offered a plethora of accessories compared to other platforms,
such as Android and Nokia. This was revealed during the background research. A case was created to
house all the data capturing devices that would be used with the iPod Touch. The components listed above
in Table 4.1 were possible choices. These were combined with the morphological matrix technique
previously described to generate designs. Research provided the concepts for each function in Table 4.1.
Design #1, #2, and #3 fulfilled all customer requirements, including “should” requirements 2 and 6 from
Table 2.1. These were capturing images of the eyes, and measuring body temperature, respectively. The
designs generated from the morphological matrix are presented below in Sec 4.1-4.3.
4.1
Design #1 for the Functional Prototype
Design #1 used the morphological matrix to create the most simplistic design possible. The approach
sought concepts to complete each sub functions that were the smallest in size and simple in incorporating
into a case design. Attachments were fitted to the iPod to carry out the needed functions. Below, Table
4.2 describes the concepts used for each sub function of Design #1.
20
Table 4.2- Sub Function and Concept for Design #1
Sub Function
Concept Chosen
1. Capture images & video of eyes
Macro Lens with Pen Lite
2. Capture images & video of skin
Camera with available light
3. Capture images & video of ears
Camera with available light
4. Record voice notes
Internal Microphone
5. Listen & record heart & lung sounds
Internal Microphone using iStethoscope Pro
6. Measure body temperature
ThermoDock
7. Wireless
Wi-Fi
The following paragraph describes the chosen concepts for Design #1 in Table 4.2. The iPod’s camera did
not have the necessary lens for appropriate viewing of the eye. A macro lens allowed the camera to focus
closer to the subject and get a clear image. The Welch Allyn Pen Lite was chosen for this design because
it was deemed safe for the eyes, and is the smallest concept option. The Pen Lite, in combination with the
lens, would be used to light the subject, allowing for captured images and videos of the eyes. The
standard rear camera was used for capturing images and videos of the skin. Images and video of the ear
was captured with a speculum attached to the macro lens. The speculum, on top of the macro lens, would
be flipped down in front of the camera. The internal microphone was chosen because it was already built
in, and would keep our design simple. It would be used to capture recordings of the voice, heart, and
lungs. The iStethoscope Pro application filtered heart and lung sounds from the internal microphone
making them easier to hear. The patient’s body temperature would be taken with the ThermoDock,
located at the bottom of the iPod. This concept was chosen because it did not have wires, which may be
caught or tangled. All information would be transmitted by the various apps through Wi-Fi, which was
integrated into the iPod Touch. Wi-Fi was chosen because it offered a greater range than Bluetooth. The
advantages and disadvantages of Design #1 are described in Table 4.3 below. A drawing of Design #1
with implemented concepts may be seen in Figure 4.1.
Table 4.3- Advantages and Disadvantages for Design #1
Advantages
Disadvantages
Quick transition between tools for capturing
images of eyes, ears, and skin; macro lens is simply
flipped down
Does not provide appropriate light for within the
ear
Easy switch of applications from recording of
voice to heart and lung sounds, rather than
switching of tools (both use internal microphones)
Pen Lite may be easily lost because it is not
attached to the device
Measures body temperature without physical
contact with patient
Internal microphone must be accurately placed for
proper recording of heart and lung sound
Design is simple
Available light in room may not be enough for
capturing image of skin
21
Macro Lens
Speculum
Internal
Microphone
ThermoDock
Figure 4.1- Design #1 Drawing
22
4.2 Design #2 for the Functional Prototype
Design #2 used the morphological matrix to create a design balancing quality of measured data and
simplicity. The approach sought concepts to complete each sub function that yielded accurate information
and simple to incorporating into a case design. Attachments would have fitted to the iPod to carry out the
needed functions. Below, Table 4.4 describes the concepts used for each sub function of Design #2.
Table 4.4- Sub Function and Concept for Design #2
Sub Function
Concept Chosen
1. Capture images & video of eyes
Macro Lens with Pen Lite
2. Capture images & video of skin
Front facing camera
3. Capture images & video of ears
Macro Lens with Speculum
4. Record voice notes
External microphone in Stethoscope
5. Listen & record heart & lung sounds
Stethoscope
6. Measure body temperature
iCelsius Temperature Sensor
7. Wireless
Bluetooth
The following paragraph describes the chosen concepts for Design #2 in Table 4.4. The iPod’s camera did
not have the necessary lens for appropriate viewing of the eye. A macro lens would allow the camera to
focus closer to the subject and achieve a clear image. The Welch Allyn Pen Lite was chosen for this
design because it was deemed safe for the eyes, and is the smallest concept option. The Pen Lite, in
combination with the lens, would be used to light the subject, allowing for captured images and videos of
the eyes. The front facing camera on the iPod would be used to capture images and videos of the skin.
Using the front camera would allow images of the skin to be taken without movement of the macro lens,
thus eliminated moving parts. Images and videos of the ear would be captured with the iPod’s camera and
a speculum attached to the macro lens. An external microphone would be placed inside of a stethoscope
and connected to the headphone jack on the iPod. This newly created stethoscope could be used to record
voice, heart, and lung sounds. This concept was chosen because it would achieve clearer and louder
sounds. The patient’s body temperature would be taken with the iCelsius thermometer. The iCelsius
thermometer was chosen because it could be placed under the tongue where physicians normally take
temperature. All information would be transmitted through Bluetooth, which is an integrated technology.
Bluetooth was chosen because it did not require an existing network to transmit information, just another
device in range. The advantages and disadvantages of Design #2 are described in Table 4.5 below. A
drawing of Design #2 with implemented concepts may be seen in Figure 4.2.
Table 4.5- Advantages and Disadvantages for Design #2
Advantages
Disadvantages
iCelsius thermometer can take temperature under
the tongue
iCelsius may not be accurate enough to measure
body temperature
The camera system is simple, no moving parts
Macro lens with speculum may not provide
suitable picture of ear
23
Bluetooth does not need an established network to
transmit information
Available light may not be enough to capture image
and video of skin
Stethoscope will offer clearer and louder sounds
Pen Lite may be easily lost because it is not
attached to the device
-------------------
Bluetooth range is limited
Macro Lens
Speculum
Front Camera
iCelsius
Thermometer
Stethoscope
External Microphone
Figure 4.2- Design #2 Drawing
24
4.3 Design #3 for the Functional Prototype
Design #3 used the morphological matrix to create a design using as many existing medical instruments
as possible. The approach sought concepts to complete each sub function that are familiar to the physician
and simple in incorporating into a case design. Attachments would be fitted to the iPod to carry out the
needed functions. Below, Table 4.6 describes the concepts used for each sub function of Design #3.
Table 4.6- Sub Function and Concept for Design #3
Sub Function
Concept Chosen
1. Capture images & video of eyes
Ophthalmoscope
2. Capture images & video of skin
Front facing camera
3. Capture images & video of ears
Otoscope
4. Record voice notes
Internal Microphone
5. Listen & record heart & lung sounds
External microphone in Stethoscope
6. Measure body temperature
ThermoDock
7. Wireless
Wi-Fi
The following paragraph describes the chosen concepts for Design #3 in Table 4.6. A medical
ophthalmoscope would be used to capture images and videos of the eyes. The front facing camera on the
iPod would be used to capture images and videos of the skin. An original medical otoscope would be used
to capture images and videos of the ears. The otoscope and ophthalmoscope would be familiar to the
physician and yield the best optical quality. These instruments contain built in lights, thus eliminating the
need for the Pen Lite. The case for the iPod Touch would possess a rotating arm that the otoscope and
ophthalmoscope would be attached to. The rotating arm would be placed each tool in front of the iPod
Touch’s camera. The internal microphone of the iPod Touch would be used to record voice notes. An
external microphone would be placed inside of a stethoscope and connected to the headphone jack on the
iPod Touch. This was chosen because an external microphone would have better audio quality. This
newly created stethoscope could be used to record heart and lung sounds. The patient’s body temperature
would be taken with the ThermoDock. This concept was chosen because it did not have wires, which may
be caught or tangled, and no physical contact is needed. All information would be transmitted by the
various apps through Wi-Fi, which is integrated into the iPod Touch. Wi-Fi was chosen because it offered
a greater range than Bluetooth. The advantages and disadvantages of Design #3 are described in Table 4.7
below. A drawing of Design #3 with implemented concepts may be seen in Figure 4.3.
Table 4.7- Advantages and Disadvantages for Design #3
Advantages
Disadvantages
Implements known medical instruments
Tools are larger than other concepts
Built in lights for ophthalmoscope and otoscope
More complex because of moving parts.
Rotating arm for quick and efficient switch
between tools
Available light may not be enough to capture image
and video of skin
25
Stethoscope will offer clearer and louder sounds
---------------
Measures body temperature without physical
contact with patient
---------------
Ophthalmoscope
Front Camera
Stethoscope
Otoscope
External Microphone
ThermoDock
Figure 4.3- Design #3 Drawing
26
5 DESIGN SELECTED FOR FUNCTIONAL PROTOTYPE
Design #3 was the design selected. The following section will justify the decision. It will also include
advantages and disadvantages.
5.1 Rationale for Design Selection of Functional Prototype
As seen in Table 4.7 the advantages of Design #3 include: known medical instruments are implemented,
lights for the otoscope and ophthalmoscope are built in, a rotating arm allowed quick and efficient
switching of tools, clearer and louder heart/lung sounds with a stethoscope are provided, and measured
body temperature without physical contact. Using existing medical instruments improved the image and
audio quality, and circumvented the need to develop optical and acoustical systems. The use of the built in
light for the instruments, in comparison to an external alternative, decreased space consumption and
increased safety, which are customer requirements 12 and 14 in Table 2.1, respectively. The rotating arm
in Design #3 offered smooth switch between instruments. All components were fastened, preventing loss
of external peripherals. The ThermoDock offered temperature readings of the patient without direct
contact. It decreased bacteria propagation and eliminated the need for securing mechanisms and loose
wires as seen in Figure 4.2 of Design #2. Infrared (IR) technology was used to make this possible.
As seen in Table 4.7 the disadvantages include: bulky tools, a more complex case design, and insufficient
light when capturing images of the skin. The existing medical instruments were larger than the proposed
alternatives in Design #1 and Design #2. Limitations with dimensions and placement arose. To overcome
this, the stethoscope and ThermoDock were placed on top of one another. The stacked placement of the
stethoscope and ThermoDock required an extra mechanism that moved the stethoscope into a functional
position. The front camera used for capturing dermatologic images uses available lighting. Therefore,
insufficient available light is an issue.
Design #3 was unsurpassed considering and comparing the advantages and disadvantages. The use of
existing medical instruments like the otoscope, ophthalmoscope, ThermoDock and stethoscope increased
measurement quality, eliminated the need to certify the safety of each instrument, gave the user a sense of
familiarity when operating the device, and circumvented designing several image and acoustical systems.
Increase in case complexity was accepted in order to accommodate these instruments. The sponsor was
mindful the functional prototype would be larger than desired. There was an understanding it would only
be used to determine functionality in the medical field. A full-scale production mockup was provided as a
project deliverable. The mockup and functional prototype look different in size and shape. Overall Design
#3 is the most desirable because it offered a simple tool switch solution, incorporated existing medical
tools, and eliminated loose gadgets.
If issues arose with the construction of Design #3, a modified design was required. Elimination or
modification of the nonessential instruments, the body temperature thermometer and ophthalmoscope,
were the first option. Eliminating these tools would allow for a simplified design. It would exclude a
rotating arm or track system for the stethoscope. These were possible options if the delivery time of the
functional prototype was jeopardized.
5.2 Design Description
This section fully describes Design #3. First, each instrument on the device will be introduced. Second,
the integration of the instruments with a designed case will be explained. The instruments fitted to the
iPod Touch includes: otoscope, ophthalmoscope, ThermoDock, stethoscope and voice recorder.
The otoscope and ophthalmoscope were closely related in our design implementation. Both tools were
attached to clips on a rotating arm as seen in Figure 5.1. The arm had a ball bearing press fitted in the
center and two ball-spring plungers press fitted, one at each end. A copper ring surrounded the ball
bearing in the center of the arm. It stayed in constant electrical contact with a copper pin, which rode on
27
the top surface, as seen in Figure 5.2. The copper pin traveled through the shaft of the ball bearing and
exited below the arm. The ball bearing allowed for smooth rotation of the arm. The two ball-spring
plungers served two purposes, tactile feel, and electrical connection. The ball-spring plungers rode along
the back of the case and securely snapped into the dimples on the rear of the case. The dimples were
electrically conductive. When the ball-spring plunger engaged into the dimple, it created an electrical
connection to the instrument positioned in front of the iPod Touch’s camera. This system supplied
electricity to the tool with the use of a battery pack, a positive lead from the ball-spring plunger
connection, and a negative lead from the copper ring connection. The battery pack was located under the
rotating arm. The tool located in front of the camera was powered, because the dimple located under the
camera was conductive.
Copper Pin
Ball Bearing
Figure 5.1- Rotating arm holding
otoscope and ophthalmoscope
Ball-spring
Plunger
Dimple
Figure 5.2 - Rotating arm with electrical
connection and tactile plunger
The following will discuss the ThermoDock. The ThermoDock traditionally inserts into the 30-pin
connecter on the bottom of the iPod Touch, seen in Figure 5.3. However, this obstructed the headphone
jack, which was needed for the external microphone and headphones for the physician. Therefore, the
design used a 20mm 30-pin dock extender that prevented the ThermoDock from covering the headphone
jack beside the 30-pin connector. Figure 5.4 shows our case designed for the ThermoDock. The
ThermoDock slid within a track and connected to the 30-pin extender. The track was located at the bottom
of the iPod Touch and placed for proper connection alignment.
28
30-Pin Connector
Headphone Jack
Figure 5.3- Bottom View of the iPod Touch
Figure 5.4- Track system to house the ThermoDock.
The following will discuss the stethoscope and voice recorder. They are closely related in the design
implementation. A traditional stethoscope head was used and modified to fit the design. The tubing from
the stethoscope head was removed, and a microphone was fitted in its place. The microphone recorded the
sound captured by the stethoscope head. The stethoscope was placed on a tray at the bottom of the iPod,
just above the ThermoDock. The tray had two pins on each side. They allowed the tray to slide in the
track. The track guided the pins and tray to the stowed and the engaged position, as seen in Figure 5.5 and
5.6 respectively. The stethoscope also recorded voice notes from the physician. The physician’s voice can
be recorded, regardless, of the stethoscopes position. Different applications were used to record the audio
files on the iPod Touch. iStethoscope Pro was used to filter certain frequencies for the recording of heart
and lungs. The built in Voice Notes app was used for voice recordings. A final dimensioned assembly is
available in Appendix E.
Stethoscope
Track
Pins
Figure 5.5– Tray for stethoscope in stowed
position.
Figure 5.6– Tray for stethoscope in engaged
position.
29
6 IMPLEMENTATION
Implementation of the PET included 6 steps: ordering of components, testing of data capturing devices,
stethoscope modification, ThermoDock implementation, printing of the case, and final assembly. Once
the components arrived, the team tested the ophthalmoscope’s and otoscope’s functionality with the iPod
Touch. After testing and conversation with a medical professional, the design for the functional prototype
was changed. The ophthalmoscope and otoscope were combined to improve images of the eyes and ears.
A petition, as seen in Appendix F, was submitted and approved by Dr. Calvo and Dr. Funk. Once the
desired design was created and printed, all components were assembled.
The first step of implementation was ordering all the components necessary for the functional prototype
and the 3D mockup. The complete list of parts was finalized. It can be seen in the bill of materials below
in Table 6. Bauer Labs provided two ophthalmoscopes and an otoscope. However after testing, the
decision was made to buy a more compact ophthalmoscope and otoscope.
The second step of implementation was testing. All the parts arrived during winter break; and testing
began the first week of winter term. Testing included capturing pictures with the ophthalmoscope and
otoscope heads placed in front of the iPod’s camera. Each component needed to be placed a certain
distance from the camera to provide clear images. The best results were found with both tools positioned
flush with the case of the iPod. Experimentation also included the use of macro lenses, but it was not
successful. The team subsequently decided to combine the ophthalmoscope and the otoscope, as seen in
Figure 6.1-2. This greatly simplified the design by removing the rotating arm on the back of the case; and
provided better images of the eyes and ears. The case for the PET, therefore, needed to be redesigned.
None of the testing procedures needed to be changed with the design change. Dr. Calvo approved a
petition for the design change.
Figure 6.1 – Redesigned case
Figure 6.2 – Side view of PET otoscope
ophthalmoscope combination
30
Modification of the stethoscope was the third step, as seen above in Figure 6.1. This design change
eliminated the need for moving parts in the design. Heart and lung sounds were heard by using the chest
piece of the stethoscope. The chest piece was removed from the stethoscope; and a microphone was
placed inside. In order to hear real time heart and lung sounds, a headphone jack was wired to the
microphone. This required researching schematics and soldering. The final step for the stethoscope was
taking measurements and designing the mount it would be placed on.
The fourth step was the ThermoDock’s implementation. The device needed to be plugged into the dock
connector, while the app needed to be downloaded. However, the app was not available for purchase in
the United States. It was only available in the UK AppStore, and the team did not have access. After
speaking with friends and family, the team connected with Daniel Brooks. He permitted the team’s access
to his UK Apple account in order to download the app. The ThermoDock was consequently functional
and provided accurate body temperatures.
The fifth step was the printing of the case. A 3D printer was used to produce the case. Drew Shepherdson,
alumni from OSU, printed the case via his personal 3D printer. Problems arose during printing causing
the case to warp. The support material was also difficult to remove. The team decided to break the case
into multiple parts in order to avoid use of supporting material during printing. The case was split into the
following parts: iPod case, stethoscope and ThermoDock support, ophthalmoscope and otoscope support,
battery box and potentiometer cover. All the parts were printed for assembly.
The sixth step was the assembly of all the components with the printed case. Assembly began by
attaching the iPod’s case to the ThermoDock and stethoscope support. All the parts were joined using
epoxy. Next, the ophthalmoscope and otoscope support was joined to the iPod case. This required precise
alignment of the camera with the viewing lens of the ophthalmoscope. Hot glue was used to attach the
otoscope on top of the ophthalmoscope. The subsequent parts to be joined were the battery, the
potentiometer switch, and the wires.
A 3D mockup was also produced for the PET. The drawn mockup shown in Figure 1.3 in Section 1.3 was
drawn in SolidWorks. The printed mockup has realistic buttons features. Parts of the 3D mockup are
raised to demonstrate the location of the buttons.
Table 6- Bill of Materials
#
1
2
3
4
5
6
7
8
9
10
11
10
11
12
Part
Ophthalmoscope head
Otoscope head
Stethoscope head
ThermoDock
Microphone
Dock extender
Wheel Potentiometer
Slide Switch
2.5 volt battery & charger
Wire
Ball bearing
Spring plunger
PLA (Polylactic acid)
PVA (Polyvinyl alcohol)
Quantity
1
1
1
1
1
1
1
1
1
10cm
1
2
2kg
1kg
Price ($)
222.99
181.86
6.99
71.18
1.66
4.23
1.99
2.19
29.00
5.37
2.83
96.00
90.00
Source
Amazon
Amazon
Walgreens
Apple Store (UK)
Amazon
Amazon
Radio Shack
Radio shack
Amazon
McMaster-Carr
McMaster-Carr
MakerBot
MakerBot
31
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
iStethoscope App
Pro Audio To Go App
Epoxy
Potentiometer
Headphones w/ Microphone
Headphone Jack
Slide Switch
Battery Holder
Potentiometer Knob
5K Linear Potentiometer
Heat Shrink
CTS 5 ohm Potentiometer
Return Online Part (shipping)
10K ohm Potentiometer
1k ohm Potentiometer
Total Expenses
Total Budget
Left Over Budget
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0.99
29.99
4.57
3.99
22.46
2.99
3.49
6.99
10.60
5.80
3.59
1.79
813.54
1,000.00
186.46
App Store
App Store
Home Depot
Radio Shack
Radio Shack
Radio Shack
Radio Shack
Radio Shack
Radio Shack
Radio Shack
Radio Shack
Radio Shack
OSU Bookstore
Radio Shack
Radio Shack
32
7 TESTING
Team 101 met with Dr. Calvo on March 13, 2013 at 2 pm for the final evaluation of the Healthcare
Toolkit Project. There were fifteen tests implemented to determine the PET’s functionality and usability.
Tylee Cairns was the PET operator, Konstantin Brainich was the patient, and Lea Cavestany was the
timekeeper for the testing. All 15 testing procedures were passed.
Testing procedure 1 was to demonstrate that the system had the ability to send collected patient data
wirelessly to another computer. Dr. Calvo’s temperature was taken using the ThermoDock on the PET
with the VitaDock app. This data was sent to Dr. Calvo’s email, and was received shortly afterwards. The
test was consequently passed.
Testing procedure 2 was to demonstrate that the system had the ability to capture an image and display it
on the system’s screen. An image of the eye was taken using the PET. The image was displayed on the
iPod’s screen and presented to Dr. Calvo. The test was consequently passed.
Testing procedure 3 was to demonstrate that the system had the ability to capture a video clip and play it
on the system’s screen. Since Dr. Calvo was aware that the iPod possessed the capability to take videos,
he did not require proof of the PET’s ability to capture a video. The test was consequently passed.
Testing procedure 4 was to demonstrate that the light built into the ophthalmoscope would be turned on.
The lights would be visible to the user. The knob on the side of the PET was turned from the off position
to the on position. This turned on the light on the ophthalmoscope, which was also used during the use of
the otoscope. The light was visible to Dr. Calvo; and test was consequently passed.
Testing procedure 5 was to demonstrate that the user of the system had the ability to actively listen to
heart and lung sounds. Headphones were plugged into the headphone jack. Dr. Calvo placed the
headphones securely in his ears. The iStethoscope Pro app was opened on the iPod; the mode was set to
“Heart-beat pure”; the stethoscope was placed on the patient’s chest. Dr. Calvo heard his heartbeat, and
was convinced that the PET could capture lung sounds too. He did not need further proof of listening to
lung sounds. The test was consequently passed.
Testing procedure 6 was to demonstrate that the system had the ability to capture and display body
temperature. This testing procedure was consequently passed since testing procedure 1 was passed.
Testing procedure 7 was to demonstrate that the system had the ability to record and play back voice
notes. The Voice Memos app was opened on the iPod. A voice note was recorded, and played back
through Dr. Calvo’s headphones. The test was consequently passed.
Testing procedure 8 was to perform a timed switch between any two combinations of tools. A timed
switch between the ThermoDock and the stethoscope was performed. Lea Cavestany timed Tylee Cairns
performing the switch. The process took 7 seconds, which was shorter than our goal of 30 seconds and a
tolerance of less than 45 seconds. The test was consequently passed.
33
Testing procedure 9 was to perform a timed set-up to wirelessly transfer collected patient data. The timer
started after the data was collected and stopped when the data was sent. The actual time to for the data to
be wirelessly transferred to another computer was not timed. After passing procedure 1, Dr. Calvo was
convinced that the process was well under our target of 90 seconds and a tolerance of less than 120
seconds. The test was consequently passed, however during testing of the PET the team’s times varied
between 30 – 40 seconds depending on the tool being used.
Testing procedure 10 was to perform an error rate test with 5 -6 participants. The test consisted of stepby-step instructions for operation of each instrument. The scores were averaged and presented. The
instructions were written for the PET. Operator error rate test was a survey that a team member filled out
while a nurse operated the PET. All nurses had an instruction manual present with precise word and
image instructions for tool operation. The user error rate test was scored based on the number of steps
needed to capture data with a tool versus the number of errors made (i.e. hitting the wrong button,
opening the wrong app). The results of the six individual surveys can be seen in Appendix G. Average
error rate result was 8.37%, which was lower than our target of 25% and tolerance of less than 30%.
These results and the surveys were presented to Dr. Calvo; and the test was consequently passed.
The error rate survey did not need to be reviewed by the Institutional Review Board (IRB) as the project
did not fall under the category of research. A project requires IRB review if both research and human
subjects are included. Human subjects were involved but research was not conducted. Research is defined
as “a systematic investigation, including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. Activities which meet all three of the elements of this
definition constitute research.” [17] The operator error rate survey for the PET did not fall under the
generalizable knowledge definition of research because the PET is a unique device. It would not be
relevant to any other devices currently in the market.
Testing procedure 11 was to present the instruction manual for the system. It covered instruction for tool
operation. The instruction manual was presented to Dr. Calvo on the iPad. He reviewed all 9 chapters; one
for each component. The test was consequently passed.
Testing procedure 12 was to survey 10 participants on the PET’s usability. The usability survey can be
found in Appendix D. Ten medical professionals performed a routine examination on a patient using the
PET. During its use, all nurses had an instruction manual present with precise word and image instruction
for tool operation. Each nurse filled out a usability survey after operating the PET. The results of
individual surveys can be seen in Appendix H. The scores were averaged and presented to Dr. Calvo. The
average was 84 %, which was higher than our goal of 80% and tolerance of greater than 75%. The test
was consequently passed.
The usability survey for the PET did not fall under the generalizable knowledge definition of research
because the PET is a unique device. It would not be relevant to any other devices currently in the market.
Testing procedure 13 was to fit the PET in a box with dimensions of 230mm by 102mm by 77mm box.
The PET was delivered to Dr. Calvo in a box with such dimensions. The test was consequently passed.
Testing procedure 14 was to weigh the PET on a scale. Prior to evaluation 2 the PET was weighed on a
scale; and its weight was photographed. The PET weighed 285.72 grams, which was lower than our target
34
of 750 grams and a tolerance of less than 1000 grams. The proof of weight was shown to Dr. Calvo, the
test was consequently passed.
Testing procedure 15 was to provide a full-scale mockup. A full-scale mockup of the PET was presented
to Dr. Calvo during evaluation 2. The test was consequently passed.
35
8 CONCLUSIONS AND RECOMMENDATIONS
The conclusion and recommendations are intended to assist in advancements for the PET. The conclusion
demonstrates the strides made with the creation of the functional prototype. It allows future groups to
understand the project’s current status. The recommendations explain the next steps for the PET as
desired by Team 101. These describe the improvements deemed necessary to improve the PET.
The PET exceeded expectations. The customer required images to demonstrate functionality and usability
in the medical field, but did not need to be of medical quality. The images of both the eyes and the ears, as
seen in Figure 8.1- 2, were close to medical quality. Originally the team assumed the best possible images
would display the eye and inside of the ear canal. Instead, the images were able to display the retina and
tympanic membrane. The images on the iPod Touch, however, are not displayed on the entire screen. A
large amount of the screen displayed the inside casing of the ophthalmoscope and otoscope. However, the
images desired for the PET would display the tympanic membrane or the retina on the entire screen. The
audio captured by the PET was the best function. It was loud and clear for the user. The audio also filtered
external sounds (i.e. conversation) with the use of an app. The ThermoDock measurements were also
adequate to demonstrate functionality and usability in the medical field.
Figure 8.1- Image of the ear with the PET
Figure 8.2- Image of the eye with the PET
There are several areas for improvement for the PET, but the most important of these is imagery.
Currently, the images and videos of the eyes and ears are not of medical quality. Improved imagery will
require the design of custom optics if the platform remains the iPod touch. The optics will need to be
created for use with a camera lens, instead of the human eye. Software to adjust the camera’s exposure is
also needed for image improvement. Currently, the iPod Touch’s camera software cannot accurately
define image exposure. The image exposure is a big issue in relation to images of the ear. Software that
allows for greater control of exposure will consequently improve the images. The potentiometer, which
controls the light’s brightness, is also helpful with this issue, and can be improved. Switching from 0-5K
Ohm to a more precise 0-5 Ohm potentiometer will give better control. Currently, it offers minimal
brightness adjustment. Custom optics, exposure software, and light adjustment will all contribute to better
optical image quality. Another possible option is changing the platform of the PET; preferably one with a
better camera. In testing, the team was able to capture much higher quality images using an iPhone 5;
however the images were still not of medical standards.
Currently, the PET is efficient at switching between different tools and acquiring data; however sending
data is time consuming. The method in which the data is sent needs improvement. The sponsor desires an
36
automated process. In order to archive this requirement, software must be created to automate data
transfer.
The stethoscope needs improvement as well. Current stethoscopes used in the medical field have the
ability to capture heart sounds through clothing. The PET must be in contact with the skin in order to
capture heart and lung sounds. Use of a low frequency microphone would improve the audio sound. It
may also allow the user to capture sounds without contact with the skin.
37
9 REFERENCES
[1]
S. DeBrum, H. Guo, Z. Su, (2012). “Applying Human System Engineering to the design of a new
physical examination kit,” Unpublished.
[2]
V. Gilchrist et al., [Online]. (2005, November.) “Physician activities during time out of the
examination room.” Available http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1466937/
[3]
D. Fletcher. [Online] (2012). Cellscope. Available: http://cellscope.com
[4]
C. Smith. [Online] (2012). Stethoscope Systems. Available:
http://www.thinklabsmedical.com/stethoscope-systems.html
[5]
R. Lindner. (2012). Thermodock Infrared Thermometer Module [Online]. Available:
http://www.medisana.com/index.php?cl=details&anid=7274e4bd2fd5a8b12.43631334
[6]
G.T. Timberlake, M. Kennedy, “The Direct Ophthalmoscope: How It Works and How To Use It,”
The University of Kansas Medical Center, p. 11- 34 2005.
[7]
J. Urkin, “The many uses of an otoscope: much more than just looking into ears,” The Internet
Journal of Otorhinolaryngology, vol. 5 Num. 2 p. 7-7, 2006
[8]
Summit Surgical Technologies, [Online] Welch Allyn 42NTB-E1 Blood Pressure Pulse Oximeter
Temperature Available:
http://www.summitsurgicaltech.com/index.php?main_page=product_info&cPath=220_243&produc
ts_id=3231
[9]
Welch Allyn, [Online] SpotVital Signs LXi Available:
http://www.welchallyn.com/apps/products/product.jsp?id=11-ac-100-0000000001118
[10] Master Fit Medical Equipment, [Online] Midmark IQVitals Vital Signs Monitor Available:
http://www.masterfitmedical.com/product/midmark-iqvitals-vital-signs-monitor
[11] StethoCloud, [Online] “How StethoCloud works” Available:
http://www.stethocloud.com/howitworks.html
[12] Apple, [Online] “iPhone specifications” Available: http://www.apple.com/iphone/specs.html
[13] Apple, [Online] “iPod Touch (4th generation) – technical specifications” [Online] Available:
http://support.apple.com/kb/SP594
[14] Android, “Android device gallery” [Online] Available: http://www.android.com/devices/
[15] J. D. Bauer and K. H Funk, [Online]. (2012, January 18) "Healthcare toolkit". Available:
http://classes.engr.oregonstate.edu/mime/spring2012/ie546/Resources/HT_Resources/Healthcare%
20Toolkit%20draft%20white%20paper.pdf
[16] J. Bauer, [Online] 2012 "Healthcare Toolkit,"
Available: http://www.bauerlabs.net/welcome/healthcare-toolkit.
[17] Office of Research Integrity, [Online] “Institutional Review Board" Oregon State University
Available: http://oregonstate.edu/research/irb/does-your-study-require-irb-review, 2013.
38
APPENDICES
Appendix A: Original Handheld Device with Details
Appendix A displays various dimensions for the rotation housing of the ophthalmoscope and otoscope. It
also gives details for the housing on the body of the Physical Examination Tool.
39
40
Appendix B: IDEF0 Model for Physical Examination Process
Appendix B is the IDEF0 model of a physical examination process. Each stage of the process is explained
in detail for easy understanding.
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DATE
Context
Medical protocols
Patient previous medical history
Environment factors
Provider factors
Doctor's initial hypothesis list
Ongoing patient-clinician relationship
Patient current status and physical data
Patient EMR/Encounter form
Patient existing conditions updated and categorized
Current status and physical data analysed
Conduct physical exam
Patient existing conditions
Updated patient EMR/Encounter form
A0
Practitioner
Equipment
Node:
C1
Title:
Physical exam
Number: Pg 1
41
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C6 C5 C4 C3 C2 C1
Ongoing patient-clinician relationship
Doctor's initial hypothesis list
Provider factors
Environment factors
Patient previous medical history
Medical protocols
I3
I2
I1
Patient existing conditions
Updated patient EMR/Encounter form
Patient EMR/Encounter form
Patient current status and physical data
Cardiologic status and data
Conduct
Cardiac
Examination
Current status and physical data analysed
Patient existing conditions updated and categorized
A1
Lung status and data
O3
O2
O1
Conduct
Pulmonary
examination
A2
Skin, hair and nails characteristics
Conduct
Dermatologic
examination
A3
Eye characteristics
Conduct Eye
examination
A4
Ear characteristics
Conduct Ear
examination
A5
Conduct
other
examinations
A6
Practitioner
Equipment
M1 M2
Node:
C3
Title:
A0: Conduct physical exam
Number: Pg 2
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Doctor's initial hypothesis list
Patient previous medical history
Environment factors
Medical protocols
Provider factors
I3
I1
Cardiologic status and data
Current status and physical data analysed
Conduct cadiac
inspection
Patient existing conditions
Patient existing conditions updated and categorized
O2
O3
Inspection findings
A11
Conduct cardiac
palpation
Palpation findings
A12
Conduct cardiac
auscultation
Auscultation findings
A13
I2
Record findings at
patient medical
records Cardiovascular
section
Patient EMR/Encounter form
Updated patient EMR/Encounter form
O1
A14
Patient
Practitioner
Equipment
M1 M2
Node:
C4
Title:
A1: Conduct Cardiac Examination
Number: Pg 3
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Patient previous medical history
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Ongoing patient-clinician relationship
I1
I2
Patient existing conditions
S1, S2, S3 identified
Cardiologic status and data
Identify heart sounds
Rythm and frequency identified
Presecence or abscence of murmurs identified
A131
Caracterize abnormal
sounds
A132
Auscultation findings
Categorize findings
O3
Current status and physical data analysed
O2
Patient existing conditions updated and c
O1
A133
Patient
Practitioner
Equipment
M2 M1 M3
Node:
C7
Title:
A13: Conduct cardiac auscultation
Number: Pg 4
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I1
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C1 C2 C6 C5 C3 C4
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Medical protocols
Patient previous medical history
Provider factors
Environment factors
Time: 11:47:59
Publication
DATE
Lung status and data
Patient existing conditions
Context
Current status and physical data analysed
Conduct thorax
inspection
Patient existing conditions updated and categorized
O2
O3
Findings
A21
Conduct thorax
palpation
Findings
A22
Conduct thorax
percusion
Findings
A23
Conduct
pulmonary
auscultation
Findings
A24
I2
Record findings at
patient medical
records (Lung
examination
section)
Patient EMR/Encounter form
Updated patient EMR/Encounter form
O1
A25
Patient
Practitioner
Equipment
M1 M2
Node:
C5
Title:
A2: Conduct Pulmonary examination
Number: Pg 5
45
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Environment factors
Provider factors
Patient previous medical history
Medical protocols
Ongoing patient-clinician relationship
I1
Patient existing conditions
Insipiration and expiration sounds identified
Identify lung
sounds
I2
Lung status and data
A241
Description of intensity, pithc and location
Describe and
characterize sounds
A242
Current status and physical data analysed
O1
Categorize sounds
and findings
Findings
O2
A243
Patient
Equipment
Practitioner
M2 M1 M3
Node:
C8
Title:
A24: Conduct pulmonary auscultation
Number: Pg 6
46
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C1 C2 C6 C5 I3 C3 C4
Ongoing patient-clinician relationship
Doctor's initial hypothesis list
Medical protocols
Patient previous medical history
Patient existing conditions
Provider factors
Environment factors
I1
I2
Patient EMR/Encounter form
Current status and physical data analysed
Skin, hair and nails characteristics
Inspect skin, hair and
nails
Patient existing conditions updated and categorized
O2
O1
Findings
A31
Palpate skin, hair and
nails
Findings
A32
Record findings at patient
medical records - skin,
hair and nails section
Updated patient EMR/Encounter form
O3
A33
Equipment
Practitioner
M2 M1
Node:
C6
Title:
A3: Conduct Dermatologic examination
Number: Pg 7
47
Appendix C: Failure mode analysis for Physical Examination Tool [1]
Appendix C is the failure mode analysis created by a previous team. It defines the various possible
failures and its effects on the prototype.
48
Fear of medical
Human beings Acquired data
A1 Conduct
3 Cardiovascul encounters, Patient react differently and information
ar
in pain,
auscultation Communication
barriers
Forgetting, not
A1 Conduct
3 Cardiovascul considering it
2 3
18
Not giving
diagnose for a
possible
condition
4
6 6 144
The
system
should
provide
means to
guide the
physical
examinati
on and
prevent
omission
of tasks
Wrong
diagnosis
3
3 4
36
The
system
should
provide
means to
iad the
physician
to identify
and
caracteriz
e heart
sounds
Wrong
diagnosis
4
3 3
36 To check The
on medical
are biased and
examinations
wrong
and acquiring
data, which can
cause e.g.
higher heart
rate
Not examining
all the areas
ar
relevant,
auscultation interruptions
Inexperience of the Confuse a
A1 Conduct
normal sound
3 Cardiovascul doctor, small
ar
lesions that are not
auscultation easily
identified,ambient
noise, status of the
physician(tired,
stress), top down
processes, not
auscultating all the
areas
3
with an
abnormal
sound and viceversa
Inexperience of the Wrongly
A1 Conduct
describe an
4 Cardiovascul doctor, small
ar
lesions that are not abnormal
auscultation easily
sound
identified,ambient
noise, status of the
physician(tired,
stress), top down
processes
with the
experts
or check
for
similar
instances
in prior
reports
online
system
should
provide
means to
aid the
recognitin
and
caracteriz
ation of
heart
sounds
49
Inexperience of the Achieve a
Wrong
A1 Conduct
wrong diagnose diagnosis,
5 Cardiovascul doctor, small
ar
lesions that are not
auscultation easily
identified,ambient
noise, status of the
physician(tired,
stress), top down
processes
A2 Conduct
Pulmonar
Ausculation
A2 Conduct
Pulmonar
Ausculation
A3 Conduct
skin, hair
and nails
exam
A3 Conduct
skin, hair
and nails
exam
4
3 2
24 Activities The
to
corrobor
ate
diagnosis
wrong
treatment,
patient
condition could
aggravate
Rapid pace of the
encounter might
lead to incorrect
site selection
Incorrect
association of
an acquired
datum with a
site setting; for
example,right
lung sounds
captured as left
lung.
Missing or
incorrect data
acquired on the
instrument and
transferred to
other systems;
potential for
misdiagnosis or
inappropriate
treatment
7
5 6 210
No instrument
preveniative
maintenance
program
Instrument is
not correctly
calibrated
Instrument
acquire and
record wrong
data
4
2 4
Fail to detect
an important
lesion
4
6 6 144 To get
Top down process, Not inspecting
forgetting due to
all the areas
distractions
Not paying
attention,
experience of the
doctor,
Not identifying a Fail to detect
suspicious
an important
lesion
lesion such as
cancer, it
spreads fast,
fatal
consequences
system
should
provide
means to
corrobora
te the
correct
caracteriz
ation of
heart
sounds
32
proper
and
complete
feedback
from
patient
regarding
symptom
s
4
2 6
48 Repeatin
g the
task
again
(or)
maintain
surroundi
ngs quite
and calm
50
A3 Conduct
skin, hair
and nails
exam
Knowledge, Lack
of previous
experience, not
paying special
attention
Describe
Wrong
lesions wrongly diagnosis, fatal
consequences
5
3 6
90 To check
with
experts
or check
for
similar
instances
in prior
reports
online
A1
4A2
5A3
3
Record
findings to
patient's
medical
record
Relevant
Enter the wrong Wrong data
information missing data
gets updated to
and data is
EMR
inconsistent,clinicia
n stressed and
distracted, failed to
detect mistake
6
5 5 150
A1
4A2
5A3
3
Record
findings to
patient's
medical
record
Data entry
problems, Data
management
Provider
receives false
patient record
Wrong data
updated to the
patient form.
Future
consequences
when treating
the patient
4
1 2
A1
4A2
5A3
3
Record
findings to
patient's
medical
record
Each datum
acquired during the
encounter must be
correctly identified
with appropriate
metadata
Incomplete
identification or
documentation
of a specific
datum
Missing or
incorrect data
acquired on the
device and
transferred to
other systems;
potential for
misdiagnosis or
inappropriate
treatment
5
4 5 100
8
51
Appendix D: Usability questionnaire for Testing Procedure 12
Usability Questionnaire
Comme
Displays
Rating (circle) nt
1
Displays are clearly visible
1 2 3 4 5
2
Displays are legible
1 2 3 4 5
3
Display content is understandable
1 2 3 4 5
4
All necessary information is displayed
1 2 3 4 5
1
Controls are easily accessible
1 2 3 4 5
2
Controls are easy to operate
1 2 3 4 5
3
Controls are adequately guarded against inadvertent operation
1 2 3 4 5
4
Controls are clearly identified
1 2 3 4 5
5
Controls move in appropriate direction
1 2 3 4 5
Controls
Overall Usability
1
System instruments can be initiated with few user actions
1 2 3 4 5
2
System operation requires minimal reference to operating
instructions
1 2 3 4 5
3
System operational state is always obvious
1 2 3 4 5
4
Overall satisfaction
1 2 3 4 5
52
5
Ease of use/ navigation
1 2 3 4 5
6
General appearance
1 2 3 4 5
7
Comfort of grip
1 2 3 4 5
Average rating
Rating Scale:
1= strongly disagree
2= disagree
3= neutral
4= agree
5= strongly agree
Reviewed by:
Signature:
Date:
53
Appendix E: Final Assembly of Physical Exam Tool
54
Appendix F: Petitions
55
56
Appendix G: User Error Rate
57
58
59
60
61
62
Appendix H: Usability Surveys
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82