Formal Technical Proposal

Company Name: Project Name:

embedic CardioScope

Prepared by:

Alex Smith, Project Manager Raymond King, Hardware Engineer Patrick Navarro, Software Engineer

Faculty Advisor:

Dr. Jay Porter, Program Director Electronics and Telecommunications Engineering Technology Texas A&M University

Project Sponsor:

Baraquiel Reyna, NASA JSC Space Medicine Division Texas Space Grant Consortium

Due: Delivered:

December 1, 2010 December 1, 2010

Edited By: ______________________ Signature: ______________________

Letter of Transmittal
Dear Dr. Joseph Morgan P.E. M.E., The attached document contains the formal technical proposal for the CardioScope prototype, by embedic. The company consists of four very qualified engineers and is based in College Station, TX. Every member of embedic will contribute in all aspects of the project. The project team includes: Alex Smith as the project manager, Raymond King as the hardware engineer, and Patrick Navarro as the software engineer. The CardioScope is a portable ambulatory 12-lead ECG device that senses the hearts electrical activity and transmits it wirelessly over a short distance. The wearable unit is a small, lightweight, battery powered device that amplifies and digitizes the signals. This unit then sends data over Wi-Fi to a host computer, which receives, digitally filters, and displays the waveforms in real-time. The wearable CardioScope unit will be robust and will allow the user to configure the number of electrodes used, the capture resolution, and which filters are applied from the host software. The project is projected to begin with on January, 17, 2011 and the final prototype is scheduled for completion on May 6, 2011. The final cost of the CardioScope project is estimated to be $138,305. The company is completely committed to finishing the CardioScope project on time and within budget. Each member will own an equal portion of the intellectual property for the CardioScope. The division of intellectual property is found in Appendix O, Intellectual Property Memorandum. Thanks and regards, Alex Smith Project Manager embedic alex@embedic.net
(832)656-7899 Page | 2

Signature: __________________________

Table of Contents
Letter of Transmittal.............................................................................................................. 2 Table of Figures ..................................................................................................................... 5 Section I - Introduction .......................................................................................................... 8 General .............................................................................................................................. 8 Background........................................................................................................................ 8 Technical Challenge............................................................................................................ 8 Benefits ........................................................................................................................... 11 Proposal Structure ........................................................................................................... 11 Section II Project Scope ..................................................................................................... 14 Enclosure ......................................................................................................................... 15 Hardware ......................................................................................................................... 16 Software .......................................................................................................................... 17 Test Matrix ...................................................................................................................... 18 Section III Statement of Work ........................................................................................... 22 A. Project Design .............................................................................................................. 22 Input section .......................................................................................................................... 22 Digital Section ........................................................................................................................ 25 Power System ........................................................................................................................ 30 B. Work to be Performed ................................................................................................. 32 Work Breakdown Structure ................................................................................................... 32 Research................................................................................................................................. 32 Design .................................................................................................................................... 37 Proof of Concept Prototype ................................................................................................... 41 Final Product .......................................................................................................................... 44 Testing ................................................................................................................................... 47 Documentation and Close Out ............................................................................................... 49 C. Precedence Diagram .................................................................................................... 52 D. Task Schedule .............................................................................................................. 54 E. Milestones ................................................................................................................... 56 F. Deliverables ................................................................................................................. 58 Deliverable Responsibilities ................................................................................................... 59 Deliverable Timeline .............................................................................................................. 59 Deliverable Descriptions ........................................................................................................ 60 G. Sponsor Requirements ................................................................................................. 62
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Section IV Risk Assessment ............................................................................................... 63 Risk Assessment............................................................................................................... 63 Risk Evaluation Matrix ..................................................................................................... 63 Risk Prioritization Matrix .................................................................................................. 64 Section V Team Organization and Qualifications ............................................................... 68 Hierarchy Chart ................................................................................................................ 68 Member Qualifications .................................................................................................... 69 Section VI Project Costs .................................................................................................... 70 Direct............................................................................................................................... 70 Indirect Costs ................................................................................................................... 72 Profit ............................................................................................................................... 72 Other Costs ............................................................................................................................ 73 Price ................................................................................................................................ 73 Sequence of Funds ........................................................................................................... 74 Appendices ......................................................................................................................... 76 Appendix A Quad Chart ................................................................................................. 76 Appendix B Capstone Design Document Presentation Slides .......................................... 77 Appendix C Capstone Design Document ........................................................................ 95 Appendix D Problem Statement Memorandum ........................................................... 126 Appendix E Conceptual Design Memorandum ............................................................. 129 Appendix F Functional Design Memorandum ............................................................... 132 Appendix G Deliverables Memorandum ...................................................................... 136 Appendix H Responsibilities Assignment Matrix........................................................... 143 Appendix Ia Network Logic Diagram (originally submitted) .......................................... 152 Appendix Ib Network Logic Diagram (revised) .............................................................. 162 Appendix J Risk Assessment ........................................................................................ 171 Appendix K Costing Data ............................................................................................. 187 Appendix L Functional Block Diagrams (revised) .......................................................... 194 Appendix M Team Member Resumes .......................................................................... 197 Appendix O Intellectual Property Memorandum .......................................................... 202 Appendix P Work Breakdown Structure ....................................................................... 216

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Table of Figures
Figure 1. Technical Merit Breakdown ............................................................................................. 9 Figure 2. CardioScope Conceptual Diagram ................................................................................. 14 Figure 3. Pin-out of ECG cable DB-15 connector .......................................................................... 23 Figure 4. 10-lead ECG cable assembly .......................................................................................... 24 Figure 5. Electrode protection circuit schematic .......................................................................... 25 Figure 6. TI ADS1198 ECG Analog Front-end IC pin-out ............................................................... 26 Figure 7. Block Diagram of TI ADS1198 chip ................................................................................. 27 Figure 8. PIC24FJ64GB002 pin-out................................................................................................ 29 Figure 9. Microchip Wi-Fi module pin-out .................................................................................... 30 Figure 10. WBS Top Level.............................................................................................................. 32 Figure 11. WBS Research .............................................................................................................. 33 Figure 12. WBS ECG Technology ................................................................................................... 33 Figure 13. WBS Analog Front End ................................................................................................. 34 Figure 14. WBS Microcontroller.................................................................................................... 35 Figure 15. WBS Wireless Communications ................................................................................... 35 Figure 16. WBS Power................................................................................................................... 36 Figure 17. WBS Software .............................................................................................................. 36 Figure 18. WBS Product Standards ............................................................................................... 37 Figure 19. WBS Design .................................................................................................................. 37 Figure 20. WBS Alpha Schematic .................................................................................................. 38 Figure 21. Alpha PCB Layout ......................................................................................................... 38 Figure 22. WBS Component Selection .......................................................................................... 39 Figure 23. WBS Pseudocode ......................................................................................................... 39 Figure 24. WBS Enclosure Design ................................................................................................. 40 Figure 25. WBS Test Plan .............................................................................................................. 40 Figure 26. WBS Proof of Concept.................................................................................................. 41 Figure 27. WBS Prototype Procurement ...................................................................................... 41 Figure 28. WBS Prototype Construction ....................................................................................... 42 Figure 29. WBS Microcontroller Programming............................................................................. 42 Figure 30. WBS Demo Host Program ............................................................................................ 43 Figure 31. WBS Prototype Debug and Test................................................................................... 43 Figure 32. WBS Final Product ........................................................................................................ 44 Figure 33. WBS Final Procurement ............................................................................................... 44 Figure 34. WBS Alpha PCB ............................................................................................................ 45
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Figure 35. WBS Beta PCB .............................................................................................................. 45 Figure 36. WBS Final Programming .............................................................................................. 46 Figure 37. WBS Final Debugging ................................................................................................... 46 Figure 38. WBS Final Enclosure ..................................................................................................... 47 Figure 39. WBS Testing ................................................................................................................. 47 Figure 40. WBS Hardware Testing ................................................................................................ 48 Figure 41. WBS Software Testing .................................................................................................. 48 Figure 42. WBS System Integration Testing .................................................................................. 49 Figure 43. WBS Documentation and Close-out ............................................................................ 49 Figure 44. WBS Documentation .................................................................................................... 50 Figure 45. WBS Presentations....................................................................................................... 51 Figure 46. WBS Cleanup ................................................................................................................ 51 Figure 47: Level 0 Gantt Chart ...................................................................................................... 54 Figure 48: Research phase Gantt chart......................................................................................... 54 Figure 49: Design phase Gantt chart ............................................................................................ 55 Figure 50: Proof of Concept Prototype phase Gantt chart ........................................................... 55 Figure 51: Final Prototype phase Gantt chart............................................................................... 55 Figure 52: Testing phase Gantt chart ............................................................................................ 56 Figure 53: Documentation & Close-out phase Gantt chart .......................................................... 56 Figure 54: Milestones Timeline ..................................................................................................... 57 Figure 55. Deliverable Timeline .................................................................................................... 59 Figure 56. Risk Evaluation Matrix ................................................................................................. 63 Figure 57. embedic Hierarchy Chart ............................................................................................. 68 Figure 58: Sequence of costs, chart .............................................................................................. 75 Figure 59: Limb-lead setup and Einthoven's Triangle (left), 5-lead setup (right) ....................... 102 Figure 60: EASI lead placement (left), V1-V6 lead placement (right) ......................................... 103 Figure 61: The electrical activity of the heart from 6 different perspectives............................. 103 Figure 62: Conceptual block diagram ......................................................................................... 106 Figure 63: Wireless technical survey .......................................................................................... 109 Figure 64: Microcontroller technical survey ............................................................................... 110 Figure 65: Battery technical survey ............................................................................................ 111 Figure 66: Functional block diagram ........................................................................................... 112 Figure 67: Deliverables timeline ................................................................................................. 116 Figure 68: Milestones timeline ................................................................................................... 118 Figure 69: Gantt chart ................................................................................................................. 119 Figure 70: Test matrix ................................................................................................................. 120 Figure 71: Technical merit .......................................................................................................... 123 Figure 72: Conceptual Block Diagram for the CardioScope ........................................................ 130
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Figure 73: Conceptual Block Diagram for the CardioScope ........................................................ 204 Figure 74. Pin-out of ECG cable DB-15 connector ...................................................................... 206 Figure 75. 10-lead ECG cable assembly ...................................................................................... 207 Figure 76. Electrode protection circuit schematic ...................................................................... 208 Figure 77. TI ADS1198 ECG Analog Front-end IC pin-out ........................................................... 209 Figure 78. Block Diagram of TI ADS1198 chip ............................................................................. 210 Figure 79. PIC24FJ64GB002 pin-out............................................................................................ 212 Figure 80. Microchip Wi-Fi module pin-out ................................................................................ 213

Table 1: Test Matrix ...................................................................................................................... 19 Table 2: ECG cable pin-out ............................................................................................................ 23 Table 3: Power budget of major components .............................................................................. 31 Table 4. Deliverable Responsibilities ............................................................................................ 59 Table 5. Risk Prioritization Matrix ................................................................................................. 66 Table 6. Direct Costs from Labor .................................................................................................. 70 Table 7. Other Direct Costs, Hardware ......................................................................................... 71 Table 8. Other Direct Costs, Software .......................................................................................... 71 Table 9. Other Direct Costs, Test .................................................................................................. 71 Table 10. Total Direct Costs .......................................................................................................... 72 Table 11. Indirect Costs................................................................................................................. 72 Table 12. Total Direct and Indirect Costs ...................................................................................... 72 Table 13. Profit .............................................................................................................................. 73 Table 14. Other Costs .................................................................................................................... 73 Table 15. Price ............................................................................................................................... 73 Table 16. Sequence of Funds ........................................................................................................ 74 Table 17: ECG cable pin-out ........................................................................................................ 206 Table 18: Power budget of major components .......................................................................... 214

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Section I - Introduction
General
Annually, heart disease causes over 17 million deaths worldwide. Today, the best way of receiving preventive prognoses of many of these problems is by using electrocardiograms (ECGs). As a result, ECG use has become increasingly more widespread in medical settings over the last fifty years. The newest trend of ECG devices has been to increase their mobility, hence increasing their versatility and allowing them to be more broadly usable (especially outside of hospitals). A critical aspect of this is using recent advances in low-power computing and wireless transmission to create a small, unobtrusive device. With such a device, patients can maintain their regular lifestyles while still receiving intermittent monitoring feedback.

Background
NASA, the military, and the developing world share similar interests for mobile medical hardware. Unfortunately, current wireless ECG devices have several shortcomings, which make them less than ideal for use in many applications. One limitation is that they are still quite unwieldy and thus interfere with patients' activities. Another is the lengthy initial setup time it takes to pair the devices. Also, most of these devices are limited to using only a few channels to measure the heart. The devices that do come close to fulfilling such objectives are often prohibitively expensive. With these constraints, its obvious that an easy to use affordable multi-channel portable ECG that could operate robustly in harsh environments while consuming minimal power would be the solution to many applications. A thorough discussion of the problem statement for the CardioScope project can be found in Appendix D.

Technical Challenge
At embedic, we evaluate a projects possible technical merit before accepting the assignment. Nine factors are strategically weighted to quantify the technical difficulty of our projects. In order for embedic to accept a project, the technical merit must be greater than 1.0. After reviewing the factors and work to be done we have determined the technical merit for this
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project to be 1.6 out of a total of 1.8. Error! Reference source not found. shows the estimated technical merit for the CardioScope project.

Figure 1. Technical Merit Breakdown

The single factor that will not be considered while completing the project is the requirement for intellectual property protection. This factor is not necessary per our customers requirements. Each factor that we have included towards the technical merit will be further described.

1. Contains a clearly described and completely understood technical challenge Our company has dedicated considerable time to discovering and understanding the technical challenges involved in the CardioScope project through research, brainstorming, and communication with our sponsor and advisor. Since none of our team has previous medical experience, we will be forced to learn more about the cardiac cycle and measurement. We have identified that measuring a persons heartbeat, and displaying it wirelessly to a mobile device is considerably difficult, therefore we have awarded ourselves the full 0.1 points for this factor.

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2. Contains a requirement for system integration CardioScope will measure the human heartbeat, which cannot be predetermined or controlled by our team. It will do this using ECG leads placed in very specific locations across the human body. We will receive, amplify, filter, convert, and transmit the signal in hardware. We will then process and display the signal using software. This meets the requirement for system integration and the full .2 points have been awarded.

3. Contains a requirement for system testing Our company will be testing the prototype hardware and software to ensure the prototype meets all functional and performance requirements. These tests will be based on a test plan generated by our team. This meets the requirement for system testing and the full 0.2 points have been awarded.

4. Contains a requirement for analysis In order to display correct ECG waveforms, CardioScope software will have to analyze the raw received waveform data during post-processing. We will also be doing analysis during our design phase in preparation for the final prototype. These factors justify the full 0.2 points for this factor.

5. Contains hardware design, development, and test The CardioScope project will span multiple revisions of schematics and board layouts. Each version will be revised based on test results from populated PCBs from previous versions. This meets the requirement for designing, developing, and testing of hardware and 0.2 points have therefore been awarded.

6. Contains software design, development, and test Our organization will develop code for a microcontroller as well as a desktop application. This software will be responsible for bidirectional wireless communication, signal processing, multiple configurations, and ECG waveform real-time display. Each revision will be extensively tested. These processes justify the full 0.3 points for technical merit in this category.
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7. Contains hardware fabrication requirement CardioScope will contain a custom enclosure to house the populated PCB and expose the proper connections. The form factor of this enclosure will be small, lightweight, and able to withstand normal abuse. This enclosure justifies the full 0.2 points for this merit factor. 8. Contains external documentation Since our project is part of the Texas Space Grant Consortium Design Challenge, we are required to submit documentation outside of class. This documentation includes three different levels of deliverables. The Level I deliverable includes a formal design project proposal. Level II includes a midterm report consisting of a project timeline, budget, and safety factors. The Level III deliverable includes a final technical report with a checklist. The listed documents justify the full 0.2 points for external documentation.

Benefits
Our group is taking the first step towards developing a wireless multi-channel ECG device by designing and implementing a low-cost hardware prototype which acquires, digitizes, and wirelessly transmits an ECG signal to a nearby computer. Our product CardioScope is a wearable ambulatory ECG device that will measure the electrical activity of a persons heart as they move using up to 10 electrodes. It will be small, lightweight, and it will continuously transmit data to a host computer for up to 24 hours on battery power. The wearable CardioScope unit will be robust and will allow the user to configure the number of electrodes used, the capture resolution, and which filters are applied.

Proposal Structure
The proposal will be divided among sections, which will describe the stages of development for the CardioScope project. Project Scope

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This section will explain the objectives and features of the CardioScope prototype. Any assumptions that have been made will be stated, and a high-level conceptual design will be presented and described.

Statement of Work The Statement of Work will begin with the presentation of the functional block diagram that represents our plan for the CardioScope prototype. A hierarchical representation of the work to be performed will then be presented and described, followed by tables demonstrating the responsible member and estimated duration and labor for each work package. These work packages will then be time-mapped using a Network Logic Diagram to provide an estimate of the project duration and critical path. The project will also be described using another timebased tool, the Gantt chart. Each milestone and deliverable Synonym Systems has committed to will be described and plotted on a timeline, and any additional sponsor requirements will be detailed.

Risk Assessment The major risks that could negatively impact the project schedule or budget will be identified, evaluated, and prioritized. Additionally, a response will be designated for each risk. These risks will also be summarized to provide a chart that can be quickly referenced to determine the most severe risks in the project.

Team Organization and Qualifications This section will establish the justification for each team members respective role in the CardioScope project. A hierarchy chart will also be provided to display the primary responsibilities of each team member.

Project Costs A comprehensive table of project costs will provide descriptions of each specific cost. Also, a timeline of the expected expenditure of funds over the project lifecycle will be provided. This section will display our best financial estimate of our project.

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Appendices The appendices will contain any content that has been referenced in the proposal. This will include any project management tools used; memorandums generated during project planning, team member resumes, and preliminary design documents.

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Section II Project Scope

This section will provide an overview of the objectives for our project, as well as the functionality that the CardioScope will and will not provide. The main objective of our project is to build a prototype called CardioScope. CardioScope will provide NASA with a fully functional 12 lead wireless ECG device. Error! Reference source not found. illustrates an overview of the CardioScope. A Conceptual Design Memorandum describing this figure in detail can be found in Appendix E. Individual objectives, customer requirements, and specifications will be discussed in more detail in the sections to follow. More information on our agreements with our sponsor can be found in Appendix C as well as our presentation slides in Appendix B. A potential quad chart was created to propose a high-level design solution and rough estimations of the cost and time required as shown in Appendix A.

Figure 2. CardioScope Conceptual Diagram

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Wearable ECG The wearable ECG unit must be a small, portable, lightweight, and rugged. The CardioScope prototype must communicate the patients heartbeat over a wireless link to the host computer. Within the device, we will process the raw ECG signal and prepare it for the transmission to the host computer. The signals coming from the electrodes will be less than 1mV so the signals will need to be amplified. These signals will be amplified using instrumentation amps. After the signal has been amplified, oversampling may occur. To solve this issue, the signals will be sent through a low pass anti-aliasing filter. From there, the signals will then be converted from their analog form to digital signals and then sent to a Wi-Fi module. The Wi-Fi module will then send the signals to the host computer.

Host Computer The host computer will have to accomplish several key tasks. It must allow the user the ability to configure the processing and filtering characteristics of the ECG. A real-time display must be included as well so the user can view the ECG signals from the unit in a graphical form. Data storage will also be necessary to enable a playback option of the signals received from the patient at any given point of time. Last, post processing must be available on the host device to compute heart rate and other important information.

Enclosure
Small Size The wearable CardioScope unit will be held to strict standards that have been set by our sponsor. One of these standards is that the unit must not exceed a maximum volume of 400 cm3. This influences our decisions on battery choices as well as the design of the printed circuit board.

Lightweight Our sponsor has specified that the ECG device must not weigh more than 300g. This constraint will limit the components that we choose to use for our hardware. Batteries will be the

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heaviest items within our unit, so it is essential that we focus on lightweight while still meeting an acceptable power density.

Rugged Since CardioScope is a wearable device, it will need to withstand harsh environments, accidental dropping, and exercise on a treadmill.

Hardware
Exclusively Powered By Battery Since the unit will be a wearable and portable device, it will not be able to be attached to wall power. Its important that the device can run on rechargeable batteries.

Long Battery Life Our customer has defined long battery life in three key situations. These situations are 2channel mode, 4-channel mode, and 8-channel mode. The CardioScope when set to the 2channel mode must meet the requirement of staying on for 24 hours. For the 4-channel mode, the device must be able to stay on for 12 hours, and for the 8-channel mode the requirement is 6 hours.

Short Range Wireless The CardioScope device must transmit to the host computer at a minimum distance of 10 feet.

Real-Time Transmission of Data The wireless medium we choose must be able to transmit a minimum theoretical throughput of 160 Kbps.

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Amplification of Signals Signals that come from ECG electrodes are usually less than 1 mV. The TI ECG Analog Front-End chip has 8 programmable gain amplifiers for this task.

Avoidance of Oversampling Issues To meet this requirement, we will use a low pass anti-aliasing filter before the ADC on the microcontroller. This filter will guarantee that only the useful frequencies from the ECG electrodes are sent to the ADC on the microcontroller.

Analog to Digital Conversion Since the ECG leads will sense analog signals from the body, its necessary to convert these signals to digital. This conversion will take place on the TI Analog Front-End chip. As a requirement, our prototype must sample 8 ADC channels simultaneously with at least a 12 bit resolution. The chip must be able to convert up to 8000 samples per second total. This conversion must also be done simultaneously and not sequentially.

Host Computer Receives Data The host computer used to communicate with the CardioScope must have wireless connectivity for data transmission.

Software
Display All Waveforms on Host Device The software on the host computer will display the ECG waveforms that are received from the CardioScope.

Choice Between Multiple Electrode Configurations

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This feature will give the user the ability to setup the CardioScope to read information from 4 to 10 electrodes.

Calculation of Missing Sensor Information From Data The software will also be able to reconstruct ECG information when not all electrodes are in use. When in the 2-channel mode, the data received from the wearable unit will be able to reconstruct 3 signals. If the 8-channel mode is selected, the software will be able to reconstruct 12 signals.

Filter Out AC Power Noise The software will need to use digital filters to remove the 60 Hz noise and harmonics from the ECG signals.

Test Matrix
As a team, we have created a test matrix that will enforce that all requirements have been met for our project. The test matrix is displayed in Error! Reference source not found.. The tests that will be performed are located on the vertical Y-axis and the functional requirements are located on the horizontal X-axis. The Xs that you see on the matrix indicate functional requirement the test covers. Some of the functional requirements are met with multiple tests and some of tests fulfill multiple requirements.

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Table 1: Test Matrix

Battery Life Tests The first functional requirement on the test matrix is battery life. The device running time will prove that we have met this requirement. This test will consist of using a fully charged battery and testing the device running time. We will test the CardioScope in 8-channel mode, 4channel mode, and the 2-channel mode.

Wireless Functionality Tests The Wireless functionality of the CardioScope will be tested by three different tests. These tests include a wireless range test, wireless bidirectional test, and real-time data transmission
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test. The wireless range test will verify the maximum distance between the ECG device and host computer without functional degradation. The wireless bidirectional test will make sure the CardioScope device can send data to the host computer as well as accept commands from the host computer.

Enclosure Tests The next functional requirement is the enclosure. The maximum volume of the enclosure must be less than 400cm3. We will test this by calculating the volume of our exterior measurements. We will also use a weight test to weigh our prototype without leads. Our prototype must not exceed 300g and we will measure this using a digital scale. The last test that will be performed is a rugged test. This test will include running with our prototype on a treadmill as well as normal dropping. The rugged test will also be applied to the safety functional requirement.

Safety Tests The Safety functional requirement will be tested using an electrode protection circuit test, battery short test, and battery discharge test. The electrode protection circuit test will prove that our protection circuit will not allow current to reach the patient. The battery short test verify that the in the case of a battery short, our device will power off safely. The battery discharge test applies to the use of lithium ion batteries. These batteries have specific discharge levels. We will test the CardioScope to make sure the device shuts down before the batteries discharge to an unsafe level.

Oversampling Tests The CardioScope will be using an anti-aliasing filter in the hardware design. This filter is used to prevent oversampling of the ECG signals. We will test our circuit to make sure the filter is not under sampling too or oversampling.

Analog to Digital Tests The ADC functional requirement will be tested by our analog to digital test. During this test, we will be sourcing a known analog signal and be capturing the digital output of the ADC. We will make sure that the digital output corresponds with the known analog signal.
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Signal Amplification Tests The Signal Amplification functional requirement will be tested with the signal magnitude test. We will be sending in a signal into our amplification circuit and monitoring the output to see if the signal has been amplified correctly.

User GUI Tests The last functional requirement that we will test is the user GUI. The user GUI will be tested by the wireless bidirectional test, real time transmission test, filtering characteristics test, channel choice test, and the waveform display test. The filtering characteristics test will check to see if the GUI can change the filtering characteristics of the ECG signals. The channel choice test will validate an option in the user GUI that will give the user the ability to set the CardioScope to read from two channels to eight channels. This will save power if the user doesnt need a detailed ECG reading. The last test is the waveform display test which works by sending a known ECG signal into the CardioScope and verifying the transmission on the host computer.

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Section III Statement of Work

A. Project Design
While a simplified version of the system, the conceptual block diagram, has already been presented, a more detailed look at the hardware is required. This is the functional block diagram, a layout of the hardware that includes all important components required by the circuit as well as how they are connected together. Furthermore, this can be broken down into sections. For the CardioScope hardware, these include: input section, the digital section, and the power section. The Functional Design Memorandum for the CardioScope can be found in Appendix F, and an updated Functional Block Diagram in Appendix L.

Input section
The input section is made up of 4 parts: the electrodes, the cable assembly, the electrode protection circuitry, and the low pass filter.

Electrodes The electrodes are the patches placed on the skin that conduct the voltages from the skin to the cables back to the device. Holter-type electrodes are designed for long-term wear over the course of a day; these will be used in this application. In addition, electrodes with metal button snaps will be used. This is because a cable set with button receptacles will be used, which will be chosen to match an electronic patient simulator using metal snaps. When the CardioScope will be used on a patient, any electrode can be used. For trial purposes, 3Ms Red Dot Multipurpose Monitoring Electrode (3M-2560) will be used as they are designed to stay in place for up to five days.

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Cable Assembly The cable assembly is the component that connects the electrodes to the wearable ECG unit. One end of the cable will have a male DB-15 connector, a 15-pin plug that is frequently used as an ECG cable standard. It should be noted that this is a 2-row DB-15 plug, with 8 pins on the top row and 7 pins on the bottom. This is a physically larger connector than a VGA DB-15 connector, which has 3 rows of 5 pins each in a DB-9 shell. The DB-15 used for the CardioScope is shown in Error! Reference source not found., and the pin-out is laid out in Table 2. The cable assembly will plug into a female DB-15 socket on the wearable ECG unit.

Figure 3. Pin-out of ECG cable DB-15 connector

Table 2: ECG cable pin-out Pin # 1 2 3 4 5 6 7 8 Connection V2 V3 V4 V5 V6 Shield <NC> <NC> Pin # 9 10 11 12 13 14 15 Connection RA LA LL V1 <NC> RL <NC>

The cable will then split into 10 individual shielded cables which each terminate in a female metal snap receptacle. Shielded cables ensure that no extra noise will be added to the small signals traveling through the cable assembly. The snaps will connect either to ECG electrodes placed on the patients body or they will connect to an electronic patient simulator.

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Many ECG cable assemblies use a DB-15 connector on one end and metal snaps on the other. The 10-Lead ECG Cable for Philips/HP Snap Button (0103020013) or a similar assembly will be used for the CardioScope, as seen in Error! Reference source not found..

Figure 4. 10-lead ECG cable assembly

Electrode Protection Circuitry The cable assembly connects the electrodes to the device, but it also connects the device to the patient. In order to ensure the patient is not harmed in the case of a device malfunction, electrode protection circuitry is place on all incoming traces. A large resistor is placed in line with each signal that will limit any current traveling between the device and the patient. This resistor must be both high in resistance, to limit current to less than a couple of milliamps, and large in power dissipation so as not to be damaged in the process. However, a resistor that is too high in resistance will add thermal noise to the signal. Two diodes are placed in parallel with the signal, one pointing from the signal to the analog voltage source (AVDD) and another from the ground (AVSS) to the signal. These diodes will only conduct when the voltage is greater than the 0.7V or less than -0.7V, the forward voltage drop of a diode. Since ECG signals are only a few millivolts at most, any higher voltage will be shunted to power and any lower voltage will be shunted to ground. The resistor and diodes together are shown in Error! Reference source not found..

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AVDD

AVSS

Signal

Figure 5. Electrode protection circuit schematic

Low Pass Filter The final part the signal must pass through before entering the digital section is the low pass filter. This is an anti-aliasing filter, designed to only allow signals below 250Hz. This frequency was chosen because little to no information about the heartbeat exists at that frequency and above, based on the normal range of heart rates a human has. An anti-aliasing filter prevents an ADC from inaccurately sampling an analog signal.

Digital Section
The digital section consists of the TI front-end analog chip, the Microchip microcontroller, and the Wi-Fi module. The front-end analog chip samples and processes the analog ECG signals, the Wi-Fi module transmits the signals wirelessly, and the microcontroller controls both.

TI Analog Front End (AFE) Chip The TI ADS1198 is a chip specifically designed to be an analog front end for an ECG device. It consists of eight differential programmable gain amplifiers (PGAs), eight 16-bit sigma-delta analog to digital converters (ADCs), and a serial peripheral interface (SPI) module to output the digital data. The PGAs allow each channel to have 8 different amplification settings. The sigmadelta ADCs convert the analog signals to digital values in such a way to eliminate the complex analog filters usually required in an analog front-end. The SPI interface allows for the rapid transmission of data from the chip to the microcontroller.
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The ADS1198 is a 64-pin device in a TQFP package as shown in Error! Reference source not found.. Pins IN1 through IN8 are the inputs for each PGA, with the P pins being the non-inverting inputs and the N pins being the inverting inputs. The chip can run on a single-sided supply as long as VCAP1 through VCAP4 are populated. Both an analog 3.0V supply and a digital 1.8V supply are needed to run the chip; these will be separated with separate grounds in order to make sure no digital noise interferes with the analog inputs.

Figure 6. TI ADS1198 ECG Analog Front-end IC pin-out

The TI chip also includes a number of other features typically found with more complicated ECG devices, such as integrated lead-off detection, Wilsons Central Terminal output, and a right-leg driver. Lead-off detection is a method of determining if an electrode is no longer connected to the device. One way of doing this is to tie each electrode to the positive rail of the device. If the electrode is not connected, it acts as an open circuit. The pull-up resistor raises the voltage to the positive rail, which can be detected by the user. Wilsons Central Terminal is required to utilize the unipolar ECG electrodes V1-V6. It is an average of the right arm, left arm, and left leg
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signals, which creates a virtual terminal in the center of the patients chest. This is used to reference the other electrodes and therefore is placed on the inverting inputs of the PGAs used for V1 through V6. The right-leg driver is a way of further reducing common mode noise by sending a voltage to the right leg electrode to drive the rest of the body. An average of all the incoming signals are taken, this average is inverted, and then sent to the right leg. All these features are included in the ADS1198 chip, as well as others that are not being used. Error! Reference source not found. shows the block diagram of the TI chip.

Figure 7. Block Diagram of TI ADS1198 chip

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The TI front end chip will amplify and digitize the 8 ECG channels simultaneously. These digital values will be sent to the microcontroller via a 4-wire SPI interface. This interface has 4 connections: clock, data in, data out, and chip select. The data lines are crossed over between two SPI devices, the data in from one connected to the data out from another and vice versa. The chip select line is a simple digital I/O that activates the SPI interface when it is low. This device acts as an SPI slave device while the microcontroller acts as the master. In the SPI system, only a master can initiate communication; since the AFE chip needs to let the microcontroller know when the data is ready, it has a DRDY line. This is connected to the microcontroller and configured as an interrupt; when the AFE chip causes a line change when it is ready, the microcontroller will initiate SPI communication. The TI AFE chip requires two voltage sources, one 3.0V source for analog and another 1.8V source for digital. With the population of VCAP1 through VCAP4, the chip can amplify both positive and negative voltages with a single-sided supply.

Microcontroller The Microchip PIC24FJ64GB002 16-bit microcontroller will be used to take in the data from the TI AFE chip and send it to the Wi-Fi module. This PIC was chosen because it has very low power consumption and two SPI modules. The PIC24 will be tasked with both configuring and receiving data from the AFE chip through one of its SPI interfaces. It will then store this data in local memory until a set time period has passed, such as 100ms, and then package it into a UDP packet. This packet will be sent over the second SPI interface to the Wi-Fi module. The PIC24 has no dedicated pins for either of the SPI interfaces. All the pins on this microcontroller are remappable, meaning any pin from RP0 to RP15 can be configured to any of the modules the PIC24 has. The pin-out for the 28-pin device is in Figure 8. The first SPI module will be dedicated to the TI AFE chip, while the second will be dedicated to the Wi-Fi module. In this way, data can be received and sent simultaneously, which is required for real-time transmission. Pins RP0 through RP2 will be used for the first SPI clock, data out, and data in, respectively. These will be connected to the clock, data in, and data out pins on the TI AFE chip, respectively. Pin RB3 will be configured as a general purpose I/O and used as an SPI chip select for the AFE chip. Additionally, pin CN27 will be configured as the interrupt pin connected to the AFEs data ready pin. To connect the Wi-Fi module, 8 pins are required. Pins RP13 through RP15 will be used for the second SPI clock, data out, and data in, respectively. These will be connected to the Wi-Fi modules clock, data in, and data out pins. Pins RB8 through RB11 will be configured as general
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purpose digital outputs. Pin RB11 will be connected to the Wi-Fi modules SPI chip select pin. Pin RB10 will be connected to the hibernate pin, pin RB9 will be connected to the write protect pin, and pin RB8 will be connected to the reset pin. Finally, pin CN23 will be configured as an interrupt and connected to the interrupt pin on the Wi-Fi module. A number of other pins must be connected so that the PIC can function properly. All VDD pins will be supplied with 3.0V, and all VSS pins will be connected to digital ground. The PICs internal voltage regulator will be disabled by tying DISVREG to VDD, which also means VCAP will not have a capacitor on it and will be tied directly to VDD as well. The OSCI and OSCO pins will be used for an external oscillator. Finally, pins PGED3 and PGEC3 will be brought out to headers to allow programming of the device.

Figure 8. PIC24FJ64GB002 pin-out

Wi-Fi Module In order to transmit the ECG data wirelessly, the PIC24 microcontroller will send the data to the Microchip MRF24WB0MA Wi-Fi module. The Wi-Fi module contains an 802.11b 2.4GHz radio with a maximum throughput of 2Mbps. An SPI interface is used to transmit and receive data to and from the microcontroller. In addition to the four pins needed for SPI, four more pins are used for various control signals. In order to control the Wi-Fi module, Microchip provides a free stack that runs on their PIC microcontrollers. This free stack also includes the UDP/IP protocol that will be used to encapsulate the data. The Wi-Fi module comes in a 36-pin surface mount package with specific mounting characteristics, as shown in Figure 9. There are 8 pins that must be connected to the microcontroller, as well as the required power and ground pins. These connections were detailed in the microcontroller section.

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Figure 9. Microchip Wi-Fi module pin-out

The UDP/IP protocol was chosen for this application. The User Datagram Protocol is a connectionless protocol with very low packet overhead that is well suited for rapid data transmission. The primary drawback of UDP is that there is no way to ensure the packets will reach the host computer, and there is nothing in the protocol that deals with resending packets. However, in this application dropped data is not a problem; it is more important to have the latest data on the host computer.

Power System
The power system supplies power to all components on the board, and consists of the batteries, the low-voltage cutoff circuit, and the voltage regulators.

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Batteries The batteries chosen for the CardioScope are a pair of single cell lithium-ion batteries. The lithium-ion chemistry was chosen for its excellent power density in comparison to other batteries. Each cell is in a standard 18650 package (18mm diameter, 650mm long), which is a single 3.7V cell. Two cells with a capacity of 2800mAh each will be placed in parallel to form a 3.7V supply with 5600mAh capacity. If the major components consume approximately 118mA (Table 3) and other components, such as voltage regulators and pull up resistors, consume even 7mA, this will mean the device will consume 125mA. With a 5600mAh supply, this means the device will run for 44 hours before needing to be replaced. In order to avoid the complexity of adding a safe way to charge the Li-ion batteries in the device, the batteries will be removable allowing any standard Li-ion 18650 cell charger to be used.
Table 3: Power budget of major components Device TI AFE chip PIC24 microcontroller (1MIPS) 802.11b module (+0dBm) Total Max Power Consumption (mA) 1.7 1.4 115 118.1

Low Voltage Cutoff Circuit Safety is a major concern with Li-ion batteries, as being over discharged can damage the batteries. While one solution is to only purchase Li-ion cells with built-in protection circuitry, a dangerous condition can still exist if non-protected batteries are used accidentally. To prevent the Li-ion cells from being over discharged, a voltage monitoring component will be used. If the voltage drops below 2.7V, then the circuit will disable the voltage regulators in the circuit. This will cut power to all components in the device, stopping current draw and preventing the battery from being damaged.

Voltage Regulators In order to power all the components of the device, battery voltage must be converted into a regulated voltage. Two voltages are required in the device: 1.8V for DVDD on the TI AFE chip,
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and 3.0V for everything else on the board. As this is a battery powered device, the voltage regulator must have a low dropout voltage and must have low quiescent current draw. While the battery voltage will be 3.7V when it is fully charged, the voltage will drop as the battery is used. A low dropout (LDO) regulator is important so less voltage is wasted making sure the regulator can run, which means longer run-time for the whole device. Of the 125mA expected current draw, less than 1mA will be used for the digital components on the AFE chip. This means the 1.8V regulator needs to source very little current and a cheaper component can be chosen. For the 3.0V regulator, it will source at least 200mA.

B. Work to be Performed
Work Breakdown Structure
The work breakdown structure is a tool that is used to represent the work that will be done during a project in a hierarchical manner. This structure is divided into different levels. The top most level is the project. The project is then divided into phases, activities, tasks, subtasks, subsubtasks, and work packages. Work packages are found at the lowest levels of the work breakdown structure, and are called work packages because they represent actual work to be done. Each of these work packages is measured in days. The CardioScope project consists of six phases. These phases include Research, Design, Proof of Concept, Final Product, Testing, and Documentation as shown in Error! Reference source not found..

Figure 10. WBS Top Level

Research

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The research phase is the first phase of the CardioScope. During this phase information will be gathered to aid in the design and implantation of the project. The information we collect will give our team a better understanding of the problem we are solving. During this time, we will select components necessary to design the CardioScope prototype. This phase is comprised of seven activities, which include: ECG Technology, Analog Front End, Microcontroller, Wireless Communications, Power, Software, and Product Standards. These activities are shown in Figure 11.

1.0 Research

1.1 ECG Technology

1.2 Analog Front End

1.3 Microcontroller Wireless

1.4 Power

1.5 Software

1.6 Product Standards

1.7

Figure 11. WBS Research

The first activity that will be discussed is ECG technology. The breakdown of this activity is shown in Figure 12. This activity includes two tasks to be completed, electrodes and leads/channels. During the electrodes task, we will research the different types of electrodes on the market. The research will include how the electrodes will be attached to the patient as well as the form factor necessary to attach the electrodes to the CardioScope device. The next task that will be addressed is research on leads and channels. Both of these tasks are essential to developing and designing the hardware for the CardioScope.

1.1 ECG Technology

1.1.1 Electrodes

1.1.2 Leads / Channels

Figure 12. WBS ECG Technology

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After ECG technology research has been completed, our next step is to do more research on the topic of the analog front-end. The breakdown of this activity is shown in Figure 13. The analog front-end activity will include two different tasks, amplification and filtering. Since the body produces such low voltages, amplification is necessary in order to use the ECG waveforms for analysis. We must understand how to amplify these signals as well as find the best components for the situation. The CardioScope will need to filter the signals before they are transferred to the microcontrollers ADC, so its also important for our team focus on the type of filter necessary, the cutoff frequency of the filter, and specific components that will be needed.
1.2 Analog Front End

1.2.1 Amplification

1.2.2 Filtering

Figure 13. WBS Analog Front End

Furthermore, we must find a microcontroller that will meet our specific needs. This activity is shown in Figure 14 and includes two tasks to be completed. The first task will involve research on analog to digital conversion. During this task we will focus on understanding the type of ADC that will meet our customers requirement and if the microcontroller can meet those requirements. The next task will be research on the serial protocol interface. This is a communication protocol that will be needed to communicate with our wireless module.

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1.3 Microcontroller

1.3.1 ADC SPI

1.3.2

Figure 14. WBS Microcontroller

Our next activity, wireless communications, is shown in Figure 15. This activity is composed of two tasks, physical medium and protocol. During the physical medium task, we will research the different wireless devices and modules on the market. Within the protocol task, we will research different protocols available. This will help us select a wireless communication that will fit the needs of our project.

1.4 Wireless Communications

1.4.1 Physical Medium/ Technology

1.4.2 Protocol

Figure 15. WBS Wireless Communications

Our next step is to do research on power, as shown in Figure 16. This activity will consist of two tasks, batteries and voltage regulation. Battery research is imperative to meet the weight and volume requirements of our device. We will compare the variety of batteries on the market today by focusing on battery capacity and size. Voltage regulation is also an important aspect of our project as shown. We will research multiple components and focus on those that have low dropout voltage characteristics.

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1.5 Power

1.5.1 Batteries

1.5.2 Voltage Regulator

Figure 16. WBS Power

Software research is key in the design of our prototype. Figure 17 shows a breakdown of how we separated software research tasks. These tasks include the software language and IDE. There are many languages and IDEs available, but choosing the combination that will meet our needs best will be a challenge.

1.6 Software

1.6.1 Language IDE

1.6.2

Figure 17. WBS Software

The last activity that will be addressed in our research phase is the product standards activity shown in Figure 18. The tasks within this activity include vibration and impact. These two factors must be addressed in order for our prototype to withstand normal activities during operation.

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1.7 Product Standards

1.7.1 Vibration Impact

1.7.2

Figure 18. WBS Product Standards

Design
The next phase of the CardioScope prototype is the design phase. During this phase, the design and development of our key functional features will take place. The hierarchy of this phase is shown in Figure 19. This phase will include several activities, including the design of the alpha schematic, alpha PCB layout, component selection, pseudocode, enclosure design, and the design of a test plan.

2.0 Design

2.1 Alpha Schematic Alpha PCB Layout

2.2

2.3 Component Selection

2.4 Pseudocode

2.5 Enclosure Design Test Plan

2.6

Figure 19. WBS Design

The first activity that will be completed in the design phase will be the alpha schematic. The breakdown of this activity is shown in Figure 20. The tasks in the activity will be completed using National Instruments Multisim schematic capture program. After all tasks have been completed, the alpha schematic will be reviewed for approval. If approved, we will begin the layout stage of the alpha prototype.
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2.1 Alpha Schematic

2.1.1 Alpha Front End Schematic

2.1.2 Alpha Microcontroller Schematic

2.1.3 Alpha Wireless Schematic

2.1.4 Alpha Power Schematic

2.1.5 Alpha Safety Schematic

2.1.6 Alpha Schematic Review

Figure 20. WBS Alpha Schematic

The alpha PCB layout activity will be the next activity to be completed. The hierarchical representation of this activity is shown in Figure 21. There are two tasks during this activity, alpha layout and alpha layout review. The finalized alpha schematic will be used and transferred to a PCB layout using National Instruments Ultiboard. After the layout has been completed, it will be reviewed for approval. If approved, we will begin to order our first PCBs.

Alpha PCB Layout

2.2

2.2.1 Alpha Layout

2.2.2 Alpha Layout Review

Figure 21. Alpha PCB Layout

The component selection activity will consist of five separate tasks shown in Figure 22. The front-end component selection task will consist of the choice components needed to amplify and filter the ECG signals coming from the patient. The microcontroller selection task will focus on the proper microcontroller to fit the needs of the project. We will focus on a few main properties in choosing the microcontroller such as processing speed and communication.
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During the wireless module selection task, we will concentrate on finding a Wi-Fi module that will work correctly with our selected microcontroller. This module must have low power properties as well as a small form factor. During the power component selection, we will select the batteries and voltage regulators needed. After all components have been selected, a Bill of Materials Review will be conducted.
2.3 Component Selection

2.3.1 Front End Component Selection

2.3.2 Microcontroller Selection

2.3.3 Wireless Module Selection

2.3.4 Power Component Selection

2.3.5 Bill of Materials Review

Figure 22. WBS Component Selection

The pseudocode breakdown is shown in Figure 23. The microcontroller pseudocode task will consist of high-level microcontroller code that will primarily use communications such as SPI and UDP. The host device pseudocode will also be completed. During this task, high-level code will be written in order to better understand the functionality necessary to communicate, filter, and display ECG waveforms. Also within this activity, we will start the design and development of the graphical user interface. This task will involve the creation of drawings and layouts that will define the user GUI. After all pseudocode has been completed, it will be reviewed for approval.

2.4 Pseudocode

2.4.1 Microcontroller Pseudocode

2.4.2 Host Pseudocode

2.4.3 Host GUI Mockup

2.4.4 Pseudocode Review

Figure 23. WBS Pseudocode

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Enclosure design is the next activity we will focus on, displayed in Figure 24. We will use Solid Works, a 3D design program, for the majority of tasks completed under this activity. The enclosure drawings task will include the mock up drawings to create the enclosure. Once the drawings have been reviewed and approved, they will then be recreated in Solid Works to develop the 3D models. After the 3D models have been completed, a review will take place for approval of the design.
2.5 Enclosure Design

2.5.1 Enclosure Drawings

2.5.2 Enclosure Drawing Review

2.5.3 Enclosure 3D Models

2.5.4 Enclosure 3D Model Review

Figure 24. WBS Enclosure Design

The last activity in this phase is the Test Plan activity, shown in Figure 25. During this activity, three tasks will be completed. These tasks include: the hardware test plan, microcontroller code test plan, and host code test plan. The hardware test plan will consist of verifying that the hardware of the CardioScope is working as desired. The microcontroller test plan will focus on verifying the code that will setup the microcontroller to perform processes such as SPI communication. The host code test plan will validate that the host code performs to all the specifications that the customer has set forth.

2.6 Test Plan

2.6.1 Hardware Test Plan

2.6.2 Microcontroller Code Test Plan

2.6.3 Host Code Test Plan

Figure 25. WBS Test Plan

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Proof of Concept Prototype

The next phase of the project will be the Proof of Concept Prototype phase. During this phase, a simple prototype will be constructed to prove that our design choices will work. This prototype will consist of breadboards and development boards. There will be five activities that will be completed which are displayed Figure 26.

3.0 Proof of Concept (PoC) Prototype

3.1 Prototype Procurement

3.2 Prototype Construction

3.3 Microcontroller Programming Host Demo Program

3.4 Prototype Debugging

3.5

Figure 26. WBS Proof of Concept

During the Prototype Procurement stage, there will be three tasks that will be completed which are displayed in Figure 27. Prototype parts selection will include the selection of development boards and parts needed to develop our design for the project. After the parts have been selected, they will be reviewed. After the parts have been approved, we will order the parts.
3.1 Prototype Procurement

3.1.1 Prototype Parts Selection

3.1.2 Prototype Parts Review

3.1.3 Order Prototype Parts

Figure 27. WBS Prototype Procurement

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Prototype construction will involve the construction of the prototype parts that will be ordered. The breakdown of this activity is displayed in Figure 28. The single channel circuit task will involve construction of one ECG channel to simplify the development process and decrease the chance of errors as well as debug time. During the PIC Development Board Task, we will create a development board for our microcontroller. This will give us the ability to breakout the pins of the device so we can easily interface it with other modules for testing purposes. During the wireless module task, we will source a wireless module to interface to the CardioScope. After the construction of the prototype hardware has been completed, it will be reviewed for approval.
3.2 Prototype Construction

3.2.1 Single Channel Circuit

3.2.2 PIC Dev Board

3.2.3 Wireless Module

3.2.4 Prototype Hardware Review

Figure 28. WBS Prototype Construction

The next activity is the microcontroller programming activity, which is displayed in Figure 29. During the initialization code task, the code to initialize the microcontroller will be created. The ADC Code task will involve the programming necessary to successfully convert the ECG analog signal to digital. The next task will verify that the microcontroller is setup to transmit information to the wireless module. Once all the tasks have been completed, they will be reviewed.
3.3 Microcontroller Programming

3.3.1 Initialization Code

3.3.2 ADC Code

3.3.3 Wireless Code

3.3.4 Microcontroller Code Review

Figure 29. WBS Microcontroller Programming

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The demo host program activity is shown in Figure 30. During this activity, several tasks will be completed. The Get Data task will prove that the host computer can receive data from the proof of concept prototype. The host program must be able to apply filters to the ECG signals that are received from the CardioScope. The Save Data task will allow the user to save the transmitted data for later use. Plot Data will visualize the data on the host computer. After the all the tasks have been completed for this activity, they will be reviewed.
3.4 Demo Host Program

3.4.1 Get Data

3.4.2 Filter Data

3.4.3 Save Data

3.4.4 Plot Data

3.4.5 Host Demo Program Review

Figure 30. WBS Demo Host Program

Once all software and hardware development has been completed, the prototype debug and test activity will take place as shown in Figure 31. The ADC Debug and Test task will verify that the ECG signals are being converted from analog to digital correctly and efficiently. The next task will be the Wireless Client Debug and Test. During this task, we will test the wireless module on the prototype by verifying that it is receiving data from the microcontroller. The Wireless Host Debug and Test task will be a check to see if the host computer is able to communicate with the prototype. In the next task, we will test the filtering characteristics of the host computer. The Display Debug and Test task will verify that the ECG signals are being displayed properly. Finally, the Single Channel Circuit Debug and Test task will validate the hardware for the entire prototype circuit.
3.5 Prototype Debug & Test

3.5.1 ADC Debug & Test

3.5.2 Wireless Client Debug & Test

3.5.3 Wireless Host Debug & Test

3.5.4 Filter Debug & Test

3.5.5 Display Debug & Test

3.5.6 Single Channel Circuit Debug & Test

Figure 31. WBS Prototype Debug and Test

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Final Product
This phase will consist of creating the final revision of the CardioScope. The hierarchy of the phase is shown in Figure 32. This phase contains multiple activities and tasks that will complete our final prototype for our project.
4.0 Final Product

4.1 Final Procurement Alpha PCB

4.2 Beta PCB

4.3

4.4 Final Programming

4.5 Final Debugging Enclosure

4.6

Figure 32. WBS Final Product

The final procurement activity will consist of two tasks shown in Figure 33. Within these two tasks, we will order all components and our alpha PCB.

4.1 Final Procurement

4.1.1 Order Bill of Materials

4.1.2 Order Alpha PCB

Figure 33. WBS Final Procurement

During the Alpha PCB activity, we will construct our prototype. Figure 34 shows the various tasks required to complete this activity. The first task is to populate the Alpha PCB with the components that have been ordered. After the PCB has been populated, the PCB will need to be debugged and tested for hardware issues. The test results will be reviewed to find changes that will needed for our beta PCB.

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4.2 Alpha PCB

4.2.1 Alpha PCB Population

4.2.2 Alpha PCB Debug & Test

4.2.3 Alpha PCB Review

4.2.4 List of Alpha PCB Changes

Figure 34. WBS Alpha PCB

After the Alpha PCB task has been completed, we will begin the Beta PCB activity. This activity is shown in Figure 35. The first task we will focus on is to make any schematic changes necessary. These changes will result from our thorough alpha PCB testing. After this task has been completed, the updated schematic will be reviewed. Once the review is approved, the beta PCB layout will be developed, reviewed, and approved. After approval, we will order the PCB and begin population of the board. During the Beta PCB Debug and Test task, we will verify that the fully populated beta PCB is working correctly. The beta PCB will be reviewed for approval.
4.3 Beta PCB

4.3.1 Schematic Changes for Beta PCB

4.3.2 Beta Schematic Review

4.3.3 Beta PCB Layout

4.3.4 Beta PCB Layout Review

4.3.5 Order Beta PCB

4.3.6 Beta PCB Population

4.3.7 Beta PCB Debug & Test

4.3.8 Beta PCB Review

Figure 35. WBS Beta PCB

The final programming activity will consist of the several tasks that will wrap up the software portion of the CardioScope prototype. The hierarchy of this activity is shown in Figure 36. During the Microcontroller Code Changes task, we will assess the current revision of microcontroller code and make changes if necessary. The next task will address the host code. Within this task, there are several subtasks such as host data collection code, host digital filter code, hose data save and load code, host display code, and host unit control code. If all subtasks are competed, we will continue to a code review. This code review will be a final look at the functionality of the prototype host software before debugging.

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4.4 Final Programming

4.4.1 Microcontroller Code Changes

4.4.2 Full Host Application

4.4.3 Code Review

4.4.2.1 Host Data Collection Code

4.4.2.2 Host Digital Filter Code

4.4.2.3 Host Data Save/ Load Code

4.4.2.4 Host Display Code

4.4.2.5 Host Unit Control Code

Figure 36. WBS Final Programming

During the final debugging activity, we will focus on debugging the final revision of the microcontroller code as well as the host program code. This activity is displayed in Figure 37. In the Microcontroller Code Debugging task, we will inspect all relevant code and stress the software to set limits in order to find weaknesses. We will do the same debugging with the host software.
4.5 Final Debugging

4.5.1 Microcontroller Code Debugging

4.5.2 Host Program Code Debugging

Figure 37. WBS Final Debugging

The final enclosure activity focuses on the construction of the exterior enclosure. The breakdown of this activity is displayed in Figure 38. During the Alpha Enclosure Creation task, we will construct the enclosure. After the enclosure is constructed, we will evaluate and make note of any necessary changes. If changes are needed, we will make those changes to the beta enclosure. We will evaluate the updated design of the beta enclosure before we move on to
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the construction of the enclosure. The final task that will be finished is Beta Enclosure Testing. This will test the ruggedness and durability of the enclosure.
4.6 Final Enclosure

4.6.1 Alpha Enclosure Creation

4.6.2 Alpha Enclosure Evaluation

4.6.3 Make Changes to Enclosure Design

4.6.4 Beta Enclosure Design Review

4.6.5 Beta Enclosure Creation

4.6.6 Beta Enclosure Testing

Figure 38. WBS Final Enclosure

Testing
During the testing phase, we will verify all components of the CardioScope prototype work as desired. This phase is displayed in Figure 39 and will address the hardware components, software, and system integration of our prototype.
5.0 Testing

5.1 Hardware Testing

5.2 Software Testing System Integration Testing

5.3

Figure 39. WBS Testing

The hardware testing activity will address the hardware aspects of the CardioScope as shown in Figure 40. The analog front-end task will test the ECG signals before they reach the microcontroller. The ADC task will test to verify the ECG signals are being converted from analog to digital correctly. In this task, we will confirm that the ADC is achieving the requirements that have been set forth by our customer. The last hardware task will focus on the wireless functionality, specifically the wireless module. It will verify that the module is receiving the data from the microcontroller and is able to relay it to the host computer. We will also test a variety of power options with the wireless module as well.

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5.1 Hardware Testing

5.1.1 Analog Front End Testing

5.1.2 ADC Testing

5.1.3 Wireless Testing

Figure 40. WBS Hardware Testing

The software activity will validate the software that will be running the CardioScope prototype. The breakdown of this activity is shown in Figure 41. In this activity, we will thoroughly test the microcontroller software as well as the host software.
5.2 Software Testing

5.2.1 Microcontroller Code Testing

5.2.2 Host Code Testing

Figure 41. WBS Software Testing

System integration testing is necessary to verify that the device will perform correctly out of the lab environment. This activity is displayed in Figure 42. The first task will test our project while it is stationary. Once the device can perform correctly on a stationary patient, we will then test our device while the patient is walking and then running. This will verify that a patient can wear the device during normal activity.

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5.3 System Integration Testing

5.3.1 Stationary Test

5.3.2 Walking Test

5.3.3 Running Test

Figure 42. WBS System Integration Testing

Documentation and Close Out

Documentation and close out will be the final phase of our project. In this phase, we will complete our documentation, presentations, and any clean up necessary. This phase is displayed in Figure 43.
6.0 Documentation & Close-out

6.1 Documentation

6.2 Presentations Clean-up

6.3

Figure 43. WBS Documentation and Close-out

The documentation activity is displayed in Figure 44. This activity includes an instruction manual we will give to our customer with all information needed to use the CardioScope. Aside from the instruction manual, we will also complete a final report describing our project.

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6.1 Documentation

6.1.1 Instruction Manual

6.1.2 Final Report

Figure 44. WBS Documentation

The presentation activity will include several important tasks over the length of our project. The breakdown of this activity can be seen in Figure 45. We will participate in weekly TAT meetings throughout the semester to keep our project on schedule. During mid-semester, we will present a Critical Design Review that will display the work that has been completed, as well as the work to be done. We will prepare a PowerPoint presentation and demonstrate the functionality of our project at that stage. The final presentation will occur at the end of the semester and will include a PowerPoint presentation and a demonstration of our final prototype.

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6.2 Presentations

6.2.1 TAT Meetings

6.2.2 Critical Design Review

6.2.3 Final Presentation

6.2.2.1 CDR PowerPoint Presentation

6.2.3.1 Final PowerPoint Presentation

6.2.2.2 CDR Demo Preparation

6.2.3.2 Final Demo Preparation

6.2.2.3 CDR Presentation Preparation

6.2.3.3 Final Presentation Preparation

Figure 45. WBS Presentations

The last activity that we will participate in is the clean up activity, which is displayed Figure 46. During this activity we will be responsible for any clean up necessary of our Capstone Design Suite.
6.3 Clean-up

6.3.1 Clean Up Lab

6.3.2 Return All Keys

Figure 46. WBS Cleanup

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C. Precedence Diagram
A precedence diagram, such as a network logic diagram (NLD) is used to determine the order in which work packages will be completed. The NLD is also used to determine total project duration, slack, and the critical path. The critical path is a sequence of work packages that must be completed on time in order to finish the entire project on time. Slippage in any work package on the critical path means the project finish date will be extended. On the forward pass of creating the NLD, the final project duration is calculated; this is the amount of time it will take the team, working in parallel, to complete the project. On the reverse pass, slack is calculated, which is the duration for each package that it can be delayed while still keeping on schedule. From this calculation, there will be a sequence of work packages that have zero slack; this sequence is the critical path. The NLD (Appendix Ib) shows that the project will be complete in 70 days and the critical path involves 30 work packages. For the majority of the project, the hardware engineer will be on the critical path, but the project manager is on the critical path at the end of the project. As there is a good amount of hardware to design and build for this project, this is not unusual. The critical path begins in the Research Phase with research into Amplification, the Voltage Regulator, and Vibration testing research. The next phase, Design, begins with the Front End Component Selection work package as being on the critical path. This is choosing the components that will be handling the ECG analog voltages before they are digitized, and includes parts for the anti-aliasing filter and amplifiers. Next on the critical path is the Bill of Materials Review, which will review the parts, which will be purchased for the device. Next, the critical path splits; this is not normal, but because some of the packages will be done simultaneously and those packages have the same length, technically they are both on the path. The Alpha Front End schematic, Alpha Safety Schematic, Alpha Microcontroller Schematic, and Alpha Wireless schematic cover four of the five major components on the board (the Alpha Power Schematic is not on the path). These schematics will consist of the symbolic circuit layout of each module combined onto one board. After this, the Alpha Schematic Review looks over the schematic and makes any required changes. Alpha Layout can then proceed, where the parts and traces for the printed circuit board (PCB) are determined. The Alpha Layout Review is similar to the schematic review, where the design is looked over and changed if necessary. These schematic and layout task are both extremely important and extremely time consuming, which is why they are on the critical path. Finally, the Hardware Test Plan work package is on the path, because without a solid test plan it will not be possible to test the hardware for functionality and reliability.
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In the next phase, Proof of Concept Prototype, the Single Channel Circuit Debug and Test work package is first on the critical path. This package has a co-dependency with the Order Prototype Parts work package; the single channel circuit cannot be debugged without receiving the parts. This debug work package will be done simultaneously while building the circuit, but the Single Channel Circuit is not on the critical path. While the proof of concept prototype is being reviewed, the Order Alpha PCB critical path work package will be done; as this requires waiting for the PCB to be fabricated and shipped, this will take time. In addition, the PCB cannot be populated without it arriving, which is another reason it is on the critical path. The Final Prototype phase critical path covers the Alpha and Beta PCB purchase, population, and test. The system integration tests that follow cannot be completed without fully working hardware; therefore, the hardware is the critical path. The Alpha PCB Debug and Test follows, to make sure the board works. The critical path splits again to cover both the Alpha PCB review and the Schematic Changes for Beta PCB; these work packages find problems and then fix those problems on the schematics for the second PCB, respectively. The Beta Schematic Review finishes the schematic portion of the Beta PCB; the Beta PCB Layout and Beta PCB Layout review finish the Beta PCB design. The Order Beta PCB work package gets the device, and the following Beta PCB Debug and Test along with the Beta PCB Review work packages finish the Beta PCB work. At this point, the critical path leaves the hardware engineer and is transferred to the project manager for the last two phases. The last work packages for the Testing phase on the critical path are Wireless Testing, Walking Test, and Running Test. These tests cannot be completed until the final beta PCB is fully operational. The first test is for wireless reliability and range, while the second and third tests are system integration tests done while the unit is being worn while walking and running. The final critical path work packages are in the Documentation and Close-out phase, and are Final Report, Clean-up Lab, and Return All Keys. The final report cannot be completed until all other tasks from all the members are completed. Likewise, the lab cannot be cleaned up and the keys cant be returned unless everything previous has been completed. The largest amount of slack in the project is 21 days in portions of the project managers path in the NLD. It occurs during primarily during the Proof of Concept Prototype phase for 8 work packages. There is a large amount of slack at this point because the project manager requires the PCB to be built and fully working before putting the microcontroller code on it. The project manager will assist the hardware engineer and software engineer in their tasks if this slack is not used.

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D. Task Schedule
The overall schedule for the project is shown in Error! Reference source not found., a Gantt chart for the level 0 view of the project. The Gantt charts for each phase are shown in Figure 48, Figure 49, Figure 50, Figure 51, Figure 52, and Figure 53. For more information regarding the corresponding work package consult Appendix H for the project Responsibility Assignment Matrix.

Jan 2011

Feb 2011

Mar 2011

Apr 2011

ID 1 2 3 4 5 6

Task Name 1.0 Research 2.0 Design 3.0 Proof of Concept Prototype 4.0 Final Prototype 5.0 Testing 6.0 Documentation and Closeout

Start 1/17/2011 1/25/2011 2/11/2011 3/11/2011 4/14/2011 4/25/2011

Finish 1/26/2011 2/15/2011 3/17/2011 4/14/2011 4/22/2011 5/6/2011

Duration
1/23 1/30 2/6 2/13 2/20 2/27 3/6 3/13 3/20 3/27 4/3 4/10 4/17 4/24 5/1

8d 16d 25d 25d 7d 10d

Figure 47: Level 0 Gantt Chart

Jan 16 2011

Jan 23 2011 19 20 21 22 23 24 25 26

ID 1 2 3 4 5 6 7

Task Name 1.1 ECG Technology 1.2 Analog Front End 1.3 Microcontroller 1.4 Wireless Communications 1.5 Power 1.6 Software 1.7 Product Standards

Start 1/17/2011 1/17/2011 1/20/2011 1/17/2011 1/19/2011 1/20/2011 1/20/2011

Finish 1/19/2011 1/18/2011 1/21/2011 1/19/2011 1/19/2011 1/26/2011 1/24/2011

Duration
17 18

3d 2d 2d 3d 1d 5d 3d

Figure 48: Research phase Gantt chart

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Jan 23 2011

Jan 30 2011 27 28 29 30 31 1 2 3 4 5

Feb 6 2011 6 7 8 9 10 11 12

Feb 13 2011 13 14 15

ID 1 2 3 4 5 6

Task Name 2.1 Alpha Schematic 2.2 Alpha PCB Layout 2.3 Component Selection 2.4 Pseudocode 2.5 Enclosure Design 2.6 Test Plan

Start 1/31/2011 2/7/2011 1/25/2011 1/25/2011 2/7/2011 2/11/2011

Finish 2/4/2011 2/10/2011 1/28/2011 1/28/2011 2/15/2011 2/15/2011

Duration
25 26

5d 4d 4d 4d 7d 3d

Figure 49: Design phase Gantt chart

Feb 2011

Mar 2011 2/27 3/6 3/13

ID 1 2 3 4 5

Task Name 3.1 Prototype Procurement 3.2 Prototype Construction 3.3 Microcontroller Programming 3.4 Host Demo Program 3.5 Prototype Debugging

Start 2/11/2011 2/24/2011 2/15/2011 2/11/2011 3/4/2011

Finish 2/23/2011 2/28/2011 3/3/2011 3/3/2011 3/17/2011

Duration
2/13 2/20

9d 3d 13d 15d 10d

Figure 50: Proof of Concept Prototype phase Gantt chart

Mar 2011

Apr 2011 3/27 4/3 4/10

ID 1 2 3 4 5 6

Task Name 4.1 Final Procurement 4.2 Alpha PCB 4.3 Beta PCB 4.4 Final Programming 4.5 Final Debugging 4.6 Enclosure

Start 3/8/2011 3/15/2011 3/24/2011 3/11/2011 3/31/2011 4/5/2011

Finish 3/14/2011 3/23/2011 4/8/2011 3/23/2011 4/14/2011 4/14/2011

Duration
3/13 3/20

5d 7d 12d 9d 11d 8d

Figure 51: Final Prototype phase Gantt chart

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Apr 10 2011

Apr 17 2011 16 17 18 19 20 21 22

ID 1 2 3

Task Name 5.1 Hardware Testing 5.2 Software Testing 5.3 System Integration Testing

Start 4/14/2011 4/14/2011 4/15/2011

Finish 4/22/2011 4/22/2011 4/22/2011

Duration
14 15

7d 7d 6d

Figure 52: Testing phase Gantt chart

Feb 2011

Mar 2011 2/20 2/27 3/6 3/13 3/20 3/27 4/3

Apr 2011 4/10 4/17 4/24

ID 1 2 3

Task Name 6.1 Documentation 6.2 Presentations 6.3 Clean-up

Start 4/21/2011 1/26/2011 5/2/2011

Finish 4/29/2011 4/29/2011 5/3/2011

Duration
1/30 2/6 2/13

7d 68d 2d

Figure 53: Documentation & Close-out phase Gantt chart

E. Milestones
Milestones are significant to our team and are generally small goals that we set in order to move forward each week. Its vital that we meet these milestones, as shown in Figure 54, since most are just part of a large deliverable that has been broken down into more manageable tasks.

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Figure 54: Milestones Timeline

Research Completed At this stage, all research will be completed and our team will be ready to continue to the design phase of our project. We will aggregate a list of all sources, documents, and websites for reference throughout our project and place this data in our Dropbox file-sharing folder.

Software Design Flow Chart Review A flow chart depicting the high-level behavior of the code will be included in this stage of our development. This flow chart will allow for an individual to follow the logical process of our source code visually.

PCB Layout Approved and Ordered At this stage of our project, we will have our final PCB reviewed, approved, and ordered. This milestone falls at the beginning of our final product phase and is of great importance to the progress of our project.

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Wireless Communication Demonstration This is a demonstration of the bidirectional communication functionality, in which our host application receives an acknowledgment of the transmitted message and can also send data back to the device.

Desktop Application Demonstration A demonstration of the working host application will be performed at this milestone. It will include full waveform processing, configuration, and visualization.

Functional Prototype Demonstration During Functional Prototype Demonstration will demonstrate a fully functional final prototype that meets all of the predetermined functional requirements agreed upon by the customer and our team.

F. Deliverables
Our company will deliver items of value to our customer and advisor periodically during the course of the project as shown in Figure 55. A memorandum describing these deliverables is attached as Appendix G. These deliverables will show our progress to the customer and demonstrate that we are on pace to complete the project on time. Error! Reference source not found. shows each deliverable, its delivery date, and the member responsible. Figure 55 displays a timeline of our deliverables.

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Deliverable Responsibilities
Table 4. Deliverable Responsibilities

Deliverable Desktop UI Mockup Final PCB Schematic Review Alpha PCB Layout Final PCB Layout
Bill of Materials

Alpha Code Build Critical Design Review Final Code Build Final Prototype Presentation Final Documentation

Date of Completion 1/28/11 2/1/11 2/15/11 2/22/11 2/22/11 3/2/11 3/18/11 4/16/11 4/29/11 5/6/11

Responsible Team Member Patrick Navarro Raymond King Raymond King Raymond King Raymond King Patrick Navarro Alex Smith Patrick Navarro Alex Smith Alex Smith

Deliverable Timeline

Figure 55. Deliverable Timeline

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Deliverable Descriptions
Desktop UI Mockup This deliverable will be a visual layout of our desktop application. This mockup will be a graphical representation of the desired user interface for CardioScope. This design will be created using Adobe Photoshop and will include all functionality that we intend on using in our final prototype application. This representation will include sample menus, menu hierarchy, and ECG configuration options. The sample menus will contain a detailed description of their purpose along with the proposed format of each command. The command sets will not contain any command that does not directly impact navigation of the user interface or is a general help command. The mockup will be submitted as both a paper hardcopy and a PDF version.

Final PCB Schematic Review This deliverable is the alpha schematic design of the hardware required for CardioScope. The schematic will include components, part names, and pin outs. The schematic will also be divided into sections using virtual connections for a cleaner design and clarity. All schematics will be designed in National Instruments Multisim program. The alpha hardware schematic will be submitted as both a paper hard copy and a PDF soft copy.

Alpha PCB Layout The alpha Printed Circuit Board (PCB) layout is the alpha version of the CardioScope hardware layout. This will be done using National Instruments Ultiboard program, allowing for our schematic files from Multisim to be transferred to Ultiboard. The layout will display the multiple layers of the PCB, trace widths, and specific locations of components. The alpha PCB layout will be submitted as both a paper hard copy and a PDF soft copy.

Test Plan A test plan will be created to effectively test every component of our functional prototype. The test plan will validate the functional requirements agreed upon by our customer. It will provide reasoning for each test along with a description of how we will conduct each test. Our test plan will be divided into three separate sections: enclosure, hardware, and software. By dividing our test plan up into these sections, it will help us verify that each component of our functional prototype will perform and meet our sponsors requirements.

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Final PCB Layout The final PCB layout is the revised design of the CardioScope hardware layout. The final layout is the last stage of design; incorporating all revisions and improvements from the previous layouts. This will be done using National Instruments Ultiboard, allowing for our schematic files from Multisim to be transferred to Ultiboard. The layout will contain amplification, filtering, and Wi-Fi module hardware. The layout shows the multiple layers of the PCB; including the copper and silkscreen footprint. We will also print out a full size layout of the PCB to verify the footprint sizes are correct before it is fabricated. The final PCB layout will be submitted as both a paper hard copy and a PDF soft copy.

Bill of Materials A Bill of Materials will be provided to the customer. This document will contain the prices of the final components selected for the prototype. The Bill of Materials is generated in a table format in Microsoft Excel that contains ten columns that consist of the description, value, quantity, designator, parts number, cost of single unit, cost of a hundred, vendor, total unit required cost, and total cost of a hundred. It also provides the cost to produce a single board as well as the cost to of hundred boards. This gives our stakeholders the ability to consider the total cost of production. We will focus on keeping our product cost as low cost as possible while fulfilling the given requirements.

Alpha Code Build An alpha stage code build will be provided for the CardioScope. This code listing will include fully commented code that has been complied, ran, and debugged. This code represents steps being taken to provide a quality prototype to the sponsor and may not include 100% of the functionality that will be present in the final code build. This code build will include all source and header files. The format for all comments, layout, and materials submitted will follow the same format for the final code build. The format may change only if the sponsor and/or advisor indicate that the provided format for the alpha code build was not sufficient. This build will be submitted with each file in its original format in a zip file with a PDF containing the code for each file.

Critical Design Review The purpose of the Critical Design Review (CDR) is to update our stakeholders on the progress
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of our project. It will inform them of how close we are to finishing the project, what problems we have encountered, and what we have remaining. This presentation should give our stakeholder an idea of whether or not we will complete our project on time and on budget. Tentatively, this will also include a successful proof of concept demonstration. This deliverable will be submitted as a softcopy.

G. Sponsor Requirements
NASA, through the Texas Space Grant Consortium (TSGC), is funding our project CardioScope. All members of embedic are in complete understanding that we must meet the following requirements set forth by the TSGC. Our group will submit weekly status reports to the TSGC as well as several term papers. We have previously completed a variety of sponsor requirements throughout this semester. The Level I, Level II, and Level III proposals have been completed, reviewed, and accepted. Our team will also be participating in the TSGC Design Challenge during spring 2011 semester. We have agreed to meet with our sponsor at the end of the project to demonstrate our final prototype.

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Section IV Risk Assessment

Risk Assessment
At embedic, risk is a factor that we must consider. Risk is defined as an event that has the potential to affect our project negatively. We cannot predict all possible risks that we may encounter during the course of our project, but we have constructed a risk assessment comprised of risks that we feel are probable. The assessment will include a Risk Prioritization Matrix, Risk Evaluation Matrix, and Risk Cards.

Risk Evaluation Matrix

The Risk Evaluation Matrix is a tool used by embedic to visualize each risk by plotting them on a color-coded matrix. The risks in the matrix are categorized by the likelihood of the risk occurring as well as the impact that the risk will have on the project. The color codes include red, yellow, and green. The red code stands for high impact with a high probability. The yellow code stands for medium impact with medium probability. The green code stands for low impact with a low probability. Figure 56 is the Risk Evaluation Matrix for the CardioScope. The numbers in the table correspond with the number issued to each risk by us at embedic.

Figure 56. Risk Evaluation Matrix Page | 63

Risk Prioritization Matrix

The Risk Prioritization Matrix will help predict which risks will have the highest priorities. This process will compare two risks at a time to determine which risk is more critical than the other. This comparison takes place between all risks until each risk has been prioritized. The number of each risk is an arbitrary number that has been issued by our team. The Total column represents the number of times the risk was selected over anther risk. The Priority column is made up of the results from the total column. The risk with the highest total will have the highest priority, one being the highest and nine being the lowest. The risks denoted with a T (i.e. T1) in the priority column means that two or more risks have the same priority.

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Table 5 is the Risk Prioritization Matrix for the CardioScope. A more in depth description can be

found in Appendix J.

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Table 5. Risk Prioritization Matrix

Risk Prioritization Matrix

Priority Total
T5 T10 11 9 4 8 2 3 T10 12 1 T10 6 9 3 2 4 10 5 13 12 3 0 14 3 8

Risk
1. Unexpected PCB revisions 2. Parts ordered incorrectly 3. Discontinued or backordered parts 4. Increase in scope 5. Communication to the host computer does not function properly 6. Project work is lost due to hard drive failure 7. Device battery life too short 8. Enclosure too heavy 9. Final demonstration does not work 10. Temporary loss of communication with customer 11. Team member is unable to continue work on the project 12. Project is over budget 13. Host program code takes longer than expected to develop 14. Host program fails at processing and visualization data 15. Test phase discovers flaws in final revision 1 1 1 2 12 33 123 444 1234 5555 12345 66666

Comparative Number

123456 777777 1234567 8888888 12345678 99999999 1 2 3 4 5 6 7 8 9 10 10 10 10 10 10 10 10 10 1 2 3 4 5 6 7 8 9 10 11 11 11 11 11 11 11 11 11 11 1 2 3 4 5 6 7 8 9 10 11 12 12 12 12 12 12 12 12 12 12 12 1 2 3 4 5 6 7 8 9 10 11 12 13 13 13 13 13 13 13 13 13 13 13 13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 14 14 14 14 14 14 14 14 14 14 14 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 15 15 15 15 15 15 15 15 15 15 15 15 15

T5 7

9 7

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At embedic, we will be using the USAAs risk assessment method. While using this method we have created Risk Evaluation Cards. These cards will have a brief description of what the risk is as well as a risk category. The risk category classifies the risk as being related to a process, technology, or personnel issues. On these cards there is also a matrix that defines the probability and impact of the risk. Once the risk is defined we will have to form a response to the risk, which is categorized into five categories. These categories are: Eliminate Reduce Likelihood Accept Transfer Reduce Impact If the risk occurs during our project we may need additional resources to rectify the effect of the risk. These resources will be listed on the cards. The Impact Horizon section helps us as a team to narrow down the time period the risk might occur. This includes the phase as well as the expected date for the occurrence. Also included on the risk card is the team member that this risk will be applied to. There is also a notes section for additional notes if necessary.

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Section V Team Organization and Qualifications

Hierarchy Chart
Our company, embedic, is comprised of three diverse and highly motivated individuals, each of whom offers a unique skill set that can be applied to every aspect of our project. The hierarchy chart for the company is shown in Figure 57. As the Project Manager, Alex Smith will be responsible for keeping our project on schedule as well as developing the microprocessor code and designing the hardware. Raymond King will serve as the Hardware Engineer and will be responsible for the hardware schematic design and custom PCB layout. As Software Engineer, Patrick Navarro will carry out the software design and development for the host application. Every member of embedic is committed to providing quality work to produce exceptional results. For further detail, please refer to each members resume in Appendix M.

Figure 57. embedic Hierarchy Chart

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Member Qualifications
Alex Smith Alex will serve as the Project Manager for embedic. He is a former Test Engineer co-op at Texas Instruments with experience in both hardware and software. His expertise includes designing printed circuit board schematics and writing embedded software in Assembly and C. His background in these areas will be a great benefit as we build our prototype.

Raymond King Raymond will serve as the Hardware Engineer for embedic. He has multiple years of experience in designing and building printed circuit boards using National Instruments Multisim and Ultiboard. He also has expertise in testing and debugging hardware issues. His experience will greatly benefit the hardware portion of the project.

Patrick Navarro Patrick will serve as the Software Engineer for embedic. He is a former Product Development Engineer intern at Advanced Micro Devices (AMD) and has extensive experience in writing analysis software. His focus on good software design principles and rapid iteration will greatly benefit the project.

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Section VI Project Costs

Direct
A direct cost is one that is required to complete a specific project. It includes resources that can solely be used for the CardioScope project; resources that are used for multiple projects are not taken into account here. More information on costing data can be found in Appendix K. Direct costs due to labor are broken down into wages and benefits. The project manager will make slightly more ($35 per hour) than the other employees ($30 per hour). Every employee gets benefits and insurance, which is 40% of their wages. The breakdown of these costs is in Table 6.
Table 6. Direct Costs from Labor Member Alexander Smith Raymond King Patrick Navarro Total Hourly Wage $35 $30 $30 Manhours 444 347 388 1179 Wage $15,540 $10,410 $11,640 $37,590 Benefits & Insurance (40%) $6,216 $4,164 $4,656 $15,036 Individual Total $21,756 $14,574 $16,296 $52,626

Other direct costs are all costs for a single project that does not include labor. These direct costs were split into three areas: hardware, software, and testing. Hardware costs consist of the money spent for the physical components for the project. This includes development kits, PCB fabrication, components for the PCB, batteries, tools, and enclosure; this is shown in Table 7. Software costs consist of the software we will use to complete this project and is shown in Table 8. National Instruments Circuit Design Suite software will be used for schematic capture and PCB layout design. Microchips MPLAB C compiler for the PIC18 we will be using will allow us to compile code for our microcontroller. Test costs include a standard oscilloscope and multimeter to test the PCB, as well as an ECG patient simulator; this is broken down in Table 9. This patient simulator will generate the 10 signals required to fully test our device without the need to be hooked up to a patient.

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Table 7. Other Direct Costs, Hardware Item PIC Development Board PIC18 Personality Module Alpha PCB Beta PCB Microchip Wi-Fi Module PICkit 3 ICD Programmer Instrumentation Amps, 2 channel Opamps, quad channel Lithium Ion Batteries Li-ion charger PIC18 Microcontroller Other board components Tools Enclosure Shipping Total Quantity 1 2 2 2 3 1 10 15 4 1 4 1 1 2 1 Cost per Unit $50 $40 $35 $35 $40 $45 $5 $5 $8 $10 $4 $100 $300 $60 $200 Subtotal $50 $80 $70 $70 $120 $45 $50 $75 $32 $10 $16 $100 $300 $120 $200 $1,338

Table 8. Other Direct Costs, Software Item NI Circuit Design Suite MPLAB C Compiler for PIC18 Total Quantity 1 1 Cost per Unit $3,600 $495 Subtotal $3,600 $495 $4,095

Table 9. Other Direct Costs, Test Item Oscilloscope Digital Multimeter ECG Patient Simulator Total Quantity 1 1 1 Cost per Unit $5,000 $1,000 $250 Subtotal $5,000 $1,000 $250 $6,250

The Total Direct Costs are the sum of the labor costs and the other direct costs. This is the cost of what is needed solely for the CardioScope project, and is listed in Table 10.

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Table 10. Total Direct Costs Labor Other Direct Costs Total $52,626 $11,683 $64,309

Indirect Costs
Indirect Costs are those costs that are required to complete the project but cannot be assigned to the CardioScope project specifically. It is the cost of being in business, and is spread across all customers. Indirect costs can be broken down into overhead and general and administrative (G & A) costs. Each one of these costs is a percentage of the total direct costs. Overhead is the cost of renting office space, utilities, internet service, and other similar costs. A value of 45% of our total direct costs was chosen as a reasonable cost for overhead. General and administrative costs include the salary for a secretary, shipping costs, project management software, and other similar costs. A value of 10% of our total direct costs was chosen as a nominal cost for G & A. Indirect costs are listed in Table 11.
Table 11. Indirect Costs Overhead G&A Total 45% 10% $28,939 $6,431 $35,370

The summation of the direct costs and indirect costs are our Total Direct and Indirect Costs (TDIC), which are listed in Table 12.
Table 12. Total Direct and Indirect Costs Direct Indirect Total $64,309 $35,370 $99,679

Profit
Profit is the return on investment for embedic for the CardioScope project. A margin system for computing profit was chosen. The following is the equation for computing profit using the margin method:

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A value of 20% was chosen to be our profit margin; this is a good return on investment for the project. Profit is shown in Table 13.
Table 13. Profit TDIC Margin Total $99,679 20% $24,920

Other Costs
Other costs are additional charges that do not fall into the direct, indirect, or profit categories. These include risk aversion and the cost of money. Risk aversion is a percentage of the TDIC plus profit dedicated to cover any risk that the company may have when producing the CardioScope. A risk aversion percentage of 10% was chosen to ensure the company is properly covered. The cost of money is the change in the value of the dollar over the time length of the project; 1% was chosen for this value. Other Costs are shown in Table 14.

Table 14. Other Costs Risk Aversion Cost of Money Total 10% 1% $12,460 $1,246 $13,706

Price
The price of the project is the summation of the TDIC, the profit, and the other costs. This is the final cost of the project, and is broken down in Table 15.
Table 15. Price Total Direct and Indirect Costs Profit Other Costs Total $99,679 $24,920 $13,706 $138,305

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Sequence of Funds
The sequence of funds breaks down how much is spent each week in the project. As the chart and graph shows, the project is more heavily weighted at the start. The red line indicates the ideal spending each week as the total price over the number of weeks. This is mostly due to the high costs associated with buying software required at the beginning. The labor and margin costs are constants across each week. The indirect and other costs occur on a monthly basis, causing small peaks in the line. This cost breakdown is listed in Table 16, and the graph of this data is in Figure 58.
Table 16. Sequence of Funds Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Labor $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 Other Direct $10,495.00 $320.00 $558.00 $95.00 $215.00 $8,842.49 Indirect Costs $8,842.49 Margin $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $1,661.32 Other Costs $3,426.46 Weekly Total $27,933.67 $5,489.72 $5,169.72 $5,727.72 $17,533.67 $5,169.72 $5,384.72 $5,169.72 $17,438.67 $5,169.72 $5,169.72 $5,169.72 $17,438.67 $5,169.72 $5,169.72 Project Total $27,933.67 $33,423.38 $38,593.10 $44,320.81 $61,854.48 $67,024.20 $72,408.91 $77,578.63 $95,017.30 $100,187.01 $105,356.73 $110,526.44 $127,965.11 $133,134.83 $138,304.54

$8,842.49

$3,426.46

$3,426.46

$8,842.49

$3,426.46

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Sequence of Cost
$140,000.00 $120,000.00 $100,000.00 $80,000.00 Cost $60,000.00 $40,000.00 $20,000.00 $0.00 0 1 2 3 4 5 6 7 8 Weeks 9 10 11 12 13 14 15 16

Figure 58: Sequence of costs, chart

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Appendices
Appendix A Quad Chart

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Appendix B Capstone Design Document Presentation Slides

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Appendix C Capstone Design Document

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Capstone Design Document

Project Name: CardioScope

Prepared by: Alex Smith, Project Manager Raymond King, Hardware Engineer Patrick Navarro, Software Engineer

Faculty Advisor: Dr. Jay Porter, Program Director Electronics and Telecommunications Engineering Technology, Texas A&M University Sponsor: Baraquiel Reyna, NASA JSC Space Medicine Division Texas Space Grant Consortium

Due: October 13, 2010 Delivered: October 13, 2010 Responsible Member: Alex Smith, alex@embedic.net Edited by: ____________________ Signature: ____________________

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Table of Contents
Letter of Transmittal.............................................................................................................. 2 Section I - Introduction .......................................................................................................... 8 General .............................................................................................................................. 8 Background........................................................................................................................ 8 Technical Challenge............................................................................................................ 8 Benefits ........................................................................................................................... 11 Proposal Structure ........................................................................................................... 11 Section II Project Scope ..................................................................................................... 14 Enclosure ................................................................................................................................ 15 Hardware ............................................................................................................................... 16 Software................................................................................................................................. 17 Section III Statement of Work ........................................................................................... 22 A. Project Design .............................................................................................................. 22 B. Work to be Performed ................................................................................................. 32 Research..................................................................................... Error! Bookmark not defined. Design ........................................................................................ Error! Bookmark not defined. Proof of Concept Prototype ....................................................... Error! Bookmark not defined. Final Product .............................................................................. Error! Bookmark not defined. Testing ....................................................................................... Error! Bookmark not defined. Documentation and Close Out ................................................... Error! Bookmark not defined. C. Precedence Diagram .................................................................................................... 52 D. Task Schedule .............................................................................................................. 54 E. Milestones ................................................................................................................... 56 F. Deliverables ................................................................................................................. 58 Deliverable Responsibilities ................................................................................................... 59 Deliverable Timeline .............................................................................................................. 59 Deliverable Descriptions ........................................................................................................ 60 G. Sponsor Requirements ................................................................................................. 62 Section IV Risk Assessment ............................................................................................... 63 Risk Assessment............................................................................................................... 63 Risk Evaluation Matrix ..................................................................................................... 63 Risk Prioritization Matrix.................................................................................................. 64 Section V Team Organization and Qualifications ............................................................... 68
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Hierarchy Chart ................................................................................................................ 68 Member Qualifications .................................................................................................... 69 Section VI Project Costs .................................................................................................... 70 Appendix A Quad Chart .................................................................................................... 76 Appendix B Capstone Design Document Presentation Slides ............................................. 77 Appendix C Capstone Design Document ............................................................................ 95 Table of Figures ................................................................................................................. 100 Version.............................................................................................................................. 101 Problem Statement ........................................................................................................... 102 Background Information .................................................................................................... 102 Functional Requirements ................................................................................................... 104 Enclosure .............................................................................................................................. 104 Software............................................................................................................................... 104 Hardware ............................................................................................................................. 105 Conceptual Block Diagram ................................................................................................. 106 Wearable ECG ...................................................................................................................... 106 Host Computer ..................................................................................................................... 106 Performance Requirements ............................................................................................... 107 Enclosure .............................................................................................................................. 107 Hardware ............................................................................................................................. 107 Software............................................................................................................................... 108 Technology Survey Assessment ......................................................................................... 109 Wireless Technology ...................................................................................................... 109 Microcontroller .............................................................................................................. 110 Battery .......................................................................................................................... 110 Functional Block Diagram .................................................................................................. 112 Sensor Characteristics........................................................................................................ 114 Communications Interfaces and Protocols ......................................................................... 114 Deliverables ...................................................................................................................... 116 Milestones ........................................................................................................................ 118 Gantt Chart ....................................................................................................................... 119
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Test Matrix ........................................................................................................................ 119 Technical Merit ................................................................................................................. 123 Appendix D Problem Statement Memorandum ............................................................... 126 Appendix E Conceptual Design Memorandum ................................................................. 129 Appendix F Functional Design Memorandum .................................................................. 132 Appendix G Deliverables Memorandum .......................................................................... 136 Appendix H Responsibilities Assignment Matrix .............................................................. 143 Appendix I Network Logic Diagram ................................................................................. 152 Appendix J Risk Assessment ............................................................................................ 162 Appendix K Costing Data ................................................................................................. 187 Direct............................................................................................................................. 188 Indirect Costs ................................................................................................................. 190 Profit ............................................................................................................................. 190 Other Costs .......................................................................................................................... 191 Price .............................................................................................................................. 191 Sequence of Funds ......................................................................................................... 192 Appendix L Gantt Chart ................................................................................................... 194 Appendix M Team Member Resumes .............................................................................. 195 Appendix O Intellectual Property Memorandum ............................................................. 202

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Table of Figures

Figure 1: Technical Merit Breakdown .............................................. Error! Bookmark not defined. Figure 2 ......................................................................................................................................... 16 Figure 3 ............................................................................................ Error! Bookmark not defined. Figure 4 ............................................................................................ Error! Bookmark not defined. Figure 5 ............................................................................................ Error! Bookmark not defined. Figure 6 ............................................................................................ Error! Bookmark not defined. Figure 7 ............................................................................................ Error! Bookmark not defined. Figure 8 ............................................................................................ Error! Bookmark not defined. Figure 9 ............................................................................................ Error! Bookmark not defined. Figure 10 .......................................................................................... Error! Bookmark not defined. Figure 11 .......................................................................................... Error! Bookmark not defined. Figure 12 .......................................................................................... Error! Bookmark not defined. Figure 13 .......................................................................................... Error! Bookmark not defined. Figure 14 .......................................................................................... Error! Bookmark not defined. Figure 15 .......................................................................................... Error! Bookmark not defined. Figure 16 .......................................................................................... Error! Bookmark not defined. Figure 17 .......................................................................................... Error! Bookmark not defined. Figure 18 .......................................................................................... Error! Bookmark not defined. Figure 19 .......................................................................................... Error! Bookmark not defined. Figure 20 .......................................................................................... Error! Bookmark not defined. Figure 21 .......................................................................................... Error! Bookmark not defined. Figure 22 .......................................................................................... Error! Bookmark not defined. Figure 23 .......................................................................................... Error! Bookmark not defined. Figure 24 .......................................................................................... Error! Bookmark not defined. Figure 25 .......................................................................................... Error! Bookmark not defined. Figure 26 .......................................................................................... Error! Bookmark not defined. Figure 27 .......................................................................................... Error! Bookmark not defined. Figure 28 .......................................................................................... Error! Bookmark not defined. Figure 29 .......................................................................................... Error! Bookmark not defined. Figure 30 .......................................................................................... Error! Bookmark not defined. Figure 31 .......................................................................................... Error! Bookmark not defined. Figure 32 .......................................................................................... Error! Bookmark not defined. Figure 33 .......................................................................................... Error! Bookmark not defined. Figure 34 .......................................................................................... Error! Bookmark not defined. Figure 35 .......................................................................................... Error! Bookmark not defined.
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Figure 36 .......................................................................................... Error! Bookmark not defined. Figure 37 .......................................................................................... Error! Bookmark not defined. Figure 38 .......................................................................................... Error! Bookmark not defined. Figure 39: Milestones Timeline ........................................................ Error! Bookmark not defined. Figure 40: Deliverable Timeline ....................................................... Error! Bookmark not defined. Figure 41 ....................................................................................................................................... 46 Figure 1: Limb-lead setup and Einthoven's Triangle (left), 5-lead setup (right) ......................... 102 Figure 2: EASI lead placement (left), V1-V6 lead placement (right) ........................................... 103 Figure 3: The electrical activity of the heart from 6 different perspectives ............................... 103 Figure 4: Conceptual block diagram ........................................................................................... 106 Figure 5: Wireless technical survey ............................................................................................ 109 Figure 6: Microcontroller technical survey ................................................................................. 110 Figure 7: Battery technical survey .............................................................................................. 111 Figure 8: Functional block diagram ............................................................................................. 112 Figure 9: Deliverables timeline ................................................................................................... 116 Figure 10: Milestones timeline ................................................................................................... 118 Figure 11: Gantt chart ................................................................................................................. 119 Figure 12: Test matrix ................................................................................................................. 120 Figure 13: Technical merit .......................................................................................................... 123 Figure 14: Conceptual Block Diagram for the CardioScope ........................................................ 130 Figure 15: Conceptual Block Diagram for the CardioScope ........................................................ 204

Version

Version # 1.0

Date 10/13/2010

Comments Initial document submission

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Problem Statement

There is a need for a small, portable ambulatory multi-channel wireless ECG that transmits the hearts electrical activity wirelessly over a short distance. At embedic, we are creating CardioScope, a lightweight, battery-powered solution which will control, display, and store the real-time digitally ltered waveforms on a host computer. Background Information

An electrocardiogram (ECG) is a non-invasive method of measuring the electrical activity of the heart. Electrodes are placed at specific positions on a persons body and the voltage differences between electrodes are recorded. Based on the placement of each pair of electrodes, the heart can be observed from different perspectives. Each perspective offers a view of different segments of each heartbeat; since the heart is a three dimensional organ, a simple planar view formed by a pair of electrodes cannot see all portions of the heartbeat.

Figure 59: Limb-lead setup and Einthoven's Triangle (left), 5-lead setup (right) The most informative and detailed type of ECG is known as the 12-lead ECG; however, other ECGs are commonly used that utilize less electrodes. The simplest form is the limb-lead ECG, which consists of 4 electrodes. By placing electrodes on the right arm (RA), left arm (LA), and left leg (LL), a configuration known as Einthovens Triangle is formed that surrounds the heart (Figure 59 left). An additional electrode is placed on the right leg (RL) and is used as an electrical ground. Another system using 5 leads adds a single lead in the center of the chest over the heart (Figure 59 right). The EASI system uses 5 electrodes in different locations plus mathematical transformations in order to simulate the results of a 12-lead ECG (Figure 60 left). The 12-lead ECG is the most accurate method of recording the heartbeat, using 6 electrodes surrounding the heart on the left side (V1, V2, V3, V4, V5, V6)(Figure 60 right), the three limb-lead electrodes (RA, LA, LL), and a ground electrode (RL). Page | 102

Figure 60: EASI lead placement (left), V1-V6 lead placement (right)

Because the electrodes physically surround the heart, it is not necessary to capture signals from every electrode to get a full picture. For the limb-lead system, capturing 2 channels worth of data will allow you to extrapolate the third channel. For the 12-lead system, only 8 channels worth of data are needed; the other 4 channels can be reconstructed. Seeing the heart from different perspectives allows the analysis of every part of the cycle of a heartbeat (Figure 61), and this information can be used for medical diagnostic purposes.

Figure 61: The electrical activity of the heart from 6 different perspectives The signal must be processed; it cannot be used raw. Because the skin is a good insulator, the voltages of interest are very small, around 1mV or less. This, in combination with noise from muscular Page | 103

contractions and AC power noise of 60Hz means that the signal is not very clean. Filtering must be done to eliminate the noise, and the signal must be amplified to be digitized. Because the system uses an analog to digital converter (ADC), an anti-aliasing filter must also be added in order to have accurate data capture. A heartbeat is not a simple sine wave; it is a more complex waveform. Due to Fouriers theorem, it is known that any complex waveform can be decomposed into a series of sine waves added together. A human heartbeat is unlikely to exceed 240 beats per minute (bps), or about 4Hz. By doing a Fast Fourier Transform (FFT) on a 4Hz heartbeat simulated from a function generator, the heartbeat could be broken down into frequency components. It was found that most of the signal was contained from 0-250Hz in the frequency domain. There are currently wireless ECG monitors that transmit over Bluetooth. However, these systems have some problems and limitations. The largest problem is that the initial setup of the wireless connection takes too long. The manual pairing and setup process can take upwards of thirty minutes, and this is a serious issue for both the medical professional and the end user. Another problem related to Bluetooth is that the connection quality is often poor. The link can become saturated with data and the connection can drop, leading to lost data. For the unit itself, there are often built-in limitations that hold back functionality of the device. The sampling rate is not changeable, digital filters are limited, and the device can usually only support one electrode configuration.

Functional Requirements

Enclosure o Small Everything that makes up the CardioScope must be able to be fitted into a small enclosure. This includes the batteries needed to power the device as well as the printed circuit board. Not included in this enclosure are the ECG Leads. Low Weight The CardioScope must be lightweight so the components as well as the outer enclosure must be created with weight in mind. Key weight savings will be made with the choice of batteries as well as the material chosen for the outer enclosure. Rugged The CardioScope must be able to withstand the normal wear and tear of a handheld device.

Software o Host Computer Receives Data

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o o

The host computer will receive the information that the CardioScope gathers. This will be the data that is gathered from the ECG Electrodes that are connected to the patient. Display All Waveforms The software created for the host computer must be able to display all the waveforms. Choose Between multiple sensors The software that will be created must be able to have the capability to choose between the number of sensors used on the CardioScope. Calculate Missing Sensor Information The host computer will be able to derive other ECG signals from the CardioScope when not all the sensors are used on the patient. Filter Out AC Power Noise After the CardioScope transmits the data it has received to the host computer the software will then have to apply filters to filter out the AC power noise, as well as applying any other filter characteristics.

Hardware o Exclusively Powered By Battery The CardioScope will be powered by batteries so that the device can be portable and safe. Long Battery Life The battery must run for an extended period of time. Short Range Wireless The CardioScope and the host computer must have a wireless communication link over a short distance. Real-Time Transmission of Data The wireless link between the CardioScope and the host computer must transmit the information from the patient instantaneously. Amplify Very Small Signals The signals received from the ECG electrodes must be amplified to be processed due to the small values of the signals. Convert Analog to Digital The CardioScope must have a hardware component that takes the voltage signals from the electrodes and convert those signals to digital signals. Electrode Safety Due to the risk of shock, circuits must be built to protect the patient. Battery Short Safety Since the CardioScope will be using Lithium Ion batteries there will need to be safety features in place to make sure the batteries are never shorted. Battery Discharge Safety Lithium Ion batteries can be damaged or ruptured if the batteries are discharged below a safe level. Page | 105

o o

o o

Avoid Oversampling Problems An anti-aliasing filter will be added before the ADC on the microcontroller.

Conceptual Block Diagram

Figure 62: Conceptual block diagram Wearable ECG The wearable ECG unit will have to be a small, portable, light weight, and rugged device. The CardioScope will have to communicate the patients heartbeat over a wireless link to the host computer. Inside the CardioScope there will be several steps that will be taken to take the raw ECG signal and prepare it for the transmission to the host computer. The signals coming from the electrodes will be less than 1mV so the signals will need to be amplified. These signals will be amplified by instrumentation amps. After the signal has been amplified the issue of over sampling will need to be addressed. To do this the signals will have to be sent through a low pass anti-aliasing filter. From there the signals will then be converted from their analog form to digital signals which then will be sent to a Wi-Fi module. The Wi-Fi module will then send the signals to the host computer. Host Computer The host computer will have to accomplish several key tasks. It will have to give the user the ability to configure the settings of the ECG as well as the processing and filtering of the signals received from the Page | 106

wearable unit. A real-time display must be included as well so that the user can see the ECG signals from the unit in a graphical form. Data storage will also be needed to enable the ability to playback the signals received from the patient at any given point of time. Last, post processing must be available on the host computer to compute heart rate and other important information.

Performance Requirements Enclosure o Small Size The wearable CardioScope unit will be held to strict standards that have been made by our sponsor. One of these standards is that the unit must not exceed a maximum volume of 400 cm3. This will affect the choice of battery size and shape as well as the design of the printed circuit board. Low Weight Our sponsor has specified that the ECG device must not weigh more than 300g. The selection of the components for the unit will have to keep weight in mind. The batteries will be the heaviest items in the unit so they will have to be light weight but still have acceptable power density. Rugged The CardioScope will be a wearable ECG device so it must be able to withstand normal abuse such as accidental dropping. As required by the sponsor this device must also be able to withstand exercise activities. For example, the device must withstand the activity of running on a treadmill.

Hardware o Exclusively Powered By Battery Since the unit will be a wearable and portable device it will not be able to be attached to wall power. Also, for the safety of the patient a device that is powered by a battery is preferred. Long Battery Life Our customer has defined long battery life in three key situations. These situations are 2 channel mode, 4 channel mode, and 8 channel mode. The CardioScope when set to the 2 channel mode must meet the requirement of staying on for 24 hours. For the 4 channel mode the device must be able to stay on for 12 hours, and for the 8 channel mode the requirement is 6 hours. Short Range Wireless The requirement for the range of wireless is that the communication between the CardioScope and the host computer must be at least 10 ft. Real-Time Transmission of Data Page | 107

The choice of the wireless medium must be able to transmit a minimum theoretical throughput of 160 Kbps. Amplify Very Small Signals Signals that come from ECG electrodes are usually less than 1 mV. Because the signals are small they will need to be sent through instrumentation amplifiers so they can be brought up to voltage levels that can be analyzed. Avoid Oversampling Problems To meet this requirement there will have to be a low pass anti-aliasing filter before the ADC on the microcontroller. This filter will guarantee that only the useful frequencies from the ECG electrodes are sent to the ADC on the microcontroller. Convert Analog To Digital Before the ECG signals gathered from the patient can be sent to the host computer there must be a conversion from analog to digital. This conversion will take place on the microcontroller. The requirement set in place by our sponsor is that the unit must have 8 ADC channels with at least a 12 bit resolution. The microcontroller must be able to convert up to 8000 samples per second total. Host Computer Receives Data The host computer used to communicate with the CardioScope must be a Windows machine with wireless connectivity.

Software o Display All Waveforms On Computer The software on the host computer will display the ECG waveforms that are received from the CardioScope. Choose Between Multiple Electrode Configurations The customer does not require the ability to change between different electrode configurations but embedic will make it a requirement. This will give the user the ability to setup the CardioScope to read information from 4 to 10 electrodes. Calculate Missing Sensor Information From Data Another function of the software is that it will have the ability to reconstruct ECG information when not all electrodes are in use. When in the 2 channel mode the data received from the wearable unit will be able to reconstruct 3 signals. It the 8 channel mode is selected the software will be able to reconstruct 12 signals. Filter Out AC Power Noise The software will need to use digital filters to remove the 60 Hz noise and harmonics from the ECG signals.

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Technology Survey Assessment

Wireless Technology

Figure 63: Wireless technical survey

We have chosen to use Wi-Fi 802.11b for the wireless communication between the CardioScope unit and the host computer. The main reason we chose to use 802.11b is that it is widely used and that it is available on almost every laptop. The speed that 802.11b is capable of will help us to transmit the realtime information without delays. We found in our research that Bluetooth was a good option due to the availability and low power consumption, but it had too many flaws for our design. The main issue that we encountered was that the initial setup can be cumbersome. Pairing Bluetooth devices can sometime be lengthy and require several steps, and this would go against the customers request for a simple and fast setup for the user. Another issue that we ran into was the fact that not all computers are equipped with Bluetooth so a dongle might be needed. Zigbee was ruled out fairly quick due to the fact that it is not optimal for continuous communication as well as a dongle would be required for the host computer.

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Microcontroller

Figure 64: Microcontroller technical survey

The device that embedic has decided upon was the Microchip PIC18. There were several reasons we chose this device. One of the first reasons was that we need a device that does not consume a lot of power. Microchip has the eXtreme Low Power (XLP) line of microcontrollers; the device chosen will be drawing a maximum of 2mA. Also the team has extensive experience with Microchip products so the learning curve for programming the microcontroller should be minimal. One of the benefits in using the Microchip device is that a free TCP/IP stack is available if the microcontroller is used with their Wi-Fi module. The other Microchip device, the dsPIC33, had excellent performance and would have been able to do digital signal processing on the device itself. However, this family of chips used an order of magnitude more current, which is unacceptable for our device. The TI MSP430 appeared to be a very promising device in terms of power consumption, using around 200uA. However, TI sells no 802.11 modules; their RF choices consist of Bluetooth and other non-standard RF communications schemes. The only ICs that matched the projects needs were either 80 or 100 pin devices, meaning they would be difficult to solder. Finally, and most importantly for our group, none of the team members had any experience with TI microcontrollers. Setting up a new programming environment and learning to program a new chip would take time, while the team has the resources to immediately begin any Microchip project. Battery Page | 110

Figure 65: Battery technical survey

In this TSA the main concern was weight and power density. Through research we found that Lithium Ion batteries have a greatest power density compared to nickel metal hydride and nickel cadmium batteries. A key aspect of this is that a Li-ion cell is 3.7V, while most other cells of comparable physical size are 1.2V. Based on these factors, we decided to use lithium ion batteries for the CardioScope. Lithium-ion batteries may be more expensive than the other options but it will require fewer cells to get the power needed for the CardioScope; for this project we need to achieve the lowest weight possible. Some of the cons that we found from using lithium ion batteries are that they can be volatile. There will be a need to design special charging and discharging circuits so that the lithium ion batteries are not damaged.

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Functional Block Diagram

Figure 66: Functional block diagram

The signals start at the ECG electrodes, shown at the top of this diagram. These sensors are conductive patches attached to the patients skin at specific locations. The full 12-lead ECG consists of 6 unipolar electrodes V1 V6 surrounding the heart, and 4 limb electrodes located on the right leg (RL), right arm (RA), left leg (LL) and left arm (LA). The expected voltage for the heartbeat is less than or equal to 1mV. Immediately upon entering the CardioScope wearable unit, the signals pass through an electrode protection circuit. This circuit ensures that no dangerous voltage differences can occur across a pair of electrodes, which could harm the patient. This is essentially a pair of diodes in parallel from the electrode to ground. If the voltage is greater than the breakdown voltage of the electrode (<-0.7V or >0.7V), the electrode will be connected to ground. Next, the signals pass through a level shifter. A heartbeat has both positive and negative voltage components, but with a single-sided power supply these cannot be amplified. Therefore, this signal is Page | 112

shifted positive slightly, so that the entire waveform lies between 0V and the positive rail. The RL electrode is the only electrode that does not have a level shifter, because it is being used as a common ground. The lead signals are then formed via the difference between two sets of electrodes. For the unipolar electrodes, each electrode is referenced to Wilsons Central Terminal (WCT). The WCT is the average of the three limb electrodes RA, LA, and LL, created via a simple resistor network. Op amps in a voltage follower configuration are used before the resistor network to stop loading. The leads V1 V6 correspond to electrodes V1 V6 in reference to WCT. Lead I is formed from the difference between LA and RA, and Lead II is formed from the difference between LL and RA. To form these differential signals without adding more noise into the system, instrumentation amps are used. Each lead signal travels through a low pass, anti-aliasing filter. This filter is set to 250Hz. The minimum sampling frequency will be 500Hz, and by the Nyquist theorem the only frequencies that can be accurately captured would be half of that, or 250Hz. Also, from independent research, it was found that for a heartbeat of 240bps (4Hz), most of the information was located under 250Hz. After passing through the anti-aliasing filter, the signal enters the microcontroller. The PIC18F67K22 microcontroller was chosen for this project (please see the Technical Survey section for more details). Each signal enters on an individual pin which will be directly connected to the ADC on the PIC. The ADC then digitizes each channel and stores that information temporarily in memory. After 100ms, all the gathered data is sent to the Wi-Fi module via SPI. The MRF24WB0MA Wi-Fi module is designed by Microchip to easily connect to their microcontrollers. Three pins are dedicated to SPI data; one pin for the clock, one pin for data out, and one pin for data in. In addition, 4 digital I/O pins are used for various control functions. One pin controls the chip select pin required by the SPI interface; this pin is active low. One pin places the module in hibernation, a very low power mode which severs the wireless connection. One pin is for write protection; when it is high, the firmware on the module can be rewritten. Finally, one last digital pin is for resetting the module. The last pin connecting the PIC to the Wi-Fi module is for an interrupt. In SPI, the slave cannot initiate communications; the master must do that. However, it is possible that data arrives at the Wi-Fi module when the SPI connection is not open. Therefore, the module will trigger an interrupt, letting the PIC know that data is coming in. The power for this device will be provided by lithium ion batteries. Two batteries, each 3.7V and 2800mAh, will be placed in parallel, creating a 5600mAh source. This should be sufficient to power the Wi-Fi module alone for 52 hours. The power immediately enters a low-voltage protection circuit which will shut down the unit if the batteries drop below 2.7V. This is done because lithium ion batteries can be damaged if their voltage drops below 2.7V. After the protection circuit, the battery power will enter a low dropout (LDO) voltage regulator, capable of outputting 3.0V and 250mA.

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Sensor Characteristics

An ECG electrode is a conductive patch attached to the skin. There are no electronics involved with the sensor; it simply conducts voltages from the skin through a wire to the ECG device. Each lead is formed by the difference between two signals. Bipolar leads, such as Limb I, take the difference between two discreet electrodes. The other type of lead is unipolar, like the V1 lead, which consists of the difference between one electrode and a reference level. This reference is known as Wilsons central terminal, and can be found by taking the average of the right arm, left arm, and left leg signals. This is done in analog via a simple resistor network. Once this analog voltage reaches the device, the signal must be modified before it is converted to a digital value. First, because the voltage may be negative and the power is single sided, the incoming signal must be shifted up. This is done by using an op-amp voltage adder circuit for each electrode. The signal then must be amplified, but in a way that doesnt add much noise into the system. Therefore, instrumentation amps are used. Finally, the signal must pass through an anti-aliasing (low pass) filter. This ensures that only the frequencies of interest are converted. If a sampling frequency of 1kHz is used for the ADC, due to the Nyquist rate, the cutoff filter should be designed for 500Hz. However, due to empirical research on the part of the team, it was found for a simulated heartbeat of 240bpm (4Hz) that the most useful information was between 0 and 250Hz. Therefore, the cutoff filter for the unit will be designed for 250Hz. Once the data is received by the host computer, it needs to be filtered. The filtering is done by taking a Fast Fourier Transform (FFT) of the incoming signal, which converts the time domain signal into a frequency domain signal. Specific bins corresponding to frequencies are then modified, and the inverse FFT is taken of the signal. The main noise that must be removed is 60Hz noise from the surrounding AC power lines. Even though the patient is not physically connected to any wall power, the 60Hz frequency along with its harmonics (120Hz, 180Hz, 240Hz, etc.) are a major source of noise. In addition, the user will be able to add their own notch, low-pass, and high-pass filters.

Communications Interfaces and Protocols

There are 2 classes of communication in this project: inter-unit communication and wireless communication. The inter-unit communication is serial peripheral interface (SPI), a four wire communication system. The wireless communication technology is 802.11b, while the protocol being used is the User Datagram Protocol (UDP). SPI communication is fast, bidirectional synchronous communication scheme that works over four wires that connects one master to one or more slaves. Slaves cannot initiate communication by themselves; Page | 114

the master must have already started the connection. The first wire carries the clock signal generated by the master; all data is synchronized to this clock. The next two lines are serial data out and serial data in; these are crossed over so that the masters data out goes into the slaves data in and vice versa. Finally, a chip select digital I/O pin is used as a hardware address. In a system with multiple SPI devices, either multiple digital I/O pins on a microcontroller or a multiplexer can be used to select which SPI device is active. SPI communication was chosen for many reasons. First, SPI is very fast and will easily be able to handle the amount of data required for our device. Second, the 802.11b module chosen for the project uses SPI to transmit data to and from the microcontroller. Finally, most modern microcontrollers have at least one SPI channel; the PIC18 chosen for this project has two. The 802.11b wireless communication standard uses the 2.4GHz frequency to transmit data a maximum of 11Mbps. It is CSMA/CA, or Carrier Sense Multiple Access with Collision Avoidance. This means each device listens to the media (wireless channel) and waits until theres no signal before transmitting, and multiple devices can use the same medium. While the Ethernet standard with one physical medium can detect collisions, 802.11b can only try to avoid collisions; this is because the radio cannot both receive and transmit at the same time. The indoor range of 802.11b is about 30m. The reasons for choosing the 802.11b standard for wireless communications in this project are listed in the Technical Survey Assessment section of this document. Over the wireless network link UDP will be used. UDP is a connectionless protocol, meaning a connection between the client and host does not have to be set up ahead of time. There is also no acknowledgement of receipt, meaning packets may be dropped, duplicated, or arrive out of order. The advantage of UDP is that it is fast; there is low overhead and no bandwidth wasted in opening or maintaining a connection. UDP has been chosen for this project because of the requirement that this be a real-time system. It is more important to the customer that the data be transmitted quickly rather than be reliable. Reducing the complexity of the system and increasing the speed also means the wireless radio will be on less of the time, saving power.

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Deliverables

Figure 67: Deliverables timeline

Test Plan A test plan will be created to effectively test our prototype in several different configurations. This test plan will validate the functional requirements created by embedic and agreed upon with our customer. The test plan will contain specific sections for hardware and software testing, respectively.

UI Mockup This deliverable will be a visual layout of our desktop application. It will include all functionality that we intend on using in our final design.

Schematic Review This deliverable will serve as the basis for our PCB layout. By this date, circuit schematics and layouts will be reviewed by our faculty advisor.

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Alpha PCB Layout This deliverable will be our first revision of the board layout. It will include all components that we feel necessary for our functional design.

Critical Design Review A demonstration of the progress of our prototype will be showcased at this stage of the semester. Tentatively, this includes a successful proof of concept demonstration, as well as the display of the test plan created for the final prototype.

Final PCB Layout In this stage, the PCB will be finalized for the final prototype. This will result from multiple iterations of PCBs that have been tested and reviewed for technical completeness. The layout will be created using National Instruments Ultiboard software.

Bill of Materials A bill of final materials will be provided to the customer. This bill will contain the prices of the final components selected for the prototype.

Full Source Code This deliverable will include the final source code for microcontroller and desktop application. The code will be fully documented and bug-free.

Final Documentation This deliverable will include complete documentation of the design. All diagrams, tables, and timelines will be finalized and combined into a single document.

Final Prototype This deliverable will be the final iteration of our design and will meet all requirements agreed upon by the customer and our team.

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Milestones

Figure 68: Milestones timeline

Research Completed At this stage, all research will be completed and our team will be ready to move on to the design phase of our project. We will provide an aggregated list of all books, documents, and websites for reference throughout our project.

Software Design Flow Chart Review A flow chart depicting the high level behavior of the code will be included in this stage of our development. This flow chart will allow for an individual to follow the logical process of our source code.

PCB Layout Approved and Ordered At this stage of our project, we will have our final PCB reviewed, approved, and ordered. This milestone falls at the beginning of our final product phase.

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Wireless Communication Demonstration This is a demonstration of the bidirectional communication functionality, in which our desktop application receives an acknowledgment of the transmitted message and also can send controls.

Desktop Application Demonstration A demonstration of the working host application will be performed at this milestone. It will include full waveform processing, configuration, and visualization.

Functional Prototype Demonstration The Functional Prototype Demonstration will be the final prototype that meets all of the predetermined functional requirements agreed upon by the customer and embedic.

Gantt Chart

Jan 2011

Feb 2011

Mar 2011

Apr 2011

ID
1 2 3 4 5

Task Name Research Design Alpha Prototype Final Product Final Test & Documentation

Start 1/18/2011 1/24/2011 2/14/2011 3/14/2011 4/11/2011

Finish 1/31/2011 2/25/2011 3/18/2011 4/22/2011 4/29/2011

Duration
1/23 1/30 2/6 2/13 2/20 2/27 3/6 3/13 3/20 3/27 4/3 4/10 4/17 4/24

10d 25d 25d 30d 15d

Figure 69: Gantt chart Test Matrix

The Test Matrix is built to ensure that each and every functional requirement that is previously mentioned will be tested before our prototype is final. Each test is being run so that at least one functional requirement will be validated. It will also be the foundation for creation of our test plan.

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Figure 70: Test matrix

Device Running Time Test In this test, we will ask a test subject to wear our device for 6 hours in 8-channel mode, 12 hours in 4channel mode, and 24 hours in 2-channel mode. We will verify that our battery runs without signal degradation throughout this test.

Device Weight Measurement Test It is essential that our prototype be very lightweight. In this test, we will ensure that the maximum weight of our PCB and enclosure is no more than 300 grams using an accurate scale.

Device Volume Test Our product must meet a very strict volume requirement of 400 cm3. In this test, we will measure our enclosure using calipers for accuracy in order to verify this.

Rugged Test Since our product must be rugged, we will test our product while running on a treadmill at various speeds. We will also test for a range of other exercises, agile movements, and overall safety.

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Wireless Range Test In this test, we will measure the minimum distance between our prototype and desktop receiver before any signal degradation happens. A minimum of 10 ft. is required for a successful test.

Wireless Bidirectional Communication Test Since our product will be communicating wirelessly, its important that we verify that our communication is functioning correctly. We will transmit ECG waveforms from our prototype and receive them using desktop software. We will also configure the software to send controls and acknowledgement to the prototype.

Real-time Data Transmission Test In this test, we will verify that our data is being transmitted, received, and displayed as close to real-time as possible. We will compare our waveforms to those of another product on the market.

Electrode Protection Circuit Test Since we want to protect the individual wearing our product, we will include a protection circuit after every electrode. We will test these by forcing a current towards the electrodes through our protection circuit to discover if any current reaches the electrodes.

Battery Short Test This test is a safety precaution that will verify the batterys protection from a short circuit.

Battery Discharge Test For this test, we will verify that our batteries do not discharge below 2.7 volts. Once they reach 2.7 volts, the device will turn off.

Analog to Digital Test This test will verify that our ADC is functioning correctly. This test is vital to the accuracy of our product.

Filtering Characteristics Test In this test, we will change the filtering characteristics on the user interface of our desktop application to control the CardioScope wearable device.

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Channel Choice Test In this test, we will use our desktop application to select variations of our device using our desktop software. These configurations include three modes: 8-channel, 4-channel, and 2-channel.

Anti-Aliasing Filter Test In order to transmit a clean ECG signal, its necessary to filter the waveform. This test will verify that we transmit the signal with minimum noise.

Waveform Display Test We will test that our desktop software efficiently processes and displays correct waveforms. This test will include all configurations of the ECG waveforms we receive wirelessly.

Signal Amplification Test Since the electrical activity from the ECG sensors is very small, amplification is necessary. In this test, we will make sure we amplify the waveforms correctly.

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Technical Merit

Technical Merit is an assessment of multiple factors in which our final prototype is graded on. In order to meet the desired requirement, a 1.0 must be met overall. We have estimated that we will meet 1.8 points out of a total of 1.9 points since we will not be pursuing intellectual property protection worth 0.1 points.

Figure 71: Technical merit

Contains a clearly described and completely understood technical challenge Our company has dedicated considerable time to discovering and understanding the technical challenges involved in the CardioScope project through research, brainstorming, and communication with our sponsor and advisor. Since none of our team has previous medical experience, we will be forced to learn more about the cardiac cycle and measurement. We have identified that measuring a persons heartbeat, and displaying it wirelessly to a host computer is considerably difficult, therefore we have awarded ourselves the full 0.1 points for this merit factor. Contains a requirement for system integration CardioScope will measure the human heartbeat, which cannot be predetermined or controlled by our team. It will do this using ECG leads placed in very specific locations across the human body. We will Page | 123

receive, amplify, filter, convert, and transmit the signal in hardware. We will then process and display the signal using software. This meets the requirement for system integration and the full .2 points have been awarded. Contains a requirement for system testing Our group will be testing the prototype hardware and software to ensure the prototype meets all functional and performance requirements. These tests will be based on a test plan generated by our team. This meets the requirement for system testing and the full 0.2 points have been awarded. Contains a requirement for analysis In order to display correct ECG waveforms, CardioScope software will have to analyze the raw received waveform data during post-processing. We will also be doing analysis during our design phase in preparation for the final prototype. These factors justify the full 0.2 points for this factor. Contains hardware design, development, and test The CardioScope project will span multiple revisions of schematics and board layouts. Each version will be revised based on test results from populated PCBs from previous versions. This meets the requirement for designing, developing, and testing of hardware and the full 0.3 points have therefore been awarded. Contains software design, development, and test Our company will develop code for a microcontroller as well as a desktop application. This software will be responsible for bidirectional wireless communication, signal processing, multiple configurations, and ECG waveform real-time display. Each revision will be extensively tested. These processes justify the full 0.3 points for technical merit in this category. Contains hardware fabrication requirement CardioScope will contain a custom enclosure to house the populated PCB and expose the proper connections. The form factor of this enclosure will be small, lightweight, and able to withstand normal abuse. This enclosure justifies the full 0.2 points for this merit factor.

Contains external documentation Since our project is part of the Texas Space Grant Consortium Design Challenge, we are required to submit documentation outside of class. This documentation includes three different levels of Page | 124

deliverables. The Level I deliverable includes a formal design project proposal. Level II includes a midterm report consisting of a project timeline, budget, and safety factors. The Level III deliverable includes a final technical report with a checklist. The listed documents justify the full 0.2 points for external documentation.

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Appendix D Problem Statement Memorandum

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Memorandum
To: Through: From: Date: Re: Dr. Joseph A. Morgan, D.E., P.E. Dr. Jay R. Porter, P.E. Raymond King 10/19/10 ENTC 419 Fall 2010 Problem Statement Memo

The National Aeronautics and Space Administration is an Executive Branch agency of the United States government responsible for the nations civilian space program and aeronautics and aerospace research. NASAs self-described mission statement is to pioneer the future in space exploration, scientific discovery and aeronautics research. NASA uses electrocardiograms (ECG) extensively to monitor the vital functions of their patients. These ECG modules tend to be bulky and have a spaghetti effect. The spaghetti effect can be described as when a patient is attached to a normal ECG, the wires from the electrode leads stretch from the patient to the ECG monitor. The patient has to pay attention to the location of the wires so that they do not trip or accidently disconnect an electrode from their body. The spaghetti effect limits the patients movement and requires them to stay in close vicinity of the ECG device. Most existing hospital ECG machines are floor units; the patient cannot walk around freely when connected to these devices. NASA would like to develop a portable ECG device that can be wearable. This would give patients the ability to move freely as well as not being confined to a small area. The wearable ECG device would transmit the ECG signals received from the patient to a host computer. The host computer would receive and receive, display, and process those signals. As of right now, the market is void of a portable ECG device that meets the requirements provided by NASA. NASA requires this device to meet several requirements in key areas such as enclosure, hardware, and software. The enclosure must be small in size, light weight, and durable. The hardware for the ECG device must be able to accept up to eight channels of ECG signals from a patient. This information will then have to be converted from an analog signal to a digital signal, and then transmitted wirelessly to a host computer. This information will have to be transmitted in real-time. The host computer will need to be a standard
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Windows machine that has a wireless adapter. The host computer must also have a user interface that is easy to use, and this interface will be aimed at a user who is familiar with ECG settings. Based on information and correspondence from NASA, embedics CardioScope will be able to meet the needs of NASA. The CardioScope will be a portable ambulatory multi-channel wireless ECG that transmits the hearts electrical activity wirelessly over a short distance. To do this the CardioScope will have a small form factor to make it portable. The device will meet NASAs requirement of a maximum volume of 400cm3. The small size of the CardioScope will allow NASA to use it in situations where a normal ECG would not be practical. The wireless transmission will be over Wi-Fi and transmit over a distance of at least ten feet. The transmission will consist of the captured ECG signals from the patient that have been converted from analog to digital. It will also be a lightweight, battery-powered solution which will control, display, and store the real-time digitally filtered waveforms on a host computer. To be light weight, special consideration will be needed in the construction of the enclosure as well as battery choice. The batteries of the CardioScope must be light weight but also have a high energy density. NASA requires the device to be able to be powered on for at least twenty four hours in two channel mode. To do this embedic has made the decision to use lithium ion batteries due to the face they have a higher power density ratio than all other available batteries. The host computer that will be used with the CardioScope will receive the ECG signals and then process them by applying digital filters. These digital filters will be set by user to give them the ability to change how the signals are processed. Raymond King, Hardware Engineer (361) 563-5416 raymond@embedic.net

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Appendix E Conceptual Design Memorandum

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Memorandum
To: Through: From: Date: Re: Dr. Joseph A. Morgan, D.E., P.E. Dr. Jay R. Porter, P.E. Raymond King 11/3/10 Conceptual Block Diagram

At embedic a high level view of the CardioScope has been created to help the customer understand how the device will meet their needs before moving forward. To fully understand how the CardioScope wearable unit will be built and what the host computer will be doing, we have included Figure 1, which illustrates the key functionality of the CardioScope. The diagram focuses on the components that make up the CardioScope wearable unit and discusses the role of the host computer.

Figure 72: Conceptual Block Diagram for the CardioScope

The key components that will be included in the CardioScope wearable unit will be signal amplification circuits, anti-aliasing low pass filters, a microcontroller, a Wi-Fi module, and an
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enclosure. Also included with the CardioScope is an application that will be installed on a host computer.

Half of the CardioScope project consists of the wearable unit, which gathers the electrical signals from the heart and transmits them via Wi-Fi. The ten electrodes used will be connected to the device via a custom cable. There will be eight ECG channels that will be brought in from the ten

electrodes that are connected to the patient. Because the signals are 1mV or less, they will be amplified to a level that is usable for input to the microcontroller. The signals will then be passed through an anti-aliasing filter to ensure they will be correctly converted from an analog to a digital signal. The microcontroller will be used to complete this conversion and will transmit the data to the Wi-Fi module. Wi-Fi was chosen for the CardioScope due to its range, speed, and ease of setup. The Wi-Fi module transmits the ECG signals to the host computer.

The host computer will be a Windows-based machine that will have a GUI application with several key functions. The program will give the user the ability to configure the settings of the wearable unit. All of the digital filtering and processing will be done in real-time on the host computer. The host computer will also do post processing, which will include parameters such as the heartbeat of the patient as well as other key cardiac indicators. The program will give the user the opportunity to see the ECG signals in real time in a graphical format, but will also store the heartbeat for later playback and analysis.

Raymond King, Hardware Engineer (361) 563-5416 raymond@embedic.net

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Appendix F Functional Design Memorandum

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Memorandum
To: Through: From: Date: Re: Dr. Joseph A. Morgan, D.E., P.E. Dr. Jay R. Porter, P.E. Alexander Smith 11/10/10 Functional Design

This memo describes the functional design for embedics CardioScope, a wireless ambulatory 12lead ECG device. The functional block diagram for the CardioScope breaks down the device into individual components arranged into functional units. The functional block diagram should include enough detail so that its possible to create a schematic directly from the diagram.

The functional block diagram starts at the top with the sensors. There are 10 ECG sensors: V1-V6, Right Leg (RL), Right Arm (RA), Left Leg (LL), and Left Arm (LA). Immediately after entering the device, each signal passes through an electrode protection circuit. This circuit makes sure no dangerous voltage differentials can exist between two electrodes that could harm the patient. The Right Leg sensor is then tied to the circuit ground; it is its only use. All other signals then pass through individual level shifters. These voltage adders shift the analog voltage signals in the positive direction so that any negative voltages can be used with a single-sided power supply. The RA, LL, and LA signals are averaged with a simple op amp circuit to be used as the Wilsons Central Terminal, required for utilizing the V1-V6 signals.

Starting from the left, there are 8 instrumentation amplifiers that the electrode signals enter in order to form the channels or leads. The name of each lead is inside the instrumentation amplifier symbol. Instrumentation amps are used because the voltages being measured are very small and the ECG electrodes have a high impedance. Each instrumentation amp magnifies the difference between its positive and negative terminals. Leads V1 through V6 are formed by placing the matching V lead
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on the positive terminal with the reference signal on the negative terminal. Lead I is formed by placing the LA signal on the positive terminal of the instrumentation amp and the RA signal on the negative terminal. Lead II is formed by placing the LL signal on the positive terminal of the instrumentation amp and the RA signal on the negative terminal. These 8 channels are enough to reconstruct all 12 leads in software. Each lead then immediately passes into a low pass filter designed to have a cutoff at 250Hz. This anti-aliasing filter allows the analog to digital converter (ADC) to sample at 500Hz.

Each lead enters the microcontroller, a Microchip PIC18F67K22, through 8 ADC pins. The PIC converts the analog voltage to a digital value and stores it internally to the PIC. After a short period of time, such as 100ms, the PIC then sends the data to the Wi-Fi module. The 802.11b module used is a Microchip MRF24WB0MA module, designed specifically to be paired with a Microchip microcontroller. Data communication between the Wi-Fi module and the PIC is done over the 4-wire SPI interface, with the PIC as the master and the Wi-Fi module as the slave. The PICs second SPI module is used due to the convenient physical grouping of the pins on the PIC. The PIC SPI clock pin (SCK2) is connected to the Wi-Fi SPI clock pin (SCK), the PIC SPI data in pin (SDI2) is connected to the Wi-Fi data out pin (SDO), and the PIC SPI data out pin (SDO2) is connected to the Wi-Fi data in pin (SDI). Four digital I/O pins on the PIC, RD7, RD3, RD2, and RD1 are used for other Wi-Fi module control signals chip select, hibernate, write protect, and reset. Finally, an interrupt signal pin on the Wi-Fi module (nINT) is connected to an interrupt input on the PIC (INT1) so that the Wi-Fi module can inform the PIC when it has received data. This is required because the SPI interface only allows the master, the PIC in this case, to initiate the connection.

As this is a portable device, batteries are the power source for all components on the board. Two 3.7V 2800mAh Lithium-Ion batteries are placed in parallel to produce 3.7V and 5600mAh. As Li-Ion batteries can be damaged by undervoltage, a 2.7V cutoff circuit is placed after the battery that will turn off the device if the voltage drops to a dangerous level. The batteries power a low dropout (LDO) voltage regulator, which produces 3.0V and a maximum of 250mA. This regulated voltage powers the rest of the circuit.
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Appendix G Deliverables Memorandum

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Memorandum
To: From: Date: Re: Dr. Joseph A. Morgan, D.E., P.E. Patrick Navarro 11/17/10 ENTC 419 Fall 2010 Deliverables Memo

The purpose of this memo is to list and explain in detail the deliverables that we have decided that will best represent the scope of our project. Deliverables are significant stages during our project that will give our advisor and sponsor insight into our progress throughout our implementation.

Deliverable Responsibilities

Deliverable Desktop UI Mockup Final PCB Schematic Review Alpha PCB Layout Final PCB Layout Bill of Materials Alpha Code Build Critical Design Review Final Code Build Final Prototype Presentation Final Documentation

Date of Completion 1/28/11 2/1/11 2/15/11 2/22/11 2/22/11 3/2/11 3/18/11 4/16/11 4/29/11 5/6/11

Responsible Team Member Patrick Navarro Raymond King Raymond King Raymond King Raymond King Patrick Navarro Alex Smith Patrick Navarro Alex Smith Alex Smith

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Deliverables Timeline

Deliverable Descriptions

Desktop UI Mockup This deliverable will be a visual layout of our desktop application. This mockup will be a graphical representation of the desired user interface for CardioScope. This design will be created using Adobe Photoshop and will include all functionality that we intend on using in our final prototype application. This representation will include sample menus, menu hierarchy, and ECG configuration options. The sample menus will contain a detailed description of their purpose along with the proposed format of each command. The command sets will not contain any command that does not directly impact navigation of the user interface or is a general help command. The mockup will be submitted as both a paper hardcopy and a PDF version.

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Final PCB Schematic Review This deliverable is the alpha schematic design of the hardware required for CardioScope. The schematic will include components, part names, and pin outs. The schematic will also be broken into sections using virtual connections for a cleaner design and clarity. Schematics will be designed in National Instrument's Multisim. The alpha hardware schematic will be submitted as both a paper hard copy and a PDF soft copy.

Alpha PCB Layout The alpha Printed Circuit Board (PCB) layout is the alpha version of the CardioScope hardware layout. This will be done using National Instrument's Ultiboard, allowing for our schematic files from MultiSim to be transferred to Ultiboard. The layout will display the multiple layers of the PCB, trace widths, and specific locations of components. The alpha PCB layout will be submitted as both a paper hard copy and a PDF soft copy.

Test Plan A test plan will be created to effectively test every component of our functional prototype. The test plan will validate the functional requirements agreed upon by our customer. It will provide reasoning for each test along with a description of how we will conduct each test. Our test plan will be divided into three separate sections: enclosure, hardware, and software. By dividing our test plan up into these sections, it will help us verify that each component of our functional prototype will perform and meet our sponsors requirements.

Final PCB Layout The final PCB layout is the revised design of the CardioScope hardware layout. The final layout is the last stage of design; incorporating all revisions and improvements from the previous layouts. This will be done using National Instrument's Ultiboard, allowing for our schematic files

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from MultiSim to be transferred to Ultiboard. The layout will contain amplification, filtering, and Wi-Fi module hardware. The layout shows the multiple layers of the PCB; including the copper and silkscreen footprint. We will also print out a full size layout of the PCB to verify the footprint sizes are correct before it is fabricated. The final PCB layout will be submitted as both a paper hard copy and a PDF soft copy.

Bill of Materials A Bill of Materials will be provided to the customer. This document will contain the prices of the final components selected for the prototype. The Bill of Materials is generated in a table format in Microsoft Excel that contains ten columns that consist of the description, value, quantity, designator, parts number, cost of single unit, cost of a hundred, vendor, total unit required cost, and total cost of a hundred. It also provides the cost to produce a single board as well as the cost to of hundred boards. This gives our stakeholders the ability to consider the total cost of production. We will focus on keeping our product cost as low cost as possible while fulfilling the given requirements.

Alpha Code Build An alpha stage code build will be provided for the CardioScope. This code listing will include fully commented code that has been complied, ran, and debugged. This code represents steps being taken to provide a quality prototype to the sponsor and may not include 100% of the functionality that will be present in the final code build. This code build will include all source and header files. The format for all comments, layout, and materials submitted will follow the same format for the final code build. The format may change only if the sponsor and/or advisor indicate that the provided format for the alpha code build was not sufficient. This build will be submitted with each file in its original format in a zip file with a PDF containing the code for each file.

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Critical Design Review The purpose of the Critical Design Review (CDR) is to update our stakeholders on the progress of our project. It will inform them of how close we are to finishing the project, what problems we have encountered, and what we have remaining. This presentation should give our stakeholder an idea of whether or not we will complete our project on time and on budget. Tentatively, this will also include a successful proof of concept demonstration. This deliverable will be submitted as a softcopy.

Final Code Build A final stage code build will be provided for the CardioScope. This code listing will include fully commented code that has been complied, ran, and debugged. This code represents 100% of the required functionality for our final prototype. It will include all source and header files necessary. The format for all comments, layout, and materials submitted will follow the same format as the alpha code build. This build will be submitted with each file in its original format in a zip file with a PDF containing the code for each file.

Final Prototype Presentation This deliverable will be the final iteration of our design and will meet all requirements agreed upon by the customer and our team. The demonstration will take approximately one hour in a location that is to be determined. We will demonstrate a fully functional CardioScope wireless ECG at this time. After the demonstration we will answer a series of questions that our audience may have.

Final Documentation The final project documentation will be a composite of all our previous documents that are finalized and updated. It will contain any new documents that we have created in the process of completing

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our project. This deliverable also includes our documented source code for our microcontroller and desktop applications. It will provide an overview of the software architecture, theory of operation, and details about functions and algorithms necessary to create a working prototype.

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Appendix H Responsibilities Assignment Matrix

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Phase Research Research Research

Task # 1.1 1.1.1 1.1.2

Task Description ECG Technology Electrodes Leads / Channels Analog Front End Amplification Filtering Microcontroller Wireless Communications Physical Medium / Technology Protocol Power Batteries Voltage Regulator Software Language IDE Product Standards Vibration Impact

Alex Raymond Patrick Duration Labor Advisor Sponsor Smith King Navarro (Days) (Hours)

L L

I I

P P

I I

R R

1 3

4 10

Research Research Research Research

1.2 1.2.1 1.2.2 1.3

P P L

L L I

I I P

R R R

I I I

2 2 2

8 8 8

Research

1.4

Research Research Research Research

1.4.1 1.4.2 1.5 1.5.1

I P

P I

L L

R R

I I

3 2

10 8

Research Research Research Research

1.5.2 1.6 1.6.1 1.6.2

P P

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L L

R R

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5 2

10 2

Research Research Research

1.7 1.7.1 1.7.2

P P

L L

I I

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3 3

10 10

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Design

2.1

Alpha Schematic Alpha Front End Schematic Alpha Microcontroller Schematic Alpha Wireless Schematic Alpha Power Schematic Alpha Safety Schematic Alpha Schematic Review Alpha PCB Layout Alpha Layout Alpha Layout Review Component Selection Front End Component Selection Microcontroller Selection Wireless Module Selection Power Component P L I I I 1 5

Design

2.1.1

Design

2.1.2

Design

2.1.3

Design

2.1.4

Design

2.1.5

Design

2.1.6

10

Design Design

2.2 2.2.1

Design

2.2.2

10

Design

2.3

Design

2.3.1

Design

2.3.2

Design Design

2.3.3 2.3.4

L P

P L

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2 2

7 7

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Selection Bill of Materials Review Pseudocode Microcontroller Pseudocode Host Pseudocode Pseudocode Review Enclosure Design Enclosure Drawings Enclosure Drawing Review Enclosure 3D Models Enclosure 3D Model Review I L P I I 2 8

Design Design

2.3.5 2.4

Design

2.4.1

Design

2.4.2

Design Design

2.4.3 2.5

Design

2.5.1

Design

2.5.2

Design

2.5.3

10

Design

2.5.4

PoC Prototype

3.1

Development Kit Procurement Development Kit Selection Development Kit Review Development Kit Purchase Prototype Page | 146

PoC Prototype

3.1.1

PoC Prototype

3.1.2

PoC Prototype PoC Prototype

3.1.3 3.2

Construction Single Channel Circuit PIC Development Board Wireless Module Prototype Hardware Review Microcontroller Programming Initialization Code ADC Code Wireless Code Microcontroller Code Review Host Demo Program Get Data Filter Data Save Data Plot Data Host Demo Program Review Prototype Debug & Test ADC Debug & L P I R I 5 30 P P P P I I I I L L L L I I I I R R R R 5 10 5 5 20 40 20 20

PoC Prototype

3.2.1

PoC Prototype PoC Prototype

3.2.2 3.2.3

P L

L P

I I

I I

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3 2

PoC Prototype

3.2.4

PoC Prototype

3.3

PoC Prototype PoC Prototype PoC Prototype

3.3.1 3.3.2 3.3.3

L L L

I I I

P P P

I I I

I I I

2 2 5

8 8 30

PoC Prototype

3.3.4

PoC Prototype PoC Prototype PoC Prototype PoC Prototype PoC Prototype

3.4 3.4.1 3.4.2 3.4.3 3.4.4

PoC Prototype

3.4.5

PoC Prototype PoC Prototype

3.5 3.5.1

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Test Wireless Client Debug & Test Wirelesss Host Debug & Test Filter Debug & Test Display Debug & Test

PoC Prototype

3.5.2

20

PoC Prototype

3.5.3

20

PoC Prototype

3.5.4

20

PoC Prototype

3.5.5

20

Final Product

4.1

Final Procurement Order Bill of Materials Order Alpha PCB Alpha PCB Alpha PCB Population Alpha PCB Debug & Test Alpha PCB Review List of Alpha PCB Changes Beta PCB Schematic Changes for Beta PCB Beta Schematic Review

Final Product Final Product Final Product

4.1.1 4.1.2 4.2

P P

L L

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2 2

Final Product

4.2.1

Final Product

4.2.2

30

Final Product

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Final Product Final Product

4.2.4 4.3

Final Product

4.3.1

Final Product

4.3.2

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Final Product

4.3.3

Beta PCB Layout Beta PCB Layout Review Order Beta PCB Beta PCB Population Beta PCB Debug & Test Beta PCB Review Final Programming Microcontroller Code Changes Full Host Application Host Data Collection Code Host Digital Filter Code Host Data Save/Load Code Host Display Code Host Unit Control Code Code Review Final Debugging Hardware System Debugging

Final Product Final Product

4.3.4 4.3.5

P P

L L

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R I

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2 1

5 2

Final Product

4.3.6

Final Product Final Product

4.3.7 4.3.8

P P

L L

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5 1

30 2

Final Product

4.4

Final Product

4.4.1

Final Product

4.4.2

20

Final Product

4.4.2.1

12

Final Product

4.4.2.2

15

Final Product

4.4.2.3

10

Final Product

4.4.2.4

10

Final Product Final Product Final Product

4.4.2.5 4.4.3 4.5

P P

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12 2

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4.5.1

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30

Final Product

4.5.2

Microcontroller Code Debugging Host Program Code Debugging Final Enclosure Alpha Enclosure Creation Alpha Enclosure Evaluation Make Changes to Enclosure Design Beta Enclosure Design Review Beta Enclosure Creation Beta Enclosure Testing

30

Final Product Final Product

4.5.3 4.6

30

Final Product

4.6.1

Final Product

4.6.2

Final Product

4.6.3

Final Product

4.6.4

Final Product

4.6.5

Final Product

4.6.6

Testing

5.1

Hardware Testing Analog Front End Testing ADC Testing Wireless Testing Software Testing Microcontroller Code Testing Host Code

Testing Testing Testing

5.1.1 5.1.2 5.1.3

P P L

L L P

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20 10 10

Testing

5.2

Testing Testing

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10 15

Testing System Integration Testing Stationary Test Walking Test Running Test L L L P P P I I I I I I R R R 2 2 2 6 6 6

Testing Testing Testing Testing

5.3 5.3.1 5.3.2 5.3.3

Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Documentation & Closeout Total

6.1

Documentation Instruction Manual

6.1.1

20

6.1.2

Final Report Final Presentation PowerPoint Presentation Demo Preparation Presentation Prepare

80

6.2

6.2.1

15

6.2.2

6.2.3

10

6.3

Clean-Up

6.3.1

Clean-Up Lab

6.3.2

Return All Keys

1 1051

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Appendix Ia Network Logic Diagram (originally submitted)

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Appendix Ib Network Logic Diagram (revised)

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Appendix J Risk Assessment

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Appendix K Costing Data

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Costing Data
This document describes the cost breakdown of embedics CardioScope project. Costs are broken down into four areas: Direct, Indirect, Profit, and Other. Direct A direct cost is one that is required to complete a specific project. It includes resources that can solely be used for the CardioScope project; resources that are used for multiple projects are not taken into account here. Direct costs due to labor are broken down into wages and benefits. The project manager, Alex Smith, will make slightly more ($35 per hour) than the other employees ($30 per hour). Every employee gets benefits and insurance, which is 40% of their wages. Direct Costs - Labor ManWage Benefits & Insurance (40%) hours 444 $15,540 $6,216 347 388 1179 $10,410 $11,640 $37,590 $4,164 $4,656 $15,036

Member Alexander Smith Raymond King Patrick Navarro Total

Hourly Wage $35 $30 $30

Individual Total $21,756 $14,574 $16,296 $52,626

Other direct costs are all costs for a single project that does not include labor. These direct costs were split into three areas: hardware, software, and testing. Hardware costs consist of the money spent for the physical components for the project. This includes development kits, PCB fabrication, components for the PCB, batteries, tools, and enclosure. Software costs consist of the software we will use to complete this project. National Instruments Circuit Design Suite software will be used for schematic capture and PCB layout design. Microchips MPLAB C compiler for the PIC18 we will be using will allow us to compile code for our microcontroller. Test costs include a standard oscilloscope and multimeter to test the PCB, as well as an ECG patient simulator. This patient simulator will generate the 10 signals required to fully test our device without the need to be hooked up to a patient.

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Other Direct Costs - Material Hardware Item Quantity Cost per Unit PIC Development Board 1 $50 PIC18 Personality Module 2 $40 Alpha PCB 2 $35 Beta PCB 2 $35 Microchip Wi-Fi Module 3 $40 PICkit 3 ICD Programmer 1 $45 Instrumentation Amps, 2 10 $5 channel Opamps, quad channel 15 $5 Lithium Ion Batteries 4 $8 Li-ion charger 1 $10 PIC18 Microcontroller 4 $4 Other board components 1 $100 Tools 1 $300 Enclosure 2 $60 Shipping 1 $200 Total

Subtotal $50 $80 $70 $70 $120 $45 $50 $75 $32 $10 $16 $100 $300 $120 $200 $1,338

Software Item Quantity NI Circuit Design Suite 1 MPLAB C Compiler for PIC18 1 Total

Cost per Unit $3,600 $495

Subtotal $3,600 $495 $4,095

Item Oscilloscope Digital Multimeter ECG Patient Simulator Total

Test Quantity 1 1 1

Cost per Unit $5,000 $1,000 $250

Subtotal $5,000 $1,000 $250 $6,250

The Total Direct Costs are the sum of the labor costs and the other direct costs. This is the cost of what is needed solely for the CardioScope project.

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Total Direct Costs Labor $52,626 Other Direct Costs $11,683 Total $64,309

Indirect Costs Indirect Costs are those costs that are required to complete the project but cannot be assigned to the CardioScope project specifically. It is the cost of being in business, and is spread across all customers. Indirect costs can be broken down into overhead and general and administrative (G & A) costs. Each one of these costs is a percentage of the total direct costs. Overhead is the cost of renting office space, utilities, internet service, and other similar costs. We chose to use 45% of our total direct costs as a reasonable cost for overhead. General and administrative costs include the salary for a secretary, shipping costs, project management software, and other similar costs. We chose to use 10% of our total direct costs as a nominal cost for G & A.

Indirect Costs Overhead 45% $28,939 G&A 10% $6,431 Total $35,370

The summation of our direct costs and indirect costs are our Total Direct and Indirect Costs (TDIC). Total Direct and Indirect Direct $64,309 Indirect $35,370 Total $99,679

Profit Profit is the return on investment for embedic for the CardioScope project. We chose to use a margin system for computing profit. The following is the equation for computing profit using the margin method:

We chose to use 20% as our profit margin, as we felt that this was a good return on investment for the project.

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Profit TDIC $99,679 Margin 20% Total $24,920 Other Costs Other costs are additional charges that do not fall into the direct, indirect, or profit categories. These include risk aversion and the cost of money. Risk aversion is a percentage of the TDIC plus profit dedicated to cover any risk that the company may have when producing the CardioScope. We chose a risk aversion percentage of 10% to ensure we are properly covered. The cost of money is the change in the value of the dollar over the time length of the project; we chose 1% for this value.

Other Costs Risk Aversion 10% Cost of Money 1% Total

$12,460 $1,246 $13,706

Price The price of the project is the summation of the TDIC, the profit, and the other costs. This is the final cost of the project. Price Total Direct and Indirect Costs Profit Other Costs Total

$99,679 $24,920 $13,706 $138,305

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Sequence of Funds The sequence of funds breaks down how much is spent each week in the project. As the chart and graph shows, the project is more heavily weighted at the start. The red line indicates the ideal spending each week as the total price over the number of weeks. This is mostly due to the high costs associated with buying software required at the beginning. The labor and margin costs are constants across each week. The indirect and other costs occur on a monthly basis, causing small peaks in the line. Sequence of Funds Indirect Margin Costs $8,842.49 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $8,842.49 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $8,842.49 $1,661.32 $1,661.32 $1,661.32 $1,661.32 $8,842.49 $1,661.32 $1,661.32 $1,661.32

Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Labor $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40 $3,508.40

Other Direct $10,495.00 $320.00 $558.00 $95.00 $215.00

Other Costs $3,426.46

$3,426.46

$3,426.46

$3,426.46

Weekly Total $27,933.67 $5,489.72 $5,169.72 $5,727.72 $17,533.67 $5,169.72 $5,384.72 $5,169.72 $17,438.67 $5,169.72 $5,169.72 $5,169.72 $17,438.67 $5,169.72 $5,169.72

Project Total $27,933.67 $33,423.38 $38,593.10 $44,320.81 $61,854.48 $67,024.20 $72,408.91 $77,578.63 $95,017.30 $100,187.01 $105,356.73 $110,526.44 $127,965.11 $133,134.83 $138,304.54

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Sequence of Cost

Cost

Weeks

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Appendix L Functional Block Diagrams (revised)

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Input, Front End, Microcontroller, and Wi-Fi Module

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Appendix M Team Member Resumes

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Raymond C. King
917 Luther St. West College Station, TX 77840 Cell: (361) 563-5416 E-mail: Raymond.Charles.King@gmail.com

OBJECTIVE EDUCATION

Seeking full-time employment in electronics engineering technology in May 2011

Texas A&M University, College Station TX

Grad: May 2011

Bachelor of Science in Electronics Engineering Technology Financed 100% of college education through loans, scholarships, work, and grants

ACTIVITIES

Formula Hybrid Volunteer and Driver Institute of Electrical and Electronics Engineers Explore Engineering Summer Workshops

2008 - 2009 2009 - 2010 2009 - 2010

HONORS

Eagle Scout Award Texas A&M Formula Hybrid World Champion Team, 2009 Invitation National Instruments NIWeek 2010 to display robotics project

WORK EXPERIENCE

Texas A&M Electronics and Telecom Department, College Station, TX Student Worker II Dec. 2008 - Present Lab Instructor for Digital Logic Course ENTC 219 Prototype and develop printed circuit boards Help to organize and host Explore Engineering Workshops BHP Engineering, Corpus Christi, TX Vehicle and Office Maintenance May 2008 Aug. 2008 Repaired and maintained company cars Remodeled a section of the office building Performed building maintenance Mustang Engineering, Houston, TX Rodman May 2007 Aug. 2007; Dec. 2007 Jan. 2008

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Organized and supplied the crews truck each morning before work Helped with the position of the back site and front site mirrors Cleared the line of sight for our eye man

BHP Engineering, Corpus Christi, TX Drafter and Fleet Manager May 2006 Aug. 2006 Picked up marks on piping drawings Helped with survey and create drawings for foundation work Repaired company cars, consultant/buyer for the purchase of a dozen vehicles at an auction Performed building maintenance

SKILLS

AutoCAD Solidworks design 3ds Studio Max AutoDesk Inventor Project Management

Technical Communication Multisim Ultiboard LabVIEW Microsoft Office

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Appendix O Intellectual Property Memorandum

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Memorandum
To: Through: From: Date: Re: Dr. Joseph A. Morgan, D.E., P.E. Dr. Jay R. Porter, P.E. Alexander Smith 11/29/10 Intellectual Property Memorandum

The purpose of this memo is to put in place an agreement on the topic of intellectual property rights as they may relate to the CardioScope wireless multi-channel ECG device. Intellectual property may include technical information, copyright, models, patterns, drawings, specifications, prototypes, software and inventions. Intellectual Property shall be owned in full by members of embedic. The following parties are in understanding that all intellectual property as it relates to the CardioScope project will belong in equal shares to the members of embedic, which includes Alex Smith, Patrick Navarro, and Raymond King. The following information is a summary of the CardioScope project. At embedic a high level view of the CardioScope has been created to help the customer understand how the device will meet their needs. To fully understand how the CardioScope wearable unit will be built and what the host computer will be doing, we have included Figure 73, which illustrates the key functionality of the CardioScope. The diagram focuses on the components that make up the CardioScope wearable unit and discusses the role of the host computer.

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Figure 73: Conceptual Block Diagram for the CardioScope

The key components that will be included in the CardioScope wearable unit will be signal amplification circuits, anti-aliasing low pass filters, a microcontroller, a Wi-Fi module, and an enclosure. Also included with the CardioScope is software that will be installed on a host computer. Half of the CardioScope project consists of the wearable unit, which gathers the electrical signals from the heart and transmits them via Wi-Fi. The ten electrodes used will be connected to the device via a custom cable. There will be eight ECG channels that will be brought in from the ten electrodes that are connected to the patient. Because the signals are 1mV or less, they will be amplified to a level that is usable for input to the microcontroller. The signals will then be passed through an anti-aliasing filter to ensure they will be correctly converted from an analog to a digital signal. The microcontroller will be used to complete this conversion and will transmit the data to the Wi-Fi module. Wi-Fi was chosen for the CardioScope due to its range, speed, and ease of setup. The Wi-Fi module transmits the ECG signals to the host computer. The host computer will be a wireless-enabled mobile computer with a GUI for functionality. The application will give the user the ability to configure the settings of the wearable unit. All of the digital filtering and processing will be done in real-time on the host computer. The host computer will also do post processing, which will include parameters such as the heartbeat of the patient as well as other key cardiac indicators. The program will give the user the opportunity to view the ECG signals in real-time in a graphical format, but will also store the ECG data for playback and analysis.

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While a simplified version of the system, the conceptual block diagram, has already been presented, a more detailed look at the hardware is required. This is the functional block diagram, a layout of the hardware that includes all important components required by the circuit as well as how they are connected together. Furthermore, this can be broken down into sections. For the CardioScope hardware, these include: input section, the digital section, and the power section. The Functional Design Memorandum for the CardioScope can be found in Appendix F, and an updated Functional Block Diagram in Appendix L.

Input section

The input section is made up of 4 parts: the electrodes, the cable assembly, the electrode protection circuitry, and the low pass filter.

Electrodes The electrodes are the patches placed on the skin that conduct the voltages from the skin to the cables back to the device. Holter-type electrodes are designed for long-term wear over the course of a day; these will be used in this application. In addition, electrodes with metal button snaps will be used. This is because a cable set with button receptacles will be used, which will be chosen to match an electronic patient simulator using metal snaps. When the CardioScope will be used on a patient, any electrode can be used. For trial purposes, 3Ms Red Dot Multipurpose Monitoring Electrode (3M-2560) will be used as they are designed to stay in place for up to five days.

Cable Assembly The cable assembly is the component that connects the electrodes to the wearable ECG unit. One end of the cable will have a male DB-15 connector, a 15-pin plug that is frequently used as an ECG cable standard. It should be noted that this is a 2-row DB-15 plug, with 8 pins on the top row and 7 pins on the bottom. This is a physically larger connector than a VGA DB-15 connector, which has 3 rows of 5 pins each in a DB-9 shell. The DB-15 used for the CardioScope

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is shown in Error! Reference source not found., and the pin-out is laid out in Table 2. The cable assembly will plug into a female DB-15 socket on the wearable ECG unit.

Figure 74. Pin-out of ECG cable DB-15 connector

Table 17: ECG cable pin-out Pin # 1 2 3 4 5 6 7 8 Connection V2 V3 V4 V5 V6 Shield <NC> <NC> Pin # 9 10 11 12 13 14 15 Connection RA LA LL V1 <NC> RL <NC>

The cable will then split into 10 individual shielded cables which each terminate in a female metal snap receptacle. Shielded cables ensure that no extra noise will be added to the small signals traveling through the cable assembly. The snaps will connect either to ECG electrodes placed on the patients body or they will connect to an electronic patient simulator. Many ECG cable assemblies use a DB-15 connector on one end and metal snaps on the other. The 10-Lead ECG Cable for Philips/HP Snap Button (0103020013) or a similar assembly will be used for the CardioScope, as seen in Error! Reference source not found..

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Figure 75. 10-lead ECG cable assembly

Electrode Protection Circuitry The cable assembly connects the electrodes to the device, but it also connects the device to the patient. In order to ensure the patient is not harmed in the case of a device malfunction, electrode protection circuitry is place on all incoming traces. A large resistor is placed in line with each signal that will limit any current traveling between the device and the patient. This resistor must be both high in resistance, to limit current to less than a couple of milliamps, and large in power dissipation so as not to be damaged in the process. However, a resistor that is too high in resistance will add thermal noise to the signal. Two diodes are placed in parallel with the signal, one pointing from the signal to the analog voltage source (AVDD) and another from the ground (AVSS) to the signal. These diodes will only conduct when the voltage is greater than the 0.7V or less than -0.7V, the forward voltage drop of a diode. Since ECG signals are only a few millivolts at most, any higher voltage will be shunted to power and any lower voltage will be shunted to ground. The resistor and diodes together are shown in Error! Reference source not found..

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AVDD

AVSS

Signal

Figure 76. Electrode protection circuit schematic

Low Pass Filter The final part the signal must pass through before entering the digital section is the low pass filter. This is an anti-aliasing filter, designed to only allow signals below 250Hz. This frequency was chosen because little to no information about the heartbeat exists at that frequency and above, based on the normal range of heart rates a human has. An anti-aliasing filter prevents an ADC from inaccurately sampling an analog signal.

Digital Section

The digital section consists of the TI front-end analog chip, the Microchip microcontroller, and the Wi-Fi module. The front-end analog chip samples and processes the analog ECG signals, the Wi-Fi module transmits the signals wirelessly, and the microcontroller controls both.

TI Analog Front End (AFE) Chip The TI ADS1198 is a chip specifically designed to be an analog front end for an ECG device. It consists of eight differential programmable gain amplifiers (PGAs), eight 16-bit sigma-delta analog to digital converters (ADCs), and a serial peripheral interface (SPI) module to output the digital data. The PGAs allow each channel to have 8 different amplification settings. The sigmadelta ADCs convert the analog signals to digital values in such a way to eliminate the complex

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analog filters usually required in an analog front-end. The SPI interface allows for the rapid transmission of data from the chip to the microcontroller. The ADS1198 is a 64-pin device in a TQFP package as shown in Error! Reference source not found.. Pins IN1 through IN8 are the inputs for each PGA, with the P pins being the non-inverting inputs and the N pins being the inverting inputs. The chip can run on a single-sided supply as long as VCAP1 through VCAP4 are populated. Both an analog 3.0V supply and a digital 1.8V supply are needed to run the chip; these will be separated with separate grounds in order to make sure no digital noise interferes with the analog inputs.

Figure 77. TI ADS1198 ECG Analog Front-end IC pin-out

The TI chip also includes a number of other features typically found with more complicated ECG devices, such as integrated lead-off detection, Wilsons Central Terminal output, and a right-leg driver. Lead-off detection is a method of determining if an electrode is no longer connected to the device. One way of doing this is to tie each electrode to the positive rail of the device. If the
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electrode is not connected, it acts as an open circuit. The pull-up resistor raises the voltage to the positive rail, which can be detected by the user. Wilsons Central Terminal is required to utilize the unipolar ECG electrodes V1-V6. It is an average of the right arm, left arm, and left leg signals, which creates a virtual terminal in the center of the patients chest. This is used to reference the other electrodes and therefore is placed on the inverting inputs of the PGAs used for V1 through V6. The right-leg driver is a way of further reducing common mode noise by sending a voltage to the right leg electrode to drive the rest of the body. An average of all the incoming signals are taken, this average is inverted, and then sent to the right leg. All these features are included in the ADS1198 chip, as well as others that are not being used. Error! Reference source not found. shows the block diagram of the TI chip.

Figure 78. Block Diagram of TI ADS1198 chip Page | 210

The TI front end chip will amplify and digitize the 8 ECG channels simultaneously. These digital values will be sent to the microcontroller via a 4-wire SPI interface. This interface has 4 connections: clock, data in, data out, and chip select. The data lines are crossed over between two SPI devices, the data in from one connected to the data out from another and vice versa. The chip select line is a simple digital I/O that activates the SPI interface when it is low. This device acts as an SPI slave device while the microcontroller acts as the master. In the SPI system, only a master can initiate communication; since the AFE chip needs to let the microcontroller know when the data is ready, it has a DRDY line. This is connected to the microcontroller and configured as an interrupt; when the AFE chip causes a line change when it is ready, the microcontroller will initiate SPI communication. The TI AFE chip requires two voltage sources, one 3.0V source for analog and another 1.8V source for digital. With the population of VCAP1 through VCAP4, the chip can amplify both positive and negative voltages with a single-sided supply.

Microcontroller The Microchip PIC24FJ64GB002 16-bit microcontroller will be used to take in the data from the TI AFE chip and send it to the Wi-Fi module. This PIC was chosen because it has very low power consumption and two SPI modules. The PIC24 will be tasked with both configuring and receiving data from the AFE chip through one of its SPI interfaces. It will then store this data in local memory until a set time period has passed, such as 100ms, and then package it into a UDP packet. This packet will be sent over the second SPI interface to the Wi-Fi module. The PIC24 has no dedicated pins for either of the SPI interfaces. All the pins on this microcontroller are remappable, meaning any pin from RP0 to RP15 can be configured to any of the modules the PIC24 has. The pin-out for the 28-pin device is in Figure 8. The first SPI module will be dedicated to the TI AFE chip, while the second will be dedicated to the Wi-Fi module. In this way, data can be received and sent simultaneously, which is required for real-time transmission. Pins RP0 through RP2 will be used for the first SPI clock, data out, and data in, respectively. These will be connected to the clock, data in, and data out pins on the TI AFE chip, respectively. Pin RB3 will be configured as a general purpose I/O and used as an SPI chip select for the AFE chip. Additionally, pin CN27 will be configured as the interrupt pin connected to the AFEs data ready pin.

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To connect the Wi-Fi module, 8 pins are required. Pins RP13 through RP15 will be used for the second SPI clock, data out, and data in, respectively. These will be connected to the Wi-Fi modules clock, data in, and data out pins. Pins RB8 through RB11 will be configured as general purpose digital outputs. Pin RB11 will be connected to the Wi-Fi modules SPI chip select pin. Pin RB10 will be connected to the hibernate pin, pin RB9 will be connected to the write protect pin, and pin RB8 will be connected to the reset pin. Finally, pin CN23 will be configured as an interrupt and connected to the interrupt pin on the Wi-Fi module. A number of other pins must be connected so that the PIC can function properly. All VDD pins will be supplied with 3.0V, and all VSS pins will be connected to digital ground. The PICs internal voltage regulator will be disabled by tying DISVREG to VDD, which also means VCAP will not have a capacitor on it and will be tied directly to VDD as well. The OSCI and OSCO pins will be used for an external oscillator. Finally, pins PGED3 and PGEC3 will be brought out to headers to allow programming of the device.

Figure 79. PIC24FJ64GB002 pin-out

Wi-Fi Module In order to transmit the ECG data wirelessly, the PIC24 microcontroller will send the data to the Microchip MRF24WB0MA Wi-Fi module. The Wi-Fi module contains an 802.11b 2.4GHz radio with a maximum throughput of 2Mbps. An SPI interface is used to transmit and receive data to and from the microcontroller. In addition to the four pins needed for SPI, four more pins are used for various control signals. In order to control the Wi-Fi module, Microchip provides a free stack that runs on their PIC microcontrollers. This free stack also includes the UDP/IP protocol that will be used to encapsulate the data. The Wi-Fi module comes in a 36-pin surface mount package with specific mounting characteristics, as shown in Figure 9. There are 8 pins that must be connected to the

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microcontroller, as well as the required power and ground pins. These connections were detailed in the microcontroller section.

Figure 80. Microchip Wi-Fi module pin-out

The UDP/IP protocol was chosen for this application. The User Datagram Protocol is a connectionless protocol with very low packet overhead that is well suited for rapid data transmission. The primary drawback of UDP is that there is no way to ensure the packets will reach the host computer, and there is nothing in the protocol that deals with resending packets. However, in this application dropped data is not a problem; it is more important to have the latest data on the host computer.

Power System

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The power system supplies power to all components on the board, and consists of the batteries, the low-voltage cutoff circuit, and the voltage regulators. Batteries The batteries chosen for the CardioScope are a pair of single cell lithium-ion batteries. The lithium-ion chemistry was chosen for its excellent power density in comparison to other batteries. Each cell is in a standard 18650 package (18mm diameter, 650mm long), which is a single 3.7V cell. Two cells with a capacity of 2800mAh each will be placed in parallel to form a 3.7V supply with 5600mAh capacity. If the major components consume approximately 118mA (Table 3) and other components, such as voltage regulators and pull up resistors, consume even 7mA, this will mean the device will consume 125mA. With a 5600mAh supply, this means the device will run for 44 hours before needing to be replaced. In order to avoid the complexity of adding a safe way to charge the Li-ion batteries in the device, the batteries will be removable allowing any standard Li-ion 18650 cell charger to be used.
Table 18: Power budget of major components Device TI AFE chip PIC24 microcontroller (1MIPS) 802.11b module (+0dBm) Total Max Power Consumption (mA) 1.7 1.4 115 118.1

Low Voltage Cutoff Circuit Safety is a major concern with Li-ion batteries, as being over discharged can damage the batteries. While one solution is to only purchase Li-ion cells with built-in protection circuitry, a dangerous condition can still exist if non-protected batteries are used accidentally. To prevent the Li-ion cells from being over discharged, a voltage monitoring component will be used. If the voltage drops below 2.7V, then the circuit will disable the voltage regulators in the circuit. This will cut power to all components in the device, stopping current draw and preventing the battery from being damaged.

Voltage Regulators

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In order to power all the components of the device, battery voltage must be converted into a regulated voltage. Two voltages are required in the device: 1.8V for DVDD on the TI AFE chip, and 3.0V for everything else on the board. As this is a battery powered device, the voltage regulator must have a low dropout voltage and must have low quiescent current draw. While the battery voltage will be 3.7V when it is fully charged, the voltage will drop as the battery is used. A low dropout (LDO) regulator is important so less voltage is wasted making sure the regulator can run, which means longer run-time for the whole device. Of the 125mA expected current draw, less than 1mA will be used for the digital components on the AFE chip. This means the 1.8V regulator needs to source very little current and a cheaper component can be chosen. For the 3.0V regulator, it will source at least 200mA.

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Appendix P Work Breakdown Structure

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