BE Design Team 050001 2.0 Project Heart Attack Detection 09/20/2006 1.0 Initial version Nicholas Lavin 09/22/2006 1.1 Added glossary and stakeholders. Nicholas Lavin, JR Shampang 09/22/2006 1.2 Added more goals. Nicholas Lavin 9/24/2006 1.3 Formatting. JR. Shampang 10/2/2006 1.4 Added UC1. JR. Shampang 10/4/2006 1.5 Corrected document Elizabeth Keyes 10/7/2006 1.6 Added product description, risks. Modified constraints and executive summary. JR. Shampang 10/8/2006 1.7 Proofreading Revisions Kieran Easter 10/8/2006 1.8 Improved glossary, edited goals. JR. Shampang 10/9/2006 1.9 Changed goals, modified risks, added work context image. JR. Shampang 10/11/2006 1.10 Modified work context diagram and work context table. JR. Shampang 10/15/2006 1.11 Modified goals. Adam Patterson 10/16/2006 1.12 Requirements and assumptions update Team 10/20/2006 1.13 Meeting update Nicholas Lavin 10/21/2006 1.14 Nonfunctional Requirements addition Elizabeth Keyes 10/22/2006 1.15 Requirements changes and removed User requirements (redundant) Adam Patterson 10/22/2006 1.16 Refined requirements. JR. Shampang 10/04/2007 1.17 Updated to reflect changes in the project. Elizabeth Keyes and Nicholas Lavin 10/12/2007 1.18 Began to bring the document up to date with the current version of the project. Nicholas Lavin 01/08/2008 2.0 Finish bringing document up to date with the project in preparation for the System Design Review 2 document. Nicholas Lavin This System Requirements Specification describes the functionality and requirements stated by Biomedical Engineering Team 050001 in regards to the Heart Attack Detection System. This document ascertains the people involved with this product, the metrics for success, and the constraints and risks involved with the creation of this product. Myocardial infarction (MI) is the leading cause of death for men and women worldwide. Early detection of MI has become a vital concern in the medical industry. People experiencing chest discomfort are at risk, and early diagnosis and treatment can prevent fatal heart damage from occurring. Medical professionals continue to pursue an efficient means of detecting and preventing a MI.

Biomedical Engineering Team 050001 aims to create a system that can determine the stage of myocardial infarction from a chest pain patient by analyzing a sample of the patient's blood. The system will determine the status of myocardial infarction within a reasonable time so that medical action can be taken if the patient is discovered to be suffering from a myocardial infarction. By analyzing the blood sample for enzymes and protein complexes that occur during myocardial infarction, the system will be able to calculate pertinent information from the blood sample, which a physician can then examine to determine a diagnosis.

The lives of myocardial infarction victims will be saved through early detection of myocardial infarction. Myocardial infarction victims will live longer. System will correctly detect myocardial infarction in 95% of tests. System will detect myocardial infarction earlier than existing alternatives. System will have a greater value to customers making it easier to distribute. Myocardial infarction detection time reduced by 95% from existing alternatives. Medical professionals using the system will have an easier time providing diagnoses to patients. Facilitating diagnosis process allows medical professionals to tend to patients more quickly. 90% of medical professionals surveyed approve use of machine. Biomedical Engineering Team 050001 Project Team Aaron Anderson Paige Ganske Bill Johnson Mike Kallin Elizabeth Keyes Nicholas Lavin Hospital Investor The hospital will invest money in the system to help save lives every day. If it does not work they will lose money and lives. Possibly have lawsuits due to the system. Patients Patient The patients count on the system to help save their lives in cases of myocardial infarctions. Technician Maintenance Maintenance personnel must remove waste and used antibodies in order to keep the system operational. Distributor Distributors Distributors will count on the product to sell well to users in order to make a profit. Nurse User Gathers then injects the blood sample into the machine in order to administer the test. Medical Professional User Analyzes results displayed from machine. Nurse Active Input patient information using a barcode reader. Inserts the blood vial into the system. Replenishes the system's materials (antibodies, wash solution, reset solution). Removes waste products from the system. Technician Active System displays an error code for technician to diagnose. Technician follows repair instructions for the provided error code. Technician begins the setup procedure. System guides technical through setup procedure. Medical Informatics System Automated The system interacts with a Medical Informatics System in order to retrieve patient information and store test results. Medical Professional Active System displays percentage concentration results for the medical professional. Testing a Blood Sample Waste Removal Refilling the System Entering Information Into the System System Initialization Data Transmission The project must be completed by senior year. The project is funded with a limited budget of under $1000. The product must comply with the standards and regulations set by the Occupational Safety and Health Administration (OSHA), such as the handling and storage of blood and biological wastes. The product must comply with the standards and regulations set by the Food and Drug Administration (FDA), such as the regulation of medical systems. The product shall have a display that utilizes pastel colors to display pertinent information. (Studies have shown that pastel colors are visually appealing to most nurses and result in increased productivity.) Testing the system is expensive due to the materials required (i.e., enzymes). Seek funding. Failure of the device could be devastating to the patient. Thorough testing before released into market. Project members do not have the training required for handling blood and therefore cannot properly test the system. The device will be tested using enzyme substitutes similar to blood. A patent is found of a very similar product. Attempt to add differing functionality. The system shall provide enough information for a medical professional to determine the presence and severity of myocardial infarction. Fit Criterion: 99% of medical professionals who use the system will correctly determine myocardial infarction. The system shall provide the ability to transfer the results of the test to a Medical Informatics System. Fit Criterion: The system will provide a valid HL7 message to a Medical Informatics System when it is configured properly. The system shall restart after a given amount of time after encountering an error. Fit Criterion: After encountering an error the system shall restart 99% of the time. The product shall be able to display the results in a way that a medical professional can understand it in a short amount of time. Fit Criterion: Trained professional reading the display correctly understands the information 100% of the time. The product shall be simple for medical personnel to operate. Fit Criterion: 95 out of 100 medical personnel using the machine will be able to correctly operate the machine without additional training. The product shall have a short time frame between inserting the blood sample and displaying the results. Fit Criterion: Blood sample testing process takes less than 20 minutes. The product shall not be noisy. Fit Criterion: Volume level stays below 50 dB (rainfall or normal conversation). The product shall not emit an offensive odor. Fit Criterion: 0% of medical personnel using machine provide complaints of the machine's odor. The product shall sustain little or no damage when dropped from a reasonable height. Fit Criterion: System continues to function properly after being dropped from a height of up to four feet a number of times TBD. The machine and creation process must follow FDA and OSHA standards. Fit Criterion: Machine complies to the rules laid out by the FDA and OSHA. The machine may not display results of previous patients to users. Fit Criterion: 100% of tests do not display previous results. The product shall have a design that is friendly to the users. Fit Criterion: 9 out of 10 users find the product friendly to use. The product shall have a display that uses pastel colors. The machine shall be easy to refill with enzymes. Fit Criterion: The refilling process takes less than 10 minutes. The machine shall have a removable waste receptacle for easy cleaning. Fit Criterion: The system shall be able to be cleaned in less than 10 minutes. The machine shall have a removable enzyme cartridge. Fit Criterion: The system's enzymes shall be able to be replaced in less than 10 minutes. The results from the machine must be accurate. Fit Criterion: The device's results correctly match alternative myocardial infarction detection systems 95% of the time. System secures blood sample preventing removal until test is complete. Fit Criterion: Blood sample can not be removed from system during test. The system shall maintain the confidentiality of personal information used by the system. Fit Criterion: Personal information can only be found during the testing use case. The system shall not contain the information from a test if power is lost. Fit Criterion: No personal information can be access after a power failure. The product shall be small and portable. Fit Criterion: System fits onto a crash cart. Myocardial Infarction A common form of a heart attack. Occurs when there is a cutoff to the heart's blood supply, causing damage to cardiac muscle and the death of heart tissue. Troponin I and Myoglobin Cardiac markers used to determine whether a patient is suffering a heart attack. Cardiac Markers Proteins and enzymes normally contained within heart muscle that are released into the blood stream when damage to the heart muscle cells causes an opening through the cell walls. Enzymes Proteins that accelerate chemical reactions. Immunoassay Reactions Biochemical tests that occur between antigens and antibodies. Antigen Substance that, when released into the body, triggers a response from the body's immune system (usually the production of antibodies). Antibody Y-shaped protein released into the blood in reponse to an antigen stimulus. Each antibody released targets a specific antigen, attaching itself to the antigen to neutralize it. Binding Receptacle Binding site for which antibodies attach during immunoassay reactions. Spectra Analysis Method of analyzing the chemical properties of matter by observing the bands of light in their optical spectrum. Reset Solution High-salt solution used within the Heart Attack Detection System to re-ionize the binding receptacles, allowing new antibodies to bind to it. Substrate Molecule an enzyme acts upon during a chemical reaction. Reactant Solution During the blood sample testing process, the resulting solution containing antibodies and substrates and which has been cleaned of unwanted materials with the wash solution. Wash Low-salt solution that removes unwanted materials from the blood sample. OSHA Occupational Safety and Health Administration. Branch of the U.S. Department of Labor responsible for enforcing safety and health standards in the workplace. FDA Food and Drug Administration. Branch of the U.S. Department of Health and Human Services responsible for regulating food, drugs, cosmetics, dietary supplements, medical systems, biological goods, and blood products. Crash Cart A wheeled cart used in hospital wards and emergency rooms. Medical Database A database system that is used to store the test results for hospital patients. Medical Personnel A member of the medical staff of a hospital. Health Level 7 HL7 is a messaging standard used by medical systems in order to communicate data between the systems. Medical Informatics System A repository that the hospital uses in order to store the large amount of information a hospital uses to operate. Health Level 7 messaging standard