Biomedical Monitoring System - School of Engineering Science
Contents
1. 1 Introduction Biomedical Monitoring System is a wireless monitoring system that is used for screening and diagnosis of heart diseases This system is easy and convenient to use in the house or fitness centre and can be used for remote real time monitoring The patient either can be monitored remotely by the doctor or the data acquired by the system can be transferred through the use of USB cable at a later time The Biomedical Monitoring System shows the length of time required for an electrical impulse to travel through the heart A graph can be generated from the data taken from the sensors and it can predict future heart failures The functional requirements of the Biomedical Monitoring System as proposed by Biomedical Embedded System Technology are outlined in the following functional specification 1 1 Scope The scope of this document is to outline the functional requirement of the Biomedical Monitoring System This document describes the functionality of the system including sensors user interface microcontroller USB daughter board wireless module and the overall system functionality This document also discusses all detailed function requirements which will be used as areference guide during the development as well as testing to ensure a safe and reliable product The specifications or design of some modules may change during the testing stage in order to maximize the performance of the system 1 2 Intended Audience This docume2. MOREM MUERE RM D EU 7 4 2 Electrical Requirement ssoreassanineia oae tn Publ iN adai rob Fuld od und ists 7 5 Micro controll r Borg eo enasini iiiad tis a d 8 5 1 General TRG Ul PoP CI uushnascciaieauRitrpnci snc c ot bct clus aR ko SExUR AED A E RDUM iadi nania 8 5 2 Envitonmetial Requimbtmelibu usen ciencias ie diedorit dS de UU IRAM UA RUP a IRE RCRUM UE MERC DM ME 8 5 9 Safety DOR NS HI entia oi iaaetci tol oso parli id e Eia RR EPA Da EUR UN MERC eb ob saiia 8 6 Graphical User Interface GUT esee eese nennen tette tn tatnen tata tasa sh suas 9 Gl real Recor oc MN Tt 9 7 WSOP Docu mentati nS T X 9 System Test uni RTT EEEN ETENEE 10 LN BodL NN niania aeae iire ea ai VERa i erea EEAS EEEE Aa R Risi 11 Mc m 12 List of Figures IP mE Corr cr A X 2 Figure 2 Modified Waterfall Model nnnsssssssseunserrrsrrrssssererrrrrerrrsssereerrrrersereres 10 Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Burnaby BC Glossary CVD Cardiovascular disease GUI Graphical User Interface BEST Biomedical Embedded Systems Technology BMS Biomedical Monitoring System MUT Module Under Test USB Universal Serial Bus ECG EKG Electrocardiography Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Burnaby BC
3. R58 II R59 I R60 II R61 II R62 II R63 I It should be easily installed It must be compatible with common operating systems such as Windows XP Vista and 7 The GUI should be extremely user friendly and anyone with basic computer knowledge should be able to work with the program The software must be programmed in C or Java The software should include a user manual that include installation process using the software as well as description on how to attach sensors The software should be delivered by a CD The software should be able to print ECG graphs The software shall warn the user to seek medical attention in case a life threatening or serious heart problem 7 User Documentation R64 III The user manual shall be written for non expert audience and assuming users have a minimum knowledge of handling electronic devices R65 III User manual shall be presented in French Spanish German Japanese Traditional Chinese and Simplified Chinese other than English so the product can compete in international markets R66 III User documentation shall construct a website including user manual general and technical support information and required drivers all written in English Copyright 2010 BEST February 2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University 8 System Test plan The life cycle of BMS will follow a slightly modif
4. The wireless receiver shall be powered by the USB Copyright 2010 BEST February 2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University 5 Micro controller board 5 1 General Requirements R47 I R48 I R49 I R50 I R51 I The operating voltage for the microcontroller shall not exceed 9 Volts Microcontroller shall not consume more than 20mA in active mode Microcontroller must have at least five 10 bit analog I O channels or pins to provide enough accuracy for readings The controller should be able to use internal interrupts to read available sensor data Microcontroller must have large enough serial flash to store the sensor data for at least 24 hours 5 2 Environmental Requirements R52 I R53 II The controller should be operational in temperatures within the range 10 to 45 degrees Celsius The enclosure of the microcontroller along with other components must be waterproof and suitable for damp environments use 5 3 Physical Requirements R54 II The dimensions of the microcontroller shall not exceed 10cm X 10 cm R55 II The controller shall not weight more than 200g Copyright 2010 BEST February 2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University 6 Requirements for Graphical User Interface GUI 6 1 General Requirements R56 II R57 II
5. Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University February 8 2010 Dr Andrew Rawicz School of Engineering Science Simon Fraser University Burnaby BC V5A 1S6 Re ENSC 440 Functional Specifications for Biomedical Monitoring System Dear Dr Rawicz Please see attached for Functional Specifications for Biomedical Monitoring System Our product is a data acquisition system to monitor patients cardiovascular health The monitoring can be done via two options USB cable or through a wireless protocol The Document outlines an overview of the system functionalities of our product Biomedical Monitoring System BMS for both the proof of concept and production phases Biomedical Embedded Systems Technology BEST is a group of innovative engineering students from diverse backgrounds The team consists of Sam Seyfollahi and Alireza Rahbar Electronics Engineers Farzad Abasi Computer Engineer Parna Niksirat Systems Engineer and Shaghayegh Hosseinpour Biomedical Engineer For any further information please feel free to contact me Yours truly resa Rahkbar Alireza Rahbar President and CEO BEST Phone 604 339 4715 Email aral4 sfu ca Enclosure Functional Specification for a Biomedical Monitoring System Burnaby BC Functional Specifications for Biomedical Monitoring System Project Team Alireza Rahbar Farzad Abasi Parna Niksirat Shaghayegh Hosseinpour Sam Seyf
6. al Embedded Systems Technology School of Enginee ring Science Simon Fraser University 10 References 1 http www who int mediacentre factsheets fs3 1 7 en index html 2 W W Royce Managing the development of large software systems concepts and techniques International Conference on Software Engineering Proceedings of the 9th international conference on Software Engineering 1987 Monterey California United States Copyright 2010 BEST February 2010 12 Burnaby BC
7. e wireless easy to carry and light weight R2 II BMS has to be user interface friendly R3 III The price of the finalized system shall be under CDN 300 R4 III The output data has to be accurate and precise R5 III The system should be safe to use and meet medical equipment standards of North America 2 3 Physical Requirements R6 I The finalized system should be pocket size and easy to carry R7 II The weight of the finalized system should be not more than 300 g R II The system should be integrated into one package R9 II The system should also provide fitness monitoring R10 III Connecting cables should be flexible and soft Copyright 2010 BEST February 2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University 2 4 Electronic Requirements R11 IIT 2 4GHz XBee XB24 is required to be connected to 3 3V at 40mA R12 III The device should have portable power source R13 I The system should operate in a low range of power 2 5 Communication Requirement R14 II 2 4GHz XBee is required to allow a very reliable and simple communication between the microcontrollers and the host computer 2 6 Mechanical Requirements R15 II The sensors connect to the controller via eight pin cable R16 II The case of the entire system has to be waterproof 2 7 Environmental Requirements R17 I The device should operate reliably from 10 to 45 degrees Celsiu
8. ge Once the three phases of the project are complete BEST will continue to maintain the code and fix any bugs reported by the customers BEST will also add improved functionality and features once the base product is complete This will ensure that the system will be reliable and useful for many years down the road 9 Conclusion The functional specifications for Biomedial monitoring systems BMS have been presented in this document The requirements given in this document are tentative and will be modified as needed during the completion of the project The final product will benefit not only health care providers but also professional athletes Our product will make it easier for athletes to constantly monitor their performance and to help detect early signs of heart failure This system will be perfectly integrated simple to use and to install We are certain that with the special features included in this system our monitoring and measuring system will stand out among all other competitors We have divided the progress of the project into two separate phases Our goal is to accomplish all the related functional requirements for the proof of concept model outlined in this document marked by I or II by target date of mid April 2010 We at BEST hope these functional specifications will supply our audiences with necessary required information regarding our product Copyright 2010 BEST February 2010 11 Burnaby BC Biomedic
9. hat has not been handled without knowing how the internal function itself is actually implemented Copyright 2010 BEST February 2010 10 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Third the designer of the module will lead their partner though a short code review This has the double advantage that the partner can catch things that the designer may not have considered and the partner will learn how the code works so at least two members of the team will have a complete understanding of the system This will help in situations where one team member may be unavailable in case questions arise during development Finally all modules will be integrated and tested after they have been merged in weekly meetings If at that point any issues arise they should be small and easily remedied To ease the task of integration BEST has created a subversion repository to be used for source control This will allow team members to independently work on their portion of code and merge their code once complete This will also allow us to revert to an older version of the code in case a new piece of code causes problems In addition to the above additional regression testing will be performed on the overall project to make sure new features and code changes don t introduce bugs in the system This will be done by using premade test cases that will be implemented using a scripting langua
10. ied Waterfall model 2 The Waterfall model is a sequential software development process with the five main phases requirement gathering design implementation verification and maintenance as shown in Figure 2 We will use modified version of this standard model which includes iteration at each step that will allow us to go back up one or more previous steps in case problems are identified This is done to ensure each phase of the development is flawlessly implemented and to ensure a high degree of success Figure 2 Modified Waterfall Model The majority of the testing for phase one will be done using lab equipment such as the oscilloscope and voltmeters BEST will ensure that the sensor readings obtained are within specified fault tolerances Since the majority of BMS is based on premade modules and microcontrollers we do not expect to face many problems in this phase of the project Testing for phases two and three will be more involved and performed at several different levels First the designer of each module under test MUT will perform white box testing on their own work Since the designer knows every function that is being tested they should be able to test each possible path independently without trouble Once the designer is comfortable with their MUT the designer will pair up together with another team member and they will perform black box testing on the other persons MUT They will attempt to give the module input t
11. n Fraser University 3 EKG ECG SENSOR ECG EKG stands for Electrocardiography which is a test that measures electrical activity of the heart using electrodes placed on the skin of the patient With each heartbeat an electrical pulse travels through the heart As a consequence the impulse wave causes the muscle to squeeze and pump blood The EKG sensor measure the voltage produces during contraction of the heart and outputs a signal to the microcontroller The functional requirements for EKG ECG sensor are specified as per following sub sections 3 1 General Requirements R32 I R33 I R34 I R35 I Three shielded leads right left and ground are required for an EKG sensor An electrolyte solution jelly is placed on the surface of the electrode that comes in contact with tissue The other side of the sensor consists of a conductive metal attached to a lead This is the lead which is connected to the microcontroller The signals coming from the wire of the intermediate connector are amplified The signal is filtered in order to minimize the distortion The heart rate signals from the electrodes are converted to digital information by microcontroller 3 2 Physical Requirements R36 I Silver Chloride should use to attach the electrodes to the skin and also aid in electrical conduction R37 I Cables connecting the electrodes to the processing unit shall be soft flexible and have sufficient length R38 II The
12. nt is intended for the Biomedical Embedded System Technology design engineers They should refer to this document in every stage of development to guarantee that the final design meets the predefined function requirements In addition this document will provide the marketing departments a better understanding of the Biomedical Monitoring System product which makes it easier to advertise or find investors for the finalized product Copyright 2010 BEST February 2010 Biomedical Embedded Systems Technology School of Engineering Science 1 Simon Fraser University BEST 1 3 Classification The numbering convention of this document is as follows Rn p A functional requirement specification R is an abbreviation for requirement n is the functional requirement number and p stands for one of the three development phase I Proof of concept stage II Ongoing developing stage III Final production stage 2 System Requirements Biomedical Embedded Systems Technology BEST is devoted to improving the quality and accuracy of heart monitoring system as well as improving the quality of life for patients suffering from heart diseases The general requirements of the Biomedical Monitoring System are presented in this section The system overview describes the project at a glance Next the systems functional specifications are described in detail 2 1 System Overview The following Figure 1 shows the system overview The c
13. ollahi Contact Person Sam Seyfollahi ensc440 group1 sfu ca Submitted to Dr Andrew Rawicz ENSC 440 Steve Whitmore ENSC 305 School of Engineering Science Simon Fraser University Due date February 8 2010 Revision 1 0 Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Burnaby BC Executive Summary Cardiovascular diseases CVDs are the number one cause of death worldwide 1 To assist doctors in the early detection of CDVs Biomedical Embedded Systems Technology BEST is developing an advanced heart monitoring system named the Biomedical Monitoring System BMS This device is a portable real time data acquisition system that is capable of acquiring the electrocardiograph heart rate and body temperature of a patient This information can provide doctors key information which can aide in the diagnosis of underlining heart conditions The statistics gathered by BMS would have traditionally required days of hospital observations or the use of expensive and uncomfortable equipment BMS will provide accurate results while maintaining the comfort of the patient The work required to create this system will be distributed evenly such that all members will have a chance to work on the hardware backend and the graphical user interface GUI of the system This will be accomplished by splitting the project up into three phases Phase one will be the design and implementation of
14. ore of the system is an Atmel microcontroller which will interface multiple sensors and modules together These sensors will collect raw data for the controller to interpret and convert to a more user readable format such as a graph This data can be retrieved to a computer using either a USB cable or wirelessly EE Wireless USB port connection A Figure 1 System Overview Copyright 2010 BEST February 2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Following Figure 1 from the left shows that the Sensors are connected to the patient s body The sensors then transmit the analog signals to the processing unit The microcontroller then evaluates the information and stores the results This data can then be transferred to a computer either using a USB cable or wirelessly This allows the physicians to monitor the condition of their patients remotely One of the most important factors for the Biomedical Monitoring System that needs to be considered is the comfort of the user during the testing The goal is to make it easy to use comfortable to wear and light to carry The functional specification for the overall system standards and regulations microcontroller USB Daughter Board GUI wireless sensors documentation and test plans are described in details respectively in the following sections 2 2 Overall System Requirement R1 II BMS has to b
15. rnaby BC Table of Contents Executive Sum uoo opx o ddvneesta inden arama means i glo A II E S ii List of 2 0 11 e AN A NS ii GLOSSAE S inst ER E E E n NOR ee iii 1 Introduction M 1 MOM SCOPE sedat ERO NECEM uS dd AE E N 1 1 2 Tntended Audien Cession ease adina E aa Tae ASTE db Ra rada 1 1 3 Classificato anda Coe bd el na bono tacitum n rb RR a cab p mere try 2 2 System Requirements eciccand doro aste rtp cit xong antri nun ae aaa 2 PAIRS isque 2 252 LOvefall Systemi Rocquikebetibus acsi itta hU UR UD er ekinen aSa Ean a aaaea Aaaa 3 2 9 Physical ROG FOF DOE n cancace dus EU epic Ge is pts Lisa LORD pte LUDUM nA Eo RAN GU RD 3 24 urere too ics cc 2 MT E 4 2 5 SO ATU AOI NP TIE essa cscs ade itaderepeus erii pencetue reete i strass T Qnin 4 2 6 Mechanical Oque Peso ooaktiiovesciiosunfyidutennt sadi huve Unete ieie pueda 4 2 l Environmental Reguirement sisssisreiiisi ursis rresten eiiiai seini nieren 4 2 0 Petfotm nce REgUITE MENi ia n EEE A ENRE 4 2 9 Relabiinand Dura Bity siseseid ee E EEEa AE tenu Due pnta 5 2 10 SA fey Bog CRT itere iieis EENE Eeee PU Ss rM NORE EEEE mr E EEE RN 5 211 C x ty Reguitemetitiessiirnedsssienireis aieiai ersen i nakee ira 5 De EKG ECG SUS cca cca accede r e a i aieiaa eini edad 6 31 General TRG a Hm 6 3 2 Physical Regui emient ernis ii E A AES dad E 6 Ecrit ii aae e E AAEE GENNES 7 d Wireless Mod le aus eq RU M nip n a dU 7 dl Cem EAD IR UME FYI AN oec tuo
16. s R18 II The system should not be disturbed by high frequency signals R19 I The device shall operate within electrical noise 2 8 Performance Requirements R20 I The data acquired from sensors has to be accurate within 10 for all conditions R21 IT The final product heart rate sensor should have an accuracy of 2 for all conditions R22 I The process time for the data display has to be less than 50 ms R23 I The Xbee wireless should be able to transmit up to 400ft 120m Copyright 2010 BEST tt February2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Burnaby BC 2 9 Reliability and Durability R24 II The device has to be able to withstand daily usage R25 II BEST shall provide product warranty for two years R26 III The device will be serviceable by company trained technician R27 II The custom application must not interfere with normal computer operation 2 10 Safety Requirements FR28 I Failure of the hardware will not cause any danger for the user FR29 T The device should adhere to Canadian CAN CSA ISO 13485 standards for medical devices R30 II The system should not explode or leak any hazardous material 2 11 Luxury Requirements R31 III The overall system package should be clean and attractive Copyright 2010 BEST February 2010 Biomedical Embedded Systems Technology School of Engineering Science Simo
17. the hardware This phase will simply involve interfacing the individual components such as sensors and modules together By the end of phase one the hardware of the BMS will be completely operational We will also ensure that our product is safe to use and complies with the medical equipment standards of North America This is to make sure that we can provide both accurate and reliable results while protecting the user from harm Phase two is development of the core backend software This is the most significant phase of our project and involves developing e Device drivers e Core data acquisition functionality e Data transmission functionality e Host computer software responsible for communication with the system We will also calibrate the sensors in this phase and make sure the readings obtained are within acceptable thresholds By the end of phase two the system will be fully operational and will be able to transmit the raw data to the host computer Phase three is the development of the GUI This phase will involve writing the software to interpret the raw data acquired by the system By the end of this phase the user will be able to view the results of the system in an easy to read format such a graph chart or table The system will also be able to transmit data to the host computer in real time so that the use can view live results Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University Bu
18. wires should have minimal movement while attached to the patient in order to achieve higher accuracy R39 I The electrode patch should make good contact with the skin to obtain a better signal Copyright 2010 BEST February 2010 Burnaby BC Biomedical Embedded Systems Technology School of Engineering Science Simon Fraser University 3 3 Safety Requirements R40 I The ground lead should be always connected on the body before connecting the negative or positive lead R41 I The sensor unit should be properly insulated to prevent a short circuit or electric shock 4 Wireless Module The main function of the wireless module is to transmit the data collected by the microcontroller to the computer for further processing without having to deal with wires The functional requirements for wireless module are specified in the following sub sections 4 1 General Requirements R42 I SPI interface for connection to the RF modules shall be supported R43 II The wireless transceiver device that 1s connected to the external antenna must be capable of transmitting serial data between the microcontroller and the host computer in a reliable way 4 2 Electrical Requirements R44 I The wireless transceiver components must be able to operate from a single 3 3 VDC power supply R45 II The wireless transmitter shall operate in low power sleep mode when not transmitting data for a reduction in power consumption R46 II
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