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Wireless Blood Pressure Monitoring System

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1. Adjustment Factor Effort Value 0 5 Data Communication 4 Distributed Data Processing 2 Performance 2 Heavily Used Configuration 2 Transaction Rate 4 On line Data Entry 4 End User Efficiency 1 On line Update 3 Complex Processing 3 Reusability 2 Installation Ease 0 Operational Ease 1 Multiple Sites 0 Facilitate Change 1 Total 29 Adjustment Factor 0 94 Adjustment Factor Total 1 65 Table 12 5 shows how the team calculated the influence multiplier or adjustment factor needed to calculate Jones First Order Approximation The team listed the 14 adjustment factors and estimated how much effort would be required from various members to complete these factors for the project Most of the factors ended up in the lower range with a few of them mostly ones involving data transmission or web handling reaching up to a level 4 but never to level 5 After totaling these numbers Formula 1 was applied to get the adjustment factor Unadjusted function point total 172 Influence multiplier 0 94 Adjusted function point total 161 68 Table 12 6 In Table 12 6 the team took the function point total and multiplied by the influence multiplier to give the adjusted function point total The multiplier did little to the total in this case as it was close to one November 13 2013 67 Beta Blockers System Requirements Specification Wireless B
2. 3 19 1 Description Patients registered on the site will be able to make notes about particular readings of theirs on the website to relay information such as changes in their health or lifestyle 3 19 2 Source Sponsor 3 19 3 Constraints Web language used 3 19 4 Standards N A 3 19 5 Priority 2 High November 13 2013 25 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 20 Patient Viewing Profile 3 20 1 Description All patients will have a viewing profile a way in which friends family members other doctors or anyone else the patient wishes to give access to can view how the patient is doing and other information This profile is separate from the standard Patient profile it will be tied to the account with a separate set of login credentials and it is extremely limited in functionality The patient will be able to change the login credentials for this at any time to restrict access 3 20 2 Source Beta Blockers 3 20 3 Constraints N A 3 20 4 Standards N A 3 20 5 Priority 3 Moderate 3 21 Create Alerts 3 21 1 Description Alerts can be created either automatically by the system if it detects a problem or a concerning trend or by a patient if they want to alert their doctor about something which will be sent to the doctor for later viewing 3 21 2 Source Beta Blockers 3 21 3 Constraints N A 3 21 4 Standards N A 3 21 5 Priority 2 High November 13 2013 26 Beta B
3. Figure 2 3 See Alerts Took a 20 min Jog My Profile This is an example of a graph that a user would see upon logging into their profile These graphs will be dynamic and can change to fit what a user would like to see Note the annotation located at the table of blood pressure readings to let their doctor and family know that the spike in their blood pressure was in part the result of a 20 minute jog November 13 2013 17 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Alert System Joanna Lemons Home Logout My Blood Pressure o 2 o Lx eg a o er El 2 8 8 a o e Your past 9 readings have been higher then your average blood pressure levels The readings are also in the high blood pressure levels Seek medical attention immediatly An Alert has be sent to your doctors profile Figure 2 4 This is an example of an alert to the user of their relatively high blood pressure levels warning them to seek medical attention from their doctor The user s irregular high blood pressure levels generated this warning November 13 2013 18 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 Customer Requirements This section will cover the requirements and expectations set by the customer and team Beta Blockers These requirements will clearly and concisely define what the product will and will not do The core requirements of th
4. as far as the team is currently aware of The only possible costs that may be required are the cost of using a web hosting service if the web service will be deployed through this method or any costs associated with setting up a web server to house the web service if any Below is a breakdown of the predicted cost of the wireless blood pressure system if the system were reversed engineered and components were integrated November 13 2013 63 Beta Blockers System Requirements Specification Table 12 1 Wireless Blood Pressure Monitor Item Cost Consumer Blood Pressure 80 00 Monitor Wireless LAN Module 50 00 Single USB Connection 20 00 Module Arduino Development 90 00 Board with WI FI Capabilities Web Hosting Service 100 Total 340 Below is a breakdown of the predicted cost of the wireless blood pressure system if the system uses a Bluetooth smart enabled blood pressure monitor with an Android device Table 12 2 November 13 2013 Item Cost Bluetooth smart enabled 120 00 Blood Pressure Monitor Web Hosting Service 100 Google Play Account 25 Total 245 64 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Below is a breakdown of the predicted cost of the wireless blood pressure system if the system were fabricated Item Cost Analog Components 140 Circuit Fabrication and 100 Mounting
5. 2013 15 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 2 3 Product Interfaces The user will interface with the monitor when needing to take blood pressure readings and the website when needing to view records or access the other modules Monitor interface User interfacing with the blood pressure monitor takes place when user needs to check blood pressure levels Interfacing with the monitor will include entering authorization credentials sending start stop commands through GUI screens and viewing recent blood pressure levels though a display Website interface Create Account Home Logout Patient Setup Does patient have a history of blood pressure Personal Info m Yes No Type Hypertension Diet Exercise Hypotension Select all that apply Medical History Perscriptions Figure 2 2 November 13 2013 16 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor This is an example of what the patient account setup page will look like The user s doctor will be able to enter information and will select other information from provided lists and radio buttons to create a full profile for the user User Blood Pressure Records Home Logout Joanna Lemons My Blood Pressure Add Annotation Contact Doctor Systolic Pressure 100 110 120 130 140 150 160 170 180 60 Diastolic Pressure Time ICI ICAO oem E
6. 4 4 Standards N A 6 4 5 Priority 2 High 6 5 Blood Pressure Monitor Mechanical Safety 6 5 1 Description The blood pressure monitor primarily the wearable components shall not be able to easily induce physical injury to the user through its physical form 6 5 2 Source Beta Blockers 6 5 3 Constraints None 6 5 4 Standards N A 6 5 5 Priority 2 High November 13 2013 39 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 7 Maintenance and Support Requirements This section details how the team will ensure that the project is easy to understand maintain and improve It also discusses how the team plans to provide a means with which to support the product from a maintenance perspective should it be released into the market including how the web service would be maintained and controlled and how the blood pressure monitor would be handled 7 1 User Manual 7 1 1 Description A general user manual will be created that will instruct the end user on how to safely operate the blood pressure monitor and access his or her information on the website 7 1 2 Source Beta Blockers 7 1 3 Constraints None 7 1 4 Standards N A 7 1 5 Priority 2 High 7 2 Blood Pressure Monitor Battery Replacement 7 2 1 Description The battery on the blood pressure monitor shall be replaceable as it will be found on the consumer marketplace The battery shall also be able to be removed easily from the devi
7. The web service will support two types of accounts patients and doctors 3 11 2 Source Beta Blockers 3 11 3 Constraints N A 3 11 4 Standards N A 3 11 5 Priority 1 Critical November 13 2013 22 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 12 Doctor Account Creation 3 12 1 Description Doctors will be able to create their own account on the web service 3 12 2 Source Beta Blockers 3 12 3 Constraints N A 3 12 4 Standards N A 3 12 5 Priority 1 Critical 3 13 Patient Account Creation 3 13 1 Description Doctors will create patient profiles and have them connected to their own The doctor will enter medical information and other key information about the patient s health The system with the doctor s permission will then send an email to the patient s email address with temporary login information The patient will then change their login credentials add their personal information if they wish and confirm the changes 3 13 2 Source Sponsor 3 13 3 Constraints N A 3 13 4 Standards N A 3 13 5 Priority 1 Critical 3 14 Patient s Doctor 3 14 1 Description A person who wishes to use this system as a patient must be affiliated with a doctor or caretaker who has an account on the web service 3 14 2 Source Sponsor 3 14 3 Constraints N A 3 14 4 Standards N A 3 14 5 Priority 1 Critical November 13 2013 23 Beta Blockers System Requirements Specification
8. Wireless Blood Pressure Monitor 3 15 Doctor Limit 3 16 3 17 3 15 1 Description A patient may only have one doctor account tied to their account on the web service If the patient wishes to have more doctors view their data those doctors will have to use the patient s viewing account to see the information 3 15 2 Source Sponsor 3 15 3 Constraints N A 3 15 4 Standards N A 3 15 5 Priority 1 Critical Doctor Editing 3 16 1 Description Doctor accounts can have their information edited by the account holder 3 16 2 Source Beta Blockers 3 16 3 Constraints N A 3 16 4 Standards N A 3 16 5 Priority 3 Moderate Patient Editing 3 17 1 Description Profile information email password full name can be edited by the given patient Medical information will be edited by the patient s doctor 3 17 2 Source Sponsor 3 17 3 Constraints N A 3 17 4 Standards N A 3 17 5 Priority 1 Critical November 13 2013 24 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 18 View Charts and Graphs 3 18 1 Description All registered users on the site will be able to view various charts and graphs on the website that describe the patient s blood pressure conditions overall health and other factors assuming that they have access to said patients information 3 18 2 Source Beta Blockers 3 18 3 Constraints N A 3 18 4 Standards N A 3 18 5 Priority 1 Critical 3 19 Annotations
9. Wireless LAN Module 50 00 Single USB Connection 20 00 Module Arduino Development 90 00 Board Web Hosting Service 100 Total 500 Table 12 3 12 5 Resource Analysis The development team consists of two computer scientist two software engineers and one computer engineer As a team the collective skills and knowledge of each member complements each other giving a dynamic work structure When evaluated individually each member has a unique skill or ability that contributes distinctively to the whole project The team s strengths come in the form of programming in Java C and multiple web languages coding to meet specifications and reverse engineering Two members of the team have a considerable amount of hardware experience the first has taken multiple classes in hardware implementation and the other has had ample experience with robotic design The other three members have a strong background in programming with multiple languages and platforms An area of concern is the team s weaknesses which include three notable skills essential to the success of the project test design product packaging and secure programming These skills are important November 13 2013 65 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor because of the nature of a medical device needing to be testable for accuracy and meeting user guidelines and HIPAA regulations As the project progr
10. availability of their tools The choice of Android 3 0 and up is due to their available and compatible feature set for this project 9 4 2 Source Beta Blockers 9 4 3 Constraints The approach of using the smartphone as the primary user interface for the blood pressure monitor to connect to the WLAN and communicate and process data with the web server over the internet is taken 9 4 4 Standards N A 9 4 5 Priority 4 Low November 13 2013 47 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 9 5 Multiple Health Modules for Website 9 5 1 Description The website will be able to support many different sets of data from many different pieces or hardware such as blood sugar readings or weight measurements to allow for a robust web service that will allow doctors to easily track patients with a wide variety of conditions or concerns 9 5 2 Source Beta Blockers 9 5 3 Constraints None 9 5 4 Standards N A 9 5 5 Priority 5 Future 9 6 Advanced Authentication Capabilities 9 6 1 Description The monitor will have advanced authentication capabilities to better ensure that the correct person is wearing the device at all times 9 6 2 Source Beta Blockers 9 6 3 Constraints None 9 6 4 Standards N A 9 6 5 Priority 5 Future 9 7 Remote Control for Blood Pressure Monitor 9 7 1 Description The blood pressure monitor will come with a control that will be used to control the system all
11. confined to within 15 accuracy 5 7 2 Source Beta Blockers 5 7 3 Constraints The blood pressure monitor is set up in its normal operating configuration the user should keep his or her physical condition relatively the same when performing the compared readings 5 7 4 Standards N A 5 7 5 Priority 2 High November 13 2013 36 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 5 8 Blood Pressure Monitor Accuracy 5 8 1 Description The blood pressure measurements obtained using the monitor shall not deviate more than 10 at any measurement range from an existing commercial blood pressure monitor 5 8 2 Source Beta Blockers 5 8 3 Constraints The blood pressure monitor is set up in its normal operating configuration the user should keep his or her physical condition relatively the same when performing the compared readings 5 8 4 Standards N A 5 8 5 Priority 2 High 5 9 Blood Pressure Monitor Mechanical Robustness 5 9 1 Description The blood pressure monitor shall be able to maintain its performance and safety requirements when being physically handled during normal use 5 9 2 Source Beta Blockers 5 9 3 Constraints The blood pressure monitor is set up in its normal operating configuration and in good condition from previous uses if any 5 9 4 Standards N A 5 7 5 Priority 2 High 5 10 Blood Pressure Monitor Startup Delay 5 10 1 Description The blood pressure m
12. for handling This will be implemented using either Bluetooth or Wi Fi technology The user interface will be taken care of by an LCD display to present blood pressure readings and mechanical or touch sensing for button keyboard implementation Other technical components of the blood pressure monitor include the power control and the USB driver control The block diagram below displays the hardware components contained by the blood pressure monitor device November 13 2013 61 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Proa System on Power Battery Sensor Programmable Chip Mechanical or Signal Touch Sensing Filtering CapSense LCD Band Pass onver Filter PWM PWM Motor Control Valve Control A Rolling Pump Figure 12 1 From a software perspective the web service is composed of the graph and table system the messaging and alert system and the advice system which are all tethered together by the user s profile and information The graph and table system will take patient s blood pressure results and generate various graphs and charts to give a visual representation of the patient s health The graphs will adjust their high and low ranges and alerts based on factors such as their general blood pressure figured over time medical conditions that could affect blood pressure and medication and diet Patients will be able to select certain readings from the graph or char
13. resume working in the near future 13 1 2 Constraint Schedule Due to the teams limited schedule we do not feel that we will have enough time to deal with the situation of a user doing manual uploads While it seems like a simple feature it is of low priority and the team expects hidden problems to occur when trying to implement it 13 2 Requirement 4 8 Connection Cable 13 2 1 Description A connection cable will be provided to manually upload the data onto a computer and uploaded to the website if Wi Fi is not available 13 2 2 Constraint Schedule See requirement 13 1 13 3 Requirement 8 7 Data Backup 13 3 1 Description The data collected by the web portion of the system will be backed up in case of an emergency or accidental deletion situation The backup must be securely handled i e encrypted and placed under an access control paradigm 13 3 2 Constraint Schedule Due to the teams schedule we do not feel it is in the team s best interest to deal with minute maintenance features while there are still major functional features to create November 13 2013 70 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 13 4 Requirement 8 8 Business Associate 13 4 1 Description The system will have a HIPAA Business Associate Agreement with every vendor that has access to the data The vendor in the scope of the project is the company that will host the system s web application The web hosting comp
14. user The research done on this aspect of the project includes researching hypertension its causes contributing factors and the meaning of a blood pressure reading This gives the team an understanding of the medical aspect of blood pressure to ensure the system is giving accurate diagnostic More research will be done in the future as more components of the system come together 12 3 Technical Analysis The project s hardware system will be determined by the implementation that the team chooses to design from the three designs researched Whether reversed engineered Bluetooth enabled or fabricated by the development team the hardware consists of three major parts the air chamber motor control the pressure sensor driver and the wireless connectivity The air chamber motor control and pressure sensor will implement an oscillometric method for measuring blood pressure using pneumatic control The oscillometric method requires that the air chamber motor made up of a relay valve and a pump induce the intra arterial pulsation while the systolic and diastolic pressure the two pressures read in order to get a blood pressure level are estimated from the amplitudes of the oscillation using the pressure sensor The signal being transmitted from the pressure sensor will be filtered and converted into digital signal by an ADC The wireless connectivity component will then take care of transmitting that data from the microcontroller unit to the server
15. web service in order to authenticate successfully and begin storing their results After the monitor measures their blood pressure the users can log into the website and see the results November 13 2013 10 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 1 2 Intended Audience The target audience is mostly middle age consumers 30 to 60 years of age people that often are at risk for blood pressure issues but are still able to use and understand new technology Younger people may purchase the product but considering they are not nearly as at risk for health issues regarding blood pressure there will be less interest from this demographic Older audiences may have relatively greater difficulty in understanding and using the system so the design will not be as oriented to handle their demographic as for the middle aged audience This product is intended to be clean and simple to use but it may end up being pricey considering the use of newer technology is being incorporated into the monitor There is an assumption that the majority of the targeted audience will have an accessible Wi Fi access point to an active internet service It is also assumed that those using the product will have a doctor willing to participate in the process of the system Another way to sell the device would be to supply the monitors to the doctors and caretakers who could then lend or rent out the device to their patients In this cas
16. Department of Computer Science and Engineering University of Texas at Arlington beta Blockers Wireless Blood Pressure Monitor Ian Jungmann Hao Nguyen Scott Phan Benjamin Bloom Sabreen Alabedredha System Requirements Specification Wireless Blood Pressure Monitor Table of Contents TABLE OF CONTENTS atinada adi acacia abad iaa 2 DOCUMENT REVISION HISTOR Y ini 7 LIST omnii OU A ada 8 LIST OF TABLES iaiecsisencuue c d ade cad dd cn rco a aa a a aaa aaa daaa aaa an iadaaa dadana aaan 9 A PRODUCT CONTCEPBT irren tton unn orania ai v2 can an nuin n rn cu aia hanc Ea wa rm EAEan Sanaa unn na Rn cV a SER wann n 10 11 Purpose DD RUOLI ITE 10 1 2 Intended Audience eee eoo ee reo ee Rer ER ee E ra NOR Op ee e UR eaa Ro oe Ede E Nea OU E US e ED CU 11 2 PRODUCT DESCRIPTION AND FUNCTIONAL OVERVIEWN eererrn anna annu ann 12 2 1 Features and Furictions eiie eese eia s eere ao sopa as oo e on eee p aya o iens o o Ooesa seed aaa arsson et ienesa dassos rossis go eoe pa Rae d sa stiot 12 22 External Inputs and OUtpUts 5 a eren iP ese aciertos 13 2 3 Product Interfaces NO 16 3 CUSTOMER REQUIREMENTS 1 neeree eren enn enn anna ana an nasa s a aE sa NADA rr 19 3 1 Non invasive Measuremients A 19 3 2 OOscillometric Method A d ado e Eas 19 3 3 Automatic Inflation Deflation cccccccsssssssssssssssssssssssssssssssssssssssssssssssssesss
17. MAINTENANCE AND SUPPORT REQUIREMENTS eren eene nennen nennt corran 40 VULT EIE 40 7 2 Blood Pressure Monitor Battery Replacement 1eeeeeeee ee eene eene eene nennen nhe sss nsns eaae sees sess sse e sese esses osse ease esses sunu 40 7 3 Web Service Software Portability resserrer ieres ir ee ea e eH eee aene cae vene e Ya ene eu e aee e gea a eoo ree ee veau e eu roa ue avenue as 41 7 4 Web Service Software Update Fffects eere eter terere eee retro enean eere nea e oaa oon ie dee eee o aoo ree de Neon lo deir esae 41 7 5 Web Service Administration Layer e eee cesses esee eene nennen nennen enhn ess sss a sse eh shes sess s sees esee esses sse esa se esses osse esse esses suuus 41 November 13 2013 4 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 8 SECURITY REQUIREMENTS rica a 42 8 1 Data Transport ENCryPtiOn EE EE M M 42 8 2 AuthorizatiOn A NAO 42 8 3 Integrity A oret eei siii e met e E RE ER E RS 43 8 4 Storage Encryption 5 e ertet ani o easa teles sie ei Seis ee eee eee Peas eee ee dva ege dodo iTo inodoro rain EE SOUPE ESSE 43 8 5 Disposal G afraritee 5 5 e erede eo ictu e tope eed e eco ge ied ev ia e e cetera sey eoa o eee ae Pesce Tae eeu eue Esse etae pecu dye a aene dedo d PRU R e ERE Ce UE PR ERU 44 8 6 WLAN Connection SecUrity eicere eese n
18. N Connection Failure Response Time ccce ecce eene eene eene eene eene tenen enne tnnt ennt n nennen nennen eene eene eene eene 35 5 6 Web Authenticatiori Latency 1 5 eoi te eo oec eee nO SUPE NE SE SE RSS RES RSEN TRERTESUT 36 5 7 Blood Pressure Monitor Consistency Regarding Battery Life cceecee eee e eee e eee e eene eee eene eene ener 36 5 8 Blood Pressure Monitor ACCUraCy eeeee eene eene eee nennen nennen nnn n nnne hne s esse nasse e ases esses sse esee sees sess sees tes ee sesso sese sees a se suuus 37 5 9 Blood Pressure Monitor Mechanical RODUStNESS sscccccssssssssssceceessssscssseceeseessssscseceeeeeessseccsceeeeeessssessceeeeeessssssenaes 37 5 10 Blood Pressure Monitor Startup Delay ccceeee eere eene eene eene eene eene eene nennen ennt nennen eene eene neenon eene 37 6 SAFETY REQUIREMENTS cion un YYDamd uva yEE Pec YRE Yd ix E Rn ER E EY RV E D E E 38 6 1 Maximum Cuff Pressure soc se sccncstscesssctssncacvecsesvanvasntestecsestveasecesvessesavoacateitessosnoeacanadvessenonesceteddessesondecsnsesvvosesnse 38 6 2 Cuff Pressure Release lem O 38 6 4 Eligible TIC M 39 6 5 Blood Pressure Monitor Mechanical Safety ce eee e ecce eee e eee e eene eee eene eene entente ettet ettet ene nennen ene 39 7
19. W ALORS e 27 3 23 Messaging SVSEBITI e E O UE SERT RUE SERERERE SERE GRE O NON 27 3 24 M ltiple NO 27 3 25 4 AAA O OOO 28 3 26 AAA A o 28 3 27 Advice Systelmi SN 28 3 28 Manual Upload of Information eoe eorr rere e eerie oae eI rie eeu nn orit Er E S EE uon e aoo r Seer e cnl o dirae eg eene ned 29 4 PACKAGING REQUIREMENTS iansccsniix iruk i vnn rg Yang nah dva E CY ERR cg ERA n CE a vu FE E E ra 30 CERERI ras A 30 4 2 Blood Press re Monit r s ssni O 30 EL NO 31 LE ME A NN 31 A A A ON 31 BG A A O 32 November 13 2013 3 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor AT Battery 32 LE MEG DIITSI Eclog ee A 32 4 9 User Manital once epe iaa 33 5 PERFORMANCE REQUIREMENTS 52min amara anuo usati a 34 5 1 Storage conditions 5 ier A 34 5 2 Operating conditions creer A Ye Se exe e Ve ee eer eee eu ea aerae uve ea ea eue eee e uen o Uo e Ve ee eva R 34 5 3 Operational Battery Lite aio a A e ep eaae ue deas acere ee aee e eu Ee aeu edo eee es en aeneae ee eeu eee ane Eee ERN e pUT 35 5 4 WLAN Authentication Latency 5 e ee eo ote e eee EV ue e eo PE e e ossos rroia eo PU e eoe oV C o eR UO P Ee o PE P P LV C EE FP PU e e UE eV C o e UO Ec eo LV c ees Co Eee EnS ors 35 5 5 WLA
20. a can be accessed only by appropriate users This requirement may rely on storage encryption section 8 4 to prevent unauthorized access as well as on the web hosting vendor to comply with the HIPAA Business Associate section 8 7 to maintain control over low level access to the web server s functionality 8 2 2 Source Beta Blockers 8 2 3 Constraints None 8 2 4 Standards HIPAA 8 2 5 Priority 1 Critical November 13 2013 42 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 8 3 Integrity 8 3 1 Description The system will attempt to prevent any PHI that will be collected and stored from the user from unauthorized modification or corruption and ensure its validity This requirement may rely on storage encryption section 8 4 and authorization protocols section 8 2 to deter unauthorized modification 8 3 2 Source Beta Blockers 8 3 3 Constraints None 8 3 4 Standards HIPAA 8 3 5 Priority 2 High 8 4 Storage Encryption 8 4 1 Description All PHI data that is being stored or archived will be encrypted and intended for storage of a minimum of five years In general the data will be encrypted using symmetric encryption of at least AES 128 strength The encrypted data can only be decrypted and accessible by users with the appropriate keys The keys will further be protected using a form of public key encryption This requirement would also further enforce the protocols of authorization sec
21. amily Account Creation Table 10 7 10 7 2 Verification Procedure Multiple accounts will be created for all types of accounts Different information will be entered for each user to test what data will be accepted and what will be rejected November 13 2013 52 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 8 10 9 Verify that charts and graphs are generating and personalized 10 8 1 Requirement s addressed Requirement Name Number 3 17 Charts and Graphs Table 10 8 10 8 2 Verification Procedure Data some real some hardcoded will be loaded into the database that represents different patients with different conditions and health statuses The team will log in as these users and view different graphs for each of them to confirm that they are generating that they are accurate and that they adjust dynamically to respond to patterns and the general health of the given patient Verify that the alert system works 10 9 1 Requirement s addressed Requirement Name Number 3 20 Create Alerts 3 21 Read Alerts Table 10 9 10 9 2 Verification Procedure The team will log into different patient accounts and request an alert be sent Data will also be fed into the system that should trigger the web service s automatic alert system The team will then log into the different patients doctors accounts to see if the alerts went throug
22. any will have all the data that is being transferred and stored so putting an agreement in place will ensure that the company will follow the HIPAA requirements for the data and the servers This guarantees that the web hosting company will provide an infrastructure that meets HIPAA compliance requirements The development team will then be responsible for applying secure programming methodologies to design and manage the website so that its functionality is HIPAA compliant 13 4 2 Constraint Business practices and necessity This is under the assumption that we even end up using a web hosting service or other type of service and also relies on there being a web hosting service willing to agree to this Due to the teams schedule and budget we do not want to focus too much attention on this at this point 13 5 Requirement 9 5 Multiple Health Modules for Website 13 6 13 5 1 Description The website will be able to support many different sets of data from many different pieces or hardware such as blood sugar readings or weight measurements to allow for a robust web service that will allow doctors to easily track patients with a wide variety of conditions or concerns 13 5 2 Constraint Schedule Budget Due to time constraints the web service will only be able to support blood pressure readings by the end of this project Also the budget does not allow us to purchase and test the various pieces of hardware we would need to create a system
23. backup must be securely handled i e encrypted and placed under an access control paradigm 8 7 2 Source Beta Blockers 8 7 3 Constraints None 8 7 4 Standards HIPAA 8 7 5 Priority 5 Future 8 8 Business Associate 8 8 1 Description The system will have a HIPAA Business Associate Agreement with every vendor that has access to the data The vendor in the scope of the project is the company that will host the system s web application The web hosting company will have all the data that is being transferred and stored so putting an agreement in place will ensure that the company will follow the HIPAA requirements for the data and the servers This guarantees that the web hosting company will provide an infrastructure that meets HIPAA compliance requirements The development team will then be responsible for applying secure programming methodologies to design and manage the website so that its functionality is HIPAA compliant 8 8 2 Source Beta Blockers 8 8 3 Constraints None 8 8 4 Standards HIPAA 8 8 5 Priority 5 Future November 13 2013 45 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 9 Other Requirements This section discusses miscellaneous requirements that did not fit under any of the other given requirements sections These requirements while still important to the project cover things that are highly specific and generally do not fit under any given label but they are too s
24. ce by the targeted audience without compromising the safety and performance requirements 7 2 2 Source Beta Blockers 7 2 3 Constraints None 7 2 4 Standards N A 7 2 5 Priority 2 High November 13 2013 40 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 7 3 Web Service Software Portability 7 3 1 Description The web service software shall be able to be deployed via an automated script that sets up the server software e g Apache MySQL etc and preloads system templates such as database schemas and defaults This is intended to ease deployment onto the client s intended web servers 7 3 2 Source Beta Blockers 7 3 3 Constraints None 7 3 4 Standards N A 7 3 5 Priority 2 High 7 4 Web Service Software Update Effects 7 4 1 Description The web service will be able to be able to be modified without having to reboot the operating system or web server e g Apache There is no guarantee that the web application itself will not restart 7 4 2 Source Beta Blockers 7 4 3 Constraints None 7 4 4 Standards N A 7 4 5 Priority 3 Moderate 7 5 Web Service Administration Layer 7 5 1 Description The web service shall have a portal for the system administrators to manage the basics of the web portal so that the source of the web application does not need to be modified and redeployed This includes website wide notifications alerts the ability to enable disable certain services and
25. ckers System Requirements Specification Wireless Blood Pressure Monitor 3 6 Blood Pressure Reading 3 6 1 Description The device will measure the blood pressure of the user it is attached to 3 6 2 Source Beta Blockers 3 6 5 Constraints N A 3 6 4 Standards Medical Standards 3 6 5 Priority 1 Critical 3 7 View Results 3 7 1 Description Users will be able to view their results on the monitor 3 7 2 Source Beta Blockers 3 7 3 Constraints N A 3 7 4 Standards N A 3 7 5 Priority 1 Critical 3 8 Multiple Readings 3 8 1 Description Users will be able to record and submit multiple readings in a session 3 8 2 Source Beta Blockers 3 8 3 Constraints N A 3 8 4 Standards N A 3 8 5 Priority 2 High November 13 2013 21 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 9 3 10 3 11 Result Transmission and Storing 3 9 1 Description The monitor will transmit the blood pressure results to the website s database for storage 3 9 2 Source Beta Blockers and sponsor 3 9 3 Constraints Database size 3 9 4 Standards Secure store up to five years worth of readings 3 9 5 Priority 1 Critical Web Service 3 10 1 Description A web service will be created to display results handle users and house other features 3 10 2 Source Beta Blockers 3 10 3 Constraints N A 3 10 4 Standards N A 3 10 5 Priority 1 Critical Account Types 3 11 1 Description
26. d The patient then places his her arm in the device s cuff and presses the start button The device automatically inflates the cuff and the sensors take a reading The patient then sees the results displayed on the device screen 11 4 2 Actor s Patient 11 4 3 TUCBW The patient presses the Start button on the device 11 4 4 TUCEW The patient sees the blood pressure results on the device display Edit Profile Information 11 5 1 Scenario The user clicks the edit profile button The website displays all the current profile information for the user to edit The user makes changes to the profile and clicks the save button The user will be redirected to his her profile and the newly added changes will be displayed 11 5 2 Actor s Patient Doctor 11 5 3 TUCBW The user clicks on edit profile button 11 5 4 TUCEW The user sees the updated information on his her profile November 13 2013 56 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 11 6 Edit Patient Medical Information 11 6 1 Scenario A doctor who is logged into the website selects a patient from their list and clicks the Edit button The website displays a form with the patient s current medical information The doctor makes the necessary edits and clicks the Save button 11 6 2 Actor s Doctor 11 6 3 TUCBW The doctor clicks on the Edit button 11 6 4 TUCEW The doctor sees the updated changes on the patient s profile 11 7 View Cha
27. e the quantity of the device would be as many as selling to individuals but perhaps it would be used by more people who only need it for short term use November 13 2013 11 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 2 Product Description and Functional Overview This section provides the reader with an overview of the wireless blood pressure monitor The primary operational aspects of the product from the perspective of the end users maintainers and administrators are defined here The key features and functions found in the product as well as critical user interactions and user interfaces are described in detail 2 1 Features and Functions The wireless blood pressure monitoring system is made up of two subsystems the blood pressure monitor and the web service The blood pressure monitor is an electronic blood pressure reading monitor that allows the user to take non invasive blood pressure readings periodically to record blood pressure levels over periods of time for evaluation The monitor will use an oscillometric method to determine the wearer s blood pressure reading from an automatically inflating and deflating cuff worn on the upper or lower arm Whenever a user begins a session the monitor initializes and requires authentication to validate the user s identity The monitor cuff will take one or more blood pressure readings display the results and immediately transmit the data to a serv
28. e blood pressure monitor will be to read a user s blood pressure and securely transmit it to the product web service which will process and display the readings to the user 3 1 Non invasive Measurements 3 1 1 Description Blood Pressure Monitor will take readings in a non invasive manner 3 1 2 Source Beta Blockers 3 1 3 Constraints N A 3 1 4 Standards N A 3 1 5 Priority 1 Critical 32 Oscillometric Method 3 2 1 Description Blood Pressure Monitor will use the oscillometric method to evaluate blood pressure 3 2 2 Source Beta Blockers 3 2 3 Constraints N A 3 2 4 Standards N A 3 2 5 Priority 1 Critical November 13 2013 19 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 3 Automatic Inflation Deflation 3 3 1 Description Blood Pressure Cuff will automatically inflate and deflate 3 3 2 Source Beta Blockers 3 3 3 Constraints N A 3 3 4 Standards N A 3 3 5 Priority 1 Critical 3 4 Cuff Location 3 4 1 Description The Blood Pressure Cuff will be worn on the upper or lower arm 3 4 2 Source Beta Blockers 3 4 3 Constraints N A 3 4 4 Standards N A 3 4 5 Priority 1 Critical 3 5 User Authentication 3 5 1 Description An authentication system will be used before all sessions to ensure user security 3 5 2 Source Beta Blockers 3 5 3 Constraints Monitor phone implementation 3 5 4 Standards N A 3 5 5 Priority 1 Critical November 13 2013 20 Beta Blo
29. e dade hor a ve bei ha 73 November 13 2013 6 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Document Revision History Revision Revision Number Date 10 09 2013 First Draft Compilation of all sections by each team member 11 01 2013 Gate Review Draft Revisions based off stake holder and peer review Description Rationale 2 0 11 13 2013 Baseline Revisions based off gate review presentation November 13 2013 T Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor List of Figures Figure Page eru M ii E 13 E EEE E E E E EEE E EE E ES 16 PLUS LA A A id 17 PU T Ed 18 Eguren A alta opu a osa ted osito 59 Ligue NE IPPO o rode eti dada tia este Mob eios alban dal iter otc ae eal spina alan 62 November 13 2013 8 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor List of Tables Figure Page Table 2 5 T zie eite tee itta dira 14 HEIDE ELLE 15 IER UEM a dali 49 Tal LO 2 5 5 ood o AA o te E A Ro tede 50 EIU c 50 WIESE RUE T 51 HEIL 51 Table 10 ii 52 Fable TOP A ta rio 52 Table 10 REM 53 Table EE EE os ta o a ale al o ia atole tbl sche cana ad 53 Table 10 D O O tv Le Cd ss sea E LM UN 54 Fable 12 322 creidtos coral ork pills tete sk pct hae ciii ise iT ill trae lin t Md 64 Wable3 22 27 e A O Le A A cC o O er re 64 able 125 92e a e e dd o E
30. e eaae na aenea ena aeneae ea aeos ena aeneae deae gone ea eae aa ea eaae na sene ae ea aea oae na senes eee aee bae eaae eese iseis 44 8 7 Data Backup iii 45 8 8 BUSINOSS AssoClate rne cecdeceeoecee cuca esbasvodececevessdaawedesseccuesvesouccnsessvedsbedeecdeses seu REOR Se Ee VER See ee ee e ete Ee PEE ERN E E SUR EE EER 45 9 OTHER REQUIREMENTS iiiiiaxevainnnasnndva Sri ky C ar D ng GV raa Y Y cw Ya LER Ra Xn D IY SR i 46 9 1 Web Browser Compatibility 7 1 et ete etta e tree eoa uod r e e eov Lea o eee eee Ree ERU a ed aviae asses esee od dee gea see eee deoa dye Re i 46 9 2 Blood Pressure Monitor Source Compatibility eeeeeee eene eene eene eene nennen nennen eene sees e esee esee esses eese eese e esee esee 46 9 3 Web Service Source Compatibility eerie reo er dees euo o Ine rn e nene eg ro neve ee uo eue eu eee peto eu oan Vene Ve eo eno re eee Va a Uo Tine 47 9 4 Smartphone Device Constraint lt cccccsecececesecceeceseccseceteccsecevecesecstecceecetecetecedeccseceteeesecsbecstecedscesecedeccsecedsceteceteccsecstecetecs 47 9 5 Multiple Health Modules for Website eeeeeeeeee eene eene eene eene enne nennen hene n esee sees esee esee esee eee esses esee esee esses eese eese e essen 48 9 6 Advanced Authentication Capabilities eeeeee eese eene e enses esee esses sese sese esses esee eese esee eese eee 48 9 7 Remote Control for Blood Pressure Monit
31. e laa CS ELTE 65 Table 12 4 1 ttt id cd 66 Table 12 5 5 5 segun uei iate i e e eed he grece Be geben celat 67 Table 12 Orsi kucha aad eiae itta uut ui 67 Table Tiana ill 68 Table 12 Boi a sd 68 Table Li AS A AE A A AS 68 November 13 2013 9 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 1 Product Concept This section describes the general idea for the wireless blood pressure monitoring system The product will include a home blood pressure monitor similar to ones that are already in many households that will have Wi Fi capabilities and user authentication and access to a web service which will record and display data on the condition of the user primarily regarding his or her blood pressure This product will allow patients and their doctor to more easily track the patient s blood pressure and coordinate what they may need to do to improve their health 1 1 Purpose and Use The purpose of this product is to allow patients to have an easy way to monitor their health and to see how their blood pressure has changed over time A patient can also connect to their doctor through the web service so that the doctor can keep track of the patient and offer advice or suggestions without having to schedule an appointment As the system continues to gather data from a patient it will begin to offer advice of its own if it finds that the patient s current condition fits a certain condition or pattern and cou
32. e team s extensive research on the various implementations of blood pressure monitors currently in the market as well as the team s abilities and skills The critical requirements include reading human blood pressure levels storing data regarding the results transmitting data securely over a wireless connection and displaying the various tables graphs and other modules associated with the website These critical requirements will be addressed first and from there the remaining requirements will be addressed gradually based on their priority Another aspect that will be addressed as a priority parallel to the mentioned critical requirements is the user friendliness of the system The device s targeted audience is comprised of middle aged individuals who may or may not be very familiar with technological devices and would not want to be hindered by the device Therefore throughout the development of the project it must be ensured that the device the website and the interfaces that the user will interact with are easy to use and understand and that they would be appealing to users in the targeted age range 12 2 Research The development team has placed a considerable emphasis on researching the two largest aspects of the project the hardware design of the blood pressure monitor and the software design of the website The largest component is the hardware design of the blood pressure monitor and cuff responsible for controlling motor and val
33. enabling disabling the entire web application 7 5 2 Source Beta Blockers 7 5 3 Constraints Does not compromise the security requirements 7 5 4 Standards N A 7 5 5 Priority 3 Moderate November 13 2013 41 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 8 Security Requirements This section defines the security requirements of the system The security requirements are derived from the Health Insurance Portability and Accountability Act HIPAA and apply to all protected health information PHI that will be collected and stored under the scope of this project PHI is information that can be used to tie any health related information to a unique individual The security of PHI is critical to protect the privacy of all users of the system 8 1 Data Transport Encryption 8 1 1 Description The web service shall encrypt all data particularly PHI that is transmitted between the blood pressure monitor and the data collecting web server This requirement is primarily focused on the level of the communication between monitor client and the web server and not the WLAN connection see section 8 5 8 1 2 Source Beta Blockers 8 1 3 Constraints None 8 1 4 Standards HIPAA 8 1 5 Priority 1 Critical 8 2 Authorization 8 2 1 Description The collected PHI data will only be accessible to authorized personnel using audited access controls Mechanisms will be designed and implemented to ensure that dat
34. equirements Name Number 3 6 Blood Pressure Reading 3 7 View Results 3 8 Multiple Reading 5 8 Blood Pressure Monitor Accuracy Table 10 2 10 2 2 Verification Procedure The wireless blood pressure monitor will be tested against other devices to ensure accuracy Multiple readings and test conditions will be implemented to make sure readings are consistent 10 3 Verify that the system is user friendly 10 3 1 Requirement s addressed Requirements Name Number 3 10 Web Service 3 18 Charts and Graphs 3 19 Annotations 3 20 Patient Viewing Profile 3 27 Advice System 4 9 Manual Table 10 3 10 3 2 Verification Procedure The website and device will be thoroughly tested by the sponsor customer to ensure user friendliness The displays and interfaces will be shown to various members of the target demographic to guarantee that they are able to understand how to interact with them November 13 2013 50 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 4 Verify the system shall authenticate user login 10 4 1 Requirement s addressed Requirements Name Number 3 5 User Authentication 5 4 Web Authentication Latency 8 1 Data Transport Encryption 8 2 Authorization 8 3 Integrity 8 6 WLAN Connection Security 8 8 Business Associate Table 10 4 10 4 2 Verification Procedure The wireless blood pressure monitor will be t
35. er Figure 2 1 November 13 2013 13 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor The Blood Pressure Monitor Input Output Device Setting and Configurations Warnings Alerts Messages Wireless Connection Credentials Data Transmission Start Stop Commands Power on Power off Blood Pressure BP Readings Table 2 1 To begin using the blood pressure monitor for the first time the user will need to have a web account setup for them by their primary doctor Once the account is set up the user must enter their web connectivity credentials into the device so that when blood pressure readings are taken they can begin transmitting the data Then the user must enter their authentication credentials into the device to complete the setup After the initial setup the user will put the blood pressure cuff around their arm After telling the device to start by hitting the corresponding buttons the cuff will automatically inflate and deflate to take the user s blood pressure Various sensors will activate to take in the input required to determine blood pressure The monitor will show the user the results and then transfer them to their web service account to view later When using the device the user should avoid certain factors that could lead to inaccurate readings Such factors include but are not limited to measuring blood pressure after taking any medications exercising immediately after awaki
36. er Batteries will not be packaged with the device 4 7 2 Source Beta Blockers 4 7 3 Constraints N A 4 7 4 Standards N A 4 7 5 Priority 3 Moderate Connection Cable 4 8 1 Description Connection cable will be provided to manually upload the data on to a computer and uploaded to the website if wifi is not available 4 8 2 Source Beta Blockers 4 8 3 Constraints None 4 8 4 Standards None 4 8 5 Priority 5 Future November 13 2013 32 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 4 9 User Manual 4 9 1 Description A user manual will be provided with the product The Manuel will contain detailed information regarding the product website and how to operate the device 4 9 2 Source Beta Blockers 4 9 3 Constraints None 4 9 4 Standards None 4 9 5 Priority 2 High November 13 2013 33 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 5 Performance Requirements This section covers the operational aspects of the entire system including the physical device on hand and the web service implemented Some of the performance requirements included in this section are derived from the ANSI AAMI SP10 2002 standard for automated blood pressure monitors 5 1 Storage conditions 5 1 1 Description The blood pressure monitor shall maintain the performance requirements specified in this document after being stored for 24 hours at 21 C 70 F give or
37. er via a wireless connection In the event that a wireless connection cannot be established the monitor will store the user s blood pressure readings temporarily until a connection is re established The user can use the monitor at any point in time to check their blood pressure level by wearing the cuff and powering on the device using the power start button In that way the blood pressure monitor can support multiple users After authenticating and taking blood pressure readings the users data is transmitted to the devices corresponding website where the user has an account created for them by their regular doctor or clinic personal that administer their medical records The data transmitted to the server will be encrypted for security and will contain a user identifier to associate the user s blood pressure readings with their account To create an account the user s doctor will be required to input information about the user such as their age gender diet physical activity medical history and prescription history Upon completion the user s profile is ready to use requiring the doctor to send the users temporary login credentials through a secure channel The user will then have to change their login credentials for their web profile The website will have two distinct profile types one belonging to the user and one belonging to doctors From the website the doctor will be able to create their own account profile The users acc
38. esses more skills will be required that may not have been foreseen The development team knows from prior experience that they are competent enough to learn new skills and concepts fairly quickly to adapt to the project 12 6 Schedule Analysis The development team used two methods to estimate approximately how long the project will take given certain factors and constraints The first method the team used was Jones s First Order Estimation To begin the projects function points had to be listed which gave a basic overview of how many components are involved in the system and how complicated they are Function Point Analysis Program Characteristics d xity Medium Complexity NA plexity Number of inputs 4x3 2x4 0x6 20 Number of outputs 4x4 2x5 0x7 26 Inquiries 5x3 1x4 1x6 25 Logical internal files 8x7 2x10 1 x15 91 External interface files 2x5 0x7 0x 10 10 Unadjusted function point total 172 Table 12 4 Table 12 4 shows the results of the analysis of the function points from the system The team found that a large number of logical internal files will be used by the system which severely raised the total The number of outputs including a couple of relatively complex outputs also helped to bump the sum up Ultimately the team wound up with 172 function points November 13 2013 66 Beta Blockers System Requirements Specification Table 12 5 Formula 1 Wireless Blood Pressure Monitor
39. ested to make sure user authentication is implemented correct Multiple test cases will be implemented to ensure the system correctly verifies valid credentials as well as invalid credentials 10 5 Verify the system is safe and noninvasive for the user 10 5 1 Requirement s addressed Requirements Name Number 6 1 Maximum Cuff Pressure 6 2 Cuff Pressure Release 6 3 Electrical Safety 6 5 Blood Pressure Monitor Mechanical Safety Table 10 5 10 5 2 Verification Procedure The blood pressure cuff will be tested to make sure it conforms to AAMI standards and is safe for the user November 13 2013 51 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 6 Verify the system is giving proper advice to the user 10 6 1 Requirement s addressed Requirement Name Number 3 27 Advice System Table 10 6 10 6 2 Verification Procedure The team and sponsor will test to see if the system is sending correct messages to the user base on their medical status and blood pressure reading Data taken from test subjects and hardcoded data will be uploaded to the system to test what advice it administers under different conditions 10 7 Verify that account creation works and can handle errors 10 7 1 Requirement s addressed Requirement Name Number 3 11 Account Types 3 12 Doctor Account Creation 3 13 Patient Account Creation 3 14 F
40. for more than one module Once we establish this as a viable product however each additional module would become easier to add from a web perspective Requirement 9 6 Advanced Authentication Capabilities 13 6 1 Description The monitor will have advanced authentication capabilities to better ensure that the correct person is wearing the device at all times 13 6 2 Constraint Knowledge Technology Blood vein analysis and other techniques are being developed to provide a better system for person verification but these techniques are still very young and not ready to be used extensively and we lack the time required to fully understand them in their current form November 13 2013 71 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 13 7 Requirement 9 7 Remote Control for Monitor 13 7 1 Description The blood pressure monitor will come with a control that will be used to control the system allowing for more portability and removing the need for a phone or a large box to support the system 13 7 2 Constraint Schedule Scheduling issues cause us to have to forgo this option in favor of using a phone for the project The remote would function similarly to the way the phone application will end up working but we would have to handle the fabrication of the entire remote the system to allow the Wi Fi chip to connect and the interaction between it and the monitor Using a phone will allow us to bypass s
41. h properly and are being displayed for the doctor November 13 2013 53 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 10 Verify Data Transfer 10 10 1 Requirement s addressed Requirement Name Number 3 9 Result Transmission 3 26 HIPPA 8 1 Data Transport Encryption 8 3 Integrity 8 4 Storage Encryption 8 6 WLAN Connection Security 8 8 Business Associate Table 10 10 10 10 2 Verification Procedure The team will ensure that the data is encrypted in a way that satisfies HIPAA and other standards needed to be a secure and approved system The blood pressure monitor will be tested for accuracy and other metrics during which the data transfer protocol can also be tested by ensuring that the requested data to be transferred gets to the database November 13 2013 54 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 11 Use Cases The use case section describes how the intended user interacts with the system There are two main sections of use cases for the blood pressure monitor the monitor device and the web service The device section describes how the user interacts with the physical device The web service section describes how a user interfaces with the website 11 1 Doctor Account Creation 11 1 1 Scenario A doctor goes to the website and clicks the doctor Sign Up button The website displays a form where they enter
42. ld alert both the doctor and patient if the patient s health is concerning which could help reduce how often the doctor has to check on the patient Clinical studies have shown that for patients who have high blood pressure keeping in contact with their doctor or caretaker and informing them of their blood pressure results as they continue to take them often allows them to stabilize their blood pressure to healthy levels more quickly and effectively The goal of this product is to expedite that process so that patients do not have to write down their results they do not have to constantly call email or visit their doctor and their doctor does not have to in turn keep all of this information and track the patient themselves Instead the patient will authenticate themselves on their monitor take their blood pressure and go on with their day Later they and their doctor can log into the website and see how the patient s latest result compared with their previous results and take any appropriate actions The entire system should be easy to use and is comprised of two separate subsystems the blood pressure monitor system which will handle authenticating the user and measuring their blood pressure and the remote web system Users will need to establish a connection from their monitor to their Wi Fi service in order for the monitor to begin uploading data and they will need to create a user account and setup their authentication credentials on the
43. le to successfully implement all of these different systems though backup plans have been prepared in case things don t go as scheduled 12 4 Cost Analysis Based on research of the market the development team predicts that the blood pressure monitor will be completed within the budget requirement Most of the hardware is available to buy in several specifications and cost variations giving the team a financial flexibility If the team chooses to reverse engineer an existing product then the cost would include the price of the consumer blood pressure monitor plus the price of the components that will be integrated like the wireless connectivity and the USB connectivity The price of the unit and the components would depend on how much of the planned system is already implemented in the unit If the team chooses to fabricate the blood pressure monitor the cost would include the price of each individual piece of hardware as well as the price of printing and surface mounting the circuit board Regardless this is where the bulk of the budget will be spent The only situation where the team could go over the budget would be if the hardware components would get damaged break or in the case of fabrication not work on the first setup and replacement parts are needed If this happened multiple times the project will quickly become costly No cost for the software side is anticipated The website will not require any specialized software to be purchased
44. lockers System Requirements Specification Wireless Blood Pressure Monitor 3 22 3 23 3 24 View Alerts 3 22 1 Description Doctors will be able to view alerts and the issue they pertain to 3 22 2 Source Beta Blockers 322 3 Constraints N A 3 22 4 Standards N A 322 5 Priority 2 High Messaging System 3 23 1 Description Doctors and patients can send messages to one another to be read later like an email system as a way of addressing things not covered by the alert system and the annotation system 3 23 2 Source Beta Blockers 3 23 3 Constraints The two parties attempting to message each other must be connected the doctor created the patient account or the patient added the family member to their account 3 23 4 Standards N A 3 23 5 Priority 4 Low Multiple Users 3 24 1 Description The blood pressure monitor will be able to support multiple users on the same device 3 24 2 Source Beta Blockers 3 24 3 Constraints N A 3 24 4 Standards N A 3 24 5 Priority 4 Low November 13 2013 21 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 25 3 26 3 27 Login to Access Data 3 25 1 Description Users will have to log into the website in order to view any data 3 25 2 Source Beta Blockers 325 3 Constraints N A 3 25 4 Standards N A 3 25 5 Priority 1 Critical HIPAA 3 26 1 Description Product will comply with all HIPAA standards as well a
45. longer than 3 minutes min 6 1 2 Source ANSI AAMI SP10 2002 6 1 3 Constraints None 6 1 4 Standards ANSI AAMI SP10 2002 4 3 1 Devices incorporating automatic inflation systems 6 1 5 Priority 1 Critical 6 2 Cuff Pressure Release 6 2 1 Description An easily accessible and clearly labeled means of allowing the user to deflate the cuff shall be provided During the rapid exhaust of the pneumatic system with fully opened valve the time for the pressure reduction from 260 mmHg to 15 mmHg shall not exceed 10 s 6 2 2 Source ANSI AAMI SP10 2002 6 2 3 Constraints None 6 2 4 Standards ANSI AAMI SP10 2002 4 3 1 Devices incorporating automatic inflation systems 6 2 5 Priority Critical November 13 2013 38 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 6 3 Electrical Safety 6 3 1 Description The blood pressure monitor shall not be able to deliver a harmful shock to its user The voltage range throughout the device will be limited to 12 volts The device will also only use DC type power as its primary source of electrical power 6 3 2 Source Beta Blockers 6 3 3 Constraints None 6 3 4 Standards N A 6 3 5 Priority 2 High 6 4 Eligible Users 6 4 1 Description The blood pressure monitor shall not be intended for neonatal users It will be only intended for those who understand how to operate the device safely 6 4 2 Source Beta Blockers 6 4 3 Constraints None 6
46. lood Pressure Monitor Jones First Order Estimation Bestin Class Average Worst in Class Unadjusted Function Point 8 3 9 1 10 7 Adjusted Function Point 8 8 9 10 4 Table 12 7 As shown in Table 12 7 from these numbers the estimated man months were calculated by multiplying the function points by Jones s First Order Estimation Number The team found that the project is a business project so the three numbers were 41 43 and 46 From these results it can be seen that in a worst case scenario the project will take a little over 10 months to complete Considering that there are 5 team members and considering that each team member has other classes and projects and thus cannot commit a full 40 hours a week this seems like a relatively reasonable amount of time This time will allow the team to finish the project but may prove troublesome if the team falls behind However the team found that they have overestimated some of the factors in the project so a reevaluation of the numbers may bring this number down as the project becomes clearer and certain aspects become more understood The second method that was used was the Basic COCOMO method which takes into account the number of lines of code and the effort expected to be put forth by the team This is an extremely simple way to calculate the needed time which can result in a wide range or an overly optimistic or pessimistic
47. ng distressing or consuming alcohol caffeine or tobacco Because the device has no way of determining these factors the user must ensure that they avoid these situations November 13 2013 14 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Web Service Account Input Output User Information Charts and Graphs Profile Connections Advice System Messaging System System Alerts Table 2 2 To access the website the user will need to have a web service account setup for them The user account setup will be administered by the user s primary doctor or clinical personal and will require information on the user such as their name login credentials gender age diet exercise routines medical history and prescription history After setting up the account the user will need to input their authentication credentials to be allowed into the site Various other forms of input are expected from the different modules of the website To manage certain aspects of their account a user has to enter or modify the information that their account privileges allows them to or when needing to connect to a doctor or family profile the user has to input the profile for connection and a mutual agreement from both profile holders is required In turn the system will allow the user access to their data upon successful authentication And the system will generate the charts and graphs of the user s data November 13
48. ng readings All readings will be automatically sent to the website when wifi is enabled or available Users will have an account created for them by their primary doctor to view and log past readings The blood pressure monitoring system will be packaged according to these requirements 4 1 Blood Pressure Cuff 4 1 1 Description The product will be packaged with a standard blood pressure cuff The cuff will weigh between 1 2 1 pound and will be fitted for arm circumference of 9 14 inches 4 1 2 4 1 3 4 1 4 4 1 5 Source Beta Blockers Constraints None Standards AAMI Priority 1 Critical 4 2 Blood Pressure Monitor 4 2 1 Description The product will come packaged with a monitor which is attached to the cuff It will be the interaction point between the patient and the system The patient can authenticate take blood pressure reading view current readings in the session and send blood pressure readings to the website The Monitor will be a 3 x 4 inch display and will weigh no more than 6 ounces 4 2 2 4 2 3 4 2 4 4 2 5 Source Beta Blockers Constraints None Standards None Priority 1 Critical November 13 2013 30 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 4 3 4 4 4 5 Android Phone 4 3 1 Description The product will require an Android phone which will not be packaged with the product The phone will use the Android application to interact
49. number Software project a b Ch d Organic 2 4 1 05 2 5 0 38 Semi detached 3 1 12 2 5 0 35 Embedded 3 6 1 2 2 5 0 32 Table 12 8 Table 12 8 shows the coefficients needed to compute the COCOMO approximation The team found that the project fit the semi detached project format so these coefficients were used in the approximation Basic COCOMO Estimation Low High Effort 14 2 30 8 Person months Development Time 6 3 8 2 Months People Required 2 3 3 7 Table 12 9 November 13 2013 68 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Formula 2 Effort Applied E a KLOC Formula 3 Development Time D c Effort Applied y Formula 4 People required P Effort Applied Development Time Table 12 9 shows the final estimate of the various results given by the basic COCOMO formula The Effort is the amount of person months it will require to complete the project and is given by Formula 2 KLOC is the total lines of code the team expects to write for the project measured in thousands of lines For this project after some assessment the team agreed that they would likely end up writing between 4 and 8 thousand lines of code Thus they will need between 14 and 30 person months to complete the project The development time is the time the project is expected to take before it has been fully completed and is given by Formula 3 The equation gave an estimated de
50. ome of these concerns giving us more time to focus on the website and the monitor November 13 2013 T4 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 14 Glossary wifi also spelled Wi Fi is the name of a wireless networking technology that uses radio waves to provide high speed network and Internet connections It is generally used as a synonym for WLAN WLAN wireless local area network sphygmomanometer a synonym for blood pressure monitor BPM acronym for blood pressure monitor BP acronym for blood pressure ANSI AAMI SP10 2002 an international standard used for blood pressure monitors It s assumed that all viable BPM s follow this standard Bluetooth a wireless standard for exchanging data over short distances using short wavelength radio transmissions November 13 2013 73 Beta Blockers
51. onitor shall be able to boot up from a cold start to a ready state for the user within 30 seconds 5 10 2 Source Beta Blockers 5 10 3 Constraints The blood pressure monitor is set up in its normal operating configuration 5 10 4 Standards N A 5 10 5 Priority 3 Moderate November 13 2013 37 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 6 Safety Requirements This section defines the safety requirements which specify the operational characteristics of the system to ensure the safety of the system s users The product will be developed as a working prototype for in house demonstration and testing the blood pressure monitor development will not follow all of the ANSI AAMI SP10 2002 standards and if any of the said requirements are derived from the standard it is explicitly noted 6 1 Maximum Cuff Pressure 6 1 1 Description For devices intended for public home or other unsupervised use a means of limiting cuff pressure shall be provided so that the maximum cuff pressure will never exceed 300 mmHg For devices intended for use under professional supervision a means of limiting cuff pressure shall be provided so that the maximum cuff pressure will never exceed 300 mmHg or 30 mmHg above the upper limit of the instrument s manufacturer specified operating range whichever is lower In addition the device shall incorporate means to ensure that cuff pressure will not be maintained above 15 mmHg for
52. or csssesesscsceceeesssssscceeeeeessssscscceeeeeessssccsceeesessssccccceseesssssssssseeeeeeessssseeaes 48 10 ACCEPTANCE CRITERIA ici adi di cd 49 10 1 Verify that the data is secured eon taIta Neve DER EEOE ERST 49 10 2 Verify that the blood pressure reading is accurate eeeeeeeee eene eene eene e sese esses esee sees esee eese 50 10 3 Verify that the system is user friendly cocccccccccccncccncncncncncnonononcccncccncncncnoconononcnononcncnononononcncncncncncncnanenonoso 50 10 4 Verify the system shall authenticate user login Leeeeeeeee eene eene eene eene nennen eese esee esee esee eese esee esee 51 10 5 Verify the system is safe and noninvasive for the user eeeeeeeeee eene e eee eee eene eene nennen enne esee eese s esee esee esee een 51 10 6 Verify the system is giving proper advice to the user Leeeeeeeee eene eee eee eene enne nene esses esee esee esee esee essen 52 10 7 Verify that account creation works and can handle errors eeeeeee eiue eeeeeeeeeeeee esee nenne nennen nnne ense nena 52 November 13 2013 5 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 8 Verify that charts and graphs are generating and personalized eese eene eene eene enne nnne 53 10 9 Verify that the alert system works eeeeeeeeeeeeeeeee esee esee esee sensns ss
53. ount will have a profile page that graphically displays all the users results in various tables and graphs make annotations on any specific blood pressure create alerts for their doctor or allow the system to generate alerts if it detects irregularities or generally alarming blood pressure levels November 13 2013 12 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor The second profile belongs to doctors This profile will allow a user s doctor to keep tabs on the user s that they have created by allowing them to see their information and readings to communicate with the user through a message system to receive alerts when the user or system thinks something is wrong and to create a new user web account Because it was the doctor that created the users account they are automatically tethered to that user and are connected through a patient doctor relationship 2 20 External Inputs and Outputs The system is made up of two distinct subsystems where different user inputs are expected with different resulting outputs The subsystems are the blood pressure monitor including the cuff and the website The diagram below illustrates user interaction with the different subsystems User Blood Pressure Monitor Wireless SS Connection Access Point v 120 80 mHG um NA oa Personal Computer zd f M AE N C lt RA Y rn d M Doctor Central Web Serv
54. owing for more portability and removing the need for a phone or a large box to support the system 9 7 2 Source Beta Blockers 9 7 3 Constraints None 9 7 4 Standards N A 9 7 5 Priority 5 Future November 13 2013 48 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 Acceptance Criteria The following criteria must be met for the wireless blood pressure monitor to be a complete product Due to the sensitivity of the data involved these guidelines must conform to HIPAA standards 10 1 Verify that the data is secured 10 1 1 Requirement s addressed Name Requirements Number 325 Login to Access Data 3 26 HIPPA 8 1 Data Transport Encryption 8 2 Authorization 8 3 Integrity 8 4 Storage Encryption 8 5 Disposal Guarantee 8 6 WLAN Connection Security 8 8 Business Associate 8 9 Device Reading Storage Time Limit Table 10 1 10 1 2 Verification Procedure Data will be encrypted using HIPPA standards and verified with the sponsor of the project The data encryption will be tested using various data penetration tools to ensure a reasonable level of encryption is used And the data transfer and online database are secure November 13 2013 49 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 10 2 Verify that the blood pressure reading is accurate 10 2 1 Requirement s addressed R
55. parse to be grouped under a new section of requirements 9 1 Web Browser Compatibility 9 1 1 Description The web interface shall be accessible and usable through popular web browsers for the user caretaker physician and administrators Such web browsers would include Internet Explorer Mozilla Firefox Google Chrome and Safari 9 1 2 Source Beta Blockers 9 1 3 Constraints None 9 1 4 Standards N A 9 1 5 Priority 1 Critical 9 2 Blood Pressure Monitor Source Compatibility 9 2 1 Description The blood pressure monitor device s source code shall be compatible with Windows 7 development environments for implementation deployment and maintenance 9 2 2 Source Beta Blockers 9 2 3 Constraints None 9 2 4 Standards N A 9 2 5 Priority 1 Critical November 13 2013 46 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 9 3 Web Service Source Compatibility 9 3 1 Description The source code of the web service functionality shall be compatible with Windows 7 and popular Linux development environments for implementation deployment and maintenance 9 3 2 Source Beta Blockers 9 3 3 Constraints None 9 3 4 Standards N A 9 3 5 Priority 1 Critical 9 4 Smartphone Device Constraint 9 4 1 Description Any implementation of functionality for mobile devices mainly smartphones will be constrained to Android 3 0 and Unix type operation systems This is due to their accessibility and
56. rk WLAN will take no longer than 10 seconds to attempt a successful connection After 10 seconds the blood pressure monitor will cease the connection activity 5 4 2 Source Beta Blockers 5 4 3 Constraints None 5 4 4 Standards N A 5 4 5 Priority 2 High 5 5 WLAN Connection Failure Response Time 5 5 Description The blood pressure monitor interface to the end user s wireless local area network WLAN will take no longer than 10 seconds intervene appropriately and notify the end user of the current status of the WLAN connection 5 5 2 Source Beta Blockers 5 5 3 Constraints None 5 5 4 Standards N A 5 5 5 Priority 2 High November 13 2013 35 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 5 6 Web Authentication Latency 5 6 1 Description The blood pressure monitor interface to the internet and to the web service will take no longer than 30 seconds to attempt a login After 30 seconds the system will cease the login activity 5 6 2 Source Beta Blockers 5 6 3 Constraints The web server provides a decent amount of computing performance 5 6 4 Standards N A 5 6 5 Priority 2 High 5 7 Blood Pressure Monitor Consistency Regarding Battery Life 5 7 1 Description The blood pressure monitor will still be able to take consistent readings until the device detects that the battery s voltage is too low to continue normal operation The variation in blood pressure readings shall be
57. rts and Graphs 11 7 1 Scenario The user clicks on the View Charts button The website displays charts and graphs based on the selected patient s most recent blood pressure readings 11 7 2 Actor s Doctor Patient 11 7 3 TUCBW The user clicks on the View Chart button 11 7 4 TUCEW The user sees the charts and graphs of the patient s blood pressure levels 11 8 Create Annotations 11 8 1 Scenario The patient clicks on the Blood Pressure Chart button and select a blood pressure reading to annotate The patient will click the Annotation button and be prompted to enter information and clicks submit The patient will see the new annotation on the chart next to the reading 11 8 2 Actor s Patient 11 8 5 TUCBW The patient clicks the Blood Pressure Chart button 11 8 4 TUCEW The patient sees the annotation on the reading November 13 2013 57 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 11 9 View Advice 11 9 1 Scenario The patient logs into the website and clicks the Advice button The website then generates an advice message based on the patient s most recent blood pressure readings 11 9 2 Actor s Patient 11 9 3 TUCBW The patient clicks the Advice button 11 9 4 TUCEW The patient sees the advice on the website 11 10 Create Alert 11 10 1 Scenario A patient is logged into the website They click on the Set Alert button The website shows a form with some alert choices The patient
58. s nass assa sans sanas sess assess assess sess sss asses assa ss sauu 53 10 10 Verify Data Transfer uere rere er eee eere eue eue eo ean eye uu ee a Unesco neuen t eae eov ee eua uev eee cune eene en 54 T1 USE CASES iria EIA n rr RE a CA A E Y naaa 55 11 1 Doctor Account CreatiON ccoo c MM 55 11 2 Patient Account Creation ii An Ue eg eee ve eeu o Yes 55 11 3 PATITUR ERA 56 11 4 E AAA O aS Saa aars SE Snas Es Sae 56 11 5 Edit Profile Informati Ns ss ssss C 56 11 6 Edit Patient Medical Information cccssssssssccseccssssssssssceeseessssscsceceeeessssescscceeeeesssssscccesesessssessceeeeeeesssescceeeeees 57 117 Miew Charts arid Graphs cnn aoai Tessie 57 11 8 Create AAA 57 LED NA TI e Te IO E TR 58 11 10 Create Alert AN 58 12 FEASIBILITY ASSESSMENT oasis ada RADA RD RH c E D 60 12 1 Scope VAMAIYSIS oi3 25i02 cicciccsicecicceiiesiceticecieceliesiccticecitcsiteciendisevicseliesiccticecitcsitesieedicecdscelbesicetivecitesitesicediceciecsiiesieetics 60 12 2 A mee E M E 60 12 3 ESA aoso O eaa dee e Erde ORT aia 61 12 4 E M 63 12 5 Resource Analysis c c O 65 12 6 Schedule Analysis ano Sota Novi Sena 66 T3 F LURELPEMS zisvasatostca tii n dria RATER ERE SI SEA DL RU RD RV D a ue 70 TA GLOSSARY ivonnguafeiienodo deag envoi rire Con hoc ue Ma r
59. s other standards that apply to medical data to ensure customer privacy This will be covered in detail in the Security Requirements section 3 26 2 Source Beta Blockers 3 26 3 Constraints N A 3 26 4 Standards N A 3 26 5 Priority Critical Advice System 3 27 1 Description The website will be able to give patients health information advice and general suggestions to keep their blood pressure in check by looking at general patterns and user information 3 27 2 Source Sponsor 3 27 3 Constraints N A 3 27 4 Standards N A 3 27 5 Priority 1 Critical November 13 2013 28 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 28 Manual Upload of Information 3 28 1 Description In the case where a patient s wireless connection goes down or begins to suffer problems the device will store the patient s readings for a set amount of time The patient will then be able to manually upload the readings using a computer if they feel that the wireless connection will not resume working in the near future 3 28 2 Source Sponsor 3 28 3 Constraints N A 3 28 4 Standards N A 3 28 5 Priority 5 Future November 13 2013 29 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 4 Packaging Requirements The blood pressure monitoring system will come with pre assembled parts and will be ready to use User will be able to easily configure the device and start taki
60. selects an alert option and clicks set alert 11 10 2 Actor s Patient 11 10 3 TUCBW The patient clicks the Set Alert button 11 10 4 TUCEW The patient sees a confirmation message that an alert was sent November 13 2013 58 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor Blood Pressure Website Doctor Account Creation Patient Account Creation Blood Pressure Monitor Authenticate User Edit Profile Information Take Blood Pressure Edit Patient Medical Information Authenticate User View Charts and Graphs Create Annotations View Advice Create Alert Figure 11 1 November 13 2013 59 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 12 Feasibility Assessment This section provides the reader with a feasibility analysis of the wireless blood pressure monitoring system consisting of the following six components scope analysis research technical analysis cost analysis resource analysis and schedule analysis Because the system s detailed design specification has not begun this assessment is based entirely on the team s judgment knowledge prior experience and critical analysis 12 1 Scope Analysis The scope of work required for the critical requirements outlined in this document is practical for the given time frame of the project and prototyping of these requirements by the deadline date appears feasible This assessment is based on th
61. sssssssessssessesscssssssessssssesssssssssssssessseeens 20 34A Cuff LO CAC ADEL 20 3 5 User AUthentication sicscicsecc scosccesceasccevsaccceveviseceeedecctevessoucsuctSueveeestseesectssdeceussde cued dccecsestcecevcsccceseescersecdvececeesesecdesece 20 3 6 A ASA 21 3 7 A RN 21 3 8 Multiple Reader Une Pe E 21 3 9 Result Transmission and Storing 111 1LLieee eee ee eee esee eene e eee nenne ease eoe e ease esas ss sees ases asses eese assess aseo sese assess sensns 22 3 10 Web Service 5 31 or so sos ease eb egeo orba iea Too ses aso pesessoeskae se Uebac eas does eobesessosebiesso spare passes doses se asseb esas Des secbosresaooP ies coop baa 22 November 13 2013 2 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 3 11 Account NAO 22 3 12 Doctor Account Creation e eeretee e teres aesae eu Pea Eee pvo Pee E apa a ee Ea ces ee tea ves eppoP sep ee ven ces aeie 23 3 13 Patient Account CCAA eere eerte ann p exeun ey eoo ee ee i ii eee eun e eee 23 3 14 Patients DeLa Ka KAS EA RR 23 3 15 Ib ere a A A E I T E T O 24 3 16 Doctor Editing 35 E E E E A E A E E EA 24 3 17 Eandem EE 24 3 18 View Charts and Graplis O 25 3 19 Punch C G 25 3 20 Patient Viewing Profile o rrr rere rtr e eee EE ea Y e eo e ee yuan eue eb eee RA ue eg eorr aa aue RATAS gen 26 3 21 Create Alerts uei OR NEUE A Deique decet eicere ee e ER EN Ead 26 3 22 W
62. t to mark them and make notes on them in case they want to say something about that result There are open source tools to help make the chart generation easier mostly the team will be dealing with the annotations and the way data will be loaded onto the system The messaging and alert system is a way for patients and doctors to interact so that they can keep in touch and inform each other of things that the service cannot The alert system will allow the web service to analyze a user s results and send an alert message to the patient s doctor 1f it detects that the patient s health is outside normal conditions Again there may be tools to help facilitate the actual communication so the team s technical skills will be mostly applied to the algorithm to look for alarming health patterns The advice module will allow the system to further analyze a person s blood pressure results and other information to dispense recommendations over time to help take some of the November 13 2013 62 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor pressure off of the doctor although the advice given will have its limits This will involve a lot of data processing and pattern recognition to find what sort of advice needs to be given The complexity of this algorithm will depend on how extensive the team wishes to make this feature With all of the technical aspects of these features considered the team believes that they will be ab
63. take 10 C variance and at a relative humidity lower than 9096 noncondensing 5 1 2 Source Beta Blockers 5 1 3 Constraints None 5 1 4 Standards N A 5 1 5 Priority 2 High 5 2 Operating conditions 5 2 1 Description The blood pressure monitor shall maintain the safety and performance characteristics specified in this document during operation over the following ranges of environmental conditions a Temperatures between 11 C and 31 C b Relative humidity under 90 noncondensing 5 2 2 Source Beta Blockers 5 2 3 Constraints The blood pressure monitor is set up in its normal operating configuration 5 2 4 Standards N A 5 2 5 Priority 2 High November 13 2013 34 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 5 3 Operational Battery Life 5 3 1 Description The blood pressure monitor shall maintain the performance characteristics specified in this document for at least 30 minutes while running the measurement acquisition process continuously 5 3 2 Source Beta Blockers 5 3 3 Constraints The blood pressure monitor is set up in its normal operating configuration the battery has been fully charged no longer than 1 hour prior to use and fully inspected to be free of defects or malfunction 5 3 4 Standards N A 5 3 5 Priority 2 High 5 4 WLAN Authentication Latency 5 4 1 Description The blood pressure monitor interface to the end user s wireless local area netwo
64. their profile information The user then clicks the Create Profile button 11 1 2 Actor s Doctor 11 1 3 TUCBW The user clicks on the Sign Up button 11 1 4 TUCEW The user sees their home screen 11 2 Patient Account Creation 11 2 1 Scenario Doctor clicks on the Register Patient button The website displays a form for the doctor to fill out with the patient personal information The doctor will specify the patient s name and a temporary password will be generated for that user After the form is completed the doctor clicks submit and the patient will be added to the system and to the doctor s patient list 11 2 2 Actor s Doctor 11 2 3 TUCBW Doctor clicks the Register Patient button 11 2 4 TUCEW Doctor sees the patient in his her list November 13 2013 29 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 11 3 11 4 11 5 Authenticate User 11 3 1 Scenario The user will turn on the device or go to the website and the system shall prompt for a user name and password The user will enter his her credential and submit the system shall verify the credential and redirect the user to the home screen if verification was successful 11 3 2 Actor s Doctor Patient 11 3 3 TUCBW The user presses the Log In button goes to the website 11 3 4 TUCEW The patient sees the home screen Take Blood Pressure 11 4 1 Scenario The patient is logged into the device and the home screen is displaye
65. tion 8 2 on PHI data 8 4 2 Source Sponsor 8 4 3 Constraints None 8 4 4 Standards HIPAA 8 4 5 Priority 2 High November 13 2013 43 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 8 5 Disposal Guarantee 8 5 1 Description PHI data when found necessary to remove from the system will be effectively purged This guarantees that when the system removes the data from its oversight it would be thoroughly deleted from itself and all of the system s underlying dependencies If a data backup system is implemented section 8 7 then this requirement will be implemented completely on this system as well This means that the backups must be thoroughly cleansed of or recompiled without the appropriate data 8 5 2 Source Sponsor 8 5 3 Constraints None 8 5 4 Standards HIPAA 8 5 5 Priority 4 Low 8 6 WLAN Connection Security 8 6 1 Description The wireless network connection between blood pressure monitor and the WLAN router shall communicated through an encryption of at least a symmetric encryption of AES 128 strength 8 6 2 Source Beta Blockers 8 6 3 Constraints None 8 6 4 Standards N A 8 6 5 Priority 4 Low November 13 2013 44 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 8 7 Data Backup 8 7 1 Description The data collected by the web portion of the system will be backed up in case of an emergency or accidental deletion situation The
66. ve drivers pressure sensor readings signal filtering display and transport of data Based on the research completed there appears to be a substantial amount of resources for the design and implementation of a standard blood pressure monitor There also appears to be a standardization of the development of home blood pressure monitoring devices administrated by the AAMI Sphygmomanometer Committee The standardized requirements clearly identify what aspects of November 13 2013 60 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor the system are critical and what are not giving the development team an idea of what requirements should be made a priority and what should not The research done on the hardware design reveals that the development team has three major options in implementing a blood pressure monitoring device reverse engineering an existing monitor and integrating the necessary components acquiring a Bluetooth smart ready blood pressure reading device and integrating a remote control or mobile device for user interface or fabricating a circuit design that will implement the monitor device from analog components Each implementation has its pros and cons that will have to be considered thoroughly by the development team The second largest component of the system is the web service responsible for retrieving storing and analyzing the data messaging and alerting user and connecting the doctor to the
67. velopment time of about 7 months Therefore the project will run considerably longer than the schedule that was allotted The People Required given by Formula 4 states that about 3 people are needed to complete the project Thus some of this time will hopefully be cut by adding two people Reevaluation of the projects requirements and scope may need to be done in order to trim time off but the team feels as though these numbers may be abnormally high due to lack of clarity in some areas of the project as well as the simplicity of the methods used to do these evaluations which leads to wide variances in the scale November 13 2013 69 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 13 Future Items This section describes requirements and features that have been discussed implementing but due to various constraints or concerns feel that the team will not be able to complete during the duration of this project These features may be added to a later version of the project should one be developed or may end up being dropped for lack of support or need 13 1 Requirement 3 28 Manual Upload of Information 13 1 1 Description In the case where a patient s wireless connection goes down or begins to suffer problems the device will store the patient s readings for a set amount of time The patient will then be able to manually upload the readings using a computer if they feel that the wireless connection will not
68. with the blood pressure monitor device 4 3 2 Source Beta Blockers 4 3 3 Constraints None 4 3 4 Standards None 4 3 5 Priority 2 High Android Application 4 4 1 Description An android application will be provided via Google play store The application will allow the user to interact with the blood pressure cuff to authenticate take blood pressure reading and send the readings to the website 4 4 2 Source Beta Blockers 4 4 3 Constraints Android 3 0 UNIX 4 4 4 Standards None 4 4 5 Priority 2 High Software Packaging 4 5 1 Description All software will be installed prior to packaging No set up will be required by the Patient 4 5 2 Source Beta Blockers 4 5 3 Constraints N A 4 5 4 Standards N A 4 5 5 Priority 1 Critical November 13 2013 31 Beta Blockers System Requirements Specification Wireless Blood Pressure Monitor 4 6 4 7 4 8 Website 4 6 1 Description The team will create a website that will receive blood pressure readings from the device These readings will be displayed on the website in chart and graph format The patient will be able to annotate view advice regarding the readings send and receive alert messages as well as contact their doctor through the website 4 6 2 Source Beta Blockers 4 6 3 Constraints HIPAA Business Associate Agreement 4 6 4 Standards N A 4 6 5 Priority 1 Critical Battery 4 7 1 Description The device will be operated via battery pow

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