Vedo Medico - School of Engineering Science
Contents
1. Special Article March 2005 http www dableducational com pdfs spring05 BP_devices_for_low_resource_setti ngs_BPMonit_Mar_2005 pdf 7 Medical Device Reliability And Associated Areas B S Dhillon Ph D 2000 8 Handbook of Reliability Engineering And Management W Grant Ireson 1996 Copyright 2006 Vedo Medico 152. e Ability to operate using an AC adaptor or replaceable battery e Easy to use user interface Other key requirements for the proof of concept model of the EMS device are outlined in the document In addition features pertaining to the final production phase user documentation and support requirements and test plans are also provided The 13 week cycle of the proof of concept phase is projected for completion by April 2006 Copyright 2006 Vedo Medico 2 amp p lt 2 Vedo Medico Functional Specification for EMS CONTENTS Exec tiye BUN ALY ME ioa a a ae een a a AS ESEE EE rai Saa AAN AKSE SEa ASE Aa EEDEN 2 GEOSSARY aces sb TC 4 MEME Soon Dinssacsiaisotas scasieasaadania aadeaiaiedansa hedapiatei a a ademaiauasaanty 5 1 1 eU E 5 1 2 Tatend d Uerum 5 L3 bcc TUS iO NNNM 5 2 Systemi Requirements esiin i iieiaeie inia aieiaiei ainia 6 2 1 Systemi ciuis T iTS 6 2 2 General R eg iremM rts MP X 8 2 3 Physical Require MENS caedi avant scale aH eU de cn id cM eM eda NUCLEAR 8 234 IACTA REPE amp 232 2771 05 TINI mE amp 2 4 Petrie eal Re epithet aissas aiana sas UD and vbi pu E Eaa SERAT PEE 9 2 5 Environmental Requitefple usan eere aA Ub snper ta 9 2 6 SN ICA TS apa boo aia uds la Fu iD o Rl es bs de a rd Ran 9 2 7 Reliability and Dura litus uiae ends e da nr i PO T no oa era ona 9 2 8 Safety Requirements EINE METER 10
3. 2 9 Performanc Mercer T 10 210 Us bilit ReguifemieritS PP aia aa 10 24 UserTnterface Sait reine suinn oaa a 10 212 Latterly RSC CHAS sristi ai airiai iaae iieii iia 11 3 User Documentation and Support aie deno dee ite peteio ee fiere iieis i i i 12 4 System Test PISBOG ienssisainnesasaszenassnsanesasasissninonsuassseihsaautaiasesaneuianssiensassinacibaaataianapssinaasisnbseuataiiens 13 NER Con ee A 15 O TRG RCP SIIC o E AE E G A E E E 15 LIST OF FIGURES Fig re 2 LEMS Syst ti Overview M 6 Figure 2 2 Interaction between user and peripheral devices sees 7 Copyright 2006 Vedo Medico 3 amp p C9 Vedo Medico Functional Specification for EMS GLOSSARY AC Alternating Current CU Control Unit Edema Swelling caused by excess fluids in body tissue EMS Edema Measurement System ES Enclosure System FAQ Frequently Asked Questions GUI Graphical User Interface IEC International Electrotechnical Commission MTBF Mean Time Between Failures PC Personal Computer Copyright 2006 Vedo Medico 4 amp p lt 2 Vedo Medico Functional Specification for EMS 1 Introduction L1 Scope This document outlines the functional requirements for Vedo Medico s proposed Edema Measurement System A complete set of requirements pertaining to the proof of concept model and future vetsions ate provided User documentation requirements and system test plans are also included The requirements provided will a
4. Vedo Medico Functional Specification for EMS February 20 2006 Dr Andrew Rawicz School of Engineering Science Simon Fraser University Burnaby British Columbia V5A 1S6 Re ENSC 440 Functional Specifications for Edema Measurement System Dear Dr Rawicz The attached document Functional Specifications for Edema Measurement System EMS outlines the functional requirements for our ENSC 440 project Vedo Medico s prototype Edema Measurement System is being designed to provide medical professionals with an easy to use device to accurately measure the amount of swelling of limbs in patients The purpose of this document is to outline the requirements that EMS will meet upon completion of the working prototype In addition other functional requirements pertaining to future prototypes are specified in the documents The overall system requirements user documentation requirements and product test plans are provided Vedo Medico consists of five talented fourth year Systems engineering students Ali Khan Sepehr Mogharei Arthur Papian Gorji Babak Shafiei and Branko Zdravkovic Please feel free to contact us with any questions or concerns regarding our project We can be reached by telephone at 778 885 6059 or by email at vedo medico ensc440 sfu ca Sincerely Babak Shafei Babak Shafiei VP Operations Vedo Medico Enclosed Functional Specifications for Edema Measurement System EMS Copyright 2006 Vedo Medico 1 Ce V
5. e specification online uset manual support forum and company profile section R67 II Additional firmware upgrades will be provided for the user through the company website R68 II Additional user support will be provided via email and by phone R69 I Minimal user training should be needed for operating the device R70 I Training for end user will be provided by project developers R71 II Training for end user will be provided via user manual email and by phone R72 II The recommended time period between calibrations should be clearly labeled on the device Copyright 2006 Vedo Medico 12 amp p lt 2 Vedo Medico Functional Specification for EMS 4 System Test Plan An essential part of a product test is a well designed test plan A test without a plan would only be considered an experiment Test cases should be developed based on the data analysis and the software operation These tests should be conducted to demonstrate e Correctness and completeness with respect to the accuracy for the programmable component e That malfunctions caused by data handling errors and control errors e Consistency in data and control flows in the device Failure and stress testing should be conducted to verify that the software responds correctly and without resulting in any invalid data These tests should include consideration of the following e Operator errors that could cause malfunction of the programmable c
6. edo Medico Functional Specification Edema Measurement System Project team Contact person Submitted to Issue date Revision Ali Khan Sepehr Mogharei Arthur Papian Gorji Babak Shafiei Branko Zdravkovic Babak Shafiei vedo medico ensc440 sfu ca Dr Andrew Rawicz Steve Whitmore February 20 2006 1 0 amp p C9 Vedo Medico Functional Specification for EMS Executive Summary If you can t prevent a disease the next best thing you can do to protect your health is to detect the symptoms of a disease early Build up of excess fluids in body tissues edema is one of the major signs of heart failure This early sign of heart failure can easily be detected by monitoring the amount of swelling in a patient s leg Constant monitoring of the swelling of various limbs can provide medical professionals with key information for proper diagnosis Vedo Medico s Edema Measurement System provides a non invasive and accurate measurement of edema in the patient s limbs The Edema Measurement System is designed with the user in mind EMS presents users with reliable information through an easy to use interface With that in mind the production of EMS will be completed in two phases a proof of concept phase and a final production phase Upon completion of the primarily proof of concept phase the Edema Measurement System will support the following features e Ability to measure and track amount of swelling in patient s limbs
7. em Overview The main function of the EMS device is to detect the change in volume of the lower part of the leg caused by edema which could be a potential symptom of health risks such as heart disease and kidney failure The high level model of the functional operation of the EMS is shown in Figure 2 1 s Figure 2 1 EMS System Overview The EMS device will consist of two main functional components The EMS Enclosure System ES will function as the measuring subpart sending results to the EMS CU which itself could be interfaced to the PC GUI and diagnostics software The user would be able to directly interact with the EMS Control Unit CU and will have access to the diagnostics results on the PC software Figure 2 2 shows the interaction between user and peripheral devices Copytight O 2006 Vedo Medico 6 Ce Vedo Medico Functional Specification for EMS Q EMS ES P 92 4 PC amp Diagnostics Software P d 3 EMS CU 5 User 1 Lower Leg of the patient Figure 2 2 Interaction between user and peripheral devices The EMS CU unit will store sufficient data for a set number of patients on the data memoty unit The measurement data can be transferred to a PC based software capable of handling the results and storing results in a larger database The uset would be able to retrieve and analyze instantaneous results directly from the EMS CU and make comparative analysis with previously taken measureme
8. hall weight no more than 400 grams R10 III The Enclosure System shall be soft and flexible in the inside layer and hard R11 II and solid on the outside The edges of the device should be soft and comfortable to the skin R12 III Enclosure should be able to hold at least 5 psi of an inert gas 23 2 Control Unit R13 III The height of the CU shall be no longer than 20 cm R14 III The width of the CU shall be no longer than 10 cm R15 II R16 II R17 I1 R18 II The CU shall have an ergonomic shape and be easy to handle by the user The CU shall weight no more than 500 grams The cord connecting the CU to the Enclosure System should be at least 2m long The mechanical components of the device shall not be visually or physically obtrusive Copyright 2006 Vedo Medico 8 amp p lt 2 Vedo Medico Functional Specification for EMS 24 Electtical Requirements R19 III The device shall be able to operate on standard 120V AC 60Hz power outlets R20 III The device shall be capable of operating using a replaceable battery R21 II The replaceable battery should be able to sustain power for at least 2 weeks R22 III The device should have an auto shutoff functionality to avoid wasting battery powet 25 Environmental Requirements R23 III The device should be able to operate normally under typical office hospital temperature range of 10 C 50 C 1 R24 II The dev
9. ice should be able to operate normally in altitudes ranging from sea level to 2 000m R25 III The device should be able to operate normally under typical office hospital environment with relative humidity ranging between 30 60 1 R26 III The device should not be constructed from any material that will be corrosive ot harmful to the environment R27 II The device should be water resistant 26 Standards R28 III The device will conform to UL Standards of Safety for electrical devices 2 R29 III The device will conform to CSA requirements for electrical devices CAN CSA C22 2 NO 0 M91 R2001 3 R30 III The device will conform to CSA requirements for medical measurement equipment CAN CSA C22 2 NO 1010 2 041 96 R2004 4 R31 III The device will conform to IEC60601 1 4 Programmable Electrical Medical Systems Standards 5 27 Reliability and Durability R32 II The device needs to provide at least 50 000 measurements without Enclosure System replacement R33 II The device should withstand a 2m vertical fall R34 III The expected lifespan of the device should be greater than 5 years R35 II All pressure measurement devices require regular calibration Calibration for the EMS subjected to intensive use should be repeated every 2 years 6 R36 III The warranty period will be 2 years and if any sub system of the device malfunctions during this time the device should be sent to the man
10. id in the design process by insuring the working prototype meets the needs of its users L2 Intended Audience This document is intended for Vedo Medico s design engineers project managers sales and marketing personnel and potential customers Design engineets will use the document as a guideline during the development process of EMS Project managers can use the document as a project milestone guideline and as a benchmark to verify device integrity Marketing personnel will use current document for initial marketing and promotional material Potential customers can use the outlined requirements to foresee the functionality that the EMS prototype will meet L3 Classification The following convention shall be used throughout this document to denote functional requirements R p A functional specification requirement Where is the functional requirement identification number and p is the priority of the functional requirement which can be any of the following values I Requirement is applicable to the proof of concept system only II Requirement is applicable to the final production system only III Requirement is applicable to both the proof of concept system and the final production system Copyright 2006 Vedo Medico 5 amp p C9 Vedo Medico Functional Specification for EMS 2 System Requirements General functional requirements of the EMS diagnostics device are presented in the following sections 2 1 Syst
11. nts stored on the PC based diagnostics software At the health professional end the Edema Measurement System will handle data storage processing and measurement display Health professionals will use this information to perform the actual patients follow ups therefore accuracy and reliability of this information are key Copyright 2006 Vedo Medico 7 amp p lt 2 Vedo Medico Functional Specification for EMS 22 General Requirements R1 III R2 III R3 I1 R4 II R5 I1 R6 II The Enclosure System shall be wearable on the lower part of a human leg with a secute and comfortable fit The Enclosure System shall be adjustable so as to fit most human leg sizes The device should be easy to carry and comfortable in the operator s hands The Enclosure System should be washable by disconnecting the component from the CU The retail price for the EMS device should be less than 150 per unit The production cost for the EMS device should be less than 75 per unit 2 3 Physical Requirements Edema Measurement System will consist of two major components Enclosure System and Control Unit CU The Enclosure System will wrap around the patient s limb while the CU will contain the user interface 2 3 1 Enclosure System R7 III R8 III R9 I1 The diameter of the limb enclosure should be less than 50 cm The width of the Enclosure System should be smaller than 30 cm The Enclosure System s
12. omponent e Hardware component faults The proposed test plans for the EMS will include event stress environmental and time reliability tests EVENT TESTING Event testing shall be performed under standard conditions at ambient temperature and typical operation parameters T1 The gas filled EMS ES shall be tested for gas leakage in terms of the number of operation cycles STRESS TESTING T2 Mechanical stress analysis shall be performed to ensure the proper operation of the EMS after it has been dropped form 2m altitude T3 Elasticity of the ES shall be tested in order to ensure the proper fit and that the device doesn t break under excessive usage conditions ENVIRONMENTAL TESTING T4 Thermal shock testing will be performed under different temperature ranges below 10 C and above 35 C Copyright 2006 Vedo Medico 13 amp p lt 2 Vedo Medico Functional Specification for EMS T5 Operating temperature testing shall be performed to ensure that the device still operates accurately in the normal operating temperature range of 10 C 35 C T6 Mechanical shock tests shall be performed to assure the device will withstand stresses of shipping handling and day to day use I7 The accuracy of the EMS will be tested in a relative humidity range of 30 60 TIME RELIABILITY TESTING T8 Time reliability testing will be performed to determine MTBF of EMS CU and Sensors T9 Failure analysis shall be performed to de
13. oof operation of the device R49 II The device will have a power on self test that will prevent taking measurements if the Enclosure System is over under inflated 2 11 User Interface Requitements R50 III The CU should consist of a small display screen mounted along with buttons these will allow users to navigate through menus and take measurements easily with visual feedback R51 III The measured data will be shown on the display for a maximum of 30 seconds to allow sufficient viewing time the user will be able to store the data or redo the measurement during this time R52 IIT Capable of scrolling through previously measured patient data in chronological order so users can view the change in swelling over time R53 III The display will be capable of scrolling lines of text horizontally to overcome limitations in small display size i e display longer lines of text R54 III The device will be able to display measurements in either metric or imperial units through the use of a switch to accommodate for users with varying measurement practices Copyright 2006 Vedo Medico 10 amp p lt 2 Vedo Medico Functional Specification for EMS 2 12 Luxury Requirements R55 II A universal enclosure to suit all leg circumferences should be provided R56 II The device should be able to give an audible output of the measurement R57 II Users will be able to assign measurements and accompanying measurement da
14. termine the mechanism of failure in order to take necessary steps to reduce the chance of future occurrences Copyright 2006 Vedo Medico 14 amp p C9 Vedo Medico Functional Specification for EMS 5 Conclusion The functional specifications outlined in this document clearly define features that can be anticipated in the proof of concept and final production model of the Edema Measurement System The design of the proof of concept model is well underway and upon completion of the product in April 2006 all requirements pertaining to the proof of concept model will be met Meeting the above requirements will ensure that Vedo Medico s product will be effective and reliable 6 References 1 National Research Council of Canada Indoor Air Quality and Thermal Comfort in Open Plan Offices October 2005 http irc nrc cntc gc ca pubs ctus 64 e html 2 Underwriters Laboratories Inc Standards February 2006 http www ul com 3 Canadian Standards Association Canadian Electrical Code February 2006 http www csa ca electronic_catalogue electrical pdf 4 Canadian Standards Association Canadian Electrical Code Part II General Requirements February 2005 http www csa intl org onlinestore GetCatalogDrillDown asp Parent 1302 5 International Electrotechnical Commission General Standards for Medical Devices February 2006 http www doctordevice com genstds html 6 Lippincott Williams amp Wilkins
15. tes to a patient ID entered via the CU R58 II The user will be able to store measurements to a patient s file in the device and synchronize this data with a PC via an accessible wired connection This will allow the user to analyze the data using a PC R59 II Patient name and data can be updated offline on a PC and then synchronized to the device so that lengthy names or patient ID s can be entered easily with a keyboatd Copyright 2006 Vedo Medico 11 amp p lt 2 Vedo Medico Functional Specification for EMS 3 User Documentation and Support The intended users of the Edema Measurement System will be medical professionals in health care facilities In order to assist the users of EMS device during the learning and troubleshooting stage the user documentation and support should meet the following requirements R60 III The user manual provided will be written in English R61 II The user manual provided will be written in English French German Japanese and Spanish R62 I The user manual will be written for users with minimal knowledge of technical electrical devices R63 III The user manual will contain a step by step guide on using the EMS device R64 I The user manual will contain a FAQ troubleshooting device specification and safety section R65 I The user manual will contain device warranty and copyright information R66 II The company website will contain device description devic
16. ufacturer for repair replacement R37 III MTBF of EMS CU and sensors should be no less than 2000 hours Copyright 2006 Vedo Medico 9 Ce Vedo Medico Functional Specification for EMS 2 8 Safety Requirements R38 III The gas filled Enclosure System will be made of a non allergic material in order to prevent complications due to allergic reactions from being in contact with the patient s skin R39 II The electronic subsystem of the device will be sealed in water resistant material so the user is protected from electrical shock and physical injuries R40 II The safety valve will prevent pressurizing the Enclosure System to more than 2 atmospheres R41 II The device should not contain any sharp edges that could harm the patient 29 Performance Requirements R42 III The device should be able to power up in less than 2 seconds R43 III The device should calculate and display the measured value within 5 seconds R44 III The device should have a measurement resolution of 1 ml R45 III The Enclosure System should not dislocate or over pressurize the edema changing the shape and volume of the limb being measured 2 10 Usability Requirements R46 III The digital display should be large and easily readable R47 III The device should be powered up by the press of a single button R48 III The user should be able to take a measurement with a single button press to allow for simple and foolpr
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