Functional Specifications for an Infant Monitoring System
Contents
1. 1999 ZENTECH 14 FUNCTIONAL SPECIFICATIONS System Evaluation and Probable Limitations System Evaluation System testing is a serious issue for a product that requires infants to be properly tested Simply finding babies to test the system presents numerous technical and ethical issues The system will first be fully tested on full grown adults then tested with a limited number of sleeping babies with the permission of their parents Unfortunately it is essentially impossible and ethically unsound to reenact the exact situation that occurs during a SIDS death Thus the system will be tested only with living babies under the assumption that removing the infant from the monitor will emulate a cessation of breathing Possible System Limitations The following may compromise the functionality of the IMS e The IMS assumes that the accepted SIDS standard of positioning of the infant in the crib will be used this position requires that the infant be placed on his back with his feet touching the foot of the crib Failure to properly position the child may reduce the effectiveness of the monitor e The IMS will not function when there is a power failure 1999 ZENTECH 15 FUNCTIONAL SPECIFICATIONS Conclusion This document discussed the functional specifications and safety environmental and physical requirements to be used as a basis for ZenTech s Infant Monitoring System IMS These functional specifications addressed2. ZenTech Canada Simon Fraser University Burnaby BC V5A 186 zentech ensc sfu ca Za CH February 16 1999 Dr Andrew Rawicz School of Engineering Science Simon Fraser University Burnaby BC V5A 1S6 Re ENSC 370 Functional Specifications for an Infant Monitoring System Dear Dr Rawicz The attached document Functional Specifications for an Infant Monitoring System describes the complete functionality of the monitoring system we are developing The monitoring system is intended to act as an aid in preventing Sudden Infant Death Syndrome SIDS which is a devastating condition that claims the lives of hundreds of Canadian children each year This document outlines the performance criteria of the system we discuss the operating parameters for the signal acquisition signal conditioning signal processing and alarm units Additionally this document details the operational physical environmental and safety specifications of the system This system shall be affordable and shall not require wires probes or electrodes that attach to the infant Scott D Kulchycki Rob Trost Tim Wilder Mike Sjoerdsma and A A Rhiannon Coppin are the creative and motivated ZenTech engineers Please feel free to contact any of us via e mail at zentech ensc sfu ca Sincerely A A Rhiannon Coppin ZenTech Canada Enclosure Proposal for the Development of an Infant Monitoring System http www sfu ca rtrost zentech F
3. Signal Acquisition The infant s breathing signal will be acquired by an array of sensors that will convert the signals into the electrical domain as shown in Figure 4 Mechanical signal vibration a Electric Signal Sensor Array Figure 4 Signal Acquisition Flowchart The sensors used to acquire the signal will Be extremely sensitive Not attach directly to the subject 1999 ZENTECH Meet all infant safety requirements Acquire vibrations and convert them to an electrical signal Output a signal with a high signal to noise ratio Be insensitive to electromagnetic interference Be contained in a water resistant package FUNCTIONAL SPECIFICATIONS Signal Conditioning The second stage of the IMS system is to filter out background noise transmission noise and capacitive effects from the acquired signal In addition it is necessary to amplify this signal and improve its signal to noise ratio Figure 5 shows the context diagram of this stage Signal Signal User Acquisition Processing Interface Figure 5 System Context Diagram Signal Conditioning The flowchart representing the operation of the signal conditioning stage is illustrated in Figure 6 The input signal from the signal acquisition stage is amplified and filtered before being transmitted to the signal processing and analysis stage Input Signal Output Signal yh Amplifi
4. acquire this signal from the infant without any direct attachments to the child s body The system will then perform conditioning and processing functions on the vibration signal to determine whether the infant is still breathing A user interface will inform the parent or caretaker of the current status of the baby s breathing This document introduces and discusses the main functional blocks comprising the IMS in addition to the operational physical environmental and safety performance specifications of the system A section describing the physiological factors associated with a SIDS death is included 1999 ZENTECH FUNCTIONAL SPECIFICATIONS Table of Contents Executive Summary ut ean n cede ce kg an ieee i List of FIGUres siena dena go e aaraa ia aaea iv Listiot lables a 5i eese cite eet V Isiifee Voi ise aise stent ferent 1 Background 4 cits citi ii c iet En e ecce Ee 2 System Overview essent 3 Signal ACQUISIEIOI scettur ertt te tege 5 Signal Conditioning sese 6 Signal Processing and Analysis sssssssss 7 User Interface oci teer eere rri eec e ere ei 9 System Safety Requirements sss 10 Crib Attachments sssssssssseseeeeennennenn 10 Mattress Attachments ssssssseee 10 Blanket Attachments sssssssesneee 11 Base Station aie deii eed eor ei dr
5. 2 IMS Durability Requirements 13 Table 3 IMS Environmental Requirements 14 Table 4 IMS Electrical Requirements 14 1999 ZENTECH V FUNCTIONAL SPECIFICATIONS Introduction It is not uncommon for parents worried for their infant s health to stay awake and watch their child sleep or to check on the infant s breathing several times during the night Some parents of children with an identifiable risk for dying from Sudden Infant Death Syndrome SIDS rightfully opt to purchase or rent expensive complex and often highly invasive monitoring equipment in the hopes of preventing a SIDS death However due to the high cost and complexity of available systems this is not an option for all parents ZenTech will create the Infant Monitoring System IMS The IMS will be a system whose interface to the sleeping child is virtually invisible requiring no direct contacts to the infant A user interface will provide the parent of caretaker with information concerning the current status of the infant s breathing The IMS will be reliable and inexpensive such that it will be accessible by almost all parents The IMS will prove to be an invaluable addition to the class of currently available home monitors The purpose of this document is to describe the physical environmental and safety requirements for the system in addition to discussing the
6. COT Death http dspace dial pipex com fsid question htm one January 1999 1999 ZENTECH 17
7. e 11 System Reliability eene 11 System Physical Requirements sssssss 13 User Training sioe et te iem t et rete 13 System Environmental and Electrical Requirements 14 1999 ZENTECH I System Evaluation and Probable Limitations 15 System Evaluation esessseseeeeeeenes 15 Possible System Limitations sesssssse 15 CONCIUSION sith estat aie 16 Isi e M 17 1999 ZENTECH I FUNCTIONAL SPECIFICATIONS FUNCTIONAL SPECIFICATIONS List of Figures Figure 1 System Context Diagram sss 3 Figure 2 System Block Diagram ssussss 3 Figure 3 System Context Diagram Signal Acquisition 5 Figure 4 Signal Acquisition Flowchart 5 Figure 5 System Context Diagram Signal Conditioning 6 Figure 6 Signal Conditioning Flowchart 6 Figure 7 System Context Diagram Signal Processing 7 Figure 8 IMS Signal Processing Flowchart 8 Figure 9 System Context Diagram User Interface 9 1999 ZENTECH IV FUNCTIONAL SPECIFICATIONS List of Tables Table 1 IMS Physical Requirements 13 Table
8. er Filter gt Figure 6 Signal Conditioning Flowchart The signal conditioning stage of the IMS will provide the following functionality e Receive an input signal from the previous signal acquisition stage e Filter out unwanted noise and information from the input signal increase the signal to noise ratio e Amplify the input signal e Provide an output signal that is available to the signal processing and analysis stage 1999 ZENTECH 6 FUNCTIONAL SPECIFICATIONS Signal Processing and Analysis The signal processing stage will use the conditioned signal generated by the preceding stage and convert it to a digital signal such that the signal can be processed and subsequently analyzed to determine the status of the infant s breathing The signal processing and analysis stage will also determine whether the system still has main power Figure 7 shows the context diagram highlighting the Signal Processing stage Signal Signal User Acquisition Conditioning Interface Figure 7 System Context Diagram Signal Processing The signal input from the signal conditioning stage is first converted from analog into digital Signal analysis is then performed on this signal to determine the status of the baby s breathing This information is then relayed to the IMS user interface The signal input for the power supply is analyzed to determine whether there is still power to the system This information is also trans
9. ers e The base station will be electrically isolated such that there is no risk of electrical shock e The base station will be fire retardant and non allergenic e The base station will generate minimal heat e The base station will not be subject to electromagnetic interference The ZenTech IMS will adhere to all CSA UL and CE consumer product standards System Reliability Because the IMS is being used to monitor infants it must have a very high accuracy rate The tolerance for not determining that a breathing problem has occurred when in fact it has false positive error will be as close to zero as possible The tolerance for detecting a problem when there is none false negative error is not as critical as false positive errors and thus will be allowed to two percent To summarize 1999 ZENTECH 11 FUNCTIONAL SPECIFICATIONS Accuracy in detecting a breathing failure false negative error 9996 Accuracy in falsely detecting a non existent breathing failure false positive error 9896 1999 ZENTECH 12 System Physical Requirements The ZenTech Infant Monitoring System will adhere to the physical requirements outlined in Table 1 Table 1 IMS Physical Requirements Crib Length Less than 20cm Attachment Less than 20cm Depth Less than 10cm Mattress Attachment Blanket Attachment Depth Less than 2 5cm Base Station Width Less than 20cm Less than 15cm Less than 1kg The ZenTech I
10. ing the child The cessation of breathing may first appear as a slowing or an abrupt stoppage of the child s breath Because current research seems to support cessation of breathing as a main cause of SIDS the ZenTech IMS will monitor the breathing of the infant This monitoring will be performed based on the vibrations emitted by the sleeping and breathing infant 1999 ZENTECH 2 FUNCTIONAL SPECIFICATIONS System Overview The Infant Monitoring System IMS will use vibrations that the infant produces while sleeping as input Figure 1 shows the system block diagram The diagram indicates that the input for the system is from a sleeping infant and the output will provide information to the parent or caretaker of the child Note that all of the sensing of the infant will be accomplished without the use of any electrodes or other devices that need to be attached to the baby rand XE Infant Monitoring C uy AM System t Alarm System User Input Figure 1 System Block Diagram The IMS will gather a signal from the infant via the input sensors This signal will then be conditioned and processed in such as manner as to allow analysis of the signal to determine the status of the infant s breathing This information will be relayed by the IMS user interface Figure 2 displays the IMS system context diagram The details of each of the major blocks are discussed in later sections Signal Signal Sig
11. mitted to the user interface The flowchart for the signal processing and analysis stage is shown in Figure 8 1999 ZENTECH 7 FUNCTIONAL SPECIFICATIONS Input from signal conditioning block Analog Digital Converter Input from power supply Verify Power Signal Verify Baby Signal Calculations Status Output Data to User Interface Figure 8 IMS Signal Processing Flowchart The signal processing stage will e Convert the input signal from the signal conditioning stage into a digital format e Perform calculations and operations on the digital signal to determine the status of the infant s breathing e Accept a signal from the system power supply e Perform calculations on the power supply signal to determine whether the system is still powered e Provide output to the user interface reflecting the current status of the child and system power supply 1999 ZENTECH 8 FUNCTIONAL SPECIFICATIONS User Interface Once properly installed all system control and feedback will be through a user interface Figure shows the context diagram highlighting the User Interface stage Signal Signal Signal Acquisition Conditioning Processing Figure 9 System Context Diagram User Interface The user interface will Be mountable on the outside of the crib and meet with all safety specifications Contain an LCD display providing infant and system status information Contain a power switch Con
12. mm in which the infant s body could become caught e The component s will have no wires or cords in which the infant could become entangled e Thecomponent s will be electrically isolated such that there is no risk of electrical shock e The componenit s will produce minimal heat and negligible sound e The componeni s will not be subject to electromagnetic interference e The componeni s will be non allergenic and fire retardant Mattress Attachments Mattress attachments are defined as any system components which will be affixed to or placed over top of the crib mattress Such components will adhere to the following safety restrictions e The component s will be firm or will not lessen the firmness of the infant s mattress e The componeni s will not cause gaps to occur between the sleeping surface of the crib and the frame of the crib which exceed 3mm e The componeni s will have no sharp edges or corners e The componeni s will have no protrusions of a height greater than 3mm the componeni s will have no protrusions on which the infant s clothing could catch e The componeni s will be waterproof fire retardant and non allergenic e The componenit s will have no wires or cords in which the infant could become entangled e The componenit s will be electrically isolated such that there is no risk of electrical shock 1999 ZENTECH 10 FUNCTIONAL SPECIFICATIONS The component s will not generate heat or sound The compo
13. nal User Acquisition Conditioning Processing Interface Figure 2 System Context Diagram 1999 ZENTECH 3 FUNCTIONAL SPECIFICATIONS The IMS will be designed such that the system provides the following functionality Utilize vibrations as the standard signal input Have a clearly marked power switch Have a response time of maximum 30 seconds to an emergency situation Require no attachments to the infant for signal acquisition Provide feedback on the status of the child which will be intuitively obvious to understand Notify the user audibly when an undesired breathing characteristic is detected Notify the user when a power failure has occurred so that they know that the infant is no longer being monitored Be economically affordable for most families Be aesthetically pleasing and require minimal space Be easily sanitized Be reliable generating no false alarms Comply with all infant bedding safety standards and regulations Be Y2K compliant 1999 ZENTECH 4 FUNCTIONAL SPECIFICATIONS Signal Acquisition The first task of the monitor is to acquire a signal that will be able to give a clear indication as to the status of the subject being monitored This consists of both physically registering a signal and converting it to an electrical waveform Figure 3 displays the context diagram for signal acquisition Signal Conditioning Signal User Processing Interface Figure 3 System Context Diagram
14. nent s will not be subject to electromagnetic interference The component s will remain stationary the component s will not bunch up The component s will not generate lint Blanket Attachments Blanket attachments are defined as any system components which will be affixed to or incorporated within the infant s sleeping blanket Such components will adhere to the following safety restrictions e The componeni s will have no sharp edges or corners e The componeni s will have no protrusions of a height greater than 3mm the component s will have no protrusions on which the infant s clothing could catch e The componeni s will be waterproof fire retardant and non allergenic e The component s will have a weight no greater than 250g e The componenit s will have no wires or cords in which the infant could become entangled e The componenit s will be electrically isolated such that there is no risk of electrical shock e The component s will not generate heat or sound e The component s will not be subject to electromagnetic interference e Thecomponent s will not generate lint Base Station The system base station is defined as the unit which will be separate from the signal acquisition components located in or on the crib where signal conditioning signal processing and user interface functions occur The system base station will adhere to the following safety restrictions e The base station will have no sharp edges or corn
15. nfant Monitoring System will adhere to the durability requirements outlined in Table 2 Table 2 IMS Durability Requirements Mattress Strength Withstand forces of baby movement Attachment Structure Waterproof and washable with a damp cloth Blanket Strength Withstand forces of baby movement Attachment Structure Waterproof and washable with a damp cloth Base Strength Withstand a drop from up to 2 meters Station Structure Washable with a damp cloth User Training The IMS will be accompanied by a short user manual which will describe how the system should be installed to the infant s crib A short description of what to do in the case of an emergency will also be included in the manual The manual will also discuss other SIDS prevention methods 1999 ZENTECH 13 FUNCTIONAL SPECIFICATIONS FUNCTIONAL SPECIFICATIONS System Environmental and Electrical Requirements The ZenTech Infant Monitoring System will operate in an environment as outlined in Table 3 Table 3 IMS Environmental Requirements Operating Temperature 10 C to 40 C Storage Temperature 40 C to 60 C Humidity Will work over standard humidity ranges Elevation Will work over standard elevation ranges In addition the IMS will have the electrical characteristics outlined in Table 4 Table 4 IMS Electrical Requirements Power Supply AC 25V 60Hz Max Power Dissipation 5W
16. tain buttons for the purpose of silencing the alarm and other functions Contain an audible alarm to notify the caregivers that the system can no longer detect breathing Be connected to the main processing unit using a cable e Have a battery back up which will sound the alarm in the event of a power failure e Meet all infant safety requirements 1999 ZENTECH 9 FUNCTIONAL SPECIFICATIONS System Safety Requirements As the ZenTech Infant Monitoring System will be integrated with an infant s crib and will be located within the nursery the product will meet the following safety requirements These requirements are in accordance with the Canadian Safety Association the Consumer Product Safety Commission the SIDS Network SIDS Canada the United States Food and Drug Administration and the Canadian Health Department in addition to parental concerns 7891011 Crib Attachments Crib attachments are defined as any system components which will be affixed to the sides of the infant s crib Such components will adhere to the following safety restrictions e The component s will have no sharp edges or corners exposed e The component s will have no protrusions with a height of greater than 3mm the component s will have no protrusions on which the infant s clothes could catch e The component s will have no openings such that the infant s head or limbs could become caught e The component s will have no spacings of width less than 6
17. the functional issues associated with building an infant monitoring system ZenTech will adhere to these specifications when building the IMS in hopes of developing a reliable monitoring system The ZenTech team is dedicated to developing a monitor that will be simple to use effective and accessible by almost all parents Only then will we have truly contributed to the fight against SIDS 1999 ZENTECH 16 FUNCTIONAL SPECIFICATIONS References 1 Reducing the Risk of Sudden Infant Death Syndrome in Canada http hwcweb hwc ca hpb Icdc brch reprod sidsjo html January 1999 Smoking and the Risk of SIDS http sids network org smok htm January 1999 Carroll John L MD SIDS suffocation asphyxia and sleeping position http www sids network org carroll2 htm January 1999 Sudden Infant Death With External Airways Covered http www ama assn org sci pubs journals most recent issues ajdc poa7470 htm January 1999 Consumer Standards Association http www csa international org January 1999 Consumer Product Safety Commission http www cpsc gov January 1999 SIDS Network http www sids network org January 1999 SIDS Canada http www sidscanada org January 1999 United States Food and Drug Administration http vm cfsan fda gov January 1999 Canada Health Department http hc sc gc ca January 1999 Delisle Jackee Interview February 5 1999 Questions and Answers About
18. unctional Specifications for an Infant Monitoring System Submitted by Contact Information Submitted to Submission Date Rhiannon Coppin Scott Kulchycki Mike Sjoerdsma Robert Trost Tim Wilder Rhiannon Coppin email acoppin sfu ca Andrew Rawicz School of Engineering Science Simon Fraser University Steve Whitmore School of Engineering Science Simon Fraser University February 18 1999 FUNCTIONAL SPECIFICATIONS Executive Summary Sudden Infant Death Syndrome SIDS quietly claims the lives of 400 infants in Canada each year Although advances have been made in identifying high risk factors children continue to die With parents who have had infants die of SIDS and new parents who worry about SIDS the question of prevention inevitability arises If there was a way of monitoring the infant to prevent SIDS parents worldwide would surely utilize the system More and more home monitoring systems are being developed but they are still expensive and complex In addition many of these systems require multiple connections to the infant ZenTech Canada is committed to creating the Infant Monitoring System IMS which will be an affordable reliable and non intrusive monitoring solution It is our sincere hope that this device will help save the lives of children around the world ZenTech s IMS will use vibrations from the sleeping infant s respiratory activity to monitor the state of the child The IMS system will
19. various functional operations which the system will perform This document has been prepared by the design engineers of ZenTech Canada for internal reference and for external distribution to Andrew Rawicz Steve Whitmore Greg Hall Jason Rothe Victor Ting and other external design consultants 1999 ZENTECH 1 FUNCTIONAL SPECIFICATIONS Background Despite the intense research and investigation directed towards SIDS there is still no clear reason as to why it occurs or what circumstances precede the SIDS death of a child Current research seems to indicate that there may be many causes of SIDS Poor prenatal care for the baby such as smoking and taking drugs during the pregnancy appears to increase the occurrence of SIDS Overheating of the infant while sleeping or second hand smoke in the nursery may trigger SIDS There are many other environmental factors currently being investigated for their links to SIDS deaths At the present time there is one factor many researchers feel to be the most likely cause of SIDS the cessation of breathing in the infant Cessation may be due to sleep apnea or internal blockage of the mouth nose or windpipe by a foreign object The stoppage of breathing may also occur when the infant s mouth or nose becomes pressed into a blanket or mattress and the child cannot move into a clear breathing position This situation may result in the build up of fatal concentrations of CO eventually suffocat
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