Product+Design+Specification

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The team divided up areas to research and met regularly to discuss health monitoring systems and technology that was found. Of primary influence was information about exercise and other monitoring systems available, summarized here:
 * 2.1 Initial Brainstorming **

** Personal Health monitoring that record but no immediate action occurs ** ** Group 1 ** - smart phones (or PDAs) equipped with biosensors that record the heart signals and transmit them to a healthcare center or hospital for analysis
 * Alive technology
 * Vitaphone
 * Ventracor pocketview
 * Welch Allyn Micropaq

** Group 2 ** - platforms for real-time remote health monitoring
 * Mobihealth
 * Telemedicare
 * Osiris-SE
 * PhMon

** Myheart ** Wearable wireless sensors monitor patient’s vital signs (e.g. ECG, oximeter, blood pressure) Intelligent biomedical clothes for monitoring, diagnosing and treatment bio data is collected and is sent to a care center or a hospital for processing and analysis.

** None of these solutions process the ECG data locally on the smart phone ** ** Personal Health monitoring that record and process the data locally ** **AMON**- wrist-worn medical monitoring and alert system targeting high-risk cardiac and respiratory



Health monitoring systems that can detect different vital signs: ECG, blood pressure, weight , blood sugar level, heart rate.

GPS is used to determine the location of the patient if the ambulance is called. Preventive measures include questionnaires incorporated in the phone and reminders which are sent to the patient by specialists.

**Passive and active monitoring is used in animals.** Passive monitoring – recorded cases. Active monitoring – similar to mobile monitoring

**Community health monitoring** Air sensors to determine air quality Humidity sensors

Some other innovative health monitoring systems were considered and can be found in the Appendix Product Design Specification Appendix

To facilitate the brainstorming, a usage scenario was performed.The picture below shows a drawing of the current health care monitoring system involving physicians and hospitals. The individual (top centre) moves through the medical system based on their type of illness or if they have chosen to get a medical checkup. Should the person be healthy and not wish a check-up the system loops back upon itself until requirements change or the desires change. Similarly an individual that has recuperated or been cleared of concern follows the system back to the top since individual health monitoring does not end. Likewise, those in a chronic condition state loop within their own self-monitoring loop until required to visit a doctor for a check-up.
 * 2.2 Usage Scenario of Current System **



**2.3 Product Characteristics and Functional Requirements**
To better understand the goals of the design, a product design specification was created. This tool would help identify what the design would cover and the manner in which it would do so. It also sets limitations or constraints on the design. The first step in the design specification was to determine the product characteristics of the system. These are singular words that describe what the system does and are usually adjectives or adverbs. The method that was utilized to determine the characteristics for the health monitoring system was to simply complete the phrase “The product must be…” several times until words could no longer be determined which could further complete this phrase without creating redundancies. Below is the list of product characteristics that were determined for this design.

The product should be: 1. Functional 2. Easy to use 3. Communicates results 4. Made of high quality 5. Safe to use 6. Customizable 7. Easy to take care of and repair 8. Durable 9. Enjoyable to use 10. Accessible to a variety of people 11. Sustainable and have a low impact on the environment 12. Secure for information

The next step was to determine the functional requirements for each characteristic. Functional requirements describe how the characteristic is fulfilled and is usually a verb. To determine the functional requirements, the question of “What does the product have to do in order to be…” had to be answered for every characteristic that was previously listed. Below are the functional requirements determined for each characteristic.

1. Functional:
 * sample and test blood for indicators of heart disease
 * test heart rate
 * test blood pressure
 * process and analyse data from tests
 * compare results from tests with standardized values
 * communicate results (to health care system, and to individual)
 * produce results in a tiimely manner
 * low power use
 * calibrate regularly
 * interact with user
 * provide reward to use
 * provide educational information
 * multiple person use

2. Usability
 * One button/few button simple operation
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Easy to read display
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Provides feedback to individual on health
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Unobtrusive (does not look medical or intimidating)
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Self-cleaning
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Hypoalergetic
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Comfortable during use
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Interactive controls
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Programmable
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Interacts with current technologies (eg. wifi)
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Compatible with current health care infrastructure (i.e. results sent to doctor or clinic)

Communicates Results:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">displays results to users
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">connects to health carre system/network
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">sends information to healthcare workers/doctors
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">information sent/received is secure
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">updates data and standards through current systems

Quality:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">multiple-use device (can be re-used)
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">light weight yet strong material
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">low maintenance
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">low waste product during manufacturing
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">self cleaning and sterilizing
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">self calibrating
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">time efficient

Safety
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">low risk of injury during use
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">low risk of disease/infection from use
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">unobtrusive size, shape and interaction
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">hypoalergetic

Customizability
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">fashionable
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">modular
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">reward selection
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">choose which tests to perform
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">choose which results (if any) to display
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">choose style of data output
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">connect to other devices (ipod, computer)
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">choose type of interaction
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">choose level of detail of displayed results
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">programmable

Maintainability
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">self-cleaning
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">low maintenance
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">replaceable parts
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">universal/standardized parts
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">interchangeable modules

Durable:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">water resistant
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">corosion resistant
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">display crack resistant
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">lightweight/strong materials
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">multiple use

Enjoyable:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">interactive
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">educational
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">fun/enjoyable
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">provides rewards/incentives
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">fashionable

Accessibility:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">located in easily accessible areas
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">easy to find/locate/access
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">affordable use

Sustainability:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">recycled materials
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">reusable components
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">low energy consumption
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">self producing energy

Security/Privacy:
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">encripted data transfer
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">secure personal data system
 * <span style="margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">multiple person use

For each requirement, some sort of constraint or limitation needed to be established. If such constraints are not set before concepts are created then requirements such as “Provides feedback to individual on health” would mean to provide all information on that individuals health all the time and done so instantly or “self-cleaning” would mean that the entire device would clean itself all the time non-stop. These constraints further defined the system as to what the product was to achieve and help lay a foundation of what should be considered in the design. The product design specification with the characteristics, functional requirements and constraints are shown below or see pdf file.





<span style="font-size: 1.1em; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 5px;">**2.4 System Transformational Diagram**
The system transformational diagram explores how the health monitoring system will affect the wider health care system, including physicians, blood analysis laboratories, blood-taking laboratories, users, medicare, health data and hospitals and emergency clinics. If the use of the health monitoring system were widespread, we would expect large transformations especially within blood taking laboratories as their volume would decrease. However, blood analysis and health data requirements would likely increase. The benefits for the user are clearly illustated through this exercise.



<span style="font-size: 1.1em; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 5px;">**2.6 System Transformational Relations**
The system transformational relations shows the interconnectedness of the various sub-systems.



<span style="font-size: 1.1em; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 5px;">**2.7 Product Architecture Schematic**
<span style="font-size: 1.1em; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 5px;">To further aid in the concept process, a product architecture schematic was developed. A PAS helps identify the inputs and outputs of the system as well as breaking down the entire design into smaller, more manageable systems. These systems can be utilized later on during the concept design phase. The development of the subsystems was done by analyzing the functional requirements that were determined while creating the PDS. These functional requirements were listed and sub systems were created that would fulfill that requirement. During this process, new subsystems were created that were either not initially considered or did not fall under the previous functional requirements. Once all of the requirements were considered, the list was analyzed again to see if any of the requirements at the top of the list fit into any of the subsystems that were developed afterwards. Below is the table of requirements and subsystems that were developed.



Inputs and outputs for the system were developed by considering the usage scenario for the system as well as considering how the system would be used for a single use. The next step was determining how the inputs, outputs and subsystems interacted with each other. Either mass, energy or information would be passed from one node to another. Again, considering the operation of the product during a single use helped to determine what type of connection was needed for each link. Below is the completed PAS for the system, where:

A Solid black line represents mass flowing in and out of the system.

A Solid red lines represents energy flowing in and out of the system.

and the dashed black lines represent information travelling through the system.

The descriptions of the subsystems are as follows: Interface refers to the interaction between the user and the device in terms of data that is either being inputted into the system or data being presented or displayed to the user. The communications subsystem deals with the collection and sending of information to an outside source, be it a doctor or another aspect of the health care network. This subsystem is separate from the interface subsystem because data that is sent to the external source does not have to be displayed to the user at that time and the information sent may be different to the information displayed to the user. The communications subsystem also deals with updates to the device that can be done separate from the users actions. The collection subsystem contains the aspects of collecting samples from the user to be analyzed and the testing of the samples to create the data results. Collection of samples deals with a blood sample so that blood tests can be performed. Collection also includes the collection of information regarding blood pressure and heart rate. The security subsystem has two main components; internal data protection and external interference. Internal data must be protected from being copied or read by other people/devices so some type of encryption system would need to be implemented. To further protect the device from intrusion, some internet security would also be implemented to protect from hackers and/or computer viruses.

The database subsystem stores the information sent from the collection subsystem, as well as stores the data on standard values sent from the healthcare network such that the test data has values in which to make a comparison.

The analysis subsystem takes the data from the database subsystem and performs a comparison of the test data to the standard values.

The cleaning subsystem controls the disposal or sanitation of the sample collection area, mainly focussing on the blood collection area.

The structural subsystem comprises of the outer shell which contains all the components and protects the device from damage by external sources.

The diagnostic subsystem performs analyses on all aspect of the device to determine if all components continue to function correctly and when certain tasks, such as cleaning should take place.

The disposal subsystem relates to the ejection or removal of any biologically contaminated component, such as the needle and/or blood test chip and provides a method in which such components can exit the system.

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