Re: ENSC 440 Project Functional Specification for a Non-invasive Glucose Measuring Device

Transcription

1 Lumen Medical Technologies Inc Harold Rd. North Vancouver, B.C. V7K 1G3 February 20, 2006 Dr. Andrew Rawicz Simon Fraser University 8888 University Drive Burnaby, BC V5A 1S6 Re: ENSC 440 Project Functional Specification for a Non-invasive Glucose Measuring Device Dear Dr. Rawicz, Attached you will find the Functional Specification for a Non-invasive Glucose Measuring Device from Lumen Medical Technologies Inc. This document outlines functional specification for the ENSC 440 project. We, at Lumen Medical Technologies Inc., are in the process of designing and building gsense, a handheld device that provides a fast and simple method for detecting and measuring the blood sugar level in a diabetic patient. The enclosed functional specifications provide a set of high level requirements for the functionality of both the prototype and production phases of the development of gsense. They include aspects such as physical makeup, operational characteristics, and safety criteria. Lumen Medical Technologies Inc. consists of six highly motivated and innovative senior level undergraduate engineering students. The team members include Mehdi Abdollahi, Deema Annyuk, Jeff Chen, Connor Gillan, Graham Laverty and Tony Tsai. Please feel free to contact me by phone at (604) or by at mehdi@lumen.co.ca should you have any questions or concerns. Sincerely, Mehdi Abdollahi Chief Executive Officer Lumen Medical Technologies Inc. Enclosure: Functional Specifications for a Non-invasive Glucose Detection Device

2 Functional Specifications for a Non-Invasive Glucose Measuring Device Project Team: Contact Person: Mehdi Abdollahi Deema Annyuk Jeff Chen Connor Gillan Graham Laverty Tony Tsai Mehdi Abdollahi all@lumen.co.ca Submitted to: Dr. Andrew Rawicz ENSC 440 Steve Whitmore ENSC 305 School of Engineering Science Simon Fraser University Issued Date: February 20, 2006 Revision: 4.0

3 Executive Summary Based on the Canadian Diabetes Association s 2005 report 1, which categorizes the state of the diabetes in Canada as an epidemic, there are more than two million Canadians with diabetes today. Diabetic patients are required to monitor their blood sugar level constantly. The monitoring devices currently available in the market require patient s blood sample. The inconvenience and pain of taking blood samples make these solutions very undesirable. This presents an opportunity for improved innovative solutions that can help those suffering from this condition. We, at Lumen Medical Technologies Inc., are in the process of designing and developing a non-invasive device that can measure the concentration of human blood simply by touch. Development of gsense will occur in two phases. Upon completion of the first phase, gsense will be able to detect and measure the concentration of glucose in a solution. This information will be displayed through an easy-to-use interface. The four-month development cycle of this prototype phase is targeted for completion by the middle of April of For the second phase of development, gsense will also be able to measure the concentration of glucose in human blood through body contact. An ideal future version of this product will be available in a size of a wristwatch and will feature extended communication capabilities. 1 Canadian Diabetes Association, Diabetes Report, [online]. Available: [accessed: January 23, 2006] Copyright 2006, Lumen Medical Technologies Inc. iii

4 Table of Contents EXECUTIVE SUMMARY...III 1. INTRODUCTION SCOPE ACRONYMS INTENDED AUDIENCE CONVENTIONS SYSTEM REQUIREMENTS SYSTEM OVERVIEW PHYSICAL REQUIREMENTS General SYSTEM REQUIREMENTS General Performance Compatibility Reliability and Serviceability INTERFACE REQUIREMENTS REGULATORY REQUIREMENTS DOCUMENTATION AND USER TRAINING CONCLUSION...9 Copyright 2006, Lumen Medical Technologies Inc. iv

5 List of Figures FIGURE 1 - NON-INVASIVE GLUCOSE MEASURING DEVICE SYSTEM OVERVIEW...3 Copyright 2006, Lumen Medical Technologies Inc. v

6 1. Introduction gsense is a non-invasive device that will measure the level of glucose in a solution. This can further be developed as a commercial product that could measure the level of glucose in a diabetic patient without the need for any blood samples. 1.1 Scope This document describes the functional requirements that must be met by a functioning gsense. A full set of functional requirements is supplied for the proof of concept device. Since it is expected that significant experience will be gained during the development of the proof of concept, the functional requirements for the generic version are simplified compared to the production device. 1.2 Acronyms FAQ MTBF Frequently Asked Questions Mean Time Between Failure 1.3 Intended Audience This document is intended to be a guideline for all members of Lumen Medical Technologies Inc. It also supplies potential customers or investors with the product specifications as experienced by the end user. The project manager will refer to this document in order to measure progress throughout the development phase. Design engineers will use this document to ensure all of the design goals are propagated from the product design stage to the implementation phase. Test engineers will use this document in order to compare functionalities of the final product to the functionality described in this document. 1.4 Conventions Throughout this document, the following convention will be used to indicate functional requirements: [Rn-p] A functional requirement. Copyright 2006, Lumen Medical Technologies Inc. 1

7 where n is the functional requirement number, and p is the priority of the functional requirement as denoted by one of four values listed below: I II III A functional requirement for both the proof of concept device, the generic version of the production device and the ideal version of the production device. A functional requirement for only the proof of concept device. A functional requirement for only the generic version of the production device. III+ A functional requirement for only the ideal version of the production device. Copyright 2006, Lumen Medical Technologies Inc. 2

8 2. System Requirements 2.1 System Overview This informative section is designed to describe the gsense device by Lumen Medical Technologies Inc. in a functional sense. Figure 1 demonstrates how a patient s blood glucose level is determined non-invasively. The gsense device measures the glucose level through the skin and displays the level to the patient, who then can take appropriate action to correct the level if necessary. This figure shows a possible representation of the ideal production device. Figure 1 - Non-Invasive Glucose Measuring Device System Overview 2.2 Physical Requirements Lumen s gsense is designed to be a portable (III), non-invasive (I) method of measuring the blood glucose level of patients with diabetes. The requirements of the device should be stated such that it will be easily integrated into the everyday functions of the user s daily life. It should also be described as an end-user consumer medical device with characteristics representative of other devices that are used to measure blood glucose levels General R[1-III] The dimensions of the gsense unit will be portable for easy transportation for every day use, approximately ipod size, ~ 4cm x 7cm x 1cm, and weigh <200g. Copyright 2006, Lumen Medical Technologies Inc. 3

9 R[2-III+] R[3-III] R[4-III] R[5-III] R[6-II] R[7-I] The dimensions of the gsense unit will be even smaller, in a watch sized compartment, worn on the wrist and weigh <100g. Connections for the external power supply shall be located on the end of the device. The display will be located on the top of the device. The sensor of the device will be located in front or on top of the device. The enclosure for the proof of concept will be much larger and not necessarily laid out as above. The device will be powered by either a battery or external power supply. 2.3 System Requirements General R[8-I] gsense will be useable in the normal consumer temperature range of 0 to 40 degrees Celsius. R[9-I] gsense will be useable in the normal consumer humidity range of 0 to 90%. R[10-I] gsense will have an external enclosure temperature of less than 30 degrees Celsius Performance R[11-III] R[12-II] R[13-I] R[14-III] R[15-I] gsense will be able to display user s glucose levels within 1 second of testing. gsense will be able to test and display changes in glucose concentrations in a solution. gsense will be able to measure a sample within 5 seconds of being turned on. gsense will be able to conserve battery power by turning off automatically after 10 seconds of not sensing a sample. gsense will be able to measure glucose concentrations of 0-100mMol/L. Copyright 2006, Lumen Medical Technologies Inc. 4

10 R[16-III] gsense will be able to store measurements in order to track the patient s glucose measurements over time Compatibility R[17-III] gsense will be able to communicate with computers to upload new software/firmware, and export stored data Reliability and Serviceability The gsense device is made with solid-state components, which are very reliable. This will help eliminate failure points. R[18-I] The operation buttons should be able to have a duty cycle of at least 1,000,000 cycles. R[19-I] R[20-III] R[21-I] As there are no mechanical parts the MTBF for gsense will be at least 2 years. The software and firmware of the device may be upgradeable by the end user. gsense will not have any user serviceable parts. Copyright 2006, Lumen Medical Technologies Inc. 5

11 3. Interface Requirements R[22-I] R[23-I] R[24-I] R[25-III] R[26-I] R[27-II] R[28-III] R[29-III] R[30-III+] Data would be recorded as signal strength at specified frequencies using a combination of one or more transmitters or receivers. Relevant output should be visually displayed to user. The user interface will have one or more buttons, including a Power button to turn the unit on, a Scan button to scan the sample, and a Reset button to reset the unit. gsense may have optional interface buttons to scroll through previous readings, and any buttons that may be necessary for assisting with unit calibration. Transmitters and receivers would be placed in whatever configuration proves best, for scanning through a round surface (such as a test tube or a human finger). Displays in whatever glucose unit/concentration level proves convenient based on signal strength. Small depression for finger application. Some individual calibration may be required on a per-user basis (possibly be a health care professional, ideally by the user). Sensors take readings through wrist. R[31-III+] Configurable programmable interval buttons (ie: discrete measurements every 10 minutes) and a button to do a measurement now. R[32-III] R[33-III] Allow a user to review recent stored readings (ie: to allow a user to review the effect a recently consumed chocolate bar had on their blood sugar level, for example). Low battery/battery replacement indicator. Copyright 2006, Lumen Medical Technologies Inc. 6

12 4. Regulatory Requirements The gsense will be an exciting new product on the market that will complement present glucose meters and will be sold worldwide. To ensure that the product is safe and reliable it will comply with the following Medical Devices Regulations and standards: R[34-I] R[35-III] R[36-III] All electrical connections will be enclosed and yield no danger to the user. gsense will follow CAN/CSA-C22.2 NO M90 (R2005), General Requirements for Safety. gsense will comply with CAN/CSA-C22.2 NO (R2005), Particular Requirements for the Safety of Microwave Therapy Equipment (Adopted IEC :1984). Copyright 2006, Lumen Medical Technologies Inc. 7

13 5. Documentation and User Training To ensure proper use and maintenance of the device the following documentations and user training materials will be available. R[37-I] R[38-I] R[39-I] R[40-I] R[41-III] R[42-III] R[43-I] A user manual will be written that explains in simple terms basic functionality and operational principle of the device. The user manual is written to general audience with little or no technical knowledge. The user manual will include section on safety and will list potential harm when used improperly. The user manual will include troubleshooting section intended for users with no technical knowledge. International language versions of the user manual will be provided. Additional documentation will be provided on Lumen Medical Technologies website and will consist of FAQs, electronic version of the user manual and user forum. Minimal user training should be necessary for this device. Copyright 2006, Lumen Medical Technologies Inc. 8

14 6. Conclusion This functional specification details the complete functional requirements for all primary phases of the gsense product design process. This includes specifications not only the proof of concept version, but also both the generic production version and the future ideal production version. The functional specifications are detailed and comprehensive to the best knowledge of Lumen Medical Technologies Inc. Small changes are expected (and encouraged) should design and development of phases indicate any that may be appropriate to better the overall design and implementation, but in general they should help coordinate and consolidate the team s activities to an overall design strategy. Copyright 2006, Lumen Medical Technologies Inc. 9