Phoenix Ambulatory Blood Pressure Monitor Project
11/7/2004 Meeting Notes




Our next meeting will occur on November 21.

Under software requirements, Chris noted that for interative/prototype development, we need three items: software needs, architecture, and an implementation. He also suggested that the software architecture should include a reference data maintenance subsystem.

Bob/Cuff Calibration: We continued with Bob's questions: * battery, * user, * other measurements, * sphygmomanometer manufacturers, * power, and * packaging.

Bob noted that needs of different customers will differ in different geographic regions. For example, you buy a battery in US, but in South America and Africa often you cannot buy a battery. Therefore, in the US and Europe our battery-based ABPM test may be appropriate (or wherever else batteries are easily accessible), but in other areas, we should define a more appropriate power source. Similarly, it is useful to have a circuit board power requirement that is not 3 times 1.5 volts (3 cells) but is zero times 1.5 volts, e.g. no batteries. Weight is critical. In implantable medical devices, they fight for fractions of a gram and advertise it when it is achieved. However, this product will not be implanted. We don't want it to be heavier than a wrist watch. As heavy as a band aid would be ideal. The processing power should be dedicated to calculating just the data and we shouldn't do anything we don't need to do. Regarding communications, we've looked at USB, Serial, and Ethernet. Everything seems to take 30 mA, except for flash memory, which takes almost nothing. We need raw data for every heart beat, 4 channels for 2 sensors and accelerometer, and temperature and time stamp. We could use an 8050 processor to get raw data wave form for every heart beat, save it and then determine how to process it into heart beat, blood pressure, blood flow, 3-D acceleration and a time stamp.

Bob provided us with a copy of ANSI/AAMI SP10-1992 and we reviewed it. He noted that page 20, Figure B.1 of standard shows phases 1-5, phase 5 is silent and less than 1% of Phase 1. Page 37 shows greater error during exercise.

Bob will provide us with the patent numbers for electrodes that don't touch the skin. During the next meeting we'll discuss: * Sphygmomanometers, * Other measurement, and * packaging (e.g. The ElectroPlaster Company in the UK that has body mounted electronics to measure muscle signals, electromyograms).

Germaine/Data Analysis Methods: Germaine said she knows of no ABPMs that are compatible with exercise. Colin had one system that it isn't an ABPM, but was part of a stationery exercise bicycle that is part of a physiometry station. She hopes to provide a PowerPoint document of analysis methods for our next meeting. She met with Chris. She is preparing a presentation for a conference in Taiwan on cartiology at which they will present at two sessions on Chronobiology. Representatitives from different pharmaceutical companies will be present.

Wade/ Impedance Plethysmograph: Wade is reviewing how to use Invention Registration Disclosure and the Manual Patent Examining Procedure (MEPE). Currently, he is working on another invention and is using "Patent It Yourself" by Pressman, edition 10. He is going through all of the steps to put an invention into the public domain, and will provide guidance on how to update our Phoenix invention process.

Wade showed us a webpage summarizing his review of 21CFR Part11 from and noted that it specified requirements for transferring information from uncontrolled documents into a legal controlled document. We will post it and reference it from our Bibliography page.

Summary of our project goals by next meeting on 11/7:

During our next meeting we will discuss: Bob's remaining questions: * battery, * user, * other measurements, * sphygmomanometer manufacturers, * power, * packaging. Our working activity will be software requirements.



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