Status Review:
* Dave Skramsted: The Sensor Team met Sunday, 7/16. Jack Gordon joined the group. He's looking into free online collaboration tools. So far, we've been exchanging papers and ideas via email (we need a forum where we can exchange document files). Alex completed building and testing a piezo board. John Gould described and showed us his Freescale motion sensor assembly. Looking ahead, we discussed lab tools; the consensus is we'll need something like Labview and an associated PC interface to sufficiently demonstrate the capability of a working prototype sensor subsystem. Also, I suggested something like the Finapres Ohmeda 2300 finger sensor as a reference system for correlation - the team agreed it would be very useful. Don't know yet where we might obtain or borrow such a system; perhaps Franz or Germaine might have some ideas (these are future needs).
In the meantime Carl, Alex, Mary Jo and I are meeting this Sunday at 1:00 PM in the lab. We are going to power up the piezo system and do some experimentation. For one thing, we are going to look more closely at the "secondary pulse" which appears at the radial artery. Carl is wondering whether it might be a venous return; it's just an idea at this point, but if it is venous return, it could potentially allow us to measure pulse transit time with a single piezo film sensor.
We need a forum where we can exchange document files. We are considering Schtuff' (http://www.schtuff.com/), for which we could include a link on the Phoenix Sensor Team page. It's simple, easy to use, has access control features and allows 200MB of free storage. I really like the design and simplicity of Schtuff. Wikispaces is also good (they offer 2GB of storage). Jack Gordon has offered to investigate alternatives - we'll see what he comes up with.
* Chris: Continuing on privacy requirements paper, needs scenario diagrams, we need pictures showing the people involved, systems involved, the major data that moves between the systems, the barriers. It is very much like an object communications diagram. The title of the paper is "Privacy Requirements for low price chronomedical devices"
* Mary Jo: At the lab we are getting sufficiently strong signals, and we are capturing them. We are calibrating them to Chen's A and B parameters by using Germaine's ABPM. We are developing a Matlab program to cross correlate to find the time difference.
* Alex: we have the software running to transfer data from the oscilloscope to computer. We are using Matlab for time series analysis. We are working through the problems associated with getting consistent measurements, such as tape adhesive. Bob suggested using rubber tubing, commonly called the Penrose Drain. Get them at University Supply store, or look in the Fischer catalog. Alex noted that it would be very interesting to hear from a person who works with patents and can tell us how not violate the patent. Bob suggested that Jim Holte has a book in his library by Petersen that is relevant.
* John: Completed his remote assignment for his employer, retunred to the Twin Cities and is contacting Mike Balow from Free Scale to resume software development of the motion sensor.
* El: Larry completed changes to the Sphygmochron program that Germaine requested and sent it to her. Norm Bayne, who has been working on SOPs for our quality system, has moved to Michigan to accept a position as a veterinarian and is leaving the project.
* Gerrmaine: Received new version of the program from Larry on a spreadsheet.
Topic: Phoenix Sphymochron Quality System.
Bob summarized a proposed quality system for the prototype
sphygmochron, a program that analyzes the data provided by the
ABPMs currently used by the Halberg Chronobiology Center. They
have gotten approval from the Institutional Review Board (IRB),
with two principal investigators, Franz and Germaine. Their relationship
is between Franz and Germaine, the people they are working with,
and the IRB. They must apply to monitor up to a specific number
of people each year. If you exceed this number you must get a
new process or update the process. Each time they have to provide
a device, they need a consent form from the researchers with signatures
of Franz and Germain, and a HIPAA document. The ABPM is FDA approved.
The program is under the research project and needs no FDA approval.
No change to drug or dosage is made, merely a change in timing
of dosage. There is no regulation for timing of dosage.
Chris noted that in clinical studies there is an IRB, the device
is under an FDA regulatory process. What if a medical device firm
agreed to provide assistance to the Halberg Chronology Center
to improve their program, does that require an FDA regulatory
process? If Germaine has a graduate student improve the program,
it does not need FDA approval. If diagnoses are made with the
program, does it need regulatory approval? If diagnoses are not
used, then it doesn't need approval.
Next Phoenix Project meeting: Sunday, August 13 at 2:30 p.m. in Mayo 748
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