Phoenix Ambulatory Blood Pressure Monitor Project
5/16/2004 Meeting Notes


Srilakshimi Bathina
Srikanta Kolluru
Wade Peterson
Franz Halberg
Germaine Cornelssen
Bob Schlentz & Eileen Schlentz
Jim Holte
Jay Rabel
El Nolley & Riva Nolley
Tina Sarabandi
Gideon Zamba, University of Iowa, Professor of Statistics
Michael Kallok, CEO, Cardiovascular Systems Inc.
Hiroshi Oyama, Medical Product Manager, International Division, A&D
Kazuhiko Niwano, Deputy General Manager, R&D Division, A&D
Nobuhiko Yasui, Assistant Manager, R&D Divison, A&D


* Franz Hallberg & Germaine Cornelssen- Halberg Chronobiology Center
Welcome & Introductions
-- BIOCOS Project
* Phoenix Project - Phoenix Project
o El Nolley - History, objectives and approach
o Bob Schlentz - Ambulatory Blood Pressure Monitor - A Patient's Perspective
o Wade Peterson - Blood Pressure Sensors
* Michael Kallok - A Perspective from the US Biomedical Device Industry
Past editor of Biomedical and Instrumentation Technology
* A&D - Mr. Hiroshi Oyama - A&D's perspective and what they've learned about BP monitoring
* Germaine Cornelissen, Franz Halberg. El Nolley - Conclusions & Thank You


Example of Cuffless measurement: the Casio watch.
A&D (AND) Presentation
1. Technologies
-- DSP Technology, $30
-- Electron Beam (EB), $30 mil
-- Weighing Sensor
2. Reliability
3. System
ISO 9001
4. Medical
BP Prof & Home markets
Accuracy is the most stringent requirement
Home Mkt leaders: #1 Omron, #2 A&D.
Russian's defined blood measure measures: defined Oscillometric "gold standard".
3 stds bodies:
1) AAMI SP10
2) British hypertension Society (BHS)
3) EHS

Demonstrations & General Discussion
The new A&D 2430 is a low power blood pressure monitor.
Cuffless BP monitor is the goal, however, US certification can be difficult.
The A&D 2425 has an activity sensor.

Bob summarized characteristics, needs and problems with current blood pressure monitors. See his presentation, linked to these notes.

Wade is building an inexpensive fixture to simulate blood pressure characteristics of an arm to support repetitive sensor measurements, tuning and tuning. The current technique is using velocity to measure pressure.

Franz noted that multiple week measurements were useful in determining an individual's weekly blood pressure cycle, but once determined, it was useful immediately. For example, changes in the weekly blood pressure cycle after surgery is often an early indicator of infection, and can occur long before body temperature increases.

Franz said that body temperature would be a useful additional measure.

Furthermore, he said that it isn't necessary that ambulatory blood pressure measurements be comparable with the standard cuff measure. Instead, clinical outcomes are important, and demonstrating that non-cuff blood pressure measurements are effective in preventing strokes, heart attacks and infections is far more important than showing that they are comparable to the standard cuff.

We asked:
1) What will change in blood pressure product technology in the next 5 years? Answer: No fundamental changes.
2) Is there an inherent difference in accuracy between piezo and cuff based blood pressure monitors? Answer: Piezo is potentially as accurate as cuff-based products. However, it is more costly to produce, and the electrical characteristics of the piezo material tend to change over time and that is costly to prevent. Additionally, measurements from blood pressure monitors must be comparable to the cuff monitor in order to satisfy market and regulatory requirements.


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