By Dave Durfee, Chief Scientist
Confidential medical device developer
Impact ES–Rhode Island developed a pocket-sized cardiac monitor for Palm OS handheld computers. This was the first ECG device cleared by the FDA for use with a PDA.
Traditional ECG devices were often large and expensive. The goal of this project was to create a portable and affordable ECG solution for EMTs, doctors, and other medical personnel to monitor patients’ heart conditions in the field or on the go. Design requirements emphasized affordability (retail price under $500), low power consumption (battery operation), and included:
High common-mode rejection ratio (greater than 100dB)
Low system noise
Active noise cancellation
Pace pulse detection
Patient impedance measurement
Impact ES–Rhode Island designed a low-cost, low-power ECG device that interfaced with Palm handheld computers, which served as the user interface. The client, a software engineer, developed the Palm and PC applications to interpret and display ECG data. This was the first FDA-cleared medical device to feature a Palm interface.
Impact ES–Rhode Island also prepared the FDA documentation and conducted testing to meet EC13 and ES1 standards. The analog front-end electronics were fully self-tested, and the design incorporated dual-function circuitry to reduce cost—using the same components for noise cancellation, patient impedance measurement, and self-testing.
This device was classified as a Class II medical device.
