Developed a pocket-sized medical cardiac monitor for Palm OS handheld computers. This was the first ECG device cleared by the FDA for use with a PDA.

Context

Since many ECGs were large and expensive, BCA helped create a portable and inexpensive ECG for EMT’s, doctors, and other medical personnel to monitor a patient’s heart condition. The design goals were focused on making the device low cost (retail <$500) and low power (battery operated). The requirements for this device were:

• high common-mode rejection ratio (greater than 100dB)
• low system noise
• active noise cancellation
• pace pulse detection
• patient impedance measurement

Solution

BCA designed the low-cost, low power ECG. The device connects to a Palm handheld, using the Palm for the human interface. The client, a software engineer, wrote the Palm code as well as the PC code to interface with the output from the ECG. This was the first medical device to include a Palm interface. BCA also wrote the hardware FDA documentation and performed FDA testing (EC13, ES1).

All of the analog front-end electronics was thoroughly self-tested. Dual function, economic design saved on circuitry. For example, the same circuitry used to measure patient impedance and cancel noise was used to perform the self-test functions.

Class II medical device.