heartbeat simulator/tester/calibrator (ECG waveform generator)


Joined Apr 5, 2008

I agree with john (jpanhalt) to merge the threads.
I merged the two threads as it looks like the continuation of a quest.

I would hope that this project is only for some sort of self training. While I realize "real" medical devices including test equipment are comparatively expensive, you really have no practical choice if you intend to use this project on humans. You will have to overcome some obstacles. First are you ready and affluent enough to be able to go through the testing and approval process of the FDA, the test device in this case may still be considered a medical device. Second, do you realize that electrical safety and simulation are for two different functions? Electrical safety testing assures that the leakage current worst case does not exceed the allowable value of 600uA (or far less in some uses) at the points that patient or caregiver could come into contact. Simulation on the other hand is used to test the function of the physio-monitoring device. They already exist in both cases, elex safety testers from say DALE, and simulators like the slim-sim or sim cube from Pronk. These are a lot less expensive since you are not trying to get something approved as a device via FDA, and besides, you are not opening yourself or institution to liability of using an untested/unapproved device on humans. (Lets loose our govt. reimbursments)...