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ADS1298ECGFE-PDK: Is the ADS1298ECGFE-PDK not save for humans? Can it be validated for medical and scientific purposes?

Part Number: ADS1298ECGFE-PDK
Other Parts Discussed in Thread: ADS1298, ADS1198

William Croft, supporter in theOpenBCI forum says about the ADS1298ECGFE-PDK:

"TI explicitly states that the kit is not safe to connect to humans."

Is William Crofts statement correct? Scientsts from Indonesia tested the ADS1298ECGFE-PDK on humans and wrote two papers about it. The compared the board to a medical grade device as far as accuracy is concerned, and concluded, that the  ADS1298ECGFE-PDK has the accuracy of a medical grade device.

For a 8 channels EEG Data Aquisition System:


For 32 channels EEG Data Aquisition System :


These papers contradict William Crofts statements from OpenBCI. What is correct? Is there a danger to use the ADS1298ECGFE-PDK with humans? Are the conclusions of the indonesian scientists wrong? Is it possible to start a study to validate the ADS1298ECGFE-PDK for medical and research applications, to make the ADS1298ECGFE-PDK a device which can be used for a broader range of applications?

  • Hi Rene,

    The primary purpose of the ADS1298ECGFE-PDK EVM is for evaluating the performance of the ADS1298 and ADS1198 device in a monitored laboratory environment. It is not a reference design for ECG and EEG applications. You may certainly use the EVM with commercially available ECG simulators like Fluke Simulator (MedSim 300B) for your research applications.

    Please find below the disclaimer information about the ADS1298ECGFE-PDK EVM.

    The ADS1298ECG-FE/ADS1198ECG-FE is to be used only under these conditions:

    1. The ADS1298ECG-FE/ADS1198ECG-FE is intended only for electrical evaluation of the features of the ADS1298 device in a laboratory, simulation, or development environment.
    2. The ADS1298ECG-FE/ADS1198ECG-FE is not intended for direct interface with a patient, patient diagnostics, or with a defibrillator.
    3. The ADS1298ECG-FE/ADS1198ECG-FE is intended for development purposes ONLY. It is not intended to be used as all or part of an end equipment application.
    4. The ADS1298ECG-FE/ADS1198ECG-FE should be used only by qualified engineers and technicians who are familiar with the risks associated with handling electrical and mechanical components, systems, and subsystems.
    5. The user is responsible for the safety of themselves, fellow employees and contractors, and coworkers when using or handling the ADS1298ECG-FE/ADS1198ECG-FE. Furthermore, the user is fully responsible for the contact interface between the human body and electronics; consequently, the user is responsible for preventing electrical hazards such as shock, electrostatic discharge, and electrical overstress of electric circuit components.

    We have explicitly mentioned this disclaimer in the EVM user guide and the GUI software. Unfortunately we shall not be able to discuss anything further in this regard.

  • Thank you for your answer, Praveen. Unfortunately, this answer makes me retreat from this board. I don’ t expect an answer from Texas Instruments. But can this board note be made safe for all kind of applications by putting it in an electronically shielded housing and apply for electronic approval?