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ADS1198 and IEC60601 Standards

Philippe Lumbierres
Prodigy 50 points
Other Parts Discussed in Thread: ADS1198

Hello,

Very interested in ADS1198 for a replacement solution for existing product, obviously some questions came up and at particularly one related to the "60601-8.5.2 Separation of PATIENT CONNECTIONS".

I saw recommendations and implementations for input protection and isolation to the end equipement (power supply isolation,...), but I cannot see any specific consideration for isolation between channels. 

Is it something you consider not applicable? If applicable it will complicated for sure the implementation around 1198?

Can you comment on that?

Thanks in advance.

Best regards.

Philippe.

  • 0
    TI__Mastermind 38745 points
    Hey Philippe,

    This device does not include any provisions for channel to channel isolation and I have not seen any medical applications where it is necessary. What is the exact wording of the IEC spec?

    Regards,
    Brian
  • 0 in reply to Brian Pisani
    Prodigy 50 points
    Thanks Brian for your comment,

    Indeed I interpreted the spec in such a way they want to ensure a MOPP (MEANS OF PROTECTION for reducing the RISK due to electric shock to the PATIENT) is used between channels connected to a human patient.
    IEC60601-8.5.2 extract:
    "
    The PATIENT CONNECTION(S) of any F-TYPE APPLIED PART shall be separated from all other parts,
    including the PATIENT CONNECTION(S) of other APPLIED PARTS, by means equivalent to one
    MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to the MAXIMUM MAINS VOLTAGE
    and shall comply with the specified limit for PATIENT LEAKAGE CURRENT with 110 % of the
    MAXIMUM MAINS VOLTAGE applied.
    A single F-TYPE APPLIED PART may include multiple functions, in which case separation
    between such functions is not required.
    If there is no electrical separation between PATIENT CONNECTION(S) of the same or another
    function (e.g. between ECG electrode and pressure catheter), then these PATIENT
    CONNECTION(S) are treated as one APPLIED PART.
    Whether multiple functions are to be considered as all within one APPLIED PART or as multiple
    APPLIED PARTS is as defined by the MANUFACTURER"

    Thus, now my understanding is that if :
    - the 8 channels of ADS1198 are considered as one APPLIED PART,
    - exists input protection as describe within ADS1198 application note (reducing the electric shock to the patient),
    - exists isolation of digital part and power supply to the host (Medical Equipment)
    the system complies this 60601 requirement, meaning no electric shock should occur if one channel is connected to the patient while another is...conected to earth or whatever...
    Am I on the good way?

    Thanks.
    Best regards.
    Philippe.
  • 0 in reply to Philippe Lumbierres
    TI__Mastermind 38745 points
    Philippe,

    I think your understanding is correct. Channel to channel isolation does not seem to be required since the ADS1198 is providing a single function and is the only piece of the system with direct contact to the patient.

    Regards,
    Brian Pisani
  • 0 in reply to Brian Pisani
    Prodigy 50 points

    Brian,

    Thanks for your comments and advice, I appreciate.

    Best regards.

    philippe.