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  • 1.  Electrostatic Discharge

    Posted 24-Jun-2017 18:06

    Hello,

    We have nearly exhausted of all our options in trying to pass ESD test (as per IEC 60601-2-25 section-202.6.2.2) on our device without success

    ME EQUIPMENT may show temporary DEGRADATION during discharges. Within 10 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any OPERATOR settings or stored data, and shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE.

    My Question is:

    What are our chances to argue to the agency or Notified Body that our device with its intended use, is OK to fail the 10 seconds recovery requirement? Our device survives the ESD events but it resets.

    Please share your experience or any valuable advice.

    Thanks,



    ------------------------------
    Bhupinder Singh
    San Jose CA
    United States
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  • 2.  RE: Electrostatic Discharge

    Posted 25-Jun-2017 08:17
    Hello Bhupinder, 

    This is a tough one - are you testing to the 3rd or 4th edition of the EMC standard? Just asking because the 4th edition requires that even higher kV be applied than the 3rd. 

    You might have some discretion here if the device is non-life sustaining or supporting and your risk management process shows a delay or other hazards due to this dropout is not a serious risk.But you may really need a redesign of grounding/shielding in your device. 

    I went through this with a lower risk device. Team refused to change design, and it had a regulatory impact not in major countries because it was non-life supporting or sustaining equipment.  But there were problems in other countries, such as China. 

    Good luck, PM  me if you need anything further.

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (715) 307-1850




    Original Message


  • 3.  RE: Electrostatic Discharge

    Posted 25-Jun-2017 10:16
    Thanks Ginger,

    I really appreciate your time and support!

    Regards,

    ------------------------------
    Bhupinder Singh
    San Jose CA
    United States
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    Original Message


  • 4.  RE: Electrostatic Discharge

    Posted 26-Jun-2017 10:33
    Hi Bhupinder,

    IEC 60601-2-25 is the particular standard defining basic safety and essential performance of diagnostic electrocardiographs.  This type of electrocardiograph is intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport.  If I were an EMT in ambulance or air transport, or a patient being rushed to hospital, it is not acceptable that an ESD pulse causes the electrocardiograph to reset.  This would normally force the EMT to re-establish the patient specific information which was entered into the electrocardiograph.  Further I believe some electrocardiographs spend some initial time upon patient connection establishing baseline information.  Unfortunately for you and your team, and assuming that this is your intended use, I think you need to solve the ESD problem. 

    Good luck,
    Mitch




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    Mitchell Johnson (RAC)
    Arden Hills MN
    United States
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    Original Message


  • 5.  RE: Electrostatic Discharge

    Posted 26-Jun-2017 11:52
    Thanks Mitch!

    Appreciate your time!


    ------------------------------
    Bhupinder Singh
    San Jose CA
    United States
    ------------------------------

    Original Message


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