Defibrillator Requirement for ME Equipment connected to HF Electrosurgical Generator

  • Thread starter Seek and Comply
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S

Seek and Comply

#1
We manufacture ME Equipment with a handpiece which provides mechanical means for surgical cutting.
We will be testing an HF accessory which attaches to the handpiece, and connects to an HF Electrosurgical Generator (ESU). The HF accessory will provide a coagulation effect using the handpiece.
The ESU has a Defibrillator-Proof Patient Return receptacle.
Is anyone aware if there a requirement that our ME Equipment must be classified as Defibrillator-Proof, due to the HF accessory connection to the ESU?
I have been unable to find anything in IEC 60601-1 or IEC 60601-2-2 which clearly states this.
 
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Peter Selvey

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#2
Re: Defibrillator Requirement for ME Equipment connected to HF Electrosurgical Genera

There is no requirement in IEC 60601-2-2 to be defibrillator proof. However, it would be popular and reasonable choice as the neutral electrode would normally remain on the patient during defibrillation.

Technically, this should also apply to accessories. For example if the generator is rated defib proof, then the accessories should also be defib proof.

But in practice it would not be a concern. IEC 60601-2-2 already reduces the voltage to 2kVp defib pulse. As this is just a short pulse (~3ms) it is actually a very weak test. Usually the other tests like HF & mains frequency dielectric strength would be tougher especially for active electrodes. Finally, active electrodes would not normally be used during defibrillation. So, it would not normally be a real consideration for active electrodes.
 
S

Seek and Comply

#3
Re: Defibrillator Requirement for ME Equipment connected to HF Electrosurgical Genera

Thank you for your input, Peter.
The applicable 60601-2-2 standard in this case does not clearly state "APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS", which is certainly the case for patient monitors (60601-2-49), electrocardiographs (60601-2-27), and pacemakers (60601-2-31).

Our compliance lab and certified body agreed with our rationale that the defibrillator-proof classification is not mandatory for our ME equipment.
 
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