S
Seek and Comply
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.
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.