Applicability of Means of Protection, working voltage in an Automated External Defibrillator

M

Mars_i

Registered
Dear Experts,

I am currently designing an AED device.
My device is internally powered and has a plastic enclosure. the patient connections are defib electrodes, used for ECG acquisition and defib shock.
In my design, the high-voltage (2000V) and low-voltage (18V) parts have a common Ground plane (GND). I sent my design for validation to a test lab.
But reviewing my architecture, the test lab for certification considers that ALL the electronic board has a WORKING VOLTAGE of (2000V) due to this common ground.
So the test lab considers that I need MOP 2000V isolation between the high-voltage circuit and electrodes, and also MOP 2000V isolation between the ECG path and electrodes, which means that the ECG path resistors should withstand 4kV D.C. because bridging a 2000V MOP (according to 60601-1 ed.3 sect. 4.8).

On my side I have a totally different interpretation of the regulation:
- I consider the WORKING VOLTAGE of my device to be 18V ( according to 60601-2-4 chapter 201.8.8.3 : For the dielectric tests of the general standard, the WORKING VOLTAGE is determined without regard to the presence of defibrillation or pacing voltages.)
- I consider that High-voltage is isolated from Low-voltage of circuit (even if common ground). This is proven by validation test of 60601-2-4 201.8.8.3
- So I don't need MOP 2000V isolation between ECG path and electrodes
- I don't need MOP 2000V isolation between High-Voltage Circuit and electrodes, because current is intended to flow through patient (60601-1 ed.3 sect. 8.4.1)
- BUT I need to pass all the tests of 60601-2-4.

Could someone tell me if my approach is ok or am I totally wrong in my comprehension of 60601-1 and 60601-2-4?


Thanks in advance!

Mars
 
T

Tahir Mahmood

Starting to get Involved
Have you read the following in the 60601-1 ?

8.5.4 * WORKING VOLTAGE
The WORKING VOLTAGE for each MEANS OF PROTECTION shall be determined as follows:
– For WORKING VOLTAGE measurement, all circuits shall be connected to earth with the
exception of floating parts providing at least one MEANS OF PROTECTION to earth in which
case the highest measured voltage on either side of the barrier is the WORKING VOLTAGE
(see Figure 41).
 
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