Question

Just as I've shown in the above table, the type, Patient circuit and class for toaster and ECG. Please let me know the type, Patient circuit and Class for portable EEG equipment.

Equipment	Type	Patient circuit	Class
Toaster	B	X	1
ECG	CF		1

Answer 1

For a portable ECG equipment, the following is the Type, patient circuit and class:

1. Type: For a portable ECG equipment, it is a type CF equipment.

This is because the type CF class of medical devices are the ones who have direct and their parts in contact with the heart. therefore the portable ECG is a Type CF Class III equipment

2. Patient Circuit: X or none/absent.

Patient circuit is in relation to the medical device for breathing systems that relays gases with the ventilator and the patient. In case of portable ECG it is not applicable.

3. Class: Class 1

Class I medical devices are FDA approved medical devices that have low to moderate risk to patient safety and health. A portable ECG does not poses any health risk to the patient safety and just used for monitoring and diagnostic purposes with no risk. Therefore a portable ECG is a Class 1 equipment.