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Hi, I understand that Type BF is for devices that have conductive contact with the patient and CF is direct conductive contact with the heart. What if the device is not in "direct" contact with the heart, but very close to the heart? For example, an applied part goes into an infant esophagus, an electrical current is released out of the applied part to pick up a signal in the esophagus. The esophagus is very close to the heart in an infant. Does this applied part need to be Type CF? Our device doesn't have a particular 60601-2-x. To be on the safe side I would go with Type CF (applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary - 601Help.com). Would love to hear your thoughts?