FTFYAuthorized users will be able to read the manual and figure out how to use the device
It is, but there's no "software manual" with most devices. The FDA is arguing for something like: - Heartrate sensing is accomplished via the 2nd ring terminal of the shock/pace lead and both terminals of the pace2 lead. It uses a bla bla bla loop informed by logic from the bla blah. - fibrillation sensing is accomplished via both terminals on the afib lead. It uses blah blah. - Updating is accomplished using our software kit, available at www.acmemed.com/mr_shocky. In order to interface with the device you must have performed a chest x-ray on the patient in order to read the two-factor authentication, which changes every thirty minutes. Thump the patient hard in the chest with "shave and a haircut" and set your device to search for bluetooth device "MR_SHOCK_E". Pair using the 2FA code provided in the upper left corner of the device on the x-ray. - blah blah blahThis is an implantable cardioverter device (ICD). It has heartrate sensing, fibrillation sensing and a cardiological self-updating envelope. It can be updated via Bluetooth 5.0 with the password "9999."