BreatheLink

BreatheLink is a secure data-transfer application designed to connect with a compatible Bluetooth pulse oximeter and transmit measurement data directly to Breathe IDTF. The app provides a simple, reliable way for users to send their SpO₂ and pulse-rate readings to the testing service that supports their provider-ordered sleep study. BreatheLink does not interpret data, provide medical analysis, or offer diagnostic or treatment guidance. It serves solely as a transmission tool between the user’s oximeter and Breathe IDTF. Key Features Connects to a supported Bluetooth pulse oximeter for automated data capture Securely sends measurement data to Breathe IDTF for use in provider-directed testing Easy setup with guided connection steps Clear indicators confirming successful transfer No analysis, recommendations, or clinical interpretation provided by the app Intended Use BreatheLink is not a medical device. It does not diagnose, monitor, or treat any condition. It functions exclusively as a data-transfer utility to support workflows managed by Breathe IDTF and the user’s healthcare provider. Under FDA guidance on Device Software Functions and Medical Device Data Systems (MDDS), software whose sole function is transfer/storage/conversion/display of medical device data is not a medical device.