The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is an accessory device intended for singlepatientuse to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for theEllipta devices.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual userentry, to a remote storage system. With the Propeller Mobile Application the user can review information collected fromthe DPI sensor, and report and review symptoms and other information about their disease management and its impact.The user may also share their information with their caregivers, physician, and healthcare providers.The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users toreview the collected information and characteristics of their DPI and its use, to capture other patient-reported informationand outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers.When used with a prescribed DPI, the system can report on information captured during the normal course of use, such asthe time between actuations that can be helpful in assessing DPI technique.The Propeller System is intended to be used in populations from Child (>2 years) to Adult.The Propeller System can be used both indoors and outdoors; home, work, and clinical settings, as well as on aircraft.The Propeller System may also be used in clinical trials where researchers need to know information about the use of DPImedication(s) by a participant.The output of the Propeller System is not intended to diagnose or replace a diagnosis provided by a licensed physician.The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity ofmedication remaining in an DPI.
A small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this data wirelessly to a separate device (e.g., smartphone with appropriate software) to evaluate dosing interval. It is typically used in conjunction with software that may, e.g., set reminders. This is a single-patient reusable device.