Device Description
The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is an accessory device intended for singlepatient
use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the
Ellipta devices.
The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user
entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from
the 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 to
review the collected information and characteristics of their DPI and its use, to capture other patient-reported information
and 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 as
the 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 DPI
medication(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 of
medication remaining in an DPI.