Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
IMPORTANT INFORMATION CONCERNING INTENDED USE
PEF is the maximum speed a person can blow air out of the lungs after taking as big a breath as possible.
FEV1 is the maximum volume of air a person can exhale from the lungs in one second after taking as big a breath as possible.
CAUTION: WHEN ALUNA IS USED TO MONITOR LUNG CONDITIONS SUCH AS ASTHMA YOU SHOULD BE UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL.
Medical studies have shown that regularly reviewing accurate measurements of PEF or FEV1 with a physician or other licensed healthcare professional may allow individuals with asthma, COPD (chronic obstructive pulmonary disease) and other lung disease to better manage their conditions.
It is important to watch for changes in your PEF or FEV1 from one measurement to the next, and to follow the actions you have to take according to the action plan provided to you by your physician or other licensed healthcare professional.
If you have breathing conditions such as asthma your physician or licensed healthcare professional may recommend that you measure PEF or FEV1 to watch your disease and discover if there are changes in your airflow. After you blow into the mouthpiece of the Aluna device when connected to the app, the app will display a number. The faster and harder you blow, the higher the number.
This number tells you how well air is moving through the airways in your lungs. When you use Aluna regularly, you will be able to detect changes in your PEF or FEV1, which will tell you and your physician or other licensed healthcare professional what is happening with your lungs.
These changes may require special treatment of your condition according to the action plan given to you by your physician or licensed healthcare professional which will tell you when and how often to use your Aluna device. They also will explain how your PEF or FEV1 measurements help them monitor your lung function and how well treatments are working.