Indications For Use
Aluna is intended for monitoring FEV1 (Forced exhalation in
the first second) and PEF (Peak Expired Flow Rate) for home
use. The device is designed for children 5 years of age and
older, adolescent and adult subjects. 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. 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
Caution: When Aluna is used to monitor lung
conditions such as asthma you should be
under the care of a physician or other licensed