Indications For Use; General Information - Nuvoair AIR NEXT Manual Del Usuario

INDICATIONS FOR USE

Air Next is intended to measure
the forced expiratory volume in
1 sec (FEV1) and the forced vital
capacity (FVC) in a forced expiratory
maneuver. These measures can be
used for detection, assessment and
monitoring of diseases affecting the
lung function.
Air Next is intended to be used by:
• Healthcare professionals trained
to perform spirometry tests on
patients of age ≥ 5 years old,
> 10 kg and ≥ 110 cm.
• Adults trained by healthcare pro-
fessionals ("competent adults").
Competent adult can assist a child
who is ≥5 years old, >10kg and
≥110 cm.
The actual diagnosis shall be done
by a healthcare professional so
home use is only for indicative
purpose.

GENERAL INFORMATION

Air Next works with iPhone and
Android devices and connects via
bluetooth. Air Next is powered by
2 x 1.5 V AAA alkaline batteries.
Dispose replaced batteries and
discarded device as electronic waste.
Air Next is designed to work with
disposable and single use NuvoAir
disposable turbines. When perform-
ing a spirometry test, the user
exhales into the turbine. The air-
flow generated sets a rotor in
motion. Air Next registers the speed
of the spinning rotor, converts it and
transfers the data via Bluetooth to
the smartphone app.
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LIMITATIONS OF USE &
CONTRAINDICATIONS
A spirometry test should only be car-
ried out when the user is at rest (i.e.
does not experience shortness of
breath) and in good health, and thus
in a suitable condition for the test.
An analysis of the results of a
spirometry test alone is not suffcient
to make a diagnosis of a clinical
condition. Test interpretation and
suggested treatment must be pro-
vided by a Healthcare professional.
A correct spirometry test depends
on the user's capability to inhale and
exhale all air completely and as fast
as possible. If these fundamental
conditions are not respected then
the results obtained during spirom-
etry testing will not be accurate, and
therefore the test results are "not
acceptable".
The acceptability of a test is the
responsibility of the user. Special
attention should be given when
EN