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 expir-
atory maneuver. These measures
can be used for detection, assess-
ment 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 iOS and
Android devices and connects via
bluetooth. Air Next is powered by
2 x 1.5 V AAA alkaline batteries.
Air Next is designed to work with
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 mo-
tion. Air Next registers the speed
of the spinning rotor, converts it
and transfers the data via Blue-
tooth to the smartphone app.
LIMITATIONS OF USE &
CONTRAINDICATIONS
A spirometry test should only be
carried 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.
7
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 fun-
damental conditions are not re-
spected then the results obtained
during spirometry 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
testing the elderly, disabled or
children.
The device should never be used
when it is possible or probable
that the validity of the results
may be compromised due to any
external factors.
EN