Nuvoair AIR NEXT User manual

AIR NEXT USER MANUAL

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WHAT’S IN THE BOX
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SETTING UP YOUR DEVICE
Download the NuvoAir app
from AppStore or Google
Play Store.
Enable Bluetooth on your
mobile device. Allow the
app to access and use
Bluetooth and follow the
instructions on the screen.
The spirometer lights up
when it is connected to the
mobile device.
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PERFORM A LUNG FUNCTION TEST
Insert a new turbine
by sliding it through
the device.
Turn the turbine
clockwise until it
locks into place.
Create an account
or sign in to an
existing one and
select your prole.
Tap the plus button
to perform a lung
function test.
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Test
2s
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Take a slow deep breath -
as deep as you can.
Close your lips around the
opening of the turbine.
Blow as hard and as fast as
you can into the mouthpiece.
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PERFORM A LUNG FUNCTION TEST
Your exhalation should
exceed 6 seconds in order
to obtain a high quality test.
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Test
6s
Results Results
Flow
Volume
Battery: 100 %
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PERFORM A LUNG FUNCTION TEST BATTERY
CHECK
Keep going until you
have completely
emptied your lungs.
You should rest
15 to 30 seconds
before starting a
new test.
Perform a minimum
of 3 tests for high
quality results.
The app displays the
best result.
Open app settings
to check battery
levels.
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You can share
the test via e-mail.
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INDICATIONS FOR USE
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
professionals (”competent adults”).
Competent adult can assist a child
who is ≥5 years old, >10kg and
≥110 cm.
Air Next is intended to perform
basic lung function and spirometry
testing.
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. If
the batteries are replaced or when
the device is discarded, dispose
the device as electronic waste.
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-
ow 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.
An analysis of the results of a
spirometry test alone is not sucient
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 and
children.
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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.
Some conditions may pose a
relative danger to a patient or
aect the validity of spirometry
performance and results. These
include, but are not limited to the
following: unstable cardiovascular
status, unstable angina, recent
myocardial infarction (within one
month) or pulmonary embolism,
haemoptysis of unknown origin,
recent pneumothorax, thoracic,
abdominal or cerebral aneurysms,
recent thoracic, abdominal or eye
surgery, acute disorders such
as nausea or vomiting, severe
respiratory distress, physical
limitations, cognitive impairment,
dementia.
IMPORTANT SAFETY WARNINGS
Air Next should never be used with
a charging phone. Make sure the
phone is unplugged before con-
ducting a spirometry test. Don’t
use the device with a connected
AC/DC adaptor.
Once removed from its packaging,
check that there is no visible dam-
age on the device. In the case of
damage do not use it and return it
to the seller.
Air Next has been examined by an
independent laboratory which has
certied the conformity of the device
to the European Safety Standards
EN 60601-1 and guarantees the
EMC Requirements within the lim-
its set in the European Standard
EN 60601-1-2 and ETSI’s
EN 300 328. It is a medical device
class IIa (“two a”) product. Air Next
is constantly controlled during its
production, therefore the product
conforms to the essential require-
ments set by the Council Directive
93/42/EEC for medical devices.
• Use only with iOS and Android
devices specied on our website
www.nuvoair.com.
• Use only in environments speci-
ed in this user manual.
• Do not expose to liquids.
• Air Next is not made with
natural rubber latex.
• Should you lose the battery
hatch with required and device
specic information on it, the
guarantee will no longer be valid
and NuvoAir cannot provide
further support or guarantee
the condition or functionality of
the product.
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Explanation of the safety signs and
symbols marked on the device:
Manufacturer’s name and address.
CE mark: indicates that the device
is certied that it conforms to the
requirements of the 93/42/EEC
medical device directive.
IP classication: indicates that the
device is protected against solid
objects over 2.5 mm entering as well
as faling drops of water, if the case is
disposed up to 15° from vertical.
Waste electrical and electronic
equipment: Dispose accordingly.
Do not dispose as unsorted
municipal waste.
Manufacturer’s LOT batch/lot code.
Follow operating instructions:
Indicates the need for the user
to consult the instructions for
important information.
The symbol is used in accordance
with IEC 60601-1-2:2014 (ED. 4)
for products including radio trans-
mitters and in accordance with
EN 300 328.
Type BF applied part: Device that
has conductive contact or medium
to long term contact with the
patient in order to fulll the
intended use.
This device complies with part 15
of the FCC Rules. Operation is
subject to the following two
conditions: (1) This device may not cause
harmful interference, and (2) this device
must accept any interference received,
including interference that may cause
undesired operation.
FCC ID Identication showing traceability
to FCC compliance.
Caution: Federal law restricts this
device to sale by or on the order of
a physician
OPERATING ENVIRONMENT
Air Next has been designed for use
in a doctor’s oce, in a hospital
setting or at home.
Air Next is not intended for use
in an operating theatre nor in the
presence of inammable liquids
or detergents, nor in the presence
of inammable anaesthetic gases
(oxygen or nitrogen). The device is
not designed to be used in direct
air currents (e.g. wind), sources
of heat or cold, direct sun rays or
other sources of light or energy,
dust, sand or any other chemical
substances.
NUVOAIR
DISPOSABLE TURBINE
Air Next is designed to be used
with NuvoAir disposable single use
turbines. The disposable turbine
is indicated for single use single
patient only. The integrity and
functionality is guaranteed by:
• Never holding the turbine under
a jet of water or air and never let
it come into contact with high
temperature uids.
• Not allowing dust or foreign
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IP32
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bodies to enter the turbine
sensor, in order to avoid incorrect
functioning and possible damage.
The presence of any impurities
such as hair, sputum, threads etc.
within the body of the turbine
sensor may seriously compromise
the accuracy of the measurements.
• Avoiding environmental
contamination by cleaning waste
products, the user must adhere
to all relevant regulations.
The single use turbine cannot be
used to perform a spirometry test
on another individual (person).
You can purchase new single use
turbines at www.nuvoair.com
CAUTION: RISK OF
CROSSCONTAMINATION
Each new individual that uses
Air Next shall use a new unused
disposable NuvoAir disposable
turbine. If the turbine is not
replaced between individuals there
is a high risk of infectious cross
contamination.
AIR NEXT TESTS
PARAMETERS SUCH AS:
FEV1 (Forced Expiratory Volume
in 1 second) The volume of air (l)
exhaled in the rst second during
a forced maximal expiratory eort
after a full inspiration.
FVC (Forced Vital Capacity) The
total volume of air (l) exhaled dur-
ing a forced maximal expiratory
eort after a full inspiration.
FEV1/FVC (Ratio) The calculated
result obtained by dividing FEV1
with FVC.
PEF (Peak Expiratory Flow) The
maximum ow rate (l/s) during a
forced maximal expiratory eort
after a full inspiration.
The nal results displayed in the
application are always the best
values obtained after performing
the desired number of tests
included in a session. The rec-
ommended number of tests per
session is 3, however the user can
perform up to 8 tests.
Displayed test are compared to a
reference table (GLI) and displayed
as percent predictive value (%pred.).
The reference used in Air Next
uses expected normal lung func-
tion values such as for FEV1,
FVC, FEV1/FVC and PEF are based
on ethnicity, gender, age and height.
Interpretation of spirometry results
should be made by a physician
or allied health care professional
with sucient training in the
performance and interpretation of
spirometry.
Note: Home use of Air Next is in-
tended only for indicative purpose.
Interpretation of the test results
and diagnosis shall be done by a
healthcare professional.
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