Aerobit PeakFlow+ User manual

PeakFlow+User Manual

WHAT’S IN THE BOX
Aerobit PeakFlow+Device
2x AAA Batteries
Reusable Turbine with Mouthpiece

SETTING UP YOUR DEVICE
1) Download the Aerobit
App from Google Play store
or Apple App Store
2) Login or Register on the
App using Email, Facebook
or Google Account
3) Enter information such
Age, Gender, Ethnicity,
Avatar etc when prompted

SETTING UP YOUR DEVICE
4) Enable Bluetooth and
GPS from your phone
settings.
5) Open the battery latch
from behind by gently
pushing on the grips and
pulling it downwards
6) Insert the two AAA
batteries into the battery
cabinet. Close the battery
latch until it snaps in place

PERFORMING A PEAK FLOW TEST
4) Insert the turbine in the
device, gently push inside
to make sure it has
reached the end
5) Rotate the turbine
clockwise to lock it in
place.
6) On the Aerobit App, Go
to Peak Flow test tab and
tap the Plus icon

PERFORMING A PEAK FLOW TEST
7) Inhale deeply.
9) Exhale as fast as
possible into the turbine.
Note: Your exhalation
should exceed 6 seconds
for accurate results
8) Seal your lips onto the
mouthpiece.

PERFORMING A PEAK FLOW TEST
10) The App will display the PEF, FEV1
values along with the graph. Tap Next
Test for conducting next test (repeat
steps 7 to 9). Take at least 10 seconds
rest between each test.
11) After completing four tests, the
device will go to Standby mode and the
App will display the best of the four
tests. Tap save test to save the results
for future reference

INDICATIONS FOR USE
PeakFlow+is intended for monitoring
PEF (Peak Expiratory Flow Rate) and
FEV1 (Forced Expiratory Volume in
one second) for patient home use.
The device is designed for paediatric
to adult patients.
Patients below 16 years shall be
supervised by an adult during the use
of this device.
When the device is used to monitor
lung conditions such as asthma and
chronic obstructive pulmonary
disease (COPD), the user should be
under the care of a licensed health
care professional.
GENERAL INFORMATION
PeakFlow+is used to measure a
person’s PEF (Peak Expiratory Flow)
and FEV1(Forced Expiratory
Volume). PEF is the fastest speed a
person can blow air out of the lungs
after taking in as big a breath as
possible.
Forced Expiratory Volume (FEV1) is a
measure of the volume of air
expelled in 1- second.
PeakFlow+ has the following
frequently used operations: -
1) Attaching the Aerobit Turbine to
PeakFlow+ device
2) Pairing with a Smartphone via
Bluetooth
3) Performing a set of test
4) Viewing results on the Aerobit
App.

PeakFlow+works with iOS and
Android devices and connects via
Bluetooth. PeakFlow+is powered by
2 x 1.5 V AAA Alkaline batteries.
Depending on the usage and
manufacturer, each set of new
batteries should last for about six to
eight months. If the batteries are
replaced or when the device is
discarded, dispose the same as
electronic waste. Use Alkaline
batteries only.
PeakFlow+is designed to work with
Aerobit Reusable Turbines. When
performing a test, the user exhales
into the turbine. The airflow
generated sets a rotor in motion.
PeakFlow+registers the speed of the
spinning rotor, converts it and
transfers the data via Bluetooth to
the smartphone app.
CAUTION
When a peak flow meter is used to
watch lung conditions such as
asthma, the user should be under the
care of a physician (or other licensed
health care professional). A licensed
health care professional’s advice is
required to understand the meaning
and importance of the measures you
get with your peak flow meter, and to
decide on an appropriate treatment
plan.
LIMITATIONS OF USE &
CONTRAINDICATIONS
A peak flow 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
peak flow test alone is not enough to
make a diagnosis of a clinical
condition. Test interpretation and
suggested treatment must be
providedby a Healthcare
professional.
A correct peak flow test depends on
the user’s capability exhale all air
completely and as fast as possible. If
these fundamental conditions are
not respected then the results
obtained during 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.
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
affect the validity of peak flow
performance and results. These
include, but are not limited to
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
Once removed from its packaging,
check that there is no visible damage
on the device. In the case of damage
do not use it and contact us
immediately.
PeakFlow+has been examined by an
independent laboratory which has
certified the conformity of the device
to the ISO 60601-1 and guarantees
the EMC Requirements within the
limits set ISO 60601-1-2 and ETSI’s
EN300328. It is a medical device
class IIa (“two a”) product. PeakFlow+
is constantly controlled during its
production, therefore the product
conforms to the essential
requirements set by the Council
Directive 93/42/EEC for medical
devices.
• Use only with iOS and Android
devices specified on our website
www.aerobithealth.com
• Use only in environments specified
in this user manual.
• Do not expose to liquids.
• Should you lose the battery
hatch with required and device

specific information on it, the
guarantee will no longer be valid and
Aerobit cannot provide further
support or guarantee the condition or
functionality of
the product.
Explanation of the safety
signs and symbols marked on
the device:
Manufacturer’s name and address.
CE mark: indicates that the device is
certified that it conforms to the
requirements of the 93/42/EEC
medical device directive.
IP classification indicates that the
device is protected against solid
objects over 2.5 mm entering as well
as falling 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 Serial Number.
Manufacturer’s product reference
number

The symbol is used in accordance
with IEC 60601-1-2:2014 (ED. 4) for
products including radio transmitters
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 fulfill the intended use.
Applied Part: The Aerobit PeakFlow+
and the Aerobit Reusable turbine are
Type BF parts.
Follow operating instructions:
Indicates the need for user to consult
the instructions for important
information.
OPERATING ENVIRONMENT
PeakFlow+has been designed for use
in a doctor’s office, in a
hospital setting or at home.
PeakFlow+is not intended for use in
an operating theatre nor in the
presence of inflammable liquids or
detergents, nor in the presence of
inflammable 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.
AEROBIT REUSABLE
TURBINE
PeakFlow+is designed to be used
with a mouthpiece attached to an
Aerobit Reusable turbine.
Before each use, the Reusable
turbine should be cleaned, and a new
unused mouthpiece should be used.
For best results, use Aerobit
Mouthpieces, visit aerobithealth.com
for more info.
The integrity and functionality are
guaranteed by:

• Never holding the turbine under a
jet of water or air and never let it
come into contact with high
temperature fluids.
•Not allowing dust or foreign 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 Reusable
turbine must be properly disinfected
before each test.
It is highly recommended to use
Aerobit Reusable Turbine and
Mouthpieces only, usage of third-
party turbines or mouthpieces could
seriously impact the accuracy of the
readings and safety of the patient.
Cleaning the Aerobit
Reusable Turbine
To clean the reusable turbine, please
refer to the following procedure: -
1) Remove the Turbine from its
compartment on the
PeakFlow+by turning it anti-
clockwise and pressing lightly.
It can be helpful to push it
gently from underneath with
one finger.
2) Immerse the turbine in the
recommended cold detergent
solution and move it within the
liquid to remove any impurities
which may be deposited inside.
3) Leave the turbine immersed for
the time specified in the
instruction of the solution. To
avoid any kind of damage to
the reusable turbine please do
not use any alcoholic or oily
substances, do not immerge
the turbine in hot water or hot
solution. Do not put the turbine
under a direct jet of water or
other liquid. If no detergent
solution is available, clean the
turbine in clean water.

4) Rinse the turbine by immerging
it in clean water (not hot).
5) Shake off the excess water
from the turbine and leave it to
dry, standing it vertically on a
dry surface.
6) Once the turbine has been
cleaned insert the turbine tube
in its place. To correctly insert
the turbine push it to the end
and turn it clockwise until
reaching the wedge which
ensures that the tube has been
blocked inside the plastic
casing.
CAUTION: RISK OF
CROSS-CONTAMINATION
To avoid cross contamination,
Aerobit Turbines are marked as
single Patient Use accessories.
However, to avoid self-
contamination, Aerobit Turbines
should be properly cleaned before
every use.
The Aerobit Reusable Turbine has a
paper Mouthpiece attached at one
end; a new unused mouthpiece must
be used for each set of tests. Used
mouthpieces must be discarded as
household wastes.
The correct functioning of the re-
usable turbine can only be
guaranteed if it has been cleaned in
the correct manner and is free from
foreign bodies which could alter its
movement. The cleaning of the
turbine should be performed
according to the instructions
contained in the User’s Manual.
PeakFlow+Tests
Parameters
FEV1(Forced Expiratory Volume in 1
second) The volume of air (l) A
forced maximal expiratory effort
after a full inspiration.
PEF (Peak Expiratory Flow) The
maximum flow rate (l/s) during a
forced maximal expiratory effort
after a full inspiration.
The final results displayed in the
application are always the best

values obtained after performing the
4 tests included in a session.
Displayed test are compared to a
reference table (GLI) and displayed
as percent predictive value (%pred.).
The reference used in PeakFlow+
uses expected normal lung function
values such as for FEV1 and PEF are
based on ethnicity, gender, age and
height.
Note: Home use of PeakFlow+is
intended only for indicative purpose.
Interpretation of the test results and
diagnosis shall be done by a
healthcare professional only.
STORAGE AND
MAINTENANCE
Handle PeakFlow+device
carefully. Store it in clean and
moisture free conditions. Before use,
always check that the device is free
from dust, contamination or any
particles.
PeakFlow+does not require
professional maintenance. If,
however, the outside of the device
needs to be cleaned make sure to
only use a damp cloth without any
detergents. The batteries of
PeakFlow+are
replaceable.
If the storage temperature is below
20C, allow the device to warm up
before use.
If the storage temperature above
60C, allow the device to cool down
before use.
Keep the PeakFlow+ device out of
reach of infants, pets or pests.
ACCESS TO BLUETOOTH
Enable Bluetooth on your mobile
device in order to pair with the
PeakFlow+device. You can enable
Bluetooth in your mobile device
settings. Check your device manual
on how to do this.
BLUETOOTH PROXIMITY
Make sure that the PeakFlow+is
within the Bluetooth proximity of
your phone. If your phone is too far

away from the PeakFlow+, the
connection could be lost.
FCC RADIO FREQUENCY
INTERFERENCE
STATEMENT
This equipment has been tested and
found to comply with the limits for a
Class B digital device, pursuant to
part 15 of the FCC Rules. These
limits are designed to provide
reasonable protection
against harmful interference in a
residential installation. This
equipment generates uses and can
radiate radio frequency energy and, if
not installed and used in accordance
with the instructions, may cause
harmful interference to radio
communications. However, there is
no guarantee that interference will
not occur in a particular installation.
If this equipment does cause harmful
interference to radio or television
reception, which can be determined
by turning the equipment off and on,
the user is encouraged to try to
correct the interference by one or
more of the following measures:
·Reorient or relocate the receiving
antenna.
· Increase the separation between
the equipment and receiver.
· Connect the equipment into an
outlet on a circuit different from that
to which the receiver is connected.
· Consult the dealer or an
experienced radio/TV technician for
help.
Aerobit is not responsible for any
radio or communication interference
caused by using other than specified
or recommended cables and battery
or by unauthorized changes or
modifications to this equipment.
Changes or modifications not
expressly approved by the
manufacturer could void the user’s
authority to operate the equipment.
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.
This equipment complies with FCC
radiation exposure limits set forth for
an uncontrolled environment. End
user must follow the specific

operating instructions for satisfying
RF exposure compliance.
IC Radio Frequency
Interference Statement
This device contains licence-exempt
transmitter(s)/receiver(s) that
comply with Innovation, Science and
Economic Development Canada’s
licence-exempt RSS(s). Operation is
subject to the following two
conditions:
- This device may not cause
interference.
- This device must accept any
interference, including interference
that may cause undesired operation
of the device.
The products are compliant with SAR
for general population/uncontrolled
exposure limits in IC RSS-102 and
has been tested in accordance with
the measurement methods and
procedures specified in IEEE 1528.
The transmitter module may not be
co-located with any other transmitter
or antenna.
TROUBLESHOOTING
-Make sure that the Aerobit
PeakFlow+ Reusable Turbine is
correctly inserted into the device.
-Make sure the turbine is not
spinning before starting the test.
-Make sure there is enough battery
before you do a test.
-Make sure the environment is not
too windy or bright.
-Make sure the Bluetooth is Enabled
on your Smartphone
Unable to setup? Unexpected errors
or outputs? Contact us immediately
and we will be more than happy to
help.

TECHNICAL FEATURES
Environment of use
Home, Clinic or hospital setting
Measurement method
Infrared Interrupt
Power Supply
2 x 1.5V AAA Alkaline battery
Flow Accuracy
±5%
Volume Accuracy
±3%
Operating Conditions
Temperature: 10°C –40°C Or 50°F –104°F
Humidity: 10% - 90%
Altitude: ≤2000m
Conditions of Storage
Temperature: -10°C –70°C Or 14°F –158°F
Humidity: 10% - 90%
Altitude: ≤2000m

Atmospheric Pressure
1000 hPa –750 hPa
Communication
Bluetooth
Expected service life of PeakFlow+ and Aerobit
Turbine
2 Years
Regulations applicable
ISO 23747
ISO 26782
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
In case of questions, feedbacks or concerns, please contact us at: -
[e-mail]
Aerobit Health Inc
11325 Random Hills Road, Suite 360,

Fairfax, VA, 22030
USA
Aerobit Labs Pvt ltd
303, Nyati Emporius, Mahalunge
Baner, Pune 411045
India
Version USM_1.0