Airofit Essential User manual

Airofit Essential
User Manual
EN

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1Purpose and Scope
2Intended Use and Users
3Safety Precautions
4Operation
5Maintenance
6 Getting started with Airofit Essential
7 Warning Notifications
8Troubleshooting
9 Technical Specifications
10 Airofit Limited Warranty 20
Contents

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1Purpose and Scope
This user manual describes the functionality and intended usage of Airofit
Essential.
2Intended Use and Users
The Airofit Essential is intended to exercise the muscles of the respiratory
system. This product is not intended to diagnose, treat, cure, or prevent any
disease. Intended users are:
•End user of the Airofit Essential
•Personnel instructing the user of the Airofit Essential
The Airofit Essential is used in conjunction with the Airofit software application
operating on a smartphone - either Android or iOS.
2.1 Manufacturer’s Liability
Airofit A/S is only liable for equipment safety, reliability, and performance,
provided that the Airofit Essential is used in compliance with these instructions.
3Safety Precautions
3.1 Health Considerations when Using Airofit Essential
To prevent damage to your Airofit Essential or injury to yourself, read the
following precautions in their entirety before using the Airofit system.

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•To prevent the potential transmission of infections, we recommend that you
do not share your Airofit Essential with any other user, including family
members. Moreover, your Airofit Essential is calibrated for only one user’s
personalized data.
•The Airofit Essential is manufactured in a safe environment. However, the
Airofit Essential is not provided as a sterile device – we recommend that you
clean the Breathing Trainer prior to use.
•Do not use Airofit Essential while performing any other activities (e.g., running,
cycling, rowing, driving).
•Do not use Airofit Essential for more than 60 minutes per day.
•Respiratory training can cause dizziness. We recommend that you remain
seated after training and breathe normally for a minimum of 1-2 minutes
before moving on to other activities.
•The Airofit Essential is suitable for ages 12 and over. Users under the age of
15 should only use Airofit under the supervision of an adult.
•Immediately stop the exercise if you feel any physical discomfort.
•If you feel light-headed or dizzy while exercising with Airofit, you should stop
and check the resistance wheel's inspiratory and expiratory settings.
•If you are suffering from a cold, sinusitis, or other respiratory tract infection,
we advise you to wait until all symptoms have disappeared before using the
Airofit Essential
•If you have any medical conditions with your respiratory system, heart, or blood
pressure, we recommend that you consult a doctor before using Airofit.
•Do not use Airofit to inhale any type of substance.

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3.2 Contraindications
To prevent damage to your Airofit Essential or injury to yourself, read
the following precautions in their entirety before using the Airofit
system. Use appropriate caution in the following situations:
•A history of spontaneous pneumothorax (collapsed lung), i.e., not due to
traumatic injury.
•A traumatic pneumothorax that has not fully healed.
•A burst eardrum that has not healed fully, or other conditions of the eardrum.
•The subgroup of asthma patients with unstable asthma with abnormally low
perception of dyspnea (shortness of breath) are also unsuitable candidates
for Inspiratory Muscle Training (IMT).
3.3 General Safety Cautions
•Only use the Airofit Essential together with the Airofit mobile application and
the selected sessions and programs. Always set resistance to the
recommended settings.
•Do not drop your Airofit Essential. Dropping the Breathing Trainer may result
in malfunction or cause a decline in performance.
•Ensure that the inhale/exhale vents located on the sides of Airofit Essential
are not obstructed while training.
•Do not immerse the E-Unit, or expose it to jets of water, or any other liquids.
For cleaning instructions, refer to the Maintenance section.
•Never use scouring pads, abrasive cleaning agents, or aggressive liquids such as
petrol or acetone to clean the device. The Airofit Essential is not dishwasher or
autoclave safe. For cleaning instructions, refer to the Maintenance section.

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•Ensure that your Airofit Essential remains hygienic and in good working
order. Always make sure that your device is dry before storing it. We advise
you to store your Airofit Essential in a suitable, clean, and hygienic way.
•Only use the supplied magnetic charging cable together with a CE-certified
USB charger (refer to Technical Specifications).
•If you have more than one Airofit Essential, do not swap the
E-Units. Each E-Unit is calibrated precisely to the device, and swapping them
will cause inconsistencies in measurement results.
4Operation
Your Airofit Essential package consists of:
•Airofit Essential
• Magnetic charging cable
•Airofit Essential Start Guide
4.1 Airofit Essential System Description
The Airofit PRO 2.0 system consists of the Airofit Essential and the Airofit
mobile application. The Breathing Trainer provides resistance to your
inspiratory and expiratory breathing, while the application provides guidance to
respiratory training and monitors your performance over time.

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4.2 Getting to Know the Airofit Essential
Power Button
Removable E-Unit
Inspiratory Resistance Wheel
A
B
B
C
C
D
D
F
F
E
E
Expiratory Resistance Wheel
Trainer Unit
Removable Mouthpiece
A

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Power Button
Press the Power button to turn ON the Airofit Essential. It will begin
to blink green to indicate that the device is ON - at this point, it is
ready to be paired with the mobile application.
To turn the device OFF, press the Power button once again.
Removable Mouthpiece
The Mouthpiece is made of a softer material than the rest of the
Airofit Essential to ensure complete comfort during exercise.
To use it, gently bend the sides of the Mouthpiece and put it in your
mouth.
Removable E-Unit
The E-Unit contains electronic components. Do not immerse the
E-Unit, or expose it to jets of water, or any other liquids.
To clean or charge your Airofit Essential, firmly squeeze the grips and
remove the E-Unit from the rest of the Trainer.
Trainer Unit
The term ‘Trainer Unit’ is used for your Airofit Essential once the
E-Unit and Mouthpiece are removed.
Charging
The charging port can be found on the inside of the E-Unit. Attach
the magnetic cable to charge. When the light is blinking green, the
cable is attached correctly, and your E-Unit is charging.
When fully charged, the light will show as solid green

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4.3 Using the Airofit Correctly
When using the Airofit Essential, you should be relaxed and sitting upright.
Keep your head facing straight forward, as looking down can cause more
salivation. Do not hold the Airofit Essential with your hand during training
unless absolutely necessary. If you must, hold it with your hand on the E-Unit
and make sure that the openings near the resistance wheels are not
obstructed.
Place the device in your mouth so that your lips cover the outer shield of the
Mouthpiece and make a complete seal. The Mouthpiece bite block should be
gripped between your teeth.
When starting the exercise, the Breathing Trainer requires a short calibration
(zeroing) of the pressure measurement. Do not breathe into the Trainer during
this process. Wait for the instructions to begin the respiration exercise.
Airofit Essential should not be used in conjunction with other physical
activities. Breathing training while performing other physical exercises will
compromise the oxygenation of the locomotor muscles.

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5Maintenance
Always make sure that your device is dry before storing it. We advise you to store
your Airofit Essential in a suitable, clean, and hygienic way. Fully charge your
device if you are storing it for more than a week without use to avoid full battery
depletion. Remember to charge the Airofit Essential fully before resuming usage.
(Youtube: Airofit PRO - Care and Maintenance)
Daily Maintenance
As the device will be exposed to saliva during use, it is important to clean it
frequently. We recommend cleaning your device after each training session.
Always remove the E-Unit before cleaning the device. Do not immerse the E-
Unit, or expose it to jets of water, or any other liquids.
We recommend washing the Trainer Unit and the Mouthpiece in warm water
(below 60°C). After washing, shake off and blow through the Trainer Unit to
remove excess water, making sure it’s completely dry before reassembling. The
Airofit Essential is not autoclave or dishwasher safe.
Weekly Maintenance
Once a week, use a drop of dish soap in water to wash your Trainer Unit and
Mouthpiece thoroughly. Once washed, hold the Trainer Unit under running
water, allowing it to run through. Shake off excess water, blow through the
Trainer Unit, and dry with a clean towel. Let it air dry. Make sure the device is
completely dry before reassembling.

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Monthly Maintenance
Charge your Airofit Essential fully at least once a month, even when not in use,
to avoid complete battery depletion.
6 Getting Started with Airofit Essential
First-time use essentials
Before you start your training, it is recommended to charge the E-Unit until
the light is solid green. While the E-Unit is charging, rinse the Trainer Unit and
Mouthpiece in warm water, wipe them with a clean towel, and let them air
dry. When the E-Unit is fully charged and the Trainer Unit and Mouthpiece are
completely dry, you can reassemble the Breathing Trainer. The E-Unit contains
electronics; do not immerse the E-Unit, or expose it to jets of water, or any
other liquids.
Sign-up procedure
The Airot app will guide you through the initial steps of your Airot journey.
6.1 Lung Test
As instructed in the Airot app, you will initially perform a lung test to establish
your breathing condition. The app notication will pop up when you should take
the lung test.
The lung test records your
•Accessible Lung Capacity, your active lung volume
•Inhale strength, your Maximal Inspiratory Pressure (MIP)
•Exhale strength, your Maximal Expiratory Pressure (MEP)

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These measures are evaluated based on your gender, age, and height (as set in
your prole). The percentages (0-200%) show how you compare to other users
in the same demographic group as you.
6.2 Start Training
Based on the goal selected in the Airot app, you will nd training
recommendations within the app. Prepare your trainer by setting the correct
resistance levels and follow the app guidance to start the training. When your
exercise is nished, the result screen will appear in the app, and you will see a
summary of your training.
Understanding training levels
•Beginner: Low pressure loads with short breathing cycles
•Intermediate: Medium pressure loads with medium breathing cycles
•Expert: High pressure loads with long breathing cycles
Understanding training duration
Training duration can vary between 1-10 minutes. We strongly recommend that
you always take a short break after every 3 minutes of training.
6.3 Training History
The app contains your training history so that you can access your lung test and
training session results at any time.

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6.4 Settings
You can update your prole in the settings. Your account is protected by a
password, which can be reset. Preferences for background music and guidance
sound can be turned on/o for your training exercise. If you have any questions
about training, you can get them answered by clicking on the FAQ button. You
can also report a problem if you nd something wrong with the app. The app
also contains the Terms and Conditions (requires internet connection) and the
Privacy Policy, which you agreed to when you created your account.
6.5 Fundamentals in Breathing Performance
Term Description
cmH2O Pressure exerted by a column of water of 1 cm in height.
1 cmH2O = 0.980665 hPa (or mbar)
Accessible Lung
Capacity
The total of usable reserves of lung capacity which you can access
Lung capacity
compliance
Compliance in percent is evaluated with respect to gender, age and
height
Respiratory
pressure
Maximal Inspiratory Pressure (MIP):
Normal range: 20 - 170 cmH2O
Average: 75 ±25 cmH2O
Maximal Expiratory Pressure (MEP):
Normal range: 20 - 230 cmH2O
Average: 95 ±35 cmH2O

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Term Description
Airow resistance Resistance to airow during respiration
Breathing
compliance
Compliance is evaluated with respect to gender, age and height
Exercise level Beginner
Intermediate
Expert
7 Warning Notications
The list of warning notications:
Battery low (20%) The battery on your Airot device is low. Please charge as soon as
possible.
Battery low (5%) The battery on your Airot device is critically low and it might turn
o unexpectedly. Please charge it as soon as possible.
Too much variant
Failed to properly calibrate the device. Please make sure you’re not
breathing into the device and the device is not cold (please warm it
up in your hand before trying again).

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8Troubleshooting
General troubleshooting guidance is available online at: https://www.airot.com/
faq/
9 Technical Specications
9.1 Airofit Essential
Description Notes
Air resistance
Inhalation air resistance A-F:
10-250 cmH2O at (1 liter/sec)
Exhalation air resistance 1-6:
10-200 cmH2O at (1 liter/sec)
Monitoring
Accessible Lung Capacity 0.5 - 10.0 liters
Respiratory pressure 10 - 230 cmH2O

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Description Notes
Lung capacity compliance 0 to 200%:
Low: < 2.5 liter
Medium: 2.5 - 4.5 liter
High: > 4.5 liter
MIP/MEP compliance 0 to 200%:
Low: < 70%
Medium: 70 - 140%
High: > 140 %
Breathing compliance 0 to 100%:
Acceptable: 20-40 %
Fair: > 40-60 %
Good: > 60-80 %
Perfect: > 80 %
Exercise level 0 to 100% of MIP/MEP
Beginner: < 50%
Intermediate: 70%
Expert: > 90 %
Exercise settings Air resistance settings
Beginner: (D4, C3, B2)
Intermediate: (E5, D4, C3)
Expert: (F6, E5, D4)

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Description Notes
Material
Mouthpiece TPE
Housing ABS
Battery
Rechargeable 3.7V Li-ion, 35mAh
Capacity 8 hours
Charger 5V, min 100mA
Charging time 8 hours
Charger plug Magnetic connector
Communication
Bluetooth BLE version 5.1
Dimensions
Size 70mm x 77mm x 33mm
Weight 45g
Smartphone App
IOS version 11 or newer
Android version 7 or newer

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9.2 Environment
Description Notes
Operating conditions
Temperature indoor 15°C to 35°C
Temperature outdoor 0°C to 45°C
Relative humidity 10% to 90% RH
Pressure 960 hPa to 1,060 hPa
IP classication IP64
Storage and transport conditions
Temperature -25°C to 50°C
Relative humidity 10% to 90% RH
Pressure 700 hPa to 1,060 hPa
Electrical shock prevention
Electrical safety Type B
Leakage current < 0.5mA
EMC IEC 60601-1-2
9.3 Standards
The Airofit Essential training system is designed according to the Medical Device
Directive - MDD 2007/47/EC. The Airofit system is manufactured with
compliance to medical device Class I.

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The Airot system complies with the EU Directive on personal data security -
2016/680/EU.
The major standards applied are:
Standard Title Date
IEC 60601-1 (ed. 3.1) Medical electrical equipment
General requirements for basic safety
and essential performance
2012
IEC 60601-1-2 Medical electrical equipment
Electromagnetic compatibility
requirements and tests
2014
ISO 13485 Medical devices
Quality management systems -
Requirements for regulatory purposes
2016
ROHS (2011/65/EU) Restriction of Hazardous Substances
in electrical and electronic equipment
2011
REACH (EC 1907/2006) Registration, Evaluation, Authorisation
and Restriction of Chemical
substances
2006
WEEE Diretive 2012/19/EU 2012

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9.4 Radio Equipment Compliance
The Airot system complies with Radio Equipment Directive (RED) - 2014/53/EU.
The device complies with part 15 of the FCC Rules. FCC ID: 2ATQX-AF003
Operation is subject to the following two conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that
may cause undesired operation.
Note: 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 and 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 o 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 dierent from that to which
the receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.