EVOLU Nano AiR MINI User manual

USER MANUAL
PORTABLE MESH
NEBULIZER
the best reason to take care of yourself {YES, YOU}
www.evolu.health
Model: Air Mask II
GB
RU
DE
User manual
Инструкция по применению
Bedienungsanleitung

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Content
1.ImportantSafetyNotes........................................... 3
2. ProductDescription.............................................. 4
3.InstallationInstructions........................................... 6
4.UseInstructions................................................. 7
5.CleaningandDisinfectionMethod................................ 10
6.StorageandMaintenance........................................ 11
7. Contraindications, Precautions, Notices and Warnings. . . . . . . . . . . . . . 12
8.TroubleShootingTips............................................ 14
9.Disposal........................................................ 15
10.After-salesService.............................................. 15
11. Symbol description & Electromagnetic compatibility . . . . . . . . . . . . . . 16
12.Configurationlist.............................................. 21
13.WarrantyCard................................................ 22
14. Manufacturer information ..................................... 24

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•In order to make sure that this product can be used correctly, please read this
manual carefully before use.
•Please keep this manual in a convenient place for easy access.
•Illustrations contained in this user manual are schematic.
1. Important Safety Notes
Before use, ensure that there is no visible damage to the device or accesso-
ries. In case of any doubt, do not use the device and contact your retailer or
the specified Customer Service address.
Do not use health products or medicines containing essential oils for nebuli-
zation.
You should always follow the instructions of your doctor regarding the type of
medication to use, the dosage, and the frequency and duration of inhala-
tion. Only use medication prescribed or recommended by your doctor or
pharmacist.
The use of this product for children and persons with special needs must be
carried out under correct guidance and supervision.
This unit is only used for specified purposes, only for nebulization. Do not use
the device for any other purpose.
Clean and disinfect the medication cup and accessories before using or not
using the unit for quite a while.
Please stop using the device if the components are damaged or fall into the
water accidentally.
Keep the device away from your eyes when it is in use, as the nebulised
medication could be harmful.
Keep packaging material away from children (risk of suocation).
Do not use any additional parts that are not recommended by the manufac-
turer.
If any serious incident that has occurred in relation to the device, please report
to the manufacturer or the distributor immediately.
Thank you very much for purchasing
EVOLU Portable Mesh
Nebulizer Nano AiR MINI

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2. Product Description
2.1. Product Name: EVOLU Portable Mesh Nebulizer Nano
AIR MINI.
2.2. Model: Air Mask II
2.3. Working Principle and Mechanism
The working principle of the product is driven by the rapid oscillation of the
circuit, making the piezoelectric ceramic transducer chip resonant oscillation,
which drives the micro-metal mesh rapid oscillation, the liquid through the
metal mesh on the tiny mesh and is quickly pop-up, the formation of numerous
tiny atomized particles, through the mask or mouthpiece to guide the patient’s
respiratory system, in order to achieve the purpose of inhalation therapy. Respi-
ratory system is an open system, the liquid is atomized into particles, the patient
inhalation of these drug fog, the drug can be directly adsorbed deposited in the
patient’s mouth, throat, trachea, bronchi, alveoli, etc., by its mucous membrane
tissue absorption to achieve the purpose of treatment.
2.4. Applicable scope and intended user
The device is a mesh nebulizer designed aerosolize liquid medication for inhala-
tion therapy in professional healthcare environment and in home healthcare
environment. Suitable for pediatric and adult patient. Infants, children and
compromised individuals should be used under adult supervision.
2.5. Specification
The median particle size in this nebulizer is measured with 0.9% physiological
saline under conditions of a temperature of 25°C and a humidity of 59% R.H. The
equivalent particle size distribution curve of the fog particles measured under
these conditions is as follows:
Power Supply: DC 3.7 V (Li-ion Battery)
or DC 5.0 V/1.0 A IEC 60601-1 with AC
adapter.
Power consumption: < 4.0 W
Nebulization Rate: 0.15 ml/min ~ 0.90
ml/min
Particle Size: MMAD < 5µm
Working Frequency: 130 kHz ± 10 kHz
Medication Cup Capacity:
6 ml (Max)
Product Size/Weight: 72.5 mm (L) ×
67.5 mm (W) × 50.5 mm (H) / 72 g
Working Environment:
Temperature: +5˚C ~ +40˚C
Relative Humidity: ≤ 80% R.H.
Non-condensing state
Atmospheric pressure:
86.0 ~ 106.0 kPa
Storage/Delivery Environment:
Temperature: -20˚C~ +55˚C,
Relative Humidity: ≤ 80% R.H.
Non-condensing state,
Atmospheric pressure:
86.0 ~ 106.0 kPa

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2.6. Product Composition
Nebulizer nano AIR MINI is composed mainly by the main unit and medication
cup, spray nozzle and micro USB cable.
2.7. Product Contents
Note: The horizontal axis is the particle size value, the value is logarithmic
distribution;
The left vertical axis is the cumulative percentage of the volume, corresponding to
therising trend of the curve;
The right vertical axis is the volume percentage of a certain section, correspond-
ing to the histogram or undulating;
1. Medication Cover
2. Medication cup
3. Spray Nozzle
4. Mesh Diaphragm
5. Main Unit
6. Power Switch
7. Electrode Contact pin
8. USB Charging Port
9. Adult Mask (PVC)
10. Child Mask (PVC)
11. Mouthpiece (PP)
12. Headband
Schematic diagram of host structure
1
2
3
4
5
6
7
12
8
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11

Air intake Air intake
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3. Installation Instructions
3.1. Remove all packings, then remove the unit and accessories.
3.2. Install the assembled bottle on the main body. When you install it, you
should hear the crisp clasp sound (as shown in the schematic diagram of the
installation of the liquid bottle).
3.3. Install the suction mask and the nozzle as shown in the schematic.
(Charging diagram)
Please be sure to install
it in place.
Connect the medication
cup.
Connect the mask Connect the mouth-
piece
Note: Before charging, please make sure the
socket connected is normally charged.
Note: This device has independent charging.
Please do not charge with any other electronic
equipment.
4) Battery Charging
a. The battery group can supply power up to 60 minutes continually after full
charging.
Note: Clean, disinfect, dry all parts before installation.
3.4. Power Supply
1) The nebulizer has a USB cable for charging, it is without power adapter, please
use an IEC 60601-1 approved AC adapter (output: DC 5.0 V, 1.0 A) for charging.
2) The power system of the device is equipped with one rechargeable lithium
battery.
3) When the device is running low, please charge it using Micro USB cable, then it
will able to work again.

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b. When the low battery level is detected, the blue indicator flashes for 5 times
and then turns o.
c. Please use the power adapter (DC 5.0 V, 1 A) to charge the batteries for about
2 hours.
d. The blue indicator flashes when charging and keeps lighting when full-
charging.
Note:
1) Battery has been loaded, do not privately disassemble.
2) Rechargeable batteries shall not be replaced by user, only replaced by
manufacturer.
3) Keep charging the device at least once per month during the storage period
exceed one month.
4) Alkaline, lithium-ion or other batteries are not applied to the device.
5) Please charge at least 30 minutes before using for the first time.
6) In order to achieve as long a battery service life as possible, fully charge the
battery at least once a month.
Warning:
· Please dispose the used batteries according to the local environmental
regulation. Do not dispose together with the rubbish to avoid environment
pollution.
· Do not dismantle or repair the equipment or components, do not dismantle,
replace the battery.
• If you need to replace the battery, please contact the distributor.
• If your skin or eyes come into contact with fluid from a rechargeable battery
cell, flush out the aected areas with water and seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries. Store
batteries out of the reach of small children.
• Risk of explosion! Never throw batteries into a fire.
• Do not disassemble, split or crush the batteries.
• Only use chargers as specified in the instructions for use.
• Batteries must be charged correctly prior to use. The instructions from the
manufacturer and the specifications regarding correct charging given in
these instructions must be observed at all times.
4. Use Instructions
4.1. Indicator description form

1 2 34
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Green light keeps on (uniform nebuli-
zation mode): Working
Green light flashes (micro-wave
mode):
Green light fleshes 3 times: Long press for 3 seconds to switch
the atomization mode
Blue light flashes 5 times: Battery low, shut down
Orange light flashes 10 times: Without medicine and shut down
Blue light flashes: Charging
Blue light keeps on: Full charged
Green light flashes 10 times: 10 minutes set time
4.2. Prepare: Cleaning and disinfecting the components, spray
nozzle and medication cup before using.
4.3. Inject the liquid: open the cap, inject the solution and cover
the cap clockwise.
Note: Please add the liquid before turning on the device.
Note: Leakage protection! When pouring medication into the medica-
tion container, ensure that you only fill it up to the maximum mark (6
ml). The recommended filling quantity is between 2 and 6ml. Nebuli-
sation only occurs while the substance to be nebulised is in contact
with the mesh. If this is not the case,nebulisation stops automatically.
So please try to hold the device as vertically as possible.
Note: There is enough liquid, but the orange light flashes 10 times, dur-
ing orange light flashing, please press switch key once to continue
work.

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a. direct inhalation c. by mouthpieceb. by mask
4.4. Nebulization
1) Connect mask or mouthpiece, press power button to turn on, start
nebulization.
2) It starts with a medium spray rate, and the spray rate can be adjusted by
pressing & as needed.
3) This device has a Micro-wave mode in which the spray rate is changed
automatically from max to mini rate or converse in 6 seconds. After
switching to the micro-wave mode, long press button for 3s (when
the green light flashes 3 times) to switch to the uniform nebulization
mode.
4) Boot before atomization, please shake slight level, make solution to fully
contact with atomization, using the following three ways of inhalation
according to individual needs.
5) Slowly taking a deep breath and then breathing in drugs.
6)The nebulizer will shut down automatically after 10 minutes. If you need to
continue to use, press the Power Button . Please make sure there is
enough liquid in the medication cup.
7) After nebulization, press the Power Button to turn o the nebulization.
Pour out the trace of residual liquid from the medication cups and do not
reuse it. (disassembly like showed below).
a. Remove the liquid
cup horizontally
b. Pour out
the liquid
c. Rotate the spray
nozzle counter
clockwise
d. Take out the
mesh diaphragm

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8) Use purified water to clean the medication cup, spray assembly, lid, thread
assemblies and accessories, and then follow the recommended method of
disinfection.
Note: 1) Host nebulizer to keep the liquid and nebulization mesh disc in full con-
tact. Slight swing does not aect the use but do not lean back the nebulization.
2) Receiving treatment according to the doctors’ recommendation. Keep quiet
and relaxed in the course of treatment.
3) Liquid will be coagulated around the spray assembly and mesh disc, which
will aect the nebulization eect after nebulization. It should stop nebuliza-
tion, remove the mouthpiece and other accessories. Then use a clean
medical gauze to wipe the residue. Do not touch the mesh disc center spray
area to prevent damage to the mesh disc.
4) Essential oils, cough syrups, gargling solutions and drops to be used as a rub
or in a steam bath are wholly unsuitable for inhalation using a nebuliser. These
additives are often viscous and can impair the correct functioning of the device
and therefore the eectiveness of the application in the long term.
5. Cleaning and Disinfection Method
After each use, it is necessary to clean and disinfect the cup
components (including medication cup, lid), spray assem-
bly, mask or mouthpiece. The specific methods of cleaning
and disinfection are recommended as follows:
5.1. Cleaning:
Please turn o the power when cleaning device. Do not connect the device with
power supply.
1) Remove the components from the main unit: the cup components (including
medication cup,lid), spray assembly, mask or mouthpiece, and soak all the
components the main unit excluding in clean warm water (which is no more
than 40°C) for about 5 minutes.
2) After cleaning, wipe all the components with clean medical gauze, and leave
on open air to dry completely.
3) Wipe the outer shell of main unit. If there is medicine residue remaining at the
electrode contact, please clean it with wet clean medical gauze. After cleaning,
keep the main unit dry.
4) Store all the parts in a dry and clean place to avoid contamination.
Note:
· The main unit can not be washed with water to prevent water from entering
the main unit.
· Use clean medical gauze to wipe the moisture of the main unit and compo-
nents and keep them dry to ensure safe use next time.
• The masks must not be placed in hot water!
5.2. Disinfection

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After each use, it is necessary to disinfect the components of the cup, spray
nozzle, mask, mouthpiece, etc., as follows:
1) Disinfection with hydrogen peroxide:
Disinfect all the components by placing them in 3% hydrogen peroxide for
10 minutes, including cup components (medication cup, lid), spray assembly,
mask or mouthpiece, the main unit excluding.
After disinfection, rinse all the parts with water, then wipe with clean and
medical gauze or air-dry naturally to keep all parts dry.
A. Please study the user guidance of hydrogen peroxide and do not immerse in
solution for a long time.
B. Do not use strong oxidizing agents such as perchlorate or disinfectants that
are corrosive to metals, polymer compounds or polymers.
2) Ethanol disinfection:
Place the cup components (including medication cup, lid), spray assembly, mask
in 75% medical ethanol for 10 minutes for disinfection. Or wipe and disinfect the
cup components (including medication cup, lid) spray assembly, mask. After
disinfection, rinse all the parts with water, then wipe with clean medical gauze or
air-dry naturally to keep all parts dry.
Note:
Disinfectants remaining on components need to be wiped with clean medical
gauze to ensure safe use next time. Do not touch the central area of the mesh
disc when washing or cleaning the spray connector, so as to avoid damaging
the mesh diaphragm.
5.3. Drying
• Dry the parts carefully using a soft cloth.
• Shake the spray assembly gently from side to side (5 – 10 times), so that the
water inside the mesh is removed from the tiny holes.
• Place the individual parts on a clean, dry and absorbent surface and leave them
to dry completely (at least 4 hours).
Note: Please ensure that the parts are completely dry after cleaning, other-
wise the risk of bacterial growth is increased. Put the parts together again if
they are completely dry and place the parts in a dry, sealed container. Ensure
that the spray assembly is completely dried o by the shaking. Otherwise, the
nebulisation may not work after reassembling the device. If this is the case,
shake the spray assembly again so that the water can escape. The nebuliser
should then work as normal.
6. Storage and Maintenance
6.1. Nebulizer Storage
1) Storage conditions:
a. Environment temperature: -20°C ~ +55°C;
b. Relative humidity: ≤ 80% R.H. Non-condensing state;
c. Atmospheric: 86.0 kPa ~ 106.0 kPa;
d. Others: Non-corrosive gas, good ventilation, avoid high temperature, humidity

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•The nebulizer is a medical device and is intended for human use only. Please
follow the instructions in the manual or under the guidance of a doctor, infants
and young children and special care crowd should be used under the supervi-
sion of the guardian.
•Please use original parts and accessories. Warranty service is not provided
for damage caused by accessory beyond our list and damaged by the user’s
personal causes.
and direct sunlight.
2) Storage instructions:
a. The device is valid for 5 years in the above mentioned storage condition.
b. The nebulizer should be promptly cleaned and disinfected after use, the
medication cup and other accessories should store into the packing box after
completely drying. Stored in the required environmental condition, avoiding
impact.
6.2. Nebulizer Maintenance
1) Normal working conditions
a. Environment temperature: +5°C ~ +40°C;
b. Relative humidity: ≤80% R.H. Non-condensing state;
c. Atmospheric pressure: 86.0 ~ 106.0 kPa;
d. Power: DC 3.7 V (Li-ion Battery) or DC 5.0 V/1.0 A with AC adapter (purchased
by user, technical specification please refer to Chapter 2 for details).
2) Maintenance Instructions:
a. Please use nebulizer under normal conditions.
b. Do not use the nebulizer near the heating device or open flame. Do not use a
microwave oven, fan and other dry nebulizer and accessories.
c. Do not expose the nebulizer and accessories to corrosive liquids and gases.
d. Do not wrap the power cord around the unit.
e. When using a nebulizer, if any irregularities are encountered, seek a solution
in accordance with Chapter 8.
f. Dry the parts immediately after washing. Store the device and the compo-
nents in the environment that meets the requirements, and be careful to avoid
collisions.
g. Direct sunlight, lint, dust may cause vibrating mesh rusted and oxydised and
decrease nebulisation rate.
h. If the nebulizer still does not work properly, please contact the distributor.
7. Contraindications, Precautions, Notices
and Warnings
7.1. Contraindications
1) This product is not suitable for Pentamidine drugs.
2) Pulmonary oedema patients are prohibited to use.
3) Acute asthma and acute pulmonary infarction episodes are prohibited to use.
7.2. Notice and suggestion:

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•The equipment waterproof classification is IP22, main unit can’t be washed, and
prevent the ingress of water.
•Please refer to Chapter 8 (Trouble Shooting Tips) when there are problems or
contact the distributor for maintenance. Do not attempt to repair the equipment
personally.
•Please clean and disinfect the unit after use and refer to Chapter 5 (Cleaning
and Disinfection Method) for details.
•The nebulizer is for medication atomization.
•Remove the liquid before or storing the device.
•Please confirm all the accessories are intact before use it.
•The nozzle is a disposable accessory, only for a single person using to avoid
cross-infection.
•Try to keep the liquid fully reach the mesh disc when use.
•Never submerge the device in water and do not use it in the bathroom. Under
no circumstances may liquid enter the device.
•Do not use the unit near flammable gas atmospheres or near oxygen and
anaesthetic mixtures.
•The instrument is expected to be used in radioactive radiation harassment
controlled electromagnetic environment, as far as possible away from the
source of harassment.
•Do not use the device in a high temperature environment, as this may cause
malfunction and fire.
•Keep the device and parts away from strong vibrations, such as impact.
•Please do not use liquid which contains esters, oil or suspended particles,
including herbal extract.
•Do not wash the main unit with running water to avoid water come inside the
device, especially the USB connector.
•Do not use the microwave ovens to dry or disinfect the unit, as this may cause fire.
•Please place it in a place where children, infants and psychotic patients can
not reach it.
•Please use qualified manufacturers of lithium battery power charger (output
5.0 V/1.0 A).
•Do not touch the center of spray mesh by hand or other sharp objects, as this
may cause damage, and can not be used.
•The nebulizer has no moisture proof and dustproof function, and the product
should not be stored in a wet or dusty environment.
•If the device has been dropped, exposed to high levels of moisture or suered
any other damage, itmust no longer be used. If in doubt, contact Customer
Services or the retailer.
• Do not disassemble, repair, modify the device, as this may cause electric shock,
leakage or fire.
• Dispose of the wasted device and accessories in accordance with local regula-
tions. Illegal disposal may pollute environment.
• Users can dispose the device as general waste recyling and reduce environ-
ment pollution.

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TROUBLE POSSIBLE CAUSE/SOLUTION
Do not work when
turn on
1) Check whether the nebulizer has enough power,
when the blue and green indicator is always on,
please recharge the device.
2) Check if the medication cup been full filled.
Low volume
1) Check if the medication cup been filled with right
medication which should be water-solubility, non-
corrosive medication.
2) Check whether the amount of liquid is too
enough.
3) The spray mesh maybe blocked, you can drop 2
or 3 drops of white vinegar into the medication cup
with 3-6 ml water, then fully nebuilzed. Clean the
medication cup to disinfection for next nebulization.
8. Trouble Shooting Tips
Trouble shooting for nebulizer
7.3. Warning
•Please refer to the doctor before use the device if you have diabetes or other
illnesses.
•Using and purchasing the device should be advised by a doctor, please refer to
the doctor’s advisements regardign the medication type, dosing and way of use.
•Please stop using the device if feeling uncomfortable and ask for a doctor for help.
•Volatile oil are not allowed, may cause damage to module.
•Only water-soluble medicines containing alcohol or saline-diluted medicines can
be used for nebulization treatment,otherwise bronchospasm may be caused.
•Oily medication are not allowed.
•The device is not workable for respiration anesthesia system and respirator
system.
•Check the leaflet of the medication for any contraindications for use with the
usual systems for aerosol treatment.
•Do not use any liquids with a viscosity of more than 5, as this can irreparably
damage the mesh.
•Only use the medication with a saline solution.
•When the user needs to carry out product maintenance, the manufacturer can
provide the product circuit diagram, key component list and other information
according to the requirements, for the user’s qualified technical personnel
maintenance reference, can contact the manufacturer’s after-sales service
department to obtain.
•DO NOT turn on without liquid in the medication cup!
• Do not spill liquid to the device to avoid leakage, the possibility of electric shock
and cause malfunction, failure to use.

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What medication is more suitable
for nebulization
1) Please refer to and follow doctor’s advise.
2) Don’t use over sticky medication.
Some medication
residual
It is a normal sign, if there is some strange noises
or the unit shut o due to insuicient medication,
please stop nebulization.
Special care for babies and
children
1) For infants, the mask should cover the nose and
mouth to ensure eective inhalation.
2) On children, the mask should also cover both the
nose and mouth. It isnot very useful to carry out
nebulisation on someone who is sleeping, as not
enough of the medication will reach the lungs in
this case. Note: Inhalation should only be carried
out under the supervision of an adult and with their
assistance, and the child should not be left alone.
Each user needs individual con-
sumable item
Each user should use individual consumable items,
including mask and mouthpiece.
9. Disposal
Battery disposal
The empty, completely flat rechargeable batteries must be disposed of through
specially designated collection boxes, recycling points or electronics retailers.
You are legally required to dispose of the batteries.
General disposal
For environmental reasons, do not dispose of the device in the
household waste at the end of its useful life. Dispose of the device at
a suitable local collection or recycling point in your country.Dispose
of the device in accordance with EC Directive – WEEE (Waste Electri-
cal and Electronic Equipment).
If you have any questions, please contact the local authorities responsible for
waste disposal.
10. After-sales Service
10.1. Please contact our distributor to obtain warranty service.
10.2. If necessary, you can provide the circuit diagram and the necessary
information for the repair. If there is any problem in the maintenance of the
electrical circuit, you can contact the manufacturer or the distributor.
Others please refer to the user manual
*The company reserves the right of final interpretation of the warranty card,
which may be subject to change without prior notice

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Refer to instruc-
tion manual/
booklet NOTE On
ME EQUIPMENT
Separate collec-
tion for electrical
and electronic
equipment
General
imperative ON/OFF Switch
keep away from
sunlight Waterproof
Grade Fragile Keep dry
The application
part of Type BF
Note, Warning
refer to enclosed
file
Authorized
representative
in the European
Community Precautions
Manufacturer Batch code Production date
CE identification
+ Notified Body
number
Cause for electric
shock Increase
nebulization rate
Decrease
nebulization rate Medical Device
0%
80%
Humidity
limitation
-200C
+550C
Temperature
limitation
86kPa
106kPa
Atmospheric
pressure limita-
tion
Charging Interface
Do not
disassemble
LF electromag-
netic radiation Importer Disributor
Do not litter! Product can be
recycled
Catalogue
number
11. Symbol description & Electromagnetic
compatibility
11.1. Signs and symbols

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11.2. EMC Declarations
1) EMC information.
With the increased number of electronic devices such as PC’s and mobile (cellular)
telephones, medical devices in use may be susceptible to electromagnetic interfer-
ence from other devices. Electromagnetic interference may result in incorrect opera-
tion of the medical device and create a potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the
aim to prevent unsafe product situations, the IEC60601-1-2 standard has been imple-
mented. This standard defines the levels of immunity to electromagnetic interferences
as well as maximum levels of electromagnetic emissions for medical devices.
The device is conform to IEC60601-1-2 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
1. NOTE: The EMISSIONS characteristics of this equipment make it suitable for
use in a residential environment (for which CISPR 11 class B is normally required)
2. WARNING: The use of accessories and cables other than those specified, with
the exception of cables sold by EVOLU as replacement parts for internal compo-
nents, may result in increased emission or decreased immunity of the device.
3. WARNING: The medical devices should not be used adjacent to or stacked
with other equipment. In case adjacent or stacked use is necessary, the medical
device should be observed to verify normal operation in the configuration in
which it will be used.
4. PORTABLE RF communications equipment (including peripheras such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of [ME QUIPMENT or ME SYSTEM], including cables specified
by the MANUFACTURER. Otherwise, degradation of the performance od this
equipment could result.
5. Do not use mobile (cellular) telephones and other devices (such as MRI,
diathermy, electrocautery, RFID and electromagnetic security systems) which
generate strong electrical or electromagnetic fields, near the medical device.
This may result in incorrect operation of the unit and create a potentially unsafe
situation. Recommendation is to keep a minimum distance of 7 m. Verify correct
operation of the device in case the distance is shorter.
Nano AIR MINI Portable Mesh Nebulizer meet the requirement of electromagnetic
compatibility in IEC60601-1-2.
The user needs to install and use according to electromagnetic compatibility
information which is attached with it.
Portable and mobile RF communication device and some household appliances,
such as mobile, interphone, microwave oven, dry blower, may influence nebulizer
performance, so nebulizer should be kept away from them during using.
Guidance and manufacturer’s declaration stated in the appendix.

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Guidance and Manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test
level Compliance level Electromagnetic environment-Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV,
±8kV, ±15 kV,
air
±8 kV contact
±2 kV,±4 kV,
±8kV,±15 kV,
air
Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humid-
ity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines *1)
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Surge IEC
61000-4-5
±0.5±1 kV
Line to line
±0.5 kV ±1 kV,
±2 kV line to earth
±0.5 kV
±1kV line to line
Mains power quality should
be that of a typical commer-
cial or hospital environment.
Voltage dips,
short interrup-
tions and volt-
age variations
on power supply
IEC 61000-4-11
<5% UT (>95%
dip in UT) for 0.5
cycle
<5 % UT(>95 %
dip in UT) for 0.5
cycle Mains power quality
should be that of a typical
commercial and/or hospital
environment. If the user
of this device requires
continued operation during
power mains interruptions,
it is recommended that the
device be powered from an
uninterruptible power supply
or battery.
<5% UT (>95%
dip in UT) for 1
cycle
<5% UT (>95%
dip in UT) for 1
cycle
70%UT (30% dip
in UT) for 25/30
cycles
70%UT (30% dip
in UT) for 25/30
cycles
<5% UT (>95%
dip in UT) for
5/6 sec
<5% UT (>95%
dip in UT) for
5/6 sec
Guidance and Manufacturer’s declaration – electromagnetic emissions
This device is intended for use in the electromagnetic environment specified below. The
customer or the user of the device should assure that it is used in such environment.
Electromagnetic emission IEC 60601-1-2
Emissions text Compliance Electromagnetic environment-guidance
RF emissions CISPR 11 Group 1
This device uses RF energy only for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interfer-
ence in nearby electronic equipment.
RF emissions CISPR 11 Class B This device is suitable for use in all establish-
ments, including domestic establishments
and those directly connected to the public
low-voltage power supply network that sup-
plies buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2 Class A
Voltage fluctuations/flicker
emissions IEC 61000-3-3 Compliance
Cables: Length (m): Whether to block: Note:
USB Cable 1No -

GB
19
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is aected by absorption and reflection from structures, objects and
people.
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be con-
sidered. If the measured field strength in the location in which the device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating this device.
2. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications
equipment and the device.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commer-
cial or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
3V rms
150KHz to 80 MHZ
6Vrms in ISM and
amateur radio
bands
10 V/m
80 MHz to 2.7 GHz
385 MHZ-5785
MHZ
Test specifications
for ENCLOSURE
PORT IMMUNITY
TO RF wireless
communication
equipment (Refer
to table 9 of IEC
60601-1-2)
3V/m
3V/m
Portable and mobile RF
communications equipment
should be used no closer
to any part of this device,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
150 KHz to 80 MHZ
80 MHz to 800 MHz
d=2 3 P
.800 MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey, *2) should be less
than the compliance level
in each frequency range
*3) Interference may occur
in the vicinity of equipment
marked with the following
symbol:

GB
20
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended
below, according to the maximum output power of the communications equipment.
Maximum
output power
rate of transmit-
ters (W)
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d=1.2 P
80 MHz to 800 MHz
d=1.2 P
800 MHz to 2,5 GHz
d=2 3 P
.
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distanced in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
Precautions
1) In order to regulate the requirements for EMC with the aim to prevent unsafe
product situations, the EN 60601-1-2 standard has been implemented. The
nebulizer Nano AIR MINI conforms to the EN 60601-1-2 standard for both
immunity and emissions.
2) Portable and mobile RF communication equipment may aect the perfor-
mance of the nebulizer, avoid strong electromagnetic interference when
using, such as close to mobile phones, microwave ovens and so on.
Warning
1) Equipment or systems should not be used or stacked with other equipment.
If they must be close to or stacked use, it should be observed that the verifi-
cation in its use of the configuration can be normal operation.
2) Expect where the manufacturer of the unit is sold as a spare part for internal
components, accessories and cables may cause an increase in the emission
of this nebulizer or a reduction in immunity.