Pic Solution AirCube User manual

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EN
INSTRUCTIONS FOR USE
THESE INSTRUCTIONS ARE IMPORTANT. PLEASE KEEP THEM FOR FUTURE REFERENCE.
Dear customer,
Thank you for choosing Pic Solution’s AirCube, an aerosol therapy unit designed and manufactured according the
most up-to-date technologies.
AirCube is a class IIa medical device which converts medicines from liquid or suspension form to aerosol form, so
they can be administered directly to the airways.
The nebuliser cup supplied with AirCube allows the medicine to correctly penetrate the respiratory tract, thanks
to size of the aerosol particles.
Before using the unit, we highly recommend that you read the short list of warnings contained in this manual, to
make sure you have correctly understood how to use it.
ACCESSORIES DEVICE COMPONENTS
A - Adult mask G - On/Off switch
B - Children's mask H - Compressed air outlet
C - Mouthpiece I - Filter
D - Nose fork L - Nebuliser cup support
E - Connection tube M - Openings for cooling
F - Nebuliser cup N - Power cord
A, B, C, D, E and F are available as spare parts in kit
02 00499 000 0000
GENERAL WARNINGS
• Before use, carefully read the information in this manual, and keep for future reference.
• Unit designed for aerosol therapy. Follow the instructions of a medical practitioner as to the type of medicine to
use, the dose, frequency and duration of inhalations. Any use other than the one for which the unit is intended
is considered improper and therefore dangerous; PIKDARE S.r.l. cannot be held liable for any damage caused
by incorrect or unreasonable use or if the device is used in electrical systems that do not conform to safety
regulations in effect.
• A power outage, a sudden failure or any other adverse condition may cause the unit to stop working, therefore
it is recommended that users have an alternative unit or medicine (agreed upon with a physician) that can be
used in the event this occurs.
• After removing the device from its packaging, check that it is intact, without any visible damage that may have
occurred during transport. If in doubt, do not use the unit, and contact the PiC Service Centre.
• Unroll the power cord completely before connecting it to the mains.
• The incomplete unrolling of the power cord may cause overheating.
• Packaging (bags, box, etc.) may be dangerous and should be kept out of reach of children. Keep the unit out of
reach of children, pets and persons with cognitive limitations.
• Before connecting the device, check that your mains voltage corresponds to that shown on the rating label. The
rating label is located on the bottom of the unit.
• In case of incompatibility between the unit plug and the electrical socket, use certied adapters if the existing
legislation in the individual country allows for it or have an PIKDARE S.r.l. S.p.A. authorised technician or personnel
from the PIC service centre replace the plug.
• To prevent overheating and damage to the compressor, switch o the device for at least 40 minutes after every
20 minutes of uninterrupted use.


• To ensure correct operation, make sure that the air lter is dry. The lter cover may be removed using a tool with
a flat blade. 

• Do not use the device in the presence of nitrous oxide, oxygen or ammable air/anaesthetic mixtures.
• Turn o the appliance and disconnect from the mains after use and before adding more medicine. Do not ll the
nebuliser cup beyond the maximum level indicated on it and check that it is assembled with all its components.
• Keep the device and power cord away from hot surfaces.
• Do not use the device while taking a bath or shower, or when in a damp place, or close to bath-tubs, sinks,
washbasins, or in any other situation in which there are liquids that may come into contact with the device.
• Never touch the device with wet or damp hands.
• Do not drop or put the device into water or other liquids. Should this occur, unplug it immediately, stop using the
appliance and contact PIKDARE S.r.l. S.p.A. or a PiC Service Centre.
• Do not block the openings for cooling air.
• Do not use the device if you feel drowsy.
• If children or persons with physical or mental disabilities use the device, proper supervision by an adult is
required. Children must be kept under adult supervision to ensure that they do not play with the device. The
device contains small parts that can be swallowed and the power cord poses risk of strangling.
• Do not use connectors or accessories not recommended by the manufacturer.
• Make sure the unit is placed on a level, stable surface when used in order to prevent spillage.
• During use, the surface must be free of any objects that may obstruct the correct ow of air.
• Do not block the holes of the lter cover located on the upper surface of the device with cloth or other items: this
could cause the motor to overheat and reduce device performance
• Do not pour liquid on the device, especially on the lter cover: this could lead to its undesired discharge/
nebulisation.
• Before cleaning or performing any maintenance work on the device, disconnect it from the mains by pulling the
plug out of the electrical socket.
• If you decide to no longer use the device, disconnect from the mains and cut o the power cord so the device
cannot work. Dispose of the device and power cord in compliance with existing laws. We also recommend
eliminating any parts that are potential hazards, particularly for children.
• Refer to laws in force for information regarding the disposal of accessories subject to wear. To dispose of the
device, refer to Directive 2012/19/EU.
• Do not use the device if, after a fall, it shows signs of damage on any of its parts. If in doubt, do not use the device,
and contact the PiC Service Centre.
• In the case of failure or malfunction of the appliance, switch it o by removing the plug from the mains and
contact the PiC Service Centre only. The power cord and fuse specied in the “Technical Specications” must be
replaced by PiC Technical Assistance Centre staff only.
              



PREPARING AND USING THE UNIT
• Take the device and the accessories out of the package.
• Pour the medicine and/or saline solution in the nebuliser tank, according to the doses recommended by your
physician, without exceeding the maximum level shown by the mark on the tank; close the nebuliser cup;
• Connect the tube to the nebuliser cup;
• Connect the nebuliser cup to the accessory needed for the therapy: Adult or children’s mask, fork, mouthpiece
(applied parts) see g. 3. In case of doubt, ask your physician about which accessory to use.
• Connect the tube to the compressed air outlet and to the nebuliser cup;
• Connect the device to the mains;

4
5
EN
INSTRUCTIONS FOR USE
THESE INSTRUCTIONS ARE IMPORTANT. PLEASE KEEP THEM FOR FUTURE REFERENCE.
Dear customer,
Thank you for choosing Pic Solution’s AirCube, an aerosol therapy unit designed and manufactured according the
most up-to-date technologies.
AirCube is a class IIa medical device which converts medicines from liquid or suspension form to aerosol form, so
they can be administered directly to the airways.
The nebuliser cup supplied with AirCube allows the medicine to correctly penetrate the respiratory tract, thanks
to size of the aerosol particles.
Before using the unit, we highly recommend that you read the short list of warnings contained in this manual, to
make sure you have correctly understood how to use it.
ACCESSORIES DEVICE COMPONENTS
A - Adult mask G - On/Off switch
B - Children's mask H - Compressed air outlet
C - Mouthpiece I - Filter
D - Nose fork L - Nebuliser cup support
E - Connection tube M - Openings for cooling
F - Nebuliser cup N - Power cord
A, B, C, D, E and F are available as spare parts in kit
02 00499 000 0000
GENERAL WARNINGS
• Before use, carefully read the information in this manual, and keep for future reference.
• Unit designed for aerosol therapy. Follow the instructions of a medical practitioner as to the type of medicine to
use, the dose, frequency and duration of inhalations. Any use other than the one for which the unit is intended
is considered improper and therefore dangerous; PIKDARE S.r.l. cannot be held liable for any damage caused
by incorrect or unreasonable use or if the device is used in electrical systems that do not conform to safety
regulations in effect.
• A power outage, a sudden failure or any other adverse condition may cause the unit to stop working, therefore
it is recommended that users have an alternative unit or medicine (agreed upon with a physician) that can be
used in the event this occurs.
• After removing the device from its packaging, check that it is intact, without any visible damage that may have
occurred during transport. If in doubt, do not use the unit, and contact the PiC Service Centre.
• Unroll the power cord completely before connecting it to the mains.
• The incomplete unrolling of the power cord may cause overheating.
• Packaging (bags, box, etc.) may be dangerous and should be kept out of reach of children. Keep the unit out of
reach of children, pets and persons with cognitive limitations.
• Before connecting the device, check that your mains voltage corresponds to that shown on the rating label. The
rating label is located on the bottom of the unit.
• In case of incompatibility between the unit plug and the electrical socket, use certied adapters if the existing
legislation in the individual country allows for it or have an PIKDARE S.r.l. S.p.A. authorised technician or personnel
from the PIC service centre replace the plug.
• To prevent overheating and damage to the compressor, switch o the device for at least 40 minutes after every
20 minutes of uninterrupted use.


• To ensure correct operation, make sure that the air lter is dry. The lter cover may be removed using a tool with
a flat blade. 

• Do not use the device in the presence of nitrous oxide, oxygen or ammable air/anaesthetic mixtures.
• Turn o the appliance and disconnect from the mains after use and before adding more medicine. Do not ll the
nebuliser cup beyond the maximum level indicated on it and check that it is assembled with all its components.
• Keep the device and power cord away from hot surfaces.
• Do not use the device while taking a bath or shower, or when in a damp place, or close to bath-tubs, sinks,
washbasins, or in any other situation in which there are liquids that may come into contact with the device.
• Never touch the device with wet or damp hands.
• Do not drop or put the device into water or other liquids. Should this occur, unplug it immediately, stop using the
appliance and contact PIKDARE S.r.l. S.p.A. or a PiC Service Centre.
• Do not block the openings for cooling air.
• Do not use the device if you feel drowsy.
• If children or persons with physical or mental disabilities use the device, proper supervision by an adult is
required. Children must be kept under adult supervision to ensure that they do not play with the device. The
device contains small parts that can be swallowed and the power cord poses risk of strangling.
• Do not use connectors or accessories not recommended by the manufacturer.
• Make sure the unit is placed on a level, stable surface when used in order to prevent spillage.
• During use, the surface must be free of any objects that may obstruct the correct ow of air.
• Do not block the holes of the lter cover located on the upper surface of the device with cloth or other items: this
could cause the motor to overheat and reduce device performance
• Do not pour liquid on the device, especially on the lter cover: this could lead to its undesired discharge/
nebulisation.
• Before cleaning or performing any maintenance work on the device, disconnect it from the mains by pulling the
plug out of the electrical socket.
• If you decide to no longer use the device, disconnect from the mains and cut o the power cord so the device
cannot work. Dispose of the device and power cord in compliance with existing laws. We also recommend
eliminating any parts that are potential hazards, particularly for children.
• Refer to laws in force for information regarding the disposal of accessories subject to wear. To dispose of the
device, refer to Directive 2012/19/EU.
• Do not use the device if, after a fall, it shows signs of damage on any of its parts. If in doubt, do not use the device,
and contact the PiC Service Centre.
• In the case of failure or malfunction of the appliance, switch it o by removing the plug from the mains and
contact the PiC Service Centre only. The power cord and fuse specied in the “Technical Specications” must be
replaced by PiC Technical Assistance Centre staff only.
              



PREPARING AND USING THE UNIT
• Take the device and the accessories out of the package.
• Pour the medicine and/or saline solution in the nebuliser tank, according to the doses recommended by your
physician, without exceeding the maximum level shown by the mark on the tank; close the nebuliser cup;
• Connect the tube to the nebuliser cup;
• Connect the nebuliser cup to the accessory needed for the therapy: Adult or children’s mask, fork, mouthpiece
(applied parts) see g. 3. In case of doubt, ask your physician about which accessory to use.
• Connect the tube to the compressed air outlet and to the nebuliser cup;
• Connect the device to the mains;

6
7
• Turn on by pressing the on/o switch and start therapy;
• During the treatment session, the nebuliser cup can be rested on its own support;
• Carry out treatment preferably seated and in a comfortable position;
• When the aerosol jet becomes intermittent, interrupt the treatment for a few seconds to allow the suspended
drops of solution to fall on the nebuliser cup walls. Resume the treatment session, which will be nished when
no more nebulised solution is released from the nebuliser cup;
• Once the treatment session is completed, switch the device o by unplugging it, remove the accessory used
and clean the device and accessories according to the instructions in the Cleaning and Maintenance paragraph.
• The patient and operator are the same person. The steps that the patient/user can do safely are only those
specied in the paragraphs “Preparing and using the appliance,” “Cleaning and maintenance of the compressor,
nebuliser cup and accessories.” Warning! Do not service and/or repair the appliance while it is being used! Any
other maintenance/service activity/operation must be done solely by a PiC Service Centre.
COMPRESSOR CLEANING AND MAINTENANCE
Warning! Do not wet the device or put it into water or other liquids. For cleaning, use a clean, dry cloth only.
CLEANING AND MAINTENANCE OF THE NEBULISER CUP AND ACCESSORIES
Remove and detach all the nebuliser cup components and dip them in boiling water for about 5 minutes.

Rinse the accessories (mask, mouthpiece, fork and tube) under running water. Cold disinfect all parts that come in
contact with the patient using denatured alcohol. Carefully dry all accessories and the device before reassembling.
Store the device and the accessories in a cool, dry place, away from light and heat.
Never use benzene, thinners or other inflammable chemical substances for cleaning.
For increased hygienic safety, never use the same accessories on more than one patient. Purchase a dedicated kit
for each user (Aerosol Kit 02004990000000).
Clean and check that the condition of the accessories before and after use. Replace them if damaged.


CHECKING AND REPLACING FILTERS
Periodically check the condition of the lter. The lter was inserted to protect the compressor.
Correct lter maintenance prolongs the life of the aerosol. The frequency with which lter should be replaced
depends on the conditions in which the device is used. The lter is located in the upper part of the aerosol.
TO REPLACE THE FILTER:
• Remove the lter cover by lifting it up carefully, using a tool with a at blade;
• Remove the lter to be replaced from its seat;
• Carefully t the new lter;
• Reposition the lter cover by pushing it down fully in its seat, making sure that it cannot be removed without
the use of a tool.


TYPE OF DEFECT CAUSE SOLUTION
Scarce nebulisation Clogged nebuliser cup Remove and detach all the nebu-
liser cup components and clean
them as illustrated in this instruc-
tion manual.
Scarce nebulisation Clogged nebuliser cup If the issue persists after cleaning,
replace the nebuliser cup.
No nebulisation Nebuliser cup components not as-
sembled correctly
Disassemble and reassemble the
nebuliser cup; if the issue persists,
replace the nebuliser cup.
No nebulisation The compressor does not work Check that the power cord plug is
disconnected from the mains and
that the on/off switch is on. If the
issue persists, contact a PIC Servi-
ce Centre.
Slow nebulisation Drug too thick Dilute the drug as instructed by
the manufacturer.
TECHNICAL SPECIFICATIONS
Nominal voltage: 230 V~ Service life in storage conditions: 1 year
Absorbed current: 1A Frequency: 50 Hz
Maximum ow: 13.5 ± 2 l/min Fuse: T 1 H 250V, 5x20mm
Max pressure: 2.2 ± 0.6 atm Operational ow: 6 ± 1 l/min
Conditions for using the device: 20' ON - 40' OFF at 40 °C Operational pressure: 0.65 ± 0.2 atm
MMAD: < 3.7 μm Weight: 1.2 kg
Nebuliser cup capacity: 10 ml Max ; 2ml Min Breathable fraction: 65.7 % ± 3.4
Device service life: 1,000 cycles/treatments Noise level at 50 cm*: 68 dB
Service life of accessories: 1 year
* Data on noise levels were measured on a new device. Values may vary over time with use.
The information on the unit’s capabilities provided by the manufacturer in accordance with EN 13544-1 may not
apply to medicines provided in suspension form or those that are highly viscous.
EN 60601-1 Medical electrical equipment – Part 1: general requirements for safety
EN 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
- Collateral standard: electromagnetic compatibility.
- Requirements and tests.
EN 13544-1 Respiratory therapy equipment – Part one: Nebulising systems and their components
This section contains information specic to product compliance with the EN 60601-1-2 standard. AirCube is a
medical electrical device that requires special precautions regarding electromagnetic compatibility and needs to
be installed and commissioned according to the electromagnetic information provided.
Mobile and portable RF communications equipment (mobile phones, transceivers, etc.) may affect the device.

6
7
• Turn on by pressing the on/o switch and start therapy;
• During the treatment session, the nebuliser cup can be rested on its own support;
• Carry out treatment preferably seated and in a comfortable position;
• When the aerosol jet becomes intermittent, interrupt the treatment for a few seconds to allow the suspended
drops of solution to fall on the nebuliser cup walls. Resume the treatment session, which will be nished when
no more nebulised solution is released from the nebuliser cup;
• Once the treatment session is completed, switch the device o by unplugging it, remove the accessory used
and clean the device and accessories according to the instructions in the Cleaning and Maintenance paragraph.
• The patient and operator are the same person. The steps that the patient/user can do safely are only those
specied in the paragraphs “Preparing and using the appliance,” “Cleaning and maintenance of the compressor,
nebuliser cup and accessories.” Warning! Do not service and/or repair the appliance while it is being used! Any
other maintenance/service activity/operation must be done solely by a PiC Service Centre.
COMPRESSOR CLEANING AND MAINTENANCE
Warning! Do not wet the device or put it into water or other liquids. For cleaning, use a clean, dry cloth only.
CLEANING AND MAINTENANCE OF THE NEBULISER CUP AND ACCESSORIES
Remove and detach all the nebuliser cup components and dip them in boiling water for about 5 minutes.

Rinse the accessories (mask, mouthpiece, fork and tube) under running water. Cold disinfect all parts that come in
contact with the patient using denatured alcohol. Carefully dry all accessories and the device before reassembling.
Store the device and the accessories in a cool, dry place, away from light and heat.
Never use benzene, thinners or other inflammable chemical substances for cleaning.
For increased hygienic safety, never use the same accessories on more than one patient. Purchase a dedicated kit
for each user (Aerosol Kit 02004990000000).
Clean and check that the condition of the accessories before and after use. Replace them if damaged.


CHECKING AND REPLACING FILTERS
Periodically check the condition of the lter. The lter was inserted to protect the compressor.
Correct lter maintenance prolongs the life of the aerosol. The frequency with which lter should be replaced
depends on the conditions in which the device is used. The lter is located in the upper part of the aerosol.
TO REPLACE THE FILTER:
• Remove the lter cover by lifting it up carefully, using a tool with a at blade;
• Remove the lter to be replaced from its seat;
• Carefully t the new lter;
• Reposition the lter cover by pushing it down fully in its seat, making sure that it cannot be removed without
the use of a tool.


TYPE OF DEFECT CAUSE SOLUTION
Scarce nebulisation Clogged nebuliser cup Remove and detach all the nebu-
liser cup components and clean
them as illustrated in this instruc-
tion manual.
Scarce nebulisation Clogged nebuliser cup If the issue persists after cleaning,
replace the nebuliser cup.
No nebulisation Nebuliser cup components not as-
sembled correctly
Disassemble and reassemble the
nebuliser cup; if the issue persists,
replace the nebuliser cup.
No nebulisation The compressor does not work Check that the power cord plug is
disconnected from the mains and
that the on/off switch is on. If the
issue persists, contact a PIC Servi-
ce Centre.
Slow nebulisation Drug too thick Dilute the drug as instructed by
the manufacturer.
TECHNICAL SPECIFICATIONS
Nominal voltage: 230 V~ Service life in storage conditions: 1 year
Absorbed current: 1A Frequency: 50 Hz
Maximum ow: 13.5 ± 2 l/min Fuse: T 1 H 250V, 5x20mm
Max pressure: 2.2 ± 0.6 atm Operational ow: 6 ± 1 l/min
Conditions for using the device: 20' ON - 40' OFF at 40 °C Operational pressure: 0.65 ± 0.2 atm
MMAD: < 3.7 μm Weight: 1.2 kg
Nebuliser cup capacity: 10 ml Max ; 2ml Min Breathable fraction: 65.7 % ± 3.4
Device service life: 1,000 cycles/treatments Noise level at 50 cm*: 68 dB
Service life of accessories: 1 year
* Data on noise levels were measured on a new device. Values may vary over time with use.
The information on the unit’s capabilities provided by the manufacturer in accordance with EN 13544-1 may not
apply to medicines provided in suspension form or those that are highly viscous.
EN 60601-1 Medical electrical equipment – Part 1: general requirements for safety
EN 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
- Collateral standard: electromagnetic compatibility.
- Requirements and tests.
EN 13544-1 Respiratory therapy equipment – Part one: Nebulising systems and their components
This section contains information specic to product compliance with the EN 60601-1-2 standard. AirCube is a
medical electrical device that requires special precautions regarding electromagnetic compatibility and needs to
be installed and commissioned according to the electromagnetic information provided.
Mobile and portable RF communications equipment (mobile phones, transceivers, etc.) may affect the device.

8
9
AirCube 02 038206 000 200 is intended for use in the electromagnetic environment specied below. Customers or users of
AirCube 02 038206 000 200 must ensure that it is used in the recommended environment.

Emissions test Complies Electromagnetic environment - guide
RF emissions CISPR 11 Group 1
AirCube 02 038206 000 200 uses RF energy only for its
internal operation. Therefore, its RF emissions are very low and it
is very unlikely that they interfere with nearby electronic devices
RF emissions CISPR 11 Class B
AirCube 02 038206 000 200 is suitable for use in every
room or domestic environment, and in rooms directly connected
to a low voltage public network powering buildings used for
domestic purposes
Harmonic current emissions IEC
61000-3-2 Class A
Voltage Fluctuations and Flicker IEC
61000-3-3 Compliant

Immunity test IEC 60601 test level Level of compliance Electromagnetic
environment - guide
Electrostatic discharge (ESD) IEC
61000-4-2
In contact ± 6 kV
In air ± 8 kV
In contact ± 6 kV
In air ± 8 kV
Floors should be wood,
concrete or ceramic tile.
If the floors are covered
with synthetic material, the
relative humidity should be
at least 30%.
Electrical fast transient/burst IEC
61000-4-4 ± 2 kV for power lines ± 2 kV for power lines
The quality of the network
voltage must be equivalent
to that of a typical
commercial or hospital
setting.
Surge IEC 61000-4-5 ± 1 kV between phases ± 1 kV between phases
Voltage dips, short interruptions
and voltage variations IEC
61000-4-11
<5 % UT (>95 % dip in UT) for
0.5 cycles
40 % UT (60 % dip in UT) for
5 cycles
70 % UT (30 % dip in UT) for
25 cycles
<5 % UT (>95 % dip in UT) for 5 s
<5 % UT (>95 % dip in UT) for
0.5 cycles
40 % UT (60 % dip in UT) for
5 cycles
70 % UT (30 % dip in UT) for
25 cycles
<5 % UT (>95 % dip in UT) for 5 s
Power frequency magnetic eld
(50/60 Hz) IEC 61000-4-8 3 A/m 3 A/m
Electromagnetic elds at
network frequency must
have levels equivalent to
those of a typical commercial
or hospital setting.
NB: UTis the network AC voltage before applying the test level.

Conducted disturbances,
induced by radio-frequency
elds IEC 61000-4-6
Radiated radio-frequency IEC
61000-4-3
3 V e from 150 kHz to 80 MHz
3 V/m from 80 MHz to 2.5 GHz
V1=3 V e from 150 kHz to
80 MHz
E1= 3 V/m from 80 MHz to
2.5 GHz
Portable and mobile RF com-
munication devices must not
be used closer to any part of
the AirCube 02 038206
000 200, including the
cables, than the separation
distance calculated by the
equation applicable to the
transmitter frequency.


d = [3.5 / V1] √P
d = [3.5 / E1] √P from 80
MHz to 800MHz
d = [7 / E1] √P from 800
MHz to 2.5 GHz
Where P is the maximum
rated output
power of the transmitter in
Watts (W) according to the
transmitter manufacturer
and d is the recommended
separation distance in
metres (m). The intensities
of the elds from xed RF
transmitters, as determined
in an electromagnetic study
of the sitea),
may be less than the
level of conformity of each
frequency intervalb).
Interference may occur
near devices marked by the
following symbol:
NOTE 1 - At 80 MHz and 800 MHz, the distance for the highest frequency range is to be applied.
NOTE 2 - These guidelines may not cover all situations. Electromagnetic radiation is affected by absorption and reflection by
structures, objects and people.
a) The eld intensities for xed transmitters like base stations for radio telephones (cellular and cordless) and terrestrial mobile radios,
HAM radio devices, AM and FM radio transmitters and TV transmitters can not be theoretically foreseen accurately. In order to
assess an electromagnetic environment caused by xed RF transmitters an electromagnetic study of the site must be considered.
If the eld intensity measured in the location where the AirCube 02 038206 000 200 is used exceeds the applicable level of
conformity above the normal operation of the AirCube 02 038206 000 200 must be placed under observation. If abnormal
performance is noted additional measures may required such as different orientation or positioning of the AirCube 02 038206
000 200.
b The eld intensity in 150 kHz to 80 MHz frequency range must be less than [V1] V/m.

8
9
AirCube 02 038206 000 200 is intended for use in the electromagnetic environment specied below. Customers or users of
AirCube 02 038206 000 200 must ensure that it is used in the recommended environment.

Emissions test Complies Electromagnetic environment - guide
RF emissions CISPR 11 Group 1
AirCube 02 038206 000 200 uses RF energy only for its
internal operation. Therefore, its RF emissions are very low and it
is very unlikely that they interfere with nearby electronic devices
RF emissions CISPR 11 Class B
AirCube 02 038206 000 200 is suitable for use in every
room or domestic environment, and in rooms directly connected
to a low voltage public network powering buildings used for
domestic purposes
Harmonic current emissions IEC
61000-3-2 Class A
Voltage Fluctuations and Flicker IEC
61000-3-3 Compliant

Immunity test IEC 60601 test level Level of compliance Electromagnetic
environment - guide
Electrostatic discharge (ESD) IEC
61000-4-2
In contact ± 6 kV
In air ± 8 kV
In contact ± 6 kV
In air ± 8 kV
Floors should be wood,
concrete or ceramic tile.
If the floors are covered
with synthetic material, the
relative humidity should be
at least 30%.
Electrical fast transient/burst IEC
61000-4-4 ± 2 kV for power lines ± 2 kV for power lines
The quality of the network
voltage must be equivalent
to that of a typical
commercial or hospital
setting.
Surge IEC 61000-4-5 ± 1 kV between phases ± 1 kV between phases
Voltage dips, short interruptions
and voltage variations IEC
61000-4-11
<5 % UT (>95 % dip in UT) for
0.5 cycles
40 % UT (60 % dip in UT) for
5 cycles
70 % UT (30 % dip in UT) for
25 cycles
<5 % UT (>95 % dip in UT) for 5 s
<5 % UT (>95 % dip in UT) for
0.5 cycles
40 % UT (60 % dip in UT) for
5 cycles
70 % UT (30 % dip in UT) for
25 cycles
<5 % UT (>95 % dip in UT) for 5 s
Power frequency magnetic eld
(50/60 Hz) IEC 61000-4-8 3 A/m 3 A/m
Electromagnetic elds at
network frequency must
have levels equivalent to
those of a typical commercial
or hospital setting.
NB: UTis the network AC voltage before applying the test level.

Conducted disturbances,
induced by radio-frequency
elds IEC 61000-4-6
Radiated radio-frequency IEC
61000-4-3
3 V e from 150 kHz to 80 MHz
3 V/m from 80 MHz to 2.5 GHz
V1=3 V e from 150 kHz to
80 MHz
E1= 3 V/m from 80 MHz to
2.5 GHz
Portable and mobile RF com-
munication devices must not
be used closer to any part of
the AirCube 02 038206
000 200, including the
cables, than the separation
distance calculated by the
equation applicable to the
transmitter frequency.


d = [3.5 / V1] √P
d = [3.5 / E1] √P from 80
MHz to 800MHz
d = [7 / E1] √P from 800
MHz to 2.5 GHz
Where P is the maximum
rated output
power of the transmitter in
Watts (W) according to the
transmitter manufacturer
and d is the recommended
separation distance in
metres (m). The intensities
of the elds from xed RF
transmitters, as determined
in an electromagnetic study
of the sitea),
may be less than the
level of conformity of each
frequency intervalb).
Interference may occur
near devices marked by the
following symbol:
NOTE 1 - At 80 MHz and 800 MHz, the distance for the highest frequency range is to be applied.
NOTE 2 - These guidelines may not cover all situations. Electromagnetic radiation is affected by absorption and reflection by
structures, objects and people.
a) The eld intensities for xed transmitters like base stations for radio telephones (cellular and cordless) and terrestrial mobile radios,
HAM radio devices, AM and FM radio transmitters and TV transmitters can not be theoretically foreseen accurately. In order to
assess an electromagnetic environment caused by xed RF transmitters an electromagnetic study of the site must be considered.
If the eld intensity measured in the location where the AirCube 02 038206 000 200 is used exceeds the applicable level of
conformity above the normal operation of the AirCube 02 038206 000 200 must be placed under observation. If abnormal
performance is noted additional measures may required such as different orientation or positioning of the AirCube 02 038206
000 200.
b The eld intensity in 150 kHz to 80 MHz frequency range must be less than [V1] V/m.

10
11
More information on distances to be kept between portable and mobile radio communications equipment and
AirCube 02 038206 000 200 can be requested from PIKDARE S.r.l. S.p.A., through the contact information
provided in this manual. It is nevertheless advisable to keep a safe distance (at least 1 m) between the ultrasound
aerosol therapy unit and mobile phones or RF transmitters in order to reduce possible interference.
LEGEND OF SYMBOLS:
Appliance date of production: the second pair of digits in the lot number identies the year, the third
pair identies the month. (LOT 1016100001; 16 = 2016; 10 = October)
CONDITIONS FOR STORAGE AND TRANSPORTATION:
ENVIRONMENTAL CONDITIONS DURING USE:

The crossed bin symbol on the appliance indicates that the product, at the end of its life, must be
disposed of separately from domestic waste, either by taking it to a separate waste disposal site for
electric and electronic appliances or by returning it to your dealer when you buy another similar
appliance. The user is responsible for taking the appliance to a special waste disposal site at the end of
its life. If the disused appliance is collected correctly as separate waste, it can be recycled, treated and disposed
of ecologically; this avoids a negative impact on both the environment and health, and contributes towards
the recycling of the product’s materials. For further information regarding the waste disposal services available,
contact your local waste disposal agency or the shop where you bought the appliance.
WARRANTY
The product is guaranteed against any conformity defect in normal conditions of use as provided for by the
instructions for use.
The warranty shall not therefore apply in the case of damages caused by improper use, wear or accidental events.
For the duration of warranty on conformity defects please refer to the specic provisions of national laws
applicable in the country of purchase, where provided.
Relative humidity: 15% / 85% RH
Store in a cool, dry place.
Temperature: -25°C / 70°C
Relative humidity: 15% / 85% RH
Temperature: 5°C / 40°C
Atmospheric pressure from 700hPa to
1060hPa
Warning! Follow the Instructions for use
Class II device
Device protected against penetration
of solids and liquids. Device protected
against vertically dripping water.
Device with Type BF applied part
Complies with Directive MDD 93/42/EEC
+ 2007/47/EC
Alternate current

On - Off
Frequency
Serial Number
Product identication code
Manufacturer
IP21