Pic Solution AIRFamily evolution User manual

AIRFamily
evolution

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EN
INSTRUCTIONS FOR USE
THESE INSTRUCTIONS ARE IMPORTANT. PLEASE KEEPTHEM FOR FUTURE REFERENCE.
Dear customer,
Thank you for choosing PIC Solution’s AirFamily Evolution, an aerosol therapy unit designed and manufactured
according the most up-to-date technologies.
AirFamily Evolution is a class IIa medical device which converts medicines from liquid or suspension to aerosol, so
they can be administered directly to the airways.
The exclusive PIC ActiFast Pro nebuliser cup supplied with AirFamily Evolution 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
A - Adult mask
B - Children’s mask
C - Mouthpiece
D - Nose fork
E - Connector for masks, mouthpiece and nose fork
F - PIC ActiFast Pro nebuliser cup
G - Air tube
G1 - Filters
A, B, C, D, E, F, G, G1 are available as spare parts in kit 02 038405 200 000
DEVICE COMPONENTS
H - On/off switch
I - Compressed air outlet
L - Filter Cover
M - Nebuliser cup support
N - Openings for cooling
O - Power cord
P - Handle
Q - Accessory holder compartment
GENERAL WARNINGS
• Before use, carefully read the information in this manual, and keep for future reference. If there are doubts about
the interpretation of any contents of this instructions manual, contact the dealer, distributor or manufacturer.
• 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 with electrical systems that do not conform to applicable
safety regulations.
• 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 it to overheat.
• 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

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rating label is located on the bottom of the unit.
• In case of incompatibility between the unit plug and the electrical socket, use certified adapters, provided
applicable legislation in the individual country allows such use, or have a PIKDARE authorised technician or
personnel from the PIC service centre replace the plug.
• To prevent overheating and damage to the compressor, switch off the appliance for at least 40 minutes after
every 20 minutes of uninterrupted use.
• WARNING! Using the device before 40 minutes have elapsed may result in motor overheating and cause the
safety cut-off devices to activate.
• To ensure correct operation, make sure that the air filter is dry. The filter cover may be removed by gripping the
handle with your thumb and index finger and turning. WARNING! keep the filter cover and the filter out of the
reach of children as these are small parts and could represent a swallowing and suffocating hazard.
• Do not use the device in the presence of nitrous oxide, oxygen or flammable air/anaesthetic mixtures.
• Turn off the device and disconnect from the mains after use and before adding more medicine.
• Do not fill the nebuliser cup beyond the maximum level indicated and check that all components have been
properly assembled.
• Keep the device and power cord away from hot surfaces.
• Do not use the appliance 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 appliance.
• Never touch the device with wet or damp hands.
• Do not drop or put the device into water or other liquids. Should this happen, immediately remove the plug from
the socket, do not use the device again and contact PIKDARE S.r.l. or the 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 flow of air.
• Do not block the holes of the filter cover located at the bottom 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 filter 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 off the power cord so the device
cannot work. Dispose of the device and power cord in compliance with applicable local laws and with Directive
2012/19/EU. We also recommend eliminating any parts that are potential hazards, particularly for children.
• For the disposal of accessories subject to wear, refer to Directive 2012/19/EU. 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 device, switch it off by removing the plug from the mains and contact
the PIC Service Centre only. The power cord and fuse listed in the “Technical Specifications” must be replaced by
PIC Service Centre staff only.
• WARNING! The mains plug of the power cable is the separating element from the electrical mains. When in use,
to disconnect the appliance from the mains, switch it off and pull out the plug from the power outlet. Always
connect the plug to an easy to reach socket to ensure that the device may be easily disconnected from the
electrical mains. Do not attempt to open, repair or tamper with the appliance.
• The patient and operator are the same person. The only operations that the patient/user may carry out safely are
those listed in the paragraphs“Preparation and use of the device”,“Cleaning and maintenance of the compressor”,
“Cleaning and maintenance of the nebuliser cup and accessories.”
• WARNING! Do not service and/or repair the appliance while it is being used! Any other action (including
disassembling and later reassembling the device) or any maintenance/service operations must be done solely
by a PiC Service Centre.

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PREPARING AND USING THE UNIT
• Take the device and the accessories out of the package and check that they are intact; in the event that they have
been damaged, replace them or refer to a PIC Service Centre (www.picsolution.com);
• Add the drug and/or the saline solution to the nebuliser cup, complying with the dose recommended by your
physician; close the nebuliser cup (MIN 2ml - MAX 10ml);
• Connect the tube to the nebuliser cup;
• Connect the nebuliser cup to the accessory needed for the therapy: Mask for adults or for children, fork,
mouthpiece (Applied parts made with biocompatible material) by means of the connector (E). 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;
• Turn on by pressing the on/off switch and start therapy;
• During the treatment session, the nebuliser cup can be rested on its own support;
• Carry out treatment preferably while seated in a comfortable position; NB: Images of the operations listed
above are included in the rapid guide provided with the device.
• 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 finished when
no more nebulised solution is released from the nebuliser cup;
• Once the treatment session is completed, switch the device off, unplug the device from the electrical mains,
remove the accessory used, and clean the device and accessories according to the instructions in the Cleaning
and Maintenance paragraph;
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.
WARNING! Do not boil the masks.
• 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 storing.
• Store the device and the accessories in a clean, 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 02 038405 200 000).
• Clean and check that accessories are in good condition before and after use. Replace them if damaged.
WARNING! Never leave the nose fork unattended as it is a small part that, if swallowed by children, could
represent an ingestion and suffocating hazard
CHECKING AND REPLACING FILTERS
Periodically check the condition of the filter. The filter was inserted to protect the compressor.
Correct filter maintenance prolongs the life of the aerosol. The frequency with which filter should be replaced depends on
the conditions in which the device is used. The filter is located at the bottom of the aerosol.
TO REPLACE THE FILTER:
• Remove the filter cover by gripping the handle with thumb and index finger and turning;
• Remove the filter to be replaced from its seat;
• Carefully fit the new filter;
• Put the filter cover back in place by pushing it down into its position and turning.
WARNING! Never leave the removed filter cover and/or filters unattended: these are small parts
and are a suffocation hazard if swallowed by children.

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DEFECT TYPE CAUSE SOLUTION
Scarce nebulisation Nebuliser cup clogged Remove all components of the
nebuliser cup, disconnect and
clean them complying with the
instructions provided in this in-
struction manual.
Scarce nebulisation Nebuliser cup clogged If the problem persists after clean-
ing, replace the nebuliser cup.
Nebulisation absent Nebuliser cup components not
assembled correctly
Take apart and reassemble the nebu-
liser cup; If the problem persists, re-
place the nebuliser cup.
Nebulisation absent The compressor does not work Be sure that the plug for the power
cord is disconnected from the
socket, check that the on/off switch
is in the "on" position and that the
electrical socket works.
Slow nebulisation Drug too thick Dilute the medicine as indicated
by the pharmaceutical company
TECHNICAL DATA
Nominal voltage: 230Vac
Service life in storage conditions: 5 years
Absorbed power: 140 VA
Frequency: 50 Hz
Maximum ow: 18 ± 4 l/min
Fuse: T1.6A L, 250 V, 5x20 mm
Max pressure: 2.2 ± 0.6 bar
Maximum pressure [internal tubing]: 3 bar
Operational ow: 7 ± 2 l/min
Conditions for using the device: 20 min ON - 40 min OFF at 40°C
Operational pressure: 0.70 ± 0.3 bar
NEB RATE: > 0.34 ml/min
MMAD: 3.08 µm ± 0.16 µm
Weight: 1.6Kg
Nebuliser cup capacity: 10ml Max; 2ml Min
Breathable fraction: 71.8% ± 2.21
Appliance service life: 1000 cycles/treatments
Noise level at 50 cm*: 63dBA*
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 perfor-
mance - Collateral standard: electromagnetic compatibility - Requirements and tests.
EN 13544-1 Respiratory therapy equipment – Part one: Nebulising systems and their components
This section contains information specific to product compliance with the EN 60601-1-2 standard. PIC aerosol 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.

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Mobile and portable RF communications equipment (mobile phones, transceivers, etc.) may affect the device.
AirFamily Evolution 02038208000000 is designed for use in an electromagnetic environment that
meets the specifications provided below. The person who purchased or who uses AirFamily Evolution
02038208000000 is responsible for ensuring that the device is used in an environment that complies with
said specifications.
Manufacturer’s Declaration and Guidelines – Electromagnetic Emissions
Phenomenon
Professional
healthcare
environments a)
HOME
ENVIRONMENT a)
Radiated and conducted radiofrequency EMISSIONS a)CISPR 11
Group 1 Class B
Harmonic distortion IEC 61000-3-2 b) Class A
Voltage fluctuations/flicker COMPLIANT WITH IEC 61000-3-3 b)
a) The device is intended for use in a home environment or professional healthcare structure and may
exclusively be used in hospital rooms and in sections of hospitals or clinics set up for respiratory therapy.
The strictest acceptance limits required for Group 1 Class B (CISPR 11) have been considered and applied.
The device is suited for use in the environments mentioned above so long as it is connected to the public
electric mains.
b) The test may be applied to this environment so long as the ME EQUIPMENT and ME SYSTEM used are
connected to the PUBLIC ELECTRIC MAINS and the power supply is compliant with the standard applicable
policy regarding electromagnetic compatibility (EMC).
Manufacturer's Declarations and Guidelines - Electromagnetic immunity - Enclosure Door
Phenomenon Applicable EMC policy
or test method
Immunity test levels
Professional
healthcare
environments
Home environment
ELECTROSTATIC
DISCHARGE IEC 61000-4-2 ± 8 kV in contact ± 2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated radio-frequency
electromagnetic fields IEC 61000-4-3 a)
10 V/m b) 80 MHz
- 2.7 GHz 80% AM
at 1 kHz
Fields near radio-
frequency devices for
wireless communication
IEC 61000-4-3 COMPLIANT
NB: further information about the distances to be
maintained from portable and mobile radio-fre-
quency communication devices (transmitters) and
AirFamily Evolution 02038208000000 may be
requested by contacting PIKDARE S.r.l. using the
contact information included in this booklet. It
is nevertheless advisable to keep the electrome-
chanical aerosol therapy device at a safe distance
(at least 1m) from mobile phones or other com-
munication devices that use radio frequencies, to
minimise interference.

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Electromagnetic fields for
RATED mains frequency.
IEC 61000-4-8 30 A/m c)
50 Hz or 60 Hz
a) The device is intended for use in a home environment or professional healthcare structure and may
exclusively be used in hospital rooms and in sections of hospitals or clinics set up for respiratory therapy. The
strictest limits for acceptance were considered and applied during immunity testing.
b) Before modulation.
c) This test level presupposes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM
and the sources of magnetic fields at the mains frequency.
Manufacturer's Declarations and Guidelines - Electromagnetic immunity - Door for access with
alternating current
Phenomenon Applicable EMC policy
or test method
Immunity test levels
Professional
healthcare
environments
Home environment
Fast electrical transient/
burst
IEC 61000-4-4 ± 2 kV
Repetition frequency at 100 kHz
Line to line voltage
impulses
IEC 61000-4-5 ± 0.5 kV, ±1 kV
Line to ground voltage
impulses
IEC 61000-4-5 Class II Device or equipped with Class II AC/DC
adapter. Test non applicable
Disturbances conducted
induced by radio-
frequency fields
IEC 61000-4-6 3 V a) 0.15 MHz - 80 MHz
6 V a) for ISM bands ranging from 0.15 MHz to
80 MHz b)
80% AM at 1 kHz
Voltage drop. IEC 61000-4-11
0% in UT; 0.5 cycles
At 0°,45°,90°,135°,180°, 225°, 270° and 315°.
0% in UT; 1 cycle and 70% in UT; 25/30 cycles
Monophase: at 0°
Voltage interruption c) IEC 61000-4-11 0% in UT; 250/300 cycles
a) Effective value (rms) before modulation.
b) Frequency bands from 0.15 MHz to 80 MHz used by Industrial, Scientific and Medical radio-frequency devices (ISM)
are: 6.765 MHz - 6.795 MHz, 13.553 MHz - 13.567 MHz, 26.957 MHz - 27.283 MHz and 40.66 MHz - 40.70 MHz. The
radio bands used for amateur radio from 0.15 MHz to 80 MHz are: 1.8 MHz - 2.0 MHz, 3.5 MHz - 4.0 MHz, 5.3 MHz - 5.4
MHz, 7 MHz - 7.3 MHz, 10.1 MHz - 10.15 MHz, 14 MHz - 14.2 MHz, 18.07 MHz - 18.17 MHz, 21.0 MHz - 21.4 MHz, 24.89
MHz - 24.99 MHz, 28.0 MHz - 29.7 MHz and 50.0 MHz - 54.0 MHz.
c) ME EQUIPMENT with DC power inlet intended for use with an AC/DC adapter tested using a converter
that is compliant with the specifications of the MANUFACTURER of the ME EQUIPMENT. THE LEVEL OF THE
IMMUNITY TEST was applied to the converter's AC power inlet.

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LEGEND OF SYMBOLS:
Warning! Follow the Instructions
for Use On - Off
Class II device Frequency
Device protected against the
penetration of solids or liquids.
Protected against vertical falling
drops of water
Serial Number
Device with BF type parts Product ID
Complies with Directive MDD
93/42/EEC + 2007/47/EC Manufacturer
Alternate current Lot number
DEVICE DATE OF PRODUCTION: the second pair of digits in the lot number identifies the year, the third pair
identifies the month. ( 1016100001; 16 = 2016; 10 = October)
STORAGE AND TRANSPORTATION CONDITIONS:
Relative humidity: 15% ÷ 85%
Store in a cool, dry place.
Temperatures: -25 °C ÷ 70 °C
Atmospheric pressure from 70kPa to 106kPa
ENVIRONMENTAL CONDITIONS DURING USE:
Relative humidity: 15% ÷ 85%
Temperature: 5 °C ÷ 40 °C

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Atmospheric pressure from 70kPa to 106kPa
THIS PRODUCT COMPLIES WITH THE DIRECTIVE 2012/19/EU.
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 for 5 years in normal conditions of use as provided for
by the instructions for use.
The warranty shall not therefore apply to damage caused by improper use, wear or accidental events. For the dura-
tion of warranty on conformity defects please refer to the specific provisions of national laws.