Pic solution Aireasy on User manual

WARRANTY

The product is covered by a 5 year warranty against any lack of conformity under the normal conditions

for use set forth in the instructions.

The warranty is therefore not applicable to damage resulting from improper use, wear or accidents.

The duration of the warranty against lack of conformity is subject to the specic provisions made by

national laws. The drug chamber and the accessories are not covered by the warranty.

SYMBOLS USED

0068

0123

Mark of conformity to directive 93/42/EEC as updated and amended

Warning!

Read the instruction manual

Equipment with BF-type applied part (masks/mouthpiece)

ON - OFF

Device with Class II Insulation

Alternating Current

Direct Current

IPX2

Degree of protection of electrical equipment against the accidental or

intentional penetration of foreign solid objects, and protection against the

penetration of liquids.

1st DIGIT

Penetration of solids

Not Protected

2nd DIGIT

Penetration of liquids

Protected against drops of water

when tilted up to 15°

Production Batch

SN Serial Number

Product ID Code

Manufacturer

WARNINGS CONCERNING PROPER DISPOSAL OF THE PRODUCT IN COMPLI

ANCE WITH EUROPEAN DIRECTIVE 2012/19/UERAEE:

A the end of its life cycle the product must not be thrown out with urban waste. It can be

handed over to the waste sorting centres provided by municipal authorities or returned

to the distributor when purchasing a new device of the same type for the same functions.

Disposing of the product as separate waste helps avoid the potentially harmful conse-

quences for health and the environment caused by improper disposal and allows for the

materials to be recycled, saving a signicant amount of energy and resources.The symbol located in the

data label indicates the collection of electrical and electronic material as separate waste.

Warning: Improper disposal of electrical and electronic appliances may result in sanctions.

EMC – ELECTROMAGNETIC COMPATIBILITY, GUIDE AND MANUFACTURER’S STATEMENT

1) This appliance must be installed and used in compliance with the information provided in the AC-

COMPANYING DOCUMENTS;

2) The selection of IMMUNITY TEST LEVELS for the basic safety and essential performance of ME appli-

ances and ME systems should be based on the probability of maintaining basic safety and essential

performance, and must be consistent with the professional environment of the health care facility, the

domestic health setting and any special environments, on the basis of the designated place of use.

3) The DOMESTIC HEALTH ENVIRONMENT is the place where the patient lives or other locations where

patients are present, excluding environments in professional health care facilities where operators with

medical training are constantly present whenever there are patients. Schools, open areas, homes, hab-

itable vehicles and guest houses are therefore also included.

TABLE A1 - Electromagnetic emissions - For all APPLIANCES and SYSTEMS

Guide and manufacturer’s declaration – Electromagnetic Emissions

The AIREasy On aerosol device can be used in the electromagnetic setting

specied hereafter. The Customer and/or the user of the AIREasy On device must

ensure that the appliance is used in such a setting

Emissions test Conformity Electromagnetic

Environment - Guidance

Emissions Radiated/

Conducted CISPR11

Group 1

The AIREasy On aerosol device only uses RF

energy for internal operation. Therefore its RF

emissions are very low and do not cause any

interference in nearby electronic equipment.

THESE INSTRUCTIONS ARE IMPORTANT. PLEASE KEEP THEM FOR FUTURE REFERENCE.

Dear customer,

Thank you for having selected AIREasy On by Pic Solution. AIREasy On is a nebulizer that uses cut-

ting-edge MESH technology. The nebulizer combines the best features of compressor technology

(nebulizes every type of drug rapidly and eectively) and ultrasound technology (absolutely silent and

portable even during use) making it ideal for every use by adults and children, whether in home care or

emergency settings, during trips or in the open (in compliance with operating conditions). In addition,

the equipment oers the benet of unique manufacturing and operating specications added during

the design phase. The design and the special shape of the drug nebulization chamber ensure ultimate

therapeutic ecacy reducing the volume of the drug that cannot be nebulized to less than 0.1 ml (the

lowest level currently declared on the market). The MESH technology has been optimised to permit

a particularly high level of nebulization, up to 93% of breathable fraction and an MMAD of 1.51 µm.

DESCRIPTION OF COMPONENTS / CONTENTS

1) Drug chamber – Vibrating Mesh

2) Mask accessory (2 pcs, Adult and Paediatric)

3) Elastic for mask accessory

4) Cable for connecting Main Unit-

Drug Chamber

5) Main Unit

6) Main Unit ON/OFF Button

7) Type-C USB Connector

8) Lightning USB Connector

9) ON/OFF LED Light

10) Mouthpiece

11) Instruction manual

WARNING: The presence of small parts poses choking hazard if ingested by infants, children

or pets. The main unit may be damaged or cause injuries. Store this product and all compo-

nents in locations that are out of the reach of children and pets. In the event that a child in-

gests small pieces, seek immediate medical advice.

WARNING: READ THE INSTRUCTION MANUAL BEFORE USING THE DEVICE. ALWAYS FOLLOW

YOUR PHYSICIAN’S INSTRUCTIONS WHEN ADMINISTERING THE DRUG. NEVER DISASSEMBLE

THE UNIT. FOR ANY INTERVENTION, CONTACT THE DISTRIBUTOR’S TECHNICAL SERVICE AND/

OR CA-MI TECHNICAL SERVICE

GENERAL WARNINGS

1. Upon opening the package, check the device and accessories for damage, especially noting any

damage to the plastic components, which may permit access to live parts inside, and any breakage

and/or stripping of the power cable. In such cases, do not connect the equipment to any power

supply. Complete these checks before every use.

2. Before connecting the equipment always check that the electrical data provided on the power sup-

ply label matches the specications on the data plate (output 5V DC 1A).

3. Comply with safety regulations for electrical equipment, especially:

- Only use original spare parts and accessories provided by the manufacturer. Only use original parts

of the type indicated in this manual.

- DO NOT THROW INTO FIRE OR PLACE NEAR FLAMES OR SOURCES OF HEAT.

- Do not wash and never immerse the device and the power cable in water. This may cause electrical

leakage or electrical shock and the device may cause issues and/or not be usable;

- Keep the equipment and the external power supply in stable positions to avoid accidental falling

and to keep them from overheating;

- Do not use the equipment in the presence of a ammable anaesthetic mixture with air, oxygen or

nitrous oxide. Do not use the device in anaesthesia and pulmonary ventilation systems

- Do not touch the main unit and the external power source with wet hands and always avoid contact

with liquids;

- Do not pull on the power cord for the main unit to detach it from the power source or from the drug

chamber, rather take hold of the connectors to detach them, after having switched o the device;

- Use and store the device, and all components, in areas that are not exposed to the weather and

are far from sources of heat. Clean and disinfect the device after every use and store away from

dust and sunlight.

- This device is meant for personal use. It is not suitable for promiscuous use by multiple people.

4. For repairs refer exclusively to the PIKDARE S.p.A. Technical Service Center (www.picsolution.com)

and request the use of original spare parts. Failure to comply with the above may compromise the

safety of the device.

5. This device must be used exclusively for its intended purpose and in the manner described

in this manual. It must therefore be used as a system for aerosol therapy. Any use other than

the one for which the device was designed is to be deemed inappropriate and therefore dangerous.

Neither the manufacturer nor the distributor may be held responsible for damage caused by improp-

er, incorrect and/or unreasonable use or by connection with electrical systems that do not comply

with applicable safety regulations.

6. Special precautions need to be taken with regard to the electromagnetic compatibility of the elec-

trical equipment, which must be installed and used in accordance with the information given in the

documents provided with the equipment.

7. Children and people with reduced cognitive capacity and/or people who are not self-sucient must

always use the medical equipment under the close supervision of an adult with full mental capacity.

8. Do not leave the equipment unguarded within reach of children and/or people who do not

have full mental faculties as they may strangle themselves with the power cable.

9. The medical device can come into contact with the patient by means of the nebulizer / masks /

mouthpiece. All of these components have been deemed compliant with standard ISO 10993-1.

10. Operation of the device is very simple. There is no need for additional steps to be taken beyond

those specied in this instruction manual.

11. WARNING: Do not modify this device without authorisation from the manufacturer. No electrical

and / or mechanical part in the appliance was designed to be repaired by the user. Failure to comply

with the above may compromise the safety of the device, making it unsafe to use.

12. Use of the equipment in environmental conditions other than those specied in this manual may

be harmful to the safety and performance of the equipment. If transported/stored at temperatures

below 5 °C, the device must be reconditioned at normal working conditions before being used.

13. The materials that come into contact with the drugs are thermoplastic polymers with elevated sta-

bility and chemical resistance and are widely used in medical settings. Still, in light of the variety

and continuous evolution of the drugs that might be used, ruling out interactions is not possible;

therefore, we recommend:

- Consuming the drug as rapidly as possible after it is opened.

- Avoiding prolonged contact between the drug and the container (Mesh Chamber) and completing

the cleaning operations immediately after each application.

- In the event that the drug chamber appears abnormal (e.g., vitried or cracked), do not introduce

any solutions and do not inhale. Contact technical service and specify the mode of use and the

drug that was used.

14. Remember to:

- Not use the product to nebulize any liquids/substances other than the drugs prescribed by your

physician.

- Complete the aerosol treatment in compliance with the mode of use, dosage and combinations

indicated by the specialist, using only the accessory indicated by the specialist on the basis of the

condition being treated.

Do not drop the main unit and/or the drug chamber or subject them to strong vibrations.

They may be damaged irreversibly or pose an electric shock hazard.

The manufacturer/distributor cannot be held responsible for accidental or indirect damage in

the event that the device has been modied or subjected to unauthorised repairs and/or

technical operations, or if any of the components have been damaged by accidents or im-

proper use and/or abuse.

Any unauthorised intervention on the device, however minimal, will immediately cause the

warranty to be null and void, and in any event does not guarantee compliance with the tech-

nical and safety requirements imposed by Directive MDD 93/42/EEC (as subsequently amend-

ed) and by applicable standards.

Never clean the mesh with cotton balls, brushes or similar items! Never touch the

mesh! Only clean as instructed in the manual.

PREPARATION AND USE

When using the device for the rst time or whenever the device has been unused for a long

period of time, we recommend that you begin by disinfecting the nebulization chamber and

the mask and mouthpiece accessories, to avoid contamination with or spreading of bacteria.

Follow the instructions provided in the paragraph on Cleaning and Disinfecting in this manual and then

continue with the operations described below.

Do not use the device to inhale water, it may cause symptoms to worsen.

Do not drop the drug chamber or subject it to strong impact, to avoid damage that may render it

unusable or result in electrical shock.

DO NOT INSERT AND NEBULIZE substances other than drugs and medical products

indicated for nebulization with aerosol. DO NOT USE WITH medical products and/or

solutions that contain high percentages of dissolved or pure hyaluronic acid, essential

oils, scented fragrances, etc. or sediment loads (e.g.:Pure Thermal Water) which may irreversi-

bly block or damage the drug chamber. Use with pure hypertonic solutions (e.g.: Seawater)

may block the equipment if proper cleaning operations are not completed after every use.

1 – INSERTING THE DRUG

A) Use your ngers to open the cover of the drug chamber.

B) Insert the prescribed drug(s) as instructed by your physician and by the drug

manufacturer.

WARNING: The drug chamber has a graduated scale that indicates the max-

imum drug volume that can be inserted, 8 ml (8 cc). Never ll past the maxi-

mum level indicated.

C) Close the drug chamber cover

Never pour drugs/liquids on the contacts at the base of the drug chamber or on those of the

cable for the main unit. Should this happen use gauze to remove liquids immediately and dry.

Using the equipment while wet may cause it to malfunction or cause an electric shock.

2 – PREPARING THE PRODUCT

Once the drug has been inserted in the drug chamber, continue with the following steps:

A) Connect the drug chamber to the power cable for the main unit, being care-

ful to respect the“polarity”, which is clearly indicated on both connectors. Make

sure the connectors are properly fastened to each other.

B) Connect the accessory (Mask or Mouthpiece) for the specic treatment in-

dicated by your physician to the product. Be sure to use a mask that is of the

right size for the patient (L for adults and S for children) to ensure the maximal

comfort and ecacy of the treatment.

C) Next, connect the main unit to the power supply selected using the USB

connector. Be sure to comply with the power specications, as indicated in the

paragraph about POWERING THE EQUIPMENT.

3 – POWERING THE EQUIPMENT

A) The equipment can be connected to any external power source so long as it is equipped with a

USB connection and limited to a nominal output of 5V 1A. It can be powered by a Power Bank, by the

internal batteries of mobile phones/tablets or by AC/DC power supplies with a certied USB connec-

tor (certied in compliance with EN 60601-1 and EN 60601-1-2 with a 2MOPP degree of protection).

The main unit is equipped with a 5V 1A input USB port, a USB connection to a suitable power supply is

all that is needed to power the device.

In the event that a mobile phone/tablet is used as a power supply, connect it to the device using

the appropriate USB adaptor for your telephone, choosing one of the two original adaptors provided

(USB Type-C or USB-Lightning) or the optional micro-USB. The device absorbs a minimal amount of

power during use and does not interfere with the proper functioning of the power supply nor does it

signicantly reduce battery life.

B) None of the power supplies mentioned are included with the device (power bank or trans-

former). The equipment complies with the electrical grade and safety requirements of IEC/

EN 60601-1.

Regardless of the type of source used, always make sure that the source cannot be damaged

by the nebulized drug generated by this equipment. Spilling the liquid directly or exposing

the power supply to the ow of nebulized material can create condensation or harmful de-

posits on any electrical device. Avoid exposing electrical/electronic equipment to accidental

spilling or to a close and direct ow of nebulized material.

3.1 Operation with an AC/DC transformer

TO safeguard the user and the device, only use transformers of the type indicated (with USB connector

and 5V 1A output) and be sure that the transformer is certied in accordance with the requirements

mentioned previously.

To avoid potential hazards, overheating, dropping and/or accidental damage, al-

ways disconnect the equipment from the power supply immediately after complet-

ing the treatment.

Always carefully disconnect the equipment from the power supply selected and

from the nebulization chamber to avoid damage that may compromise the proper

functioning of the device. Damage caused by the penetration of liquids or the me-

chanical rupture of the connectors is not covered by the warranty.

DO NOT FORGET TO SWITCH OFF THE PRODUCT when you are done using it. The de-

vice DOES NOT SWITCH OFF AUTOMATICALLY once the drug has been used up. It

only switches o automatically after 20 minutes of operation.

4 – USE OF THE DEVICE

Once it has been prepared correctly, the device is ready to be connected to the power supply selected

and used as follows:

a) Connect the device’s USB connection to the power supply selected.

b) When it connects the green LED on the device will light up for about 2 sec-

onds to conrm that the device has been powered correctly.

c) Position the device on the face in accordance with the accessory being used,

then press the ON/OFF button to start the device. The product will begin to

nebulize and the green LED light will begin to blink slowly to conrm that the

device is operating properly.

d) At the end of the treatment, when no more nebulized material can be seen

coming out, press the ON/OFF button again to switch o the product.

4.1 DURING THE TREATMENT

- Breathe calmly and deeply for optimal inhalation of the nebulized material.

- The speed of nebulization may be lower for solutions that have elevated surface activity (bubbles) or

high viscosity. This is normal.

- Hearing a light sound produced by the Mesh during nebulization and until the device is switched

o is normal.

- If the solution has elevated surface activity, a small quantity of the solution may exude from the surface

of the Mesh. This is normal.

- ALWAYS remember to switch o the device when the liquid in the chamber is exhausted to avoid the

risk of causing damage to the Mesh.

- When the drug is about to run out, users are advised to incline the nebulization chamber lightly

toward the patient to help the Mesh nebulize the residual liquid.

- When the mask accessory is used, do not cover the openings on the mask with your hands or other

objects.

- To avoid interfering with proper nebulization, do not block or cover the vent hole located on the cover

of the drug chamber while the device is in use.

- If the user senses discomfort during inhalation, switch o the device and consult a physician im-

mediately.

IMPORTANT: The equipment can be used continuously, but it is equipped with a safety feature

against switching on accidentally or failure to switch o.This feature will switch the device o au-

tomatically after 20 minutes of continuous operation (without interruption), but it can be switched

back on immediately.

WARNING: During use, the device must be held vertically or inclined towards the patient. The de-

vice can operate at a forward incline of up to 90°; however, if it is inclined backwards (i.e., away from

the patient), the drug will not reach the nebulization Mesh and the ow of nebulized material will be

interrupted.

To avoid clogging and/or damaging the Mesh, the product must be used until the

drug has been completely consumed (until the ow of vapour comes to a complete

halt). If the treatment is interrupted before the content in the chamber is used up,

empty out the chamber completely. In either case, thoroughly rinse the drug chamber only

under lukewarm tap water (using a low pressure stream to avoid damaging the MESH compo-

nent) and insert a few drops of demineralised water. Reattach the chamber to the device and

switch the device on for the time needed (a few seconds) to empty out the residual content.

When no more vapour comes out of the device, switch the product o and proceed with the

cleaning operations described below.

CLEANING AFTER EVERY USE

The procedure for cleaning this product must be completed after every use, not just to preserve proper

hygiene, but also to ensure proper functioning and maintain the level of performance.

Incorrect cleaning or failure to clean the drug chamber immediately after each use

may partially or completely compromise the proper functioning of the device and

result in the device needing to be replaced.

AFTER EACH USE, PROCEED AS FOLLOWS:

Complete the SELF-CLEANING MODE procedure described in the following paragraph, then

continue with the operations described below:

A) After having switched o the device, disconnect the device from the drug chamber and power

source and put it away in a safe, dry location;

B) Once the main unit has been put away in a safe place (far from sinks or surfaces where it may come

into contact with liquids or fall), open the nebulization chamber and empty out any residual drug;

C) Clean the accessories and the drug chamber with water. Rinse the MESH carefully to remove depos-

its, which often remain on the Mesh when it is used to nebulize particularly dense and highly viscous

drugs such as solubilising or expectorating agents.

The drug chamber and the mouthpiece and mask accessories may also be immersed in a 1:1

solution of water and white vinegar for about 1 hour to clean and/or remove residues and

deposits.

DO NOT CLEAN THE MAIN UNIT USING WATER, AVOID CONTACT WITH WET SURFACES

AND EXPOSURE TO POSSIBLEWATER SPRAY. DO NOT CLEANTHE DEVICE, ITS PARTS OR

ACCESSORIES IN THE DISHWASHER. DO NOT USE DETERGENTS, CHEMICAL SUBSTANC-

ES OR DESCALERS TO CLEAN THE DEVICE AND ITS ACCESSORIES.

E) Position the drug chamber and accessories on a clean, dry cloth and allow them to air-dry completely

(about 2 hours) before storing or reusing.

Do not use balls of cotton, paintbrushes or other objects to clean or dry the drug chamber

Mesh. Never touch the mesh. If needed, use a dry cotton cloth to dry the accessories and

the drug chamber.

F) To clean the main unit and the electrodes, use a soft, dry cloth. Always keep the electrodes clean and

dry, and always remove drug residue from the main unit.

G) Once dry, reconnect the drug chamber to the main unit and place the device with all accessories

away in a dry location protected against atmospheric agents.

MESH SELF-CLEANING FUNCTION

Step 1: Place a small amount of clean water (distilled or demineralised water is best) in the drug chamber.

Step 2: With the device o, press on the ON/OFF button for at least 5 seconds. The green light on the

front will switch on and shine steadily to conrm that self-cleaning mode has been activated.

Step 3: After 30 seconds the self-cleaning function will nish, and the device will switch o automat-

ically.

Step 4: Eliminate the water left in the drug chamber, switch the device back on in normal mode for a

few seconds until no more material is nebulized, which indicates that there is no more liquid in

the Mesh. Dry the unit carefully with a soft cloth without touching the Mesh.

EXECUTE THE SELF-CLEANING FUNCTION AFTER EACH USE

DISINFECTING

Always carry out the cleaning procedure illustrated in the previous paragraph before you disinfect the device.

DRUG CHAMBER, MASKS AND MOUTHPIECE can be disinfected using 75% denatured ethyl alco-

hol or a hypochlorite solution available in pharmacies. Before reusing these accessories, they must be

rinsed in warm water until all traces of the disinfectant have been removed then dried and stored in a

dry location away from dust.

DO NOT USETHE MICROWAVE TO STERILISETHE DEVICE AND ITS ACCESSORIES

MAINTENANCE

The AIREasy On equipment does not have any parts inside that require maintenance and/or lubri-

cation. However, some simple checks need to be completed before each use to verify that the device

is operating safely and correctly. Take the device out of the box and always check that there is no

visible damage; pay special attention to cracks in the plastic which may expose electrical components.

Check that the drug chamber was not damaged during the previous use. If any of the parts are dam-

aged, do not use the device. Use of a damaged device may result in inadequate treatment,

damage, injury and/or serious danger.

ACCESSORIES / SPARE PARTS

SPARE PARTS THAT CAN BE PURCHASED SEPARATELY

KIT (masks, mouthpiece and chamber)

Drug Chamber

USB adaptor kit (3 pcs)

Only use original accessories/spare parts envisioned and indicated by the manufac-

turer.

DRUG CHAMBER: For each patient, replacing the drug chamber 3 months after the rst treatment is

advised. In addition, the drug chamber must be replaced if it is damaged or if the holes in the Vibrating

Mesh inside are partially or completely obstructed by drug, dust or scale deposits, etc.

For diseases where there is a risk of microbial contamination and infection, personal use of the

accessories and drug chamber, as well as compliance with the sterilisation procedures indicated

in this manual, is recommended (always consult your medical specialist).

The mouthpiece and masks must be replaced when the constituent materials show visible signs of wear.

Expected minimal lifespan: 2 years (in accordance with standard testing and operating conditions).

POSSIBLE PROBLEMS AND SOLUTIONS

DEFECT TYPE

CAUSE REMEDY

1. Nebulization

scarce or absent

(with device on)

The holes in the vibrating mesh

located inside the drug chamber

are obstructed

Complete the procedure for clean-

ing the drug chamber indicated in

the manual. If the problem persists

after the cleaning procedure,

replace the drug chamber with

a new one

The power supply used for the

device is nearly spent

Replace and/or recharge the

power supply

Drug very oily Dilute the drug with saline solution

2. Nebulization

absent with device

on (Green LED

light on)

The electrodes of the drug chamber

or main unit are dirty and/or

oxidised

Clean the contacts removing the

cause of the poor electrical contact.

The contacts of the main unit are

wet with water or the drug

Remove the liquid from the

contacts

The Mesh is extremely oxidised

or broken

Replace the drug chamber with

a new one

The is a defect in the cable for the

main unit Replace the main operating unit

The drug chamber is not connected

to the main unit or was not inserted

correctly

Connect the drug chamber to the

main unit and verify that it ts in

place correctly

3. No nebulization

and LED indicating

operation o

The main unit is not properly

connected to the power source

Check that the USB connection

has been properly connected to a

suitable power source

The power supply is completely

spent

Replace and/or recharge the

power supply

4. Liquid leaks

from the Mesh/

Drug Chamber

The drug chamber is damaged Replace the drug chamber

Defects 1-2-3-4 None of the solutions worked Contact the retailer or the man-

ufacturer's technical service

The manufacturer declares that the information contained in this manual matches

the safety and technical specications for the device referred to in the manual. The

technical data provided in this document is up to date at the moment of publication

and applies exclusively to the device described. The manufacturer reserves the right to make

changes or improvements to this documentation without notication.

TECHNICAL SPECIFICATIONS

TYPE (93/42/EEC) Class IIa Medical Appliance

MODEL AIREasy On

POWER SUPPLY USB input port 5V 1A from external power supply

POWER ABSORBED about 2.0 W

RESIDUAL VOLUME (2 spitting) < 0.1 ml

MMAD (EN 13544-1) * 1.51 µm

GSD (EN 13544-1) * 1.75

AEROSOL OUTPUT (EN 13544-1) 1.58 ml

AEROSOL OUTPUT RATE (EN 13544-1)

0.22 (ml/min) 1 min

AVERAGE NEBULIZED VOLUME 0.30 ml/min (2 ml NaCl 0.9%)

INSULATION CLASS Class II (if used with an external power supply)

WEIGHT About 18 g (without accessories)

DIMENSIONS 46 (W) x 60 (H) x 35 (D) mm

OPERATION Continuous

MAXIMUM SOUND LEVEL ≤ 35 dB (A)

MAXIMUM DRUG CAPACITY 8 ml

OPERATING CONDITIONS Ambient temperature: 10 to 40 °C

Ambient humidity percentage: 30 to 85% RH

(non-condensing)

Atmospheric pressure: 860 to 1060 hPa

CONDITIONS FOR STORAGE

AND TRANSPORTATION

Ambient temperature: -20 to 50 °C

Ambient humidity percentage: 30 to 85% RH

(non-condensing)

Atmospheric pressure: 860 to 1060 hPa

* MMAD = Mass Median Aerodynamic Diameter (with Marple Personal Cascade Impactor)

** GSD = Geometric Standard Deviation

PARTICLE DISTRIBUTION GRAPH PER EN 13544-1

Cumulative Fraction (%)

Mean Mass Fraction (%)

AeroDynamic Diameter (µm)

Individual test

Mean

Emissions Radi-

ated/

Conducted

CISPR11

Class [B] The AIREasy On aerosol device is suitable

for use in all environments, including

domestic settings and those directly con-

nected the public electrical infrastructure

that provides power for environments

used for domestic purposes.

Harmonics IEC

61000-3-2

Class [A]

Change of voltage

/ icker IEC

61000-3-3

Compliant

TABLE A2 - Electromagnetic immunity - For the domestic health care environment EQUIP-

MENT/SYSTEMS

Guide and manufacturer’s declaration – Electromagnetic Immunity

The AIREasy On aerosol device can be used in the electromagnetic setting specied hereafter.

The customer and/or the user of the AIREasy On device must ensure that the appliance is used

in such a setting

Immunity Test EN 60601

IEC 60601 test

Level

of Conformity

Electromagnetic

Environment -

Guidance

Electrostatic

Discharge (ESD) IEC

61000-4-2

±8kV on contact ±8kV on contact Floors should be made

of wood, concrete

or ceramic tile. If the

oors are covered with

synthetic material, the

relative humidity should

be at least 30%.

±2kV, ±4 kV,

±8kV, ±15kV

in air

±2kV, ±4 kV,

±8kV, ±15kV

in air

Electric fast transients

/ bursts

IEC 61000-4-4

±2KV for power

supply lines

±2KV for power

supply lines

The quality of the mains

power supply should

be that of a typical

business or hospital

setting.

Surge IEC 61000-4-5 ±1kV line to line

±2kV line to earth

±1kV line to line

±2kV line to earth

The quality of the mains

power supply should

be that of a typical

business or hospital

setting.

Magnetic Field and

Mains Frequency

(50/60Hz)

IEC 61000-4-8

30A/m 30A/m The magnetic elds at

mains frequency should

be at the characteristic

levels of a typical

position in a business or

hospital setting.

Voltage dips, brief

interruptions and

variations in the

voltage of the power

supply

IEC 61000-4-11

0 % UT;

0.5 cycles at 0°, 45°,

90°, 135°, 180°,

225°, 270° and 315°

0 % UT;

0.5 cycles at 0°, 45°,

90°, 135°, 180°,

225°, 270° and

315°

The quality of the mains

power supply should

be that of a typical

business or hospital

setting. If continuous

operation of the AIRE-

asy On during mains

power supply outages

is a necessity for the

user the device should

be powered using an

uninterruptible power

supply or a battery.

Conducted RF IEC

61000-4-6

3Vrms from 150kHz

to 80MHz

3Vrms The MANUFACTURER

should consider

reducing the minimum

separation distance,

on the basis of RISK

MANAGEMENT and

using more elevated

IMMUNITY TEST LEVELS

that are suitable for

the reduced minimum

separation distance.

Minimum separation

distances for a superior

IMMUNITY TEST

Radiated RF IEC

61000-4-3

10V/m from 80MHz

to 2.7GHz

10 V/m The levels must be

calculated using the

following equation:

Where P is the maxi-

mum Power expressed

in W, d is the minimum

separation distance

expressed in m, and E

is the IMMUNITY TEST

LEVEL in V/m.

NOTE: UT is the AC mains voltage before the test level is applied.

INSTRUCTIONS FOR USE

SEE THE INSTRUCTIONS FOR USE

AIREasy OnAIREasy On

CA-MI Srl

Via Ugo La Malfa, 13 – frazione Pilastro 43013 Langhirano

(PR) Italy

Tel. +39 0521 637133/ 631138

Fax +39 0521 639041

e-mail: vendit[email protected] / expor[email protected] www.ca-mi.it

Distributed by: PIKDARE S.p.A.

Via Saldarini Catelli, 10 - 22070 Casnate con Bernate

(CO) - Italy

www.pikdare.com

7810

N.B.:The curves and measurements are not

valid for drugs provided in suspensions

with a high viscosity.

Rev. 00-05/2021

Cat.No. 02038214100000

RE 300912/02

76 038214 100 000