Pic AIREasy On - Nebulizer Manual

INSTRUCTIONS FOR USE

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 cutting-edge MESH technology. The nebulizer combines the best features of compressor technology (nebulizes every type of drug rapidly and effectively) 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 offers the benefit of unique manufacturing and operating specifications added during the design phase. The design and the special shape of the drug nebulization chamber ensure ultimate therapeutic efficacy 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 UnitDrug 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

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 components in locations that are out of the reach of children and pets. In the event that a child ingests small pieces, seek immediate medical advice.

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 supply label matches the specifications 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 flammable 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 off 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 improper, 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 electrical 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-sufficient 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 specified in this instruction manual.
11. 
    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 specified 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 stability 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., vitrified 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 modified or subjected to unauthorised repairs and/or technical operations, or if any of the components have been damaged by accidents or improper 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 technical and safety requirements imposed by Directive MDD 93/42/EEC (as subsequently amended) 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 first 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 irreversibly 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.

INSERTING THE DRUG

1. Use your fingers to open the cover of the drug chamber.
2. Insert the prescribed drug(s) as instructed by your physician and by the drug manufacturer.
   
   The drug chamber has a graduated scale that indicates the maximum drug volume that can be inserted, 8 ml (8 cc). Never fill past the maximum level indicated.
3. 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.

PREPARING THE PRODUCT

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

1. Connect the drug chamber to the power cable for the main unit, being careful to respect the "polarity", which is clearly indicated on both connectors. Make sure the connectors are properly fastened to each other.
2. Connect the accessory (Mask or Mouthpiece) for the specific treatment indicated 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 efficacy of the treatment.
   
3. Next, connect the main unit to the power supply selected using the USB connector. Be sure to comply with the power specifications, as indicated in the paragraph about POWERING THE EQUIPMENT.
   

POWERING THE EQUIPMENT

1. 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 certified USB connector (certified 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 significantly reduce battery life.
2. None of the power supplies mentioned are included with the device (power bank or transformer). 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 flow of nebulized material can create condensation or harmful deposits on any electrical device. Avoid exposing electrical/electronic equipment to accidental spilling or to a close and direct flow of nebulized material.

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 certified in accordance with the requirements mentioned previously.

To avoid potential hazards, overheating, dropping and/or accidental damage, always disconnect the equipment from the power supply immediately after completing 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 mechanical 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 device DOES NOT SWITCH OFF AUTOMATICALLY once the drug has been used up. It only switches off automatically after 20 minutes of operation.

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:

1. Connect the device's USB connection to the power supply selected.
2. When it connects the green LED on the device will light up for about 2 seconds to confirm that the device has been powered correctly.
   
   
3. 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 confirm that the device is operating properly.
   
4. At the end of the treatment, when no more nebulized material can be seen coming out, press the ON/OFF button again to switch off the product.

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 off 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 off 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 off the device and consult a physician immediately.

The equipment can be used continuously, but it is equipped with a safety feature against switching on accidentally or failure to switch off. This feature will switch the device off automatically after 20 minutes of continuous operation (without interruption), but it can be switched back on immediately.

During use, the device must be held vertically or inclined towards the patient. The device 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 flow 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 flow 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 component) 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 off 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:

1. After having switched off the device, disconnect the device from the drug chamber and power source and put it away in a safe, dry location;
2. 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;
   
3. Clean the accessories and the drug chamber with water. Rinse the MESH carefully to remove deposits, 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 POSSIBLE WATER SPRAY. DO NOT CLEAN THE DEVICE, ITS PARTS OR ACCESSORIES IN THE DISHWASHER. DO NOT USE DETERGENTS, CHEMICAL SUBSTANCES OR DESCALERS TO CLEAN THE DEVICE AND ITS ACCESSORIES.

5. 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.
6. 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.
7. 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 off, press on the ON/OFF button for at least 5 seconds. The green light on the front will switch on and shine steadily to confirm that self-cleaning mode has been activated.

Step 3: After 30 seconds the self-cleaning function will finish, and the device will switch off automatically.

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 alcohol 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 USE THE MICROWAVE TO STERILISE THE DEVICE AND ITS ACCESSORIES

MAINTENANCE

The AIREasy On equipment does not have any parts inside that require maintenance and/or lubrication. 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 damaged, do not use the device. Use of a damaged device may result in inadequate treatment, damage, injury and/or serious danger.

ACCESSORIES / SPARE PARTS

Only use original accessories/spare parts envisioned and indicated by the manufacturer.

DRUG CHAMBER: For each patient, replacing the drug chamber 3 months after the first 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

The manufacturer declares that the information contained in this manual matches the safety and technical specifications 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 notification.

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

N.B.: The curves and measurements are not valid for drugs provided in suspensions with a high viscosity.

Videos

Pic AIREasy On - Tutorial Video

Documents / Resources

References

• Pic Solution - È facile con Pic!

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

Download Pic AIREasy On - Nebulizer Manual