Pic Solution 0068 AirProjet Plus Instruction Manual

Pic Solution 0068 AirProjet Plus

USING INSTALLATION

Specifications

• Model: AirProjet more
• Model Number: 0068
• Components: A , B, C, D, E, F, G, H, I, L, M
• Accessories: AIRSOFT MASK 2-in-1 for adults and children, Mouthpiece, Fork, Corrugated Tube
• Replacement Accessories: A, B (available separately)
• Manufacturer: PIKDARE SpA

Product Usage Instructions

Important Instructions
Keep these instructions for future use.

Components of the Device

• E – Nebulizer Mouthpiece Protective Cap
• F – Tank Cover
• G – Nebulizer Mouthpiece
• H – Flow Regulator
• I – Medication Tank
• L – Removable Power Cord
• M – On/Off Switch

INSTRUCTIONS FOR USE

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

Dear customer,

• Thank you for choosing PiC Solution’s AirProjet plus, an ultrasound aerosol therapy unit designed and manufactured according the most up-to-date technologies.
• AirProjet Plus is the fruit of a new development in ultrasound technology that transforms the drug into an extremely fine mist that spreads through the lungs quickly and effectively. AirProjet plus is reliable and easy to use thanks to its exclusive ready-to-use sealed tank that does not require any added water for the unit’s entire service life.
• 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.
• For your convenience, consult the Quick User Guide found inside the package.

ACCESSORIES

• A – 2-in-1 “AIRSOFT MASK” for adults and children

• B – Mouthpiece

• C – Nose fork

• D – Corrugated tube

  • A, B, C, and D are available as spare parts in Kit 02038406100000
  • A and B are available as spare parts 02038040000000
    

• DEVICE COMPONENTS

• E – Nebulisation nozzle cap

• F – Tank cover

• G – Nebulisation nozzle “

• H – Flow regulator

• I – Drug tank

• L – Detachable power cord

• M – On/Off switch

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 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, 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 appliance 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.
• If the power cord is not unrolled completely, the appliance may overheat.
• Never disassemble the unit. Any technical intervention must be performed by technical personnel authorized by PIKDARE. For information contact the PiC Technical Assistance Centre.
• Packaging (bags, boxes, 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 unit, 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 certified adapters if the existing legislation in the individual country allows for it or have a PIKDARE S.p.A. authorized technician replace the plug.
• To prevent overheating and device damage, turn the unit off after 10 minutes of continuous use and allow it to cool for 30 minutes.
•  WARNING! Using the appliance before 30 minutes have elapsed may result in motor overheating and cause the safety cut-off devices to activate.
• Do not use the appliance in the presence of nitrous oxide, oxygen, or flammable air/anesthetic mixtures.
• Turn off the unit and disconnect from the mains after use before removing the residual drug and adding more medicine.
• Do not overfill the tank with the drug. Follow the quantity indications shown in the “TECHNICAL SPECIFICATIONS”.
• Keep the unit and power cord away from hot surfaces.
• Do not use the unit while having a bath or shower, or when in a damp place, or close to bathtubs, sinks, washbasins, or in any other situation in which some liquids may come into contact with the unit.
• Never touch the unit with wet hands.
• Do not drop or put the unit into water or other liquids. Should this occur, unplug it immediately, stop using the unit, and consult a qualified technician.
• If the unit accidentally gets wet, unplug it immediately, dry it thoroughly and, if liquid may have penetrated inside the unit, contact a PIKDARE authorized service center.
• Do not block the openings for cooling air.
• Do not use the unit if you feel drowsy.
• If children or persons with physical or mental disabilities use the unit, proper supervision by an adult is required. The device contains small parts that can come off and be accidentally swallowed. Children must be kept under adult supervision to ensure that they do not play with the unit. The unit contains small parts that can be swallowed and the power cord poses a 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 to prevent spillage.
• During use, the surface must be free of any objects that may obstruct the correct flow of air.
• Never leave the unit appliance plugged in when it is not in use or when it is unattended.
• Before removing the drug, cleaning or performing any maintenance work on the unit, disconnect the unit from the mains power by removing the plug from the electrical socket.
• If you decide to no longer use the unit, disconnect from the mains and cut the power cord so the unit cannot work. Dispose of the appliance and power cord immediately in compliance with existing local laws and Directive 2012/19/EU. We also recommend eliminating any potentially hazardous parts, particularly for children.
• Refer to laws in force for information regarding the disposal of accessories subject to wear. To dispose of the appliance, refer to Directive 2012/19/EU.
• Do not use the appliance 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 and/or malfunction of the unit, switch it off by removing the plug from the mains and contact the PiC Service Centre only. The fuse specified in the “Technical Specifications” must be replaced by PiC Technical Service Centre staff only.
• WARNING! Do not attempt to open, repair, alter, or tamper with the appliance.
• Do not switch on the unit if the drug tank is empty, as this may damage the unit.
• Do not lift the tank cover and do not enter into direct contact with the drug while the unit is operating.
• Do not leave any residual drug in the tank. Closely follow the instructions in the section “CLEANING AND MAINTENANCE OF THE DRUG TANK”.
• Do not use the unit in rooms in which sprays have been used recently: ventilate the room before proceeding with the treatment.
• Do not insert any object into the cooling vents.
• The detachable power cord plug or connector must always be within reach during use, as these are necessary to disconnect the appliance from the mains.
• 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;
• 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 “Preparing and using the appliance”, “Cleaning and maintenance of the drug tank”, “Cleaning and maintenance of 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.

ACCESSORIES KIT

The exclusive PicSolution accessories kit 02038406100000 features a single super-soft, innovative mask that adapts to your face, minimizing drug waste. It was designed to ensure correct and efficient therapy for children and adults alike. Adults should use the mask covering only the mouth, as this is the most efficient way to deliver the flow of solution directly into the lower airways, while the mask should be turned upside down for children so that it covers both nose and mouth – this is because children are not yet able to coordinate their breathing. The new connection system between the mouthpiece and mask ensures the solution flows directly into the mouth, for further efficacy. It is also possible to use the mouthpiece without the mask.

PREPARING AND USING THE APPLIANCE

• Remove the unit and the accessories from the package or aerosol bag.
• WARNING! Carefully check the surface of the drug tank and of all components before use. In the event of breakage or damage, do not use the unit, and contact the PiC Technical Service Centre.
• Lift the drug tank cover (F);
• Pour the drug into the tank (I) following the doses recommended by your physician or pharmacist;
• The tank content must never exceed the reference mark on the tank (Fig. 4).
• The drug tank (I) has a maximum capacity of 8 ml; if the solution has a greater volume, divide it into multiple inhalations;
• The drug tank (I) has a minimum capacity of 3 ml; if the solution does not reach the minimum capacity, it must be diluted with saline solution unless otherwise specified by the drug’s information leaflet;
• Close the tank cover making sure that it is sealed well;
• Choose the most appropriate accessory to deliver the therapy: mask, mouthpiece, nosepiece (applied parts), in case of doubt, contact your physician or a pharmacist.

Use of the mask 2 in 1 for adults and children
Connect the mask (A) to the mouthpiece (B); then connect the mouthpiece to the corrugated tube (D);

Use of the nose fork
Connect the nose fork (C) to the corrugated tube (D);

• Lift the nozzle cap (E);
• Connect the tube to the nebulization nozzle (G);
• Connect the detachable power cord to the unit;
• Connect the plug of the detachable power cord to the mains;
• Start the unit by pressing the button on the switch (M), selecting the therapy flow, by increasing or reducing it with the flow regulator (H), and start treatment preferably seated and in a comfortable position;
• Continue inhalation until the outlet flow is exhausted. If you are not sure that the drug has been finished, you can suspend the therapy shortly and then restart it. After treatment, there will be a small amount of residual liquid (approx. 0.5 ml) in the nebulizer chamber.
• The unit has a system that switches it off automatically after 5 minutes from its start. If you need to continue the therapy, add the drug in the tank again (I) by removing the cover (F). After fitting the cover back on again, start the unit again by pressing the button on the switch (M).
• WARNING! Never carry out more than two consecutive 5-minute cycles! At the end of a second consecutive cycle, wait 30 minutes before using it again! If you fail to follow these warnings, the unit’s safety cut-off may be triggered.
• At the end of the treatment or when necessary, press the button on the switch (M), disconnect the plug of the detachable power cord (L) from the mains socket, and disconnect the accessory and tube; clean the unit and accessories according to the instructions in the section “CLEANING AND MAINTENANCE”.

CLEANING AND MAINTENANCE

CLEANING AND MAINTENANCE OF THE DRUG TANK
Before cleaning and maintenance of the tank, switch off the unit (if on) by pressing the button on the On/Off switch (M), unplug the detachable power cord (L) from the mains socket, and disconnect the connector of the detachable cable from the unit.

Warning! Do not wet the unit or put it into water or other liquids.

To clean any residual drug from the tank, use only a soft, clean cloth moistened in warm water. Clean the drug tank surfaces thoroughly (I), especially in intersection points. Cleaning must be done at the end of every therapy session. Do not use detergents to clean the device, as they may cause damage.

• WARNING! Never clean the drug tank with sharp or rough objects.
• WARNING! Never use flammable substances during cleaning and maintenance of the drug tank and unit. Carefully dry the drug tank and the unit before putting them away.
  Before putting the unit away, shut the drug tank with its cover and make sure to close the nebulization nozzle. Please clean and check the condition of the drug tank before and after use and do not use the unit if it has clear signs of damage.

CLEANING AND MAINTENANCE OF ACCESSORIES

• Remove all used accessories (mask, mouthpiece, nose fork and tube) and rinse them under running water. WARNING! Do not put the mask in boiling water. Cold disinfect all parts that come in contact with the patient using denatured alcohol. Clean and check that the condition of the accessories before and after use. Replace them if damaged.
• Carefully dry all components and the unit before putting it away.
• Store the unit 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 (AirProjet kit 02038406100000).

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.

TECHNICAL SPECIFICATIONS

• Nominal voltage: 100 -240V~
• Nominal power: 46 VA
• Frequency: 50/60 Hz
• Fuse: T 2A – L250 V
• Transducer vibration frequency: 2.45 MHz ± 50 kHz
• Conditions for using the device: 10’ ON – 30’ OFF MMAD: 3.81± 0.18 μm
• Drug tank maximum capacity: 8 ml
• Appliance service life : 1,000 cycles/treatments Service life of accessories: 1 year
• Service life in storage conditions: 1 year
• Weight : approx. 0.75 Kg Breathable fraction: 67.8 ± 2.9%Noise level at 50 cm*: about 39 dB
• Drug tank minimum capacity: 3 ml

Data on noise levels were measured on a new device. Values may vary 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 basic safety and essential performance.
• 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 1: Nebulising systems and their components

This section contains information specific to product compliance with the 60601-1-2. AirProjet plus 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.

AirProjet plus  02038204100000 is designed for use in an electromagnetic environment that meets the specifications provided below. The person who purchased or uses AirProjet plus  02038204100000 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-frequen- cy communication devices (transmitters) and AirPro- jet plus  02038204100000 may be requested by contacting PIKDARE S.p.A. using the contact information included in this booklet. It is nevertheless advisable to keep the electromechanical aerosol therapy device at a safe distance (at least 0.5 m) from mobile phones or other communication devices that use radio frequencies, to minimize interference.

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 AirProjet plus  02038204100000 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 not applicable.

± 0.5 kV, ±1kV; ±2kV

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.

More information on distances to be kept between portable and mobile radio communications equipment and AirProjet plus 02038204100000 can be requested from PIKDARE 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 to reduce possible interference.

LEGEND OF SYMBOLS

• Warning! Follow the Instructions for Use
• Class II device
• Device protected against the penetration of solids or liquids. Protected against vertical falling drops of water
• A device with Type BF applied part
• Complies with Directive MDD 93/42/EEC + 2007/47/EC
• Alternate Current
• Device was tested by the University of Parma-Pharmaceutical Department in accordance to EN 13544-1 for the measurement of MMAD, Neb Rate, and Breathable fraction.
• On – Off
• Frequency
• Serial Number
• Product ID
• Manufacturer
• Lot number

CONDITIONS FOR STORAGE AND TRANSPORTATION:

• Relative humidity: 15% ÷ 85%
• Temperatures: -25°C ÷ 70 °C
• Temperatures: -25°C ÷ 70 °C

ENVIRONMENTAL CONDITIONS DURING USE:

• Relative humidity: 15% ÷ 85%
• Temperature: 5 °C ÷ 40 °C
• Atmospheric pressure from 700hPa to 1060hPa

ENVIRONMENTAL CONDITIONS DURING USE

• Relative humidity: 15% ÷ 85%
• Temperature: 5 °C ÷ 40 °C
• Atmospheric pressure from 700hPa to 1060hPa

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 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 specific provisions of national laws applicable in the country of purchase, where provided.

PIKDARE S.p.A.
Via Saldarini Catelli, 10
22070 – Casnate con Bernate (CO) – Italia www.picsolution.com

Made in China – Fabricado na China
Fabricado en China – apáyEtal otnv Kiva

References

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