Nebi Air Mask - Medical nebulizer Lionelo - Free user manual and instructions

USER MANUAL Nebi Air Mask Lionelo

A BImportant informaon Please read this manual before you start operang the product to learn its funcons and use it as intended. The failure to follow the safety instrucons and use incompliant with the manual may result in a bodily injury.

This device is not a toy. Do not let children play with it. Keep out of reach of children and pets.

2. Check the device regularly for any signs of damage. Do not use a damaged device.

Do not try to repair the device yourself. Contact an authorized repair service of the manufacturer. If the power cord is damaged, it should be replaced by the manufacturer to avoid any hazard.

3. Do not use medical substances or medicaons that are oily or contain essenal oils,

including herbal extracts, for nebulizaon. It is acceptable to use suspended liquids if the parameters of the substance are within the values specied in the product specicaons.

The type, dose and method of drug administraon should be consulted with a doctor.

5. Administering the drug to children and people with special needs must take place

under close supervision and according to the doctor’s guidelines.

6. The device can be used solely for nebulizaon. Do not use it for any other purpose

than its designed use.

7. Before you use the device, consult a doctor.

8. If you experience any discomfort, stop using the device immediately and contact

9. Use the device with medicinal drugs which solve in water or contain alcohol and

saline soluons. Using any other drugs may cause bronchospasm.

10. The device shall not be used to anestheze the respiratory system.

Before use or a prolonged period of no use, clean and disinfect the medicine cup and accessories.

12. Stop using the device if any of its components are damaged or immersed in water

13. Do not switch the device on unless the mask ts the face correctly.

14. Always use any spare parts supplied or recommended by the manufacturer.

15. The device must be switched o and disconnected from the mains aer use and

before assembly, dismounng and cleaning.

16. Do not immerse the device or its power cord in water or other liquids.

17. Aer use, remove any remaining liquid from the device.

When using the device, maintain the liquid level ensuring that the mesh disc is covered completely.

Do not use the device in the presence of any ammable gases or mixtures of oxygen and anesthecs.

20. Do not use the device at high temperatures.

21. Do not use the nebulizer near any heang device or open ame.

22. Do not expose the device to strong shock and vibraons.

23. Do not use microwave ovens to dry or disinfect the device due to the re hazard.

24. Do not touch the mesh disc with your hand or any sharp objects due to the risk

25. Do not store the device in a damp or dusty environment.

26. Do not use the device if it was dropped, exposed to heavy moisture or immersed

in water. Contact an authorized repair service of the manufacturer.

27. Do not expose the device and its accessories to corrosive liquids and gases.

28. Do not wrap the power cord round the device.

29. Do not remove the baery yourself.

If you do not use the device longer than one month, it should be charged at least once a month.

31. Always use the power cord specied in the operaon manual.

32. Charge the device before rst use.

33. Do not repair or maintain the device when it is operated.

34. The device is operated by the paent.

35. The device is a BF applied part.

When you have any doubts concerning switching the device on, using or maintaining it, and also if there is any failure of the device, contact an authorized repair service of the manufacturer. Counter indicaons

1. Do not use the device with any medicaons containing pentamidine.

2. The device must not be used by paents with pulmonary edema.

3. The device must not be used by paents who had pulmonary infarcon and suering from acute asthma.

4. If the paent suers from diabetes or another chronic disease, contact the doctor before use.

The product conforms to the requirements of European Union direcons. According to Direcve 2012/19/EU, this product is subject to separate waste collecon. Do not dispose the product with municipal waste as it may pose hazard to the environment and human health. The product past its service life should be taken to the site recycling electrical and electronic devices. Intended use A portable mesh nebulizer is designed for inhalaon therapy in health care facilies or for home health care. The device can be used both for adults and for children and people with limited capacies provided it is used under adult supervision. Specicaon Power supply Baery 3.7 V DC 230 mAh Parcle size MMAD < 5 µm Power consumpon < 4.0 W Medicine cup volume 6 ml Nebulizaon rate 0.15 ml/min~0.90 ml/min Product dimensions / weight 6.8 x 6.6 x 4.05 cm / 57.5 g Work frequency 110 kHz ± 10 kHz Safety class BF applied part ENThe mean parcle size in the nebulizer is measured in a 0.9% saline soluon at 25°C and relave humidity of 59% R.H. The equivalent distribuon curve for mist parcle size in the said condion is as follows: Please note! The horizontal axis is the parcle size value. The value is a log distribuon. The le vercal axis is a cumulave size percentage corresponding to the increasing curve trend. The right vercal axis is a percentage value of the secon corresponding to the histogram. Kit The kit includes the main unit, medicine cup, USB power cord, adult mask, child mask and mouthpiece. Part list (Fig. 1) A. Container components

• Aach the container to the main device unit. The container is aached correctly when you hear a characterisc click (Fig. 2). Next, install the appropriate mask or mouthpiece (Fig. 3). PLEASE NOTE! Before use, clean, disinfect and dry all the device parts as instructed in the “Cleaning and disinfecon” chapter. Power supply

• To charge the nebulizer, use the USB cable and an appropriate adapter with the output parameters of 5.0 V DC 1.0 A.

• The device power supply system has one lithium baery.

• To charge a discharged baery, connect the device to the mains (Fig. 4). Please note! Before you charge, ensure that the mains socket has the suitable voltage. Please note! The device has an autonomous charging system. Do not charge together with any other electronic equipment. Baery charging

• The fully-charged baery may supply power to the device for up to 60 minutes connuously.

• Low baery level is indicated by a LED which is going to blink blue 5 mes and then switch o.

• Use the charger to charge the baery. Ca. 2 hours are required to charge it completely.

• The LED blinks when charging and is solid when it is fully charged. Operaon manual (Fig. 5)

LED is solid blue Operang LED blinks blue 5 mes Low baery / Switching o LED blinks blue 3 mes No liquid / The device is not vercal / Switching o LED blinks green Charging LED is solid green Baery fully charged 2. Preparaon: Before use, clean, disinfect and dry all the device components as instructed in the “Cleaning and disinfecon” chapter. 3. Pouring liquid: open the cover, inject the soluon and close the cover. Please note! Before you switch the device on, pour the liquid into the cup. Please note: protecon from leakage! When you pour the medicine into the medicine cup, ensure that you ll it up to the maximum value (6 ml). The recommended liquid amount is 2 to 6 ml. Nebulizaon takes place solely when the substance to be produced has contact with the mesh disc. Otherwise, nebulizaon stops automacally. Keep the device upright.

Before you start nebulizing, shake the device horizontally to sr the soluon. Based on your individual needs, use the following two nebulizaon methods (see Fig. 6).

• Put on the mask or place the mouthpiece between your lips and press the power buon. A – Nebulizing with a mouthpiece B – Nebulizing with a mask

• Take a slow, deep breath and wait unl the medicaon release starts.

• The nebulizer switches o automacally in 10 minutes. To extend the use, press the power buon. Ensure there is sucient liquid in the medicine cup.

• Aer nebulizaon is completed, press the power buon to switch the device o. Press the container unlocking buon, remove the container and empty it (Fig. 7).

• To install the container, press the “press” buon and slide the container in the device vercally. Ensure that the container is located correctly (Fig. 8).

• Please note! The liquid may start thickening round the nozzle and the mesh disc which may aect the nebulizaon result. Stop nebulizing, remove the mouthpieceand other accessories and then wipe the residues away with a sterile gauze. Do not touch the mesh disc with your hand or sharp objects due to the risk of damage. Cleaning

• Before cleaning, switch the device o and disconnect all the accessories. The device must not be connected to the mains.

• Immerse the accessories in warm water (no more than 40°C) for ca. 5 minutes.

• Aer cleaning, dry the accessories with a sterile gauze.

• Store the accessories in a dry and clean place.

• The main unit should be cleaned with a dry cloth. If there are any medicaon residues on the device, they should be cleaned with a damp, sterile gauze and le to dry completely.

• Please note! Do not immerse the mask in hot water. Disinfecon Aer every use, disinfect the medicine cup, spray nozzle, mask, cup cover and mouthpiece.

1. Disinfecng with hydrogen peroxide

Immerse the accessories in 2% hydrogen peroxide for ca. 10 minutes. Aer you have disinfected them, rinse the accessories with water and dry with a sterile gauze or leave to dry. Do not use any strong oxidizing agents.

2. Disinfecng with ethyl alcohol

Immerse the accessories in ethyl alcohol for ca. 10 minutes. Aer you have disinfected them, rinse the accessories with water and dry with a sterile gauze or leave to dry. Drying

• Shake the medicine cup to remove any remaining water from the cup and the mesh disc.

• Leave the accessories to dry for at least 4 hours.

• Ensure that all the accessories are perfectly dry, including but not limited to the mesh disc and medicine cup. Storage and maintenance

Ambient temperature: -10°C~+50°C Relave humidity, non-condensing: 30–85% RH Ambient pressure: 86–106 kPa Other: non-corrosive gases, good venlaon, avoiding high temperature, humidity and direct sun rays.

2. Storage instrucons

The device has a shelf life of 5 years, provided the above storage condions are ensured. The medicine cup should be replaced aer no more than 18 months. Aer use, clean and disinfect the device and the accessories. Store the device in the original packaging. Avoid any shock.

Temperature: 5°C~40°C Relave humidity, non-condensing: 30-80% RH Ambient pressure: 86–106 kPa Power supply: lithium baery 3.7 V DC 230 mAh Power supply parameters (not included): 5.0 V DC 1.0 A Troubleshoong Problem Cause/soluon The device does not switch on. Check the baery level. Check if the medicine cup is lled. Keep the device upright. Poor nebulizaon. Check if the cup is lled with an appropriate, water-soluble medicine. Check if there is sucient amount of the medicine. Check if the mesh disc is not clogged. The device switches o or makes a strange noise. Check if there is sucient amount of the medicine. Specic indicaons for children

• The mask should cover the mouth and the nose.

• Do not nebulize a sleeping child.

• Please note! Children require adult help and supervision when using the device. Electromagnec compability (EMC) symbols This device fullls the requirements relang to the electromagnec compability (IEC60601-1-2). Use the device according to the provided EMC informaon. The device must not be subject to any interference from radio communicaon devices. Such devices should be used at least 30 m away from it. Do not use the device near any devices generang strong magnec eld and, whenever this is required, the device should be watched to check its correct operaon in the relevant conguraon. Using any accessories and cables other than provided may result in increased emissions or reduced product resistance.To meet the EMC (electromagnec compability) requirements and prevent any dangerous situaons, the IEC60601-1-2 standard was implemented. The standard denes the device resistance to electromagnec interference and the maximum electromagnec emissions level for medical devices. This device conforms to the IEC60601-1-2 standard for resistance and emission level. Guidelines and declaraons concerning electromagnec emissions This device is intended for use in the below-menoned electromagnec environment. The user should use the device solely in that environment. Emissivity tesng Conformity Electromagnec environment — guidelines Radio frequency emissions CISPR 11 Group 1 The nebulizer generates radio frequency energy solely as a result of its internal funcons. RF emission is negligible and there is lile probability that it will cause any interference with any electronic devices near the device. Radio frequency emissions CISPR 11 B class The nebulizer may be used in all facilies, including residenal premises and premises connected directly to the LV grid providing power to residenal premises. Harmonic emissions IEC 61000-3-2 A class Voltage uctuaons/ickering IEC 61000-3-3 Conforming Guidelines and declaraons concerning electromagnec immunity This device is intended for use in the below-menoned electromagnec environment. The user should use the device solely in that environment. Immunity tesng IEC 60601 test level Conformity level Electromagnec environment — guidelines Stac discharge (ESD)

±8 kV by touch, ±2 kV, ±4 kV, ±8 kV, ±15 kV by air, ±8 kV by touch, ±2 kV, ±4 kV, ±8 kV, ±15 kV by air, The oor should be made from wood, concrete or covered with ceramic les. If the oor is covered with a synthec material, relave humidity should be at least 30%. Transient state and pulses IEC 61000-4-4 ±2 kV for feeders, ±1 kV for output / input lines ±2 kV for feeders The quality of the service line should correspond to the level of the standard commercial or hospital environment. Discharge IEC 61000-4-5 ±0.5 ±1 kV between the lines ±0.5 kV ±1 kV ±2 kV line to the base ±0.5 ±1 kV between the lines The quality of the service line should correspond to the level of the standard commercial or hospital environment. Voltage drops, short breaks and changes of the supply voltage in feeders IEC 61000- 4-11 <5% UT (>95% UT voltage drop) for one half of the cycle <5% UT (>95% UT voltage drop) for one half of the cycle The quality of the service line should correspond to the level of the standard commercial or hospital environment. If connuous power supply is required for any power outage from the service line, it is recommended that an UPS or baery is used. <5% UT (>95% UT voltage drop) for one cycle <5% UT (>95% UT voltage drop) for one cycle 70% UT (30% UT voltage drop) for 25 cycles 70% UT (30% UT voltage drop) for 25 cycles <5% UT (>95% UT voltage drop) for 5/6 seconds <5% UT (>95% UT voltage drop) for 5/6 secondsMagnec eld with the feeder frequency (50 Hz/60 Hz) IEC 61000-4-8 30 A/m 30 A/m The magnec eld with the feeder frequency should have the level corresponding to the standard commercial or hospital environment. Immunity to radio- electric disturbances introduced in the conductors according to IEC61000-4-6 3 V/m 150 KHz to 80 MHZ 6 Vrms in ISM and amateur radio bands 3 V/m Portable radio communicaon devices should not be used in the vicinity of any part of the nebulizer, including cables, at a distance shorter than the recommended one, calculated based on the relevant equaon matching the transmier frequency. Recommended distance: d = 1,2√P d = 1,2√P 80 MHz do 800 MHz d = 2,3√P 800 MHz do 2,5 GHz where P is the maximum rated output power of transmiers in was (W) specied by the transmier manufacturer and d is the recommended distance in meters (m). The eld strength of the constant radio transmiers determined by measuring the background electromagnec interference should be lower than the conformity level for every frequency range. The interference may occur near devices marked with the following symbol: Radio-electric radiaon according to

10 V/m 80 MHz to 2.7 GHz 385 MHZ – 5785 MHZ 3 V/m PLEASE NOTE! For 80 MHz and 800, a higher frequency range applies. PLEASE NOTE! These guidelines may not apply in certain cases. Electromagnec wave propagaon changes as a result of absorpon and reecons from structures, objects and people. 1. It is not possible to determine the strength of the eld from permanent transmiers, including base transceiver staons (for mobile/wireless networks), portable terrestrial transceivers and amateur radio transceivers, AM and FM radio transceivers and TV transceivers. To determine the electromagnec condions relang to permanent radio transceivers, electromagnec interference in the locaon should be measured. If the measured eld strength in the locaon where the nebulizer is used exceeds the applicable conformity level specied above, the nebulizer should be watched to verify its correct operaon. If you noce any extraordinary operaon, some extra measures may be required, including e.g. nebulizer reorientaon or relocaon.

2. For the frequency range 150 kHz to 80 MHz, the eld strength should be below 3 V/m.