LOC-NEBI lionelo Nebi Air Mask User Manual

User manual

Nebi Air Mask

Important information

Please read this manual before you start operating the product to learn its functions and use it as intended. The failure to follow the safety instructions and use in compliant with the manual may result in a bodily injury.

1. 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 medications that are oily or contain essential oils, including herbal extracts, for nebulization. It is acceptable to use suspended liquids if the parameters of the substance are within the values specified in the product specifications.
4. The type, dose and method of drug administration 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 nebulization. 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 your doctor.
9. Use the device with medicinal drugs which solve in water or contain alcohol and saline solutions. Using any other drugs may cause bronchospasm.
10. The device shall not be used to anesthetize the respiratory system.
11. 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 accidentally.
13. Do not switch the device on unless the mask fits the face correctly.
14. Always use any spare parts supplied or recommended by the manufacturer.
15. The device must be switched off and disconnected from the mains after use and before assembly, dismounting and cleaning.
16. Do not immerse the device or its power cord in water or other liquids.
17. After use, remove any remaining liquid from the device.
18. When using the device, maintain the liquid level ensuring that the mesh disc is covered completely.
19. Do not use the device in the presence of any flammable gases or mixtures of oxygen and anesthetics.
20. Do not use the device at high temperatures.
21. Do not use the nebulizer near any heating device or open flame.
22. Do not expose the device to strong shock and vibrations.
23. Do not use microwave ovens to dry or disinfect the device due to the fire hazard.
24. Do not touch the mesh disc with your hand or any sharp objects due to the risk of damage.
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 battery yourself.
30. 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 specified in the operation manual.
32. Charge the device before first use.
33. Do not repair or maintain the device when it is operated.
34. The device is operated by the patient.
35. The device is a BF applied part.
36. 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 indications

1. Do not use the device with any medications containing pentamidine.
2. The device must not be used by patients with pulmonary edema.
3. The device must not be used by patients who had pulmonary infarction and suffering from acute asthma.
4. If the patient suffers from diabetes or another chronic disease, contact the doctor before use.

0197

The product conforms to the requirements of European Union directions.
According to Directive 2012/19/EU, this product is subject to separate waste collection. 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 inhalation therapy in health care facilities or for home health care. The device can be used both for adults and for children and people with limited capacities provided it is used under adult supervision.

Specification

6.6 x 4.05 cm / 57.5 g
Work frequency| 110 kHz ± 10 kHz| Safety class| BF applied part

The mean particle size in the nebulizer is measured in a 0.9% saline solution at 25°C and relative humidity of 59% R.H. The equivalent distribution curve for mist particle size in the said condition is as follows:
Please note! The horizontal axis is the particle size value. The value is a log distribution. The left vertical axis is a cumulative size percentage corresponding to the increasing curve trend. The right vertical axis is a percentage value of the section 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

1. Cover
2. Medicine cup
3. Spray nozzle
4. Main unit
5. Power switch
6. USB port
7. Electrode contacts
8. Child mask
9. Adult mask
10. Headband
11. Cup unlocking button
12. Mouthpiece
13. Mesh disc

Assembly

• Attach the container to the main device unit. The container is attached correctly when you hear a characteristic 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 disinfection” 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 battery.
• To charge a discharged battery, 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.

Battery charging

• The fully-charged battery may supply power to the device for up to 60 minutes continuously.
• Low battery level is indicated by a LED which is going to blink blue 5 times and then switch off.
• Use the charger to charge the battery. Ca. 2 hours are required to charge it completely.
• The LED blinks when charging and is solid when it is fully charged.

Operation manual (Fig. 5)

1. LED

LED is solid blue| Operating| LED blinks blue 5 times| Low battery / Switching of
---|---|---|---
LED blinks blue 3 times| No liquid / The device is not vertical / Switching of| LED blinks green| Charging
LED is solid green| Battery fully charged

2. Preparation: Before use, clean, disinfect and dry all the device components as instructed in the “Cleaning and disinfection” chapter.
3. Pouring liquid: open the cover, inject the solution and close the cover. Please note! Before you switch the device on, pour the liquid into the cup.
Please note: protection from leakage! When you pour the medicine into the medicine cup, ensure that you fill it up to the maximum value (6 ml). The recommended liquid amount is 2 to 6 ml. Nebulization takes place solely when the substance to be produced has contact with the mesh disc. Otherwise, nebulization stops automatically. Keep the device upright.
4. Nebulization

• Before you start nebulizing, shake the device horizontally to stir the solution. Based on your individual needs, use the following two nebulization methods (see Fig. 6).

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

• Take a slow, deep breath and wait until the medication release starts.

• The nebulizer switches off automatically in 10 minutes. To extend the use, press the power button. Ensure there is sufficient liquid in the medicine cup.

• After nebulization is completed, press the power button to switch the device off. Press the container unlocking button, remove the container and empty it (Fig. 7).

• To install the container, press the “press” button and slide the container in the device vertically. 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 affect the nebulization result. Stop nebulizing, remove the mouthpiece and 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 off 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.
• After 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 medication residues on the device, they should be cleaned with a damp, sterile gauze and left to dry completely.
• Please note! Do not immerse the mask in hot water.

Disinfection

After every use, disinfect the medicine cup, spray nozzle, mask, cup cover and mouthpiece.

1. Disinfecting with hydrogen peroxide
   Immerse the accessories in 2% hydrogen peroxide for ca. 10 minutes. After 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. Disinfecting with ethyl alcohol
   Immerse the accessories in ethyl alcohol for ca. 10 minutes. After 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

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

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

3. Operating conditions
   Temperature: 5°C~40°C Relative humidity, non-condensing: 30-80% RH Ambient pressure: 86–106 kPa
   Power supply: lithium battery 3.7 V DC 230 mAh Power supply parameters (not included): 5.0 V DC 1.0 A

Troubleshooting

Check if the medicine cup is filled.
Keep the device upright.
Poor nebulization.| Check if the cup is filled with an appropriate, water- soluble medicine.
Check if there is sufficient amount of the medicine.
Check if the mesh disc is not clogged.
The device switches off or makes a strange noise.| Check if there is sufficient amount of the medicine.

Specific indications 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.

Electromagnetic compatibility (EMC) symbols

This device fulfills the requirements relating to the electromagnetic compatibility (IEC60601-1-2).
Use the device according to the provided EMC information.
The device must not be subject to any interference from radio communication devices. Such devices should be used at least 30 m away from it.
Do not use the device near any devices generating strong magnetic field and, whenever this is required, the device should be watched to check its correct operation in the relevant configuration.
Using any accessories and cables other than provided may result in increased emissions or reduced product resistance.

To meet the EMC (electromagnetic compatibility) requirements and prevent any dangerous situations, the IEC60601-1-2 standard was implemented. The standard defines the device resistance to electromagnetic interference and the maximum electromagnetic emissions level for medical devices. This device conforms to the IEC60601-1-2 standard for resistance and emission level.

Guidelines and declarations concerning electromagnetic emissions

This device is intended for use in the below-mentioned electromagnetic environment.
The user should use the device solely in that environment.

Emissivity testing| Conformity| Electromagnetic environment — guidelines
---|---|---
Radio frequency emissions CISPR 11| Group 1| The nebulizer generates radio frequency energy solely as a result of its internal functions. RF emission is negligible and there is little 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 facilities, including residential premises and premises connected directly to the LV grid providing power to residential premises.
Harmonic emissions IEC 61000-3-2| A class
Voltage fluctuations/flickering IEC 61000-3-3| Conforming

Guidelines and declarations concerning electromagnetic immunity

This device is intended for use in the below-mentioned electromagnetic environment.
The user should use the device solely in that environment.

Immunity testing| IEC 60601 test level| Conformity level| Electromagnetic environment — guidelines
---|---|---|---
Static discharge (ESD) IEC 61000-4-2| ±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 floor should be made from wood, concrete or covered with ceramic tiles. If the floor is covered with a synthetic material, relative 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 continuous power supply is required for any power outage from the service line, it is recommended that an UPS or battery 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 seconds
Magnetic field with the feeder frequency (50 Hz/60 Hz) IEC 61000-4-8| 30 A/m| 30 A/m| The magnetic field with the feeder frequency should have the level corresponding to the standard commercial or hospital environment.
Immunity to radioelectric 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 communication 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 equation matching the transmitter 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 transmitters in watts (W) specified by the transmitter manufacturer and d is the recommended distance in meters (m).
The field strength of the constant radio transmitters determined by measuring the background electromagnetic 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 radiation according to IEC61000-4-3| 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. Electromagnetic wave propagation changes as a result of absorption and reflections from structures, objects and people.

1. It is not possible to determine the strength of the field from permanent transmitters, including base transceiver stations (for mobile/wireless networks), portable terrestrial transceivers and amateur radio transceivers, AM and FM radio transceivers and TV transceivers. To determine the electromagnetic conditions relating to permanent radio transceivers, electromagnetic interference in the location should be measured. If the measured field strength in the location where the nebulizer is used exceeds the applicable conformity level specified above, the nebulizer should be watched to verify its correct operation. If you notice any extraordinary operation, some extra measures may be required, including e.g. nebulizer reorientation or relocation.
2. For the frequency range 150 kHz to 80 MHz, the field strength should be below 3 V/m.

Maximum rated output power of the transmitter (W)| Distance adapted to the transmitter frequency (m)
---|---
150 kHz to 80 MHz d = 1,2√P| 80 MHz to 800 MHz d = 1,2√P| 800 MHz to 2.5 GHz d = 2,3√P
0,01| 0,12| 0,12| 0,23
0,1| 0,38| 0,38| 0,73
1| 1,2| 1,2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23

Recommended distance between portable radio communication devices and

the nebulizer

The nebulizer is designed for use in an electromagnetic environment with limited interference caused by radio waves. The nebulizer user may help to reduce electromagnetic interference by ensuring the minimum distance between the mobile radio communication devices (transmitters) and the nebulizer as specified below, as appropriate for the maximum rated output power of the communication device.

For transmitters for which the maximum rated output power was not mentioned above, the recommended distance d in meters (m) may be estimated by the equation appropriate for the transmitter frequency, where P is the maximum output rated power of transmitters in watts (W) specified by the transmitter manufacturer.

The photos are illustrative and the actual appearance of the products may differ from the one in the photos.

Symbols explained

| The package contains an operation manual which should be read before you start using the device| | Authorized representative’s details
---|---|---|---
| Sterilized with ethylene oxide
| Keep away from sunlight and heat sources| | Date of manufacture
| Manufacturer’s details
| Ingress protection rating| | BF applied part
| Delicate product| | Medical device
| Top|  | Lot no
| Store in a dry place| | Device serial number

Model: Air Mask

Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd,
2595AA, The Hague, Netherlands.

0197 Made in PRC

FEELLIFE HEALTH INC.
Room 1903, Building A, No.9 Furong Road,
Tantou Community, Songgang Subdistrict, Bao’an
District, Shenzen 518104, Guangdong, China

IMPORTER:
BrandLine Group Sp. z o.o.
ul. A. Krcglewskiego 1, 61-248 Poznan, Poland

V2: 04.11.2022_full

www.lionelo.com

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