Product Description

Helpmedi NebuCare Mesh Nebulizer NE-M01L

Medical Device

The NebuCare mesh nebulizer is intended for nebulization of children during the treatment of respiratory tract diseases. It is distinguished by its small size and ultra-quiet operation. It does not require connection to a power source and operates wirelessly thanks to a high-capacity battery charged via a USB port.

• The nebulizer can operate in one of two modes: high speed ≥ 0.25 ml/min (mode 1) or low speed ≥ 0.15 ml/min (mode 2). The operating mode can be changed by briefly pressing the "On/Off" button. This allows you to adjust the inhalation rate to the child's needs.
• The NebuCare nebulizer produces microparticles 5 microns in size – they easily reach deep into the respiratory system, making inhalations more effective and treatment shorter.
• NebuCare minimizes medication loss – the entire dose is converted into mist. The respirable fraction is no less than 60%.
• During inhalation, it is recommended to keep the device in a vertical position, but it is possible to inhale with the child lying down.
• The nebulizer is equipped with a fluid level sensor. If there is no fluid on the sensor, the device will automatically turn off (it will flash an intermittent orange light). In this case, place the device in a vertical position and restart nebulization.
• The time required to fully charge the battery is 1 hour. After charging, the nebulizer should operate for approximately 50-60 minutes.
• The package contains a mouthpiece and two masks: a smaller one for small children and a larger one for older children and adults.

Stages of the treatment procedure

Preparation:

1. Remove, clean, and disinfect the medication container before use.
2. Pouring the medication: Open the container lid and pour the medication into it.
3. Close the container lid.
4. Install the medication container on the main part of the device.
5. Install the mask.

Operation:

To turn on the device, briefly (1 second) press the start button. After 1 second, the indicator light will turn green and the device will begin spraying the medication.
Note: If you hold the start button down too long, the device enters calibration mode. In this case, make sure there is no liquid in the medication container, press the button for 5 seconds, until the green LED turns off and the orange LED turns on. After turning off the device, restart the device, i.e., fill the nebulizer container with salt/medication and briefly press the start button (1 second).

To change the nebulizer mode to mode 2, briefly press the button (1 second). To turn off the device, press the button longer until the green LED turns off.

Cleaning the nebulizer:

1. The device should be cleaned and disinfected after each use.
2. Remove the accessories (mask or mouthpiece) from the main body of the device.
3. Open the medication container lid and remove any remaining medication.
4. Add 75% ethanol solution to the medication container, close the lid, and wait at least 10 minutes. For a better disinfection effect, you can gently shake the container.
5. Remove the disinfectant and fill the medication container with distilled or demineralized water. Turn on the device for 10 minutes to clean the nebulizing layer.
6. After cleaning, remove any remaining water from the medication cup, and then leave the cup with the lid open to dry naturally.
7. Use 75% medical-grade alcohol to wipe the surface of the device housing, air dry, or wipe dry with a clean, soft cloth.

Disinfection and cleaning of accessories:

1. Remove the accessories (mask or mouthpiece) from the main body of the device.
2. Immerse the accessories in the ethanol solution and cover the cup. The ethanol solution concentration should be 75% and the soaking time should be 10 minutes or longer.
3. Remove the accessories and clean them with clean water.
4. After cleaning, remove any remaining water using a new medical gauze pad and dry thoroughly.
5. After completing all the above steps, store the nebulizer, medication cup, and accessories in a clean and dry place.

NOTE: Do not disinfect the medication cup or accessories in boiling water, as this may distort the parts. Do not dry the parts in a microwave. Parts disinfected with a disinfectant must be thoroughly cleaned, as any residue of this agent may cause a deterioration in health.

Technical specifications
Color: White
Dimensions in the package (in mm): 138x93x110
Product weight: 416 g
Age range: From the first days of life
Certificates, standards, approvals: CE0123, DOC
Packaging equipment: Mesh nebulizer, 2 masks (small and large), mouthpiece, USB charging cable
Power supply type: Lithium-ion battery
Adjustment in levels: 2-stage
Nebulizer capacity in ml: 10 ml
Noise level in dB: ≤50 dB
Particle size: Below 5 microns
Device power Input power: up to 5 VA
Working time in minutes: 50-60 min, nebulization treatment should not exceed 20 min.
Nebulization rate in mode I: ≥ 0.25 ml/min
Nebulization rate in mode II: ≥ 0.15 ml/min
Equivalent volume distribution of particle diameter: the volume distribution coefficient of small atomized particles (diameter <5 μm) is not less than 60%.

The nebulizer CANNOT be used with:

• highly concentrated drugs/steroids
• highly viscous drugs/steroids
• oily drugs/steroids, essential oils, suspensions, volatile, liquid medicines
• physiological saline with hyaluronic acid, e.g. Nebu-dose Hialuronic, or other preparations with hyaluronic acid
• physiological saline with ectoine, e.g. Ectodose, or other preparations with ectoine

Helpmedi NebuCare Mesh Nebulizer NE-M01L - package contents:

• mesh nebulizer
• two masks
• mouthpiece
• USB cable

Read the instructions for use and the most important recommendations for use contained in the leaflet enclosed with the device.

Responsible entity:

Duna Sp. z o.o.
ul. Przemysłowa 13/1
30-701 Kraków

This is a medical device. Use it according to the instructions for use or label.