microlife NEB 150 MINI Compressor Nebuliser User Guide

microlife NEB 150 MINI Compressor Nebuliser

Specifications

• Manufacturer: Microlife
• Model: NEB 150 MINI
• Type: Piston Compressor Nebuliser
• Intended Use: Aerosol therapy system for domestic use
• Age Group: Children from 2 years old, adolescents, and adults

Product Usage Instructions

Assembly

Before using the nebulizer, assemble the components in the following order

1. Connect the power lead to the nebulizer.
2. Insert the air filter into the designated compartment.
3. Attach the nebuliser to the compressor.
4. Connect the air tube to the nebuliser.
5. Choose the appropriate face mask or mouthpiece for the patient.

Operation

Follow these steps to operate the nebuliser:

1. Ensure the device is placed on a stable surface.
2. Turn on the nebuliser using the ON/OFF switch.
3. Breathe normally through the mouthpiece or mask while the medication is being administered.

Cleaning and Maintenance

To ensure proper functioning and longevity of the nebuliser, it is important to clean and maintain it regularly:

1. After each use, detach the nebuliser kit and wash it with warm, soapy water.
2. Air dry all components thoroughly before reassembling.
3. Check the air filter regularly and replace it if necessary.

microlife NEB 150 MINI Compressor Nebuliser

1. Piston compressor
2. Power lead
3. ON/OFF Switch
4. Air filter compartment
5. Nebuliser -a: Vaporiser head
6. Air tube
7. Mouthpiece
8. Adult face mask
9. Child face mask
10. Assembling nebuliser kit
11. Nose piece
12. AL Air filter

Intended use

The device is an aerosol therapy system suitable for domestic use. The device is designed for the production of compressed air to operate a small-volume nebulizer for the production of medical aerosol for lung respiratory disorders.
Patient population
The device is intended for use with children from 2 years old, adolescents, and adult patients.
Intended user
The use of the device does not require specific knowledge or professional ability. The patient is the intended operator except in the case of a child and a patient who requires special assistance.
Indications
Lung acute or chronic diseases of respiratory disorders organs, or inflammation of the upper respiratory system.
Contra-indications
The device is not indicated to be used with quick-relief medications during life-threatening asthma attacks. No contraindications exist to the administration of aerosols by inhalation. Contraindications related to the medicine used must be checked on the medicine package leaflet. Consult your physician in case of doubts.

Dear Customer,
This nebulizer is an aerosol therapy system suitable for domestic use. This device is used for the nebulization of liquids and liquid medication (aerosols) and the treatment of the upper and lower respiratory tract.
If you have any questions, or problems or want to order spare parts please contact your local Microlife-Customer Service. Your dealer or pharmacy will be able to give you the address of the Microlife dealer in your country. Alternatively, visit the Internet at
www.microlife.com where you will find a wealth of invaluable information on our products.
Stay healthy – Microlife Corporation

Important safety instructions

• Use the device only as described in this manual and therefore as a therapy system, following the indications of your doctor. Any use different from the intended one is to be considered improper and hence dangerous; the manufacturer cannot be held liable for any damage caused by improper, incorrect,, and/or unreasonable use, or if the equipment is connected to electrical installations which do not comply with current safety regulations.
• Keep the user manual for future reference.
• Do not operate the unit in the presence of any anesthetic mixture inflammable with oxygen or nitrogen protoxide.
• The correct functioning of the equipment can be affected by electromagnetic interferences that exceed the limits indicated by the European standards in force. In case this device inter-feres with other electrical devices, move it and plug it into a different power socket.
• In case of failure and/or malfunction, read the «Malfunctions and actions to take» section in the user manual. Do not handle or open the compressor housing.
• For repair operations address only to a technical service centre authorized by the manufacturer and require the use of original spare parts. The non-observation of the above-mentioned indications can compromise the device’s safety.
• Comply with the safety regulations concerning electrical devices and in particular:
• use only original applied parts and components;
• never submerge the unit in water;
• never wet the device, it is not protected against water penetration;
• never touch the unit with wet or moist hands;
• do not leave the unit exposed to the weather elements;
• place the unit on a stable and horizontal surface during its operation;
• the use of this device by children and people with disabilities requires always close supervision by an adult with full mental faculties;
• do not pull the power cord or the device itself to unplug it from the power socket;
• the power plug is the separation element from the grid power; keep the plug accessible when the device is in use.
• Before plugging in the device, make sure that the electrical rating, shown on the rating plate on the bottom of the unit, corresponds to the mains rating.
• In case the power plug provided with the device does not fit your wall socket, contact qualified personnel for a replacement plug with that a suitable one. In general, the use of adapters, simple or multiple, and/or extension cables is not recommended. If their use is indispensable, it is necessary to use types complying with safety regulations, paying attention that they do not exceed the maximum power limits, indicated on adapters and extension cables.
• Do not leave the unit plugged in when not in use; unplug the device from the wall socket when it is not in operation.
• The installation must be carried out according to the instructions of the manufacturer. An improper installation can cause damage to persons, animals, or objects, for which the manufacturer cannot be held responsible.
• The power cord of this device cannot be replaced by the user. In case of a power cord damage, address to a technical service center authorized by the manufacturer for its replacement.
• The power supply cord should always be fully unwound to prevent dangerous overheating.
• Before performing any maintenance or cleaning operation, turn off the device and disconnect the plug from the main supply.
• Some parts of the unit are so small that they may be swallowed by children; keep the equipment out of children’s reach.
• If you decide not to use the device any longer, it is recommended to dispose of it according to the current regulations.
•  Make sure to: use this device only with medicines prescribed by your doctor;
• make the treatment using only the applied parts recommended by your doctor depending on the pathology;
• use the nosepiece applied part only if expressly indicated by your doctor and pay attention to NEVER introduce the bifurcations in the nose, but only bring them as close as possible.
• Check in the medicine instruction leaflet for possible contraindications for use with common aerosol therapy systems.
•  To avoid strangulation and entanglement, keep cable and air tubes out of reach of young children.
• Do not position the equipment so that it is difficult to operate the disconnection device.
• The nebulizer and applied parts are single patient use. The device is for multi-patient use.
• This nebulizing system is not suitable for use in an anesthetic breathing system or a ventilator breathing system. The patient cannot undergo an MRI scan while using this device.
• This device is designed to nebulize solution and suspension liquids.
• Do not use this device if you think it is damaged or notice anything unusual.
• This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the «Technical specifications» section.
• The use of this device is not a replacement for visiting the doctor. In case of no health improvement after treatment consult your doctor again.

Preparation and usage of this device

• The device must be checked before each use to identify any malfunctions and/or damage caused during transportation and/or storage. During inhalation, sit upright and relaxed to avoid compressing the airways and impairing treatment effectiveness. The applied parts must be used only with a single patient, it is not recommended to use them with several patients.

• After unpacking the device, check it for visible damages or defects; pay particular attention to cracks in the plastic housing, which may expose electrical components. Check if the applied parts are intact.

• Before using the device, proceed with the cleaning operations as described in the chapter «Cleaning and disinfecting».

  • Assemble the nebuliser kit AT. Ensure that all parts are complete.
  • Fill the nebuliser with the inhalation solution as per your doctor’s instructions. Ensure that you do not exceed the maximum level.
  • Connect the nebuliser with the air tube 6 to the compressor 1 and plug the power lead 2 into the socket (230V 50 Hz AC).
  • To start the treatment, set ON/OFF switch 3 into the «I» position.
  • The mouthpiece 7 gives you a better drug delivery to the lungs.
  • Choose between adult 8 or child face mask 9 and make sure that it encloses the mouth and nose area completely.
  • Use all applied parts including the nose piece AK as prescribed by your doctor.
  • During inhalation, sit upright and relaxed at a table and not in an armchair, to avoid compressing your respiratory airways and impairing the treatment’s effectiveness. Do not lie down while inhaling. Stop inhalation if you feel unwell.
  • Inhale the aerosol solution using the prescribed applied part.
  • Once you have finished the treatment, switch the appliance off by pressing the ON/OFF switch 3.
    8. Empty the remaining medication from the nebulizer and clean the device as described in the section «Cleaning and disinfecting»

• This device was designed for intermittent use of 30 min. On / 30 min. Off. Switch off the device after 30 min. use and wait for another 30 min. before you resume treatment.

• The device requires no calibration.

• Tampering with the device is forbidden. No modification to the device is permitted.

Installation

Cleaning and disinfecting

Device(s): Aerosol therapy nebuliser applied parts

**| Before the first use and after each treatment** Follow carefully the cleaning and disinfection instructions of the applied parts as they are very important for the device’s performances and the therapy’s success.

·   Use original applied parts only.

·   Do not clean or disinfect the air tube.

·   The applied parts cannot be cleaned and disinfected by automated method. ·   Do not boil nor autoclave the masks.

Limitations on processing| The nebulizer must be replaced after a long period of inactivity, in case it shows deformations or breakings, or when the nebuliser nozzle is obstructed by dry medicine, dust, etc. We recommend replacing the nebulizer after a period between 6 months and 1 year, depending on the usage. The maximum times of cleaning and disinfection of the nebulizer are 360 times.

The maximum times of cleaning and disinfection of the mask, the nosepiece, and the mouthpiece are 360 times.

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Instructions

Preparation

before cleaning

| ·    Detach the air tube from the nebuliser.

·    Detach the mouthpiece nosepiece or mask from the nebuliser.

·    Make sure that all residual volume is removed from the nebuliser.

·    Disassemble the nebulizer 5 by turning the top counterclockwise and removing the medi- cine conduction cone.

Note: To avoid microbial growth and residual drug drying, clean and disinfect the applied parts immediately after each use.

Cleaning| Briefly rinse all parts in running tap water for at

At least 10 seconds beforehand.

Mix a little dish detergent and warm tap water (i.e. FAIRY brand dishwashing liquid for hand washing in a ratio of 2 ml: 1 L) in a clean container.

Immerse the components of disassembled nebuliser, the mask, the mouthpiece, and the nosepiece into the mixed water for about 5 min. And then scrub the surface of all the components with a clean and small brush for at least 8 times.

Afterward rinse all parts thoroughly in running tap water at least 30 seconds, to fully remove any possible dish washing liquid residue.

Disinfection| ·    After cleaning, disinfect all of the disassem-

bled parts (only parts that have been cleaned can be disinfected effectively).

·    Boil the disassembled nebuliser, the mouth- piece and the nosepiece for 5 minutes in boiling tap water.

Immerse the mask in a 2% sodium hypochlorite (NaOCl) solution for 15 minutes, (i.e. a solution made from the disinfecting agent Amuchina® or a 2% sodium hypochlorite solution mixed by your pharmacist). Afterwards immerse the mask with sterile water for 3 min, and then rinse all the surface of the mask with other clean sterile water twice, to fully remove any possible residue of the disinfectant solution.

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Drying| ·    Reassemble the nebuliser components and

connect it to the air-outlet, switch the device on and let it work for 10 –15 minutes.

·    Let all parts dry completely before reassem- bling and reuse to avoid risk of germ grow.

Care needs to be taken not to contaminate the parts after they have been cleaned and disin- fected. Contamination can be avoided by good hand washing and not touching the inside sections of the device when laying them out to dry or when reassembling.

Inspection| Inspect all product components after each

cleaning and disinfection. Replace any broken, misshapen or seriously discolored parts.

Packaging| Pack dry parts in a clean and sealed container when not in use. Do NOT pack wet or damp parts.
Storage

| Storage conditions refer to «Technical specifi- cations».

Note: re-clean and re-disinfect the parts if they are stored more than one day.

Trans- portation| After cleaning and disinfection, always trans- port the parts with clean and sealed container. Contamination can be avoided by good hand washing and not touching the inside sections of the parts when taking out and re-assembling the parts for use.
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The instructions provided above have been validated by the manu-facturer of the medical device as being capable of preparing a medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result. This requires verification and/or validation and routine monitoring of the process.

Maintenance, Care and Service

Order all spare parts from your dealer or pharmacist, or contact Microlife- Service (see foreword).

Replacement of the nebuliser
Replace the nebuliser 5 after a long period of inactivity, in cases where it shows deformities, breakage, or when the vaporiser head 5-a is obstructed by dry medicine, dust, etc. We recommend to replace the nebuliser after a period between 6 months and 1 year depending on the usage.
Only use original nebulisers!

Replacement of the air filter
In normal conditions of use, the air filter AL must be replaced approximately after 200 working hours or after each year. We recommend to periodically check the air filter (10 – 12 treatments) and if the filter shows a grey or brown colour or is wet, replace it. Extract the filter and replace it with a new one.

• Do not try to clean the filter for reusing it.
• The air filter shall not be serviced or maintained while in use with a patient.
  Only use original filters! Do not use the device without filter!

Malfunctions and actions to take

The device cannot be switched on

• Ensure the power lead 2 is correctly plugged into the socket.
• Ensure the ON/OFF switch 3 is in the position «I».
• Make sure that the device has been operating within operating limits indicated in this manual (30 min On / 30 min Off).

The nebuliser functions poorly or not at all

• Ensure the air tube 6 is correctly connected at both ends.
• Ensure the air tube is not squashed, bent, dirty or blocked. If necessary, replace with a new one.
• Ensure the nebuliser 5 is fully assembled and the vaporiser head 5-a is placed correctly and not obstructed.
• Ensure the required medication has been added.

Guarantee

This device is covered by a 5 year guarantee from the date of purchase. During this guarantee period, at our discretion, Microlife will repair or replace the defective product free of charge. Opening or altering the device invalidates the guarantee.
The following items are excluded from the guarantee:

• Transport costs and risks of transport.
• Damage caused by incorrect application or non-compliance with the instructions for use.
• Damage caused by accident or misuse.
• Packaging/storage material and instructions for use.
• Regular checks and maintenance (calibration).
• Applied and wearing parts: Nebuliser, masks, mouthpiece, nose piece, tube, filters, nasal washer (optional).

Should guarantee service be required, please contact the dealer from where the product was purchased, or your local Microlife service. You may contact your local Microlife service through our website: www.microlife.com/support
Compensation is limited to the value of the product. The guarantee will be granted if the complete product is returned with the original invoice. Repair or replacement within guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

Disposal

All comply with RoHS and REACH, and all could be safety disposal. This product is subject to European Directive 2012/19/ EU on waste electrical and electronic equipment and is marked accordingly. Never dispose of electronic devices with household waste. Please seek out information about the local regulations with regard to the correct disposal of electrical and electronic products.
2| Applied parts: air tube 6,

nebuliser 5, nose piece AK, mouthpiece 7,

masks 8 / 9

| The components are plastic.

All comply with ROHS and REACH. Before disposal, all the applied parts should be cleaned according to manual instructions and then disinfected by boiling for 5 minutes.

Technical specifications

• Model: NEB 150 MINI
• Type: GCE855

AEROSOL PERFORMANCES ACCORDING TO EN ISO 27427:2019 based on adult ventilatory pattern withSodium Fluoride (NaF):

• Aerosol output: 0.67 ml

• Aerosol output rate: 0.06 ml/min.

• Percentage of fill volume emitted per min: 1.38 %

• Residual Volume: 0.8 ml

• Particle size (MMAD): 2.07 μm

• GSD (geometric standard deviation): 2.1 μm

• RF (respirable fraction < 5 μm): 72 %

• Large particle range (> 5 μm): 28 %

• Middle particle range (2-5 μm): 22 %

• Small particle range (< 2 μm): 50 %

• Operating air flow: 2.5 l/min.

• Acoustic noise level: 52 dBA

• Power source: 230V 50 Hz AC

• Current: ≤ 1000 mA

• Power lead length: 1.4 m

• Nebuliser capacity: min. 2 ml; max. 6 ml

• Operating limits: 30 min. On / 30 min. Off

• Operating conditions:
  10 – 40 °C / 50 – 104 °F
  10 – 95 % relative maximum humidity
  700 – 1060 hPa Atmospheric pressure

• Storage and shipping conditions:
  -25 – +70 °C / -4 – +140 °F
  10 – 95 % relative maximum humidity
  700 – 1060 hPa Atmospheric pressure

• Weight: approx. 850 g

• Dimensions: 165 x 112 x 112 mm

• IP Class: IP21

• Reference to standards:
  EN ISO 27427; EN 60601-1; EN 60601- 1-2; EN 60601-1-6; IEC 60601-1-11

• Expected service life: 500 hours

Class II device as regards protection against electric shocks. Nebuliser, mouthpiece and masks are type BF applied parts.

The technical specifications may change without prior notice.

Please report any serious incident that has occurred in relation to the device, injury or adverse event to the local competent authority and to the manufacturer or to the European authorized representative (EC REP).
Vigilance contact point:
https://ec.europa.eu/growth/sectors/medical-devices/contacts AEROSOL CHARACTERISTICS IN ACCORDANCE WITH REGULATION EN ISO27427

Standards applied

Electric safety standards CEI EN 60601-1 electromagnetic compatibility according to CEI EN 60601-1-2.
The device is a Class II medical device. The device complies with the European Regulation on Medical Devices EU MDR 2017/745. Important information regarding Electromagnetic Compati-bility (EMC): This product, manufactured by Globalcare Medical Technology Co., Ltd., conforms to the Electromagnetic Compati-bility (EMC) standard EN 60601-1-2:2015/A1:2021. Further documentation in compliance with this EMC standard is available from Microlife on www.microlife.com/electro-magnetic-compatibility.

Frequently Asked Questions

Q: Can this nebuliser be used for quick-relief medications during asthma attacks?

A: No, this nebuliser is not indicated for use with quick-relief medications during life-threatening asthma attacks. Consult your physician for appropriate treatment options in such cases.

Q: What age group is this nebuliser suitable for?

A: This nebulizer is intended for use with children from 2 years old, adolescents, and adult patients.

Q: How should I dispose of the nebuliser when no longer in use?

A: The device is subject to waste electrical and electronic equipment regulations. Do not dispose of it with household waste. Seek information on local regulations for proper disposal methods to protect the environment and human health.

References

• The Most Iconic Photographs of All Time - LIFE
• Microlife
• Hypertension and Fever Management - Microlife AG
• Support - Microlife AG
• Verenpainemittaus ja kuumemittaus - Microlife AG
• Microlife - Hipertenzijos ir karščiavimo kontrolė - Microlife AG
• Mājaslapa - Microlife AG
• Preventief je gezondheid managen - Microlife Nederland - Microlife AG
• Advies of hulp nodig? | Microlife - Microlife AG

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