microlife NEB 410 Children Nebuliser Instruction Manual

: July 27, 2024
: microlife

Table of Contents

NEB 410 Children Nebuliser
Important Safety Instructions
Preparation and usage of this device
Cleaning and disinfecting
Maintenance, Care and Service
Malfunctions and Actions to take
Guarantee
Disposal
Technical specifications
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

NEB 410
Children Nebuliser

NEB 410 Children Nebuliser

Piston compressor
Power lead
ON/OFF Switch
Air filter compartment
Nebuliser
-a: Vaporiser head
Air tube
Mouthpiece
Adult face mask
Child face mask
Replacing air filter
Assembling nebuliser kit
Nose piece
Air filter

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. Correct disposal helps to protect the environment and human health.

| Read the instructions carefully
before using this device.
---|---
| Type BF applied part
Icon | Class II equipment
| Serial number
| Reference number
| Manufacturer
| Date of manufacture
| ON
| OFF
IP21| Protection against solid foreign objects and harmful effects due to the ingress of water
| Authorized representative in the European Community
| Medical device
| Importer
| Caution
| Single patient multiple use (for accessories only)
| Humidity limitation for operating and storage
| Temperature limitation for operating or storage
| Ambient pressure limitation
| Unique Device Identifier
| Type number
| CE Marking of Conformity

Intended use:
The device is an aerosoltherapy system suitable for domestic use.
The device is designed for the production of compressed air to operate a small volume nebuliser for the production of medical aerosol for lung respiratory disorders.
Patient population:
The device is intended for use with children from 2 years old, adolescent and adult patients.
Intended user:
The use of the device does not require a specific knowledge or professional ability. The patient is the intended operator except in case of child and patient that required 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 nebuliser is an aerosol therapy system suitable for domestic use. This device is used for the nebulisation of liquids and liquid medication (aerosols) and for the treatment of the upper and lower respiratory tract.
This device has been specifically designed to make treatment more pleasant for children, whilst ensuring all the quality and safety standards of Microlife products.
If you have any questions, 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!

Table of contents

Important Safety Instructions
Preparation and usage of this device
Cleaning and disinfecting
Maintenance, Care and Service
Replacement of the nebuliser
Replacement of the air filter
Malfunctions and Actions to take
The device cannot be switched on
The nebuliser functions poorly or not at all
Guarantee
Disposal
Technical specifications

Important Safety Instructions

Use the device only as described in this manual and therefore as an aerosoltherapy 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 presence of any anesthetic mixture inflammable with oxygen or nitrogen protoxide.
The correct functioning of the equipment can be affected by electromagnetic interferences which exceed the limits indicated by the European standards in force. In case this device interferes 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 safety.
Comply with the safety regulations concerning the electrical devices and in particular:
– use only original accessories 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 the 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 youwall socket, contact qualified personnel for a replacement plugwith that of 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 instructionof 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 userIn case of a power cord damage, address to a technical servicecenter authorized by the manufacturer for its replacement.
The power supply cord should always be fully unwound in ordeto prevent dangerous overheating.
Before performing any maintenance or cleaning operation, turnoff the device and disconnect the plug from the main supply.
Some parts of the unit are so small that they may be swallowedby 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 accessory recommended by your doctor depending on the pathology;
– use the nosepiece accessory only if expressly indicated by your doctor and paying attention to NEVER introduce the bifurcations in the nose, but only bringing them as close aspossible.
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.
Nebuliser and accessories are single patient use. Device is multi-patient use.
This nebulising system is not suitable for use in anaesthetic breathing system or a ventilator breathing system. The patient cannot undergo MRI scan while using this device.
This device is designed to nebulise 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.

This device is not a toy! Keep out of reach of children and do not leave children alone during treatment.

Preparation and usage of this device

The device must be checked before each use in order 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 accessories 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 accessories are intact.
Before using the device, proceed with the cleaning operations as described in the chapter «Cleaning and disinfecting».

Assemble the nebuliser kit AK. 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 accessories including the nose piece AL as prescribed by your doctor.
During inhalation, sit upright and relaxed at a table and not in an armchair, in order to avoid compressing your respiratory airways and impairing the treatment effectiveness. Do not lie down while inhaling. Stop inhalation if you feel unwell.
Inhale the aerosol solution using the prescribed accessory.
Once you have finished the treatment, switch the appliance off by pressing the ON/OFF switch 3.
Empty the remaining medication from the nebuliser 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 minuse and wait for another 30 min. before you resume treatment.
The device requires no calibration.
Tampering with the device is absolutely forbidden.
No modification to the device is permitted.

Cleaning and disinfecting

Device(s): Aerosoltherapy nebuliser accessories

| Before the first use and after each treatment Follow carefully the cleaning and disinfection instructions of the accessories as they are very important for the device performances and the therapy success.
• Use original accessories only.
• Do not clean or disinfect the air tube.
• The accessories cannot be cleaned and disinfected by automated method.
• Do not boil nor autoclave the masks.
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Limitations onprocessing| The nebuliser must be replaced after a long period of inactivity, in case it shows deformations or breakings, or
when the nebulser nozzle 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. 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.
Instructions|
Preparation before cleaning| • Detach the air tube from the nebuliser.
• Detach the mouthpiece or nosepiece or mask from the nebuliser.
• Make sure that all residual volume is removed from the nebuliser.
• Disassemble the nebuliser 5 by turning the top counterclockwise and remove the medicine conduction cone. Note: To avoid microbial growth and residual drug drying, clean and disinfect the accessories immediately after each use.
Cleaning| Briefly rinse all parts in running tap water for at least 10 seconds beforehand. Mix little dish detergent and warm tap water (i.e. FAIRY brand dish washing liquid for hand washing in a ratio of 2 ml : 1 L) in a clean container.
Immerse the components of disassembled nebulser, the mask, the mouthpiece and the nosepiece into the mixed water for about 5 min.
And then scrub all the surface of all the components with clean and small brush for at least 8 times. Afterwards
rinse all parts thoroughly in running tap water at least 30 seconds, to fully remove any possibledish washing
liquid residue.
Disinfection| • After cleaning, disinfect all of the disassembled parts (only parts thathave been cleaned can be disinfected effectively).
• Boil the disassembled nebuliser, the mouthpiece and the nosepiece for 5 minutes in boilingtap 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.
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 reassembling and reuse to avoid risk of germ grow.
Care needs to be taken not to contaminate the parts after they have been cleaned and disinfected. 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 brokenmisshapen 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 specifications».
Note: re-clean and re-disinfect the parts if they are stored more than one day.
Transportation| After cleaning and disinfection, always transport the parts with clean and sealed container. Contamination
can be avoided by good hand washing and not touching theinside sections of the parts when taking out and
re-assembling the parts for use.

The instructions provided above have been validated by the manufacturer 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 AM 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).
Accessories and wearing parts: Nebuliser, masks, mouthpiece, nose piece, tube, filters, nasal washer (optional).

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

Disposal

Item	Component	Disposal Description
1	Device 1	The component mainly includes plastic and electronic components.

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| Accessories:
air tube 6,
nebuliser 5,
nose piece AL,
mouthpiece 7,masks 8 / 9| The components are plastic.
All comply with ROHS and REACH.
Before disposal, all the accessories should be cleaned according to manual instructions and then disinfected by boiling for 5 minutes.

Technical specifications

Model: NEB 410
Type: GCE850
AEROSOL PERFORMANCES ACCORDING TO EN ISO 27427:2019 based on adult ventilatory pattern with Sodium Fluoride (NaF):
Aerosol output: 0.259 ml
Aerosol output rate: 0.07 ml/min.
Percentage of fill volume emitted per min: 3.5 %
Residual Volume: 0.8 ml
Particle size (MMAD): 2.83 µm
GSD (geometric standard deviation): 0.73 µm
RF (respirable fraction < 5 µm): 63.3 %
Large particle range (> 5 µm): 36.7 %
Middle particle range (3-5 µm): 12 %
Small particle range (< 3 µm): 51.3 %
Operating air flow: 5.31 l/min.
Acoustic noise level: 52 dBA
Power source: 230V 50 Hz AC
Current: ≤ 1000mA
Power lead length: 1.6 m
Nebuliser capacity: min. 2 ml; max. 8 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. approx. 1300 g
Dimensions: 196 x 140 x 134 mm
IP Class: IP21
Reference to standards: EN ISO 27427; EN 60601-1; EN 606011-2; EN 60601-1-6; IEC 60601-1-11
Expected service life: 1000 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 authorised 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 IIa medical device.
Device complies with European Regulation on medical devices EU MDR 2017/745.
Important information regarding Electromagnetic
Compatibility (EMC):This product, manufactured by Globalcare Medical Technology Co., Ltd., conforms to the Electromagnetic Compatibility (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- magneticcompatibility.

Guarantee Card

Name of Purchaser
Serial Number
Date of Purchase
Specialist Dealer

Globalcare Medical Technology Co., Ltd
7th Building, 39 Middle Industrial Main Road,
European Industrial Zone, Xiaolan Town,
528415 Zhongshan City, Guangdong Province, PRC
Phone: +86 760 22589901
Donawa Lifescience
Piazza Albania, 10, 00153 Rome/Italy
Importer
Microlife UAB
P. Lukšio g. 32
08222 Vilnius / Lithuania
www.microlife.com
www.donawa.com/contacts

Revision Date: 2024-02-21
IB NEB 410 E-V12 1524