microlife NEB410 Children Nebuliser Instructions

: June 6, 2024
: microlife

Table of Contents

NEB410 Children Nebuliser
Explanation of Symbols
Important Safety Instructions
Preparation and Usage of this Device
Cleaning and Disinfecting
Maintenance, Care, and Service
Malfunctions and Actions to take
Guarantee
Technical Specifications
Guarantee Card
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

NEB410 Children Nebuliser

NEB410
Children Nebuliser

microlife NEB410 Children Nebuliser - overview

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
AT Replacing an air filter
AK Assembling nebulizer kit
AL Nose piece
AM Air filter
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Intended use:
This nebulizer is an aerosol therapy system suitable for domestic use.
This nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders.
Patient population: The device is intended for use with children from 2 years old, adolescent and adult patients. Intended users: 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 patient that required special assistance.
Dear Customer,
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 AG!

Explanation of Symbols

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.
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| Type BF applied part
| Class II equipment
| Serial number
| Reference number
| Manufacturer

Ì

| ON

Ο

| OFF

IP21

Important Safety Instructions

Follow instructions for use. This document provides important product operation and safety information regarding this device. Please read this document thoroughly before using the device and keep it for future reference.
This device may only be used for the purposes described in these instructions. The manufacturer cannot be held liable for damage caused by the incorrect application.
Retain instructions in a safe place for future reference.
Do not operate the unit in presence of any anesthetic mixture inflammable with oxygen or nitrogen protoxide.
This device is designed to nebulize solution and suspension liquids.
This nebulizing system is not suitable for use in an anesthetic breathing system or a ventilator breathing system.
This device is not suitable for anesthesia and lung ventilation.
This device should only be used with original accessories as shown in these instructions.
Do not use this device if you think it is damaged or notice anything unusual.
Never open this device.
This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the «Technical Specifications» section.
Protect it from:
– water and moisture
– extreme temperatures
– impact and dropping
– contamination and dust
– direct sunlight
– heat and cold
Comply with the safety regulations concerning the electrical devices and in particular:
– Never touch the device with wet or moist hands.
– Place the device on a stable and horizontal surface during its operation.
– Do not pull the power cord or the device itself to unplug it from the power socket.
– The power plug is a separate 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 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 instructions of the manufacturer. An improper installation can cause damage to persons, animals or objects, for which the manufacturer cannot be held responsible.
Do not replace the power lead of this device. In case of power lead damage, contact a technical service center authorized by the manufacturer for its replacement.
The power supply cord should always be fully unwound in order to prevent dangerous overheating.
Before performing any maintenance or cleaning operation, turn off the device and disconnect the plug from the main supply.
Only use the medication prescribed for you by your doctor and follow your doctor’s instructions with regard to dosage, duration, and frequency of the therapy.
Depending on the pathology, only use the treatment that is recommended by your doctor.
Only use the nose piece if expressly indicated by your doctor, paying special attention NEVER to introducing the bifurcations into the nose, but only positioning them as close as possible.
Check in the medicine instruction leaflet for possible contraindications for use with common aerosol therapy systems.
Do not position the equipment so that it is difficult to operate the disconnection device.
Nebuliser and accessories are single patient use. The device is multi-patient use.
Never bend the nebulizer over 60°.
Do not use this device close to strong electromagnetic fields such as mobile telephones or radio installations. Keep a minimum distance of 3.3 m from such devices when using this device.

Ensure that children do not use this device unsupervised; some parts are small enough to be swallowed. Be aware of the risk of strangulation in case this device is supplied with cables or tubes.
Use of this device is not intended as a substitute for a consultation with your doctor.
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

Prior to using the device for the first time, we recommend cleaning it as described in the section «Cleaning and Disinfecting».

Assemble the nebulizer kit AK. Ensure that all parts are complete.
Fill the nebulizer with the inhalation solution as per your doctor’s instructions. Ensure that you do not exceed the maximum level.
Connect the nebulizer with air tube 6 to 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 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.
After completing the inhalation period recommended by your doctor, switch the ON/OFF switch 3 to position «O» to turn off the device and unplug it from the socket.
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 min. use and wait for another 30 min. before you resume treatment.
The device requires no calibration.

No modification to the device is permitted.

Cleaning and Disinfecting

Thoroughly clean all components to remove medication residuals and possible impurities after each treatment.
Use a soft and dry cloth with non-abrasive cleaners to clean the compressor.
Make sure that the internal parts of the device are not in contact with liquids and that the power plug is disconnected.
Cleaning and disinfecting of the accessories
Follow carefully the cleaning and disinfecting instructions of the accessories as they are very important to the performance of the
device and success of the therapy.
Before and after each treatment
Disassemble the nebulizer 5 by turning the top counterclockwise and removing the medicine conduction cone. Wash the components of the disassembled nebulizer, the mouthpiece 7, and the nose piece AL by using tap water; dip in boiling water for 5 minutes. Reassemble the nebulizer components and connect it to the air tube connector, switch the device on and let it work for 10-15 minutes.
Wash masks and air tubes with warm water.
Only use cold disinfecting liquids following the manufacturer’s instructions.
Do not boil nor autoclave the air tube and masks.

Maintenance, Care, and Service

Order all spare parts from your dealer or pharmacist, or contact Microlife- Service (see foreword).
Replacement of the nebulizer
Replace the nebulizer 5 after a long period of inactivity, in cases where it shows deformities, breakage, or when the vaporizer head 5-a 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.
Only use original nebulizers!
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 periodically checking the air filter (10 – 12 treatments) and if the filter shows a grey or brown color 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 a 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 nebulizer 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 it with a new one.
Ensure the nebulizer 5 is fully assembled and the colored vaporizer 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 leaking batteries.
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, nosepiece, 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 the guarantee does not prolong or renew the guarantee period. The legal claims and rights of consumers are not limited by this guarantee.

Technical Specifications

Model: NEB 410
Type: GCE850
Aerosol performances according to EN13544-1:2009 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
RF (respirable fraction < 5 µm): 63.3 %
Large particle range (> 5 µm): 36.7 %
Maximum air pressure: 2.2 bar
Operating airflow: 5.31 l/min.
Acoustic noise level: 52 dBA Power source: 230V 50 Hz AC
Current: ≤ 1000mA
Power lead length: 1.6 m
Nebulizer capacity: min. 2 ml; max. 8 ml Operating limits: 30 min. On / 30 min. Off
Operating conditions: 10 – 40 °C / 50 – 104 °F
15 – 95 % relative maximum humidity
700 – 1060 hPa Atmospheric pressure
Storage and shipping conditions: -20 – +60 °C / -4 – +140 °F
15 – 95 % relative maximum humidity
700 – 1060 hPa Atmospheric pressure
Weight: approx. 1300 g
Dimensions: 157.5 x 105 x 61.5 mm
IP Class: IP21
Reference to: EN 13544-1; EN 60601-1; EN 60601-2;
standards: EN 60601-1-6; IEC 60601-1-11
Expected service life: 1000 hours

This device complies with the requirements of the Medical Device Directive 93/42/EEC.
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

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
www.globalcare.com.hk/contact
Donawa Lifescience Consulting Srl
Piazza Albania, 10, 00153 Rome/Italy
www.donawa.com/contacts
Distributor
Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com