MT 410 - Thermometer MICROLIFE - Free user manual and instructions

Product Type	Compressor Nebulizer
Brand	Microlife
Model	NEB 410
Weight	Approximately 1300 g
Power Supply	230 V, 50 Hz AC, ≤1000 mA
Reservoir Capacity	2 ml to 8 ml
Particle Size (MMAD)	2.83 μm
Aerosol Output	0.259 ml
Aerosol Output Rate	0.07 ml/min
Maximum Air Pressure	2.2 bar
Effective Air Flow	5.31 l/min
Sound Level	52 dBA
Power Cord Length	1.6 m
Continuous Operation Time	30 minutes (then 30 min pause)
Total Service Life	1000 hours
Operating Conditions	10 °C to 40 °C, RH 15–95%, 700–1060 hPa
Storage Conditions	-20 °C to +60 °C, RH 15–95%, 700–1060 hPa
Warranty	5 years
Included Accessories	Adult mask, child mask, mouthpiece, nasal tip, tubing, air filter, nebulizer kit
Maintenance	Cleaning after each use, disinfection of accessories, replace air filter every 200 h or 1 year, replace nebulizer every 6 months to 1 year
Standards	EN 13544-1, EN 60601-1, EN 60601-2, IEC 60601-1-11
Safety	Automatic shut-off after 30 min, do not use without filter, use only with original accessories

Frequently Asked Questions - MT 410 MICROLIFE

How to assemble the nebulizer before first use?

Assemble the nebulizer kit following the instructions in the manual: screw on the cap, insert the conduction cone and connect the tubing to the pump. Make sure the colored nebulizer insert is correctly placed. Before first use, clean all parts as indicated in the Cleaning and disinfection section.

Which solution should I use in the nebulizer?

Use only the solutions prescribed by your doctor. Fill the reservoir up to the maximum level mark (8 ml) without exceeding it. Do not use essential oils or non-medical solutions.

How long does a typical treatment session last?

The duration is determined by your doctor. Generally, a session lasts between 5 and 15 minutes. The device automatically turns off after 30 minutes of continuous operation; it must then cool down for 30 minutes before reuse.

How to clean the device after each treatment?

Disassemble the nebulizer, mouthpiece or mask, and wash them with tap water. Soak them in boiling water for 5 minutes. For the compressor, wipe it with a soft, dry cloth. Never immerse the compressor in water. Wash the tubing and masks with warm water.

When and how to replace the air filter?

Replace the air filter after approximately 200 hours of use or every year. Check it every 10 to 12 treatments; if it is brown or damp, replace it. To replace, remove the old filter and insert a new one. Never use the device without a filter. Use only original Microlife filters.

What to do if the device does not turn on?

First check that the power cord is properly plugged into the mains socket and that the On/Off button is in the 'I' position. Also ensure that the device has not exceeded the 30-minute continuous operation time (let it cool for 30 min). If the problem persists, contact customer service.

What to do if the vapor flow is weak or absent?

Check that the tubing is not bent, crushed, or blocked. Make sure the nebulizer is properly assembled and that the colored nebulizer insert is not clogged with dried medication residue. Also check that medication has been added. If necessary, replace the nebulizer.

Can I use accessories from other brands?

No, for safety and efficiency reasons, use only original Microlife accessories listed in the manual. Use of inappropriate accessories may impair performance and void the warranty.

Is the device suitable for children?

Yes, the device is intended for children from 2 years old, adolescents, and adults. Use the provided child mask and always supervise the child during treatment. Never leave the child unattended.

Where can I buy spare parts or get after-sales service?

You can order spare parts from your dealer, pharmacy, or contact Microlife customer service. Visit the website www.microlife.com to find the contact details of your local representative.

USER MANUAL MT 410 MICROLIFE

Globalcare Medical Technology Co., Ltd

7th BUIKING, 39 Middle Industrial Main Floor,

European Industrial Zone, Jordan 15KN

Плоре: [phone]

www.gcbcare.com.uk/cnniacl

Domawa Lifescience Consulting Sr

Plaza Alvinio, 10, 20153 Remolitary

Distributor

Microlife AC

1. 2017年1月1日

www.microsoft.com

C€0123

microlife®

NEB410

Children Nebuliser

Microlife NEB 410 Microlife NEB 410 Guarantee Card

microlife

Name of Purchaser / Nom de l'acheteur / Nome del rivencillore / Name des Käulors / Alcorm adi / Nombre del comprador / Nome do comprador / Naam koper / Ovajortenüvujo ayapoctn / نام خريدار / اسم المッチري

Serial Number / Numéro de serie / Numero di serie / Seren Nr. / Ser numarasi / Número de serie / Número deserie/Serienummer/Apo/porcupac/ مдел رقم التس barrel

Date of Purchase / Date d'achat / Deta d'acquisto / Kaufdalum / Salin alma larihi / Facha de compra / Data da compra / Datum van aankoop / Huepourvio aynpat / تثماره سريال / تاريخ الشراة

Specialist Dealer / Revendeur / Categoría rivenditore / Fachnándler / Uzman satci / Distributor especializado / Revendedor autorizado / Specialist Dealer / Ejebiko μενος αντιμοδυμα / تاريخ خريد / اتاجر المختص

microlife®

Microlife NEB 410

EN

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 Replacing air filter
⑪ Assembling nebuliser kit
⑫ Nose piece
⑬ Air filter

Intended use:

This nebuliser is an aerosol therapy system suitable for domestic use.

This nebuliser is designed for the production of compressed air to operate a nebuliser 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 a specific knowledge or professional ability. The patient is the intended operator except in case of 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!

Table of Contents

1. Explanation of Symbols
2. Important Safety Instructions
3. Preparation and Usage of this Device

4. Cleaning and Disinfecting

5. Cleaning and disinfecting of the accessories
   • Before and after each treatment

6. Maintenance, Care, and Service

7. Replacement of the nebuliser

8. Replacement of the air filter

9. Malfunctions and Actions to take

• The device cannot be switched on
• The nebuliser functions poorly or not at all

1. Guarantee

2. Technical Specifications

Guarantee Card (see Back Cover)

1. 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.

Type BF applied part

Class II equipment

Serial number

Reference number

Manufacturer

I 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

Distributor

Caution

Single patient multiple use (for accessories only)

Humidity limitation

Temperature limitation

Ambient pressure limitation

C€0123

CE Marking of Conformity

2. 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 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 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 nebulise solution and suspension liquids.

• This nebulizing system is not suitable for use in anaesthetic breathing system or a ventilator breathing system.

• This device is not suitable for anaesthesia 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 a 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 introduce 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. Device is multi-patient use.
• Never bend the nebuliser 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.

3. 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».

1. Assemble the nebuliser kit ⑪. Ensure that all parts are complete.

2. Fill the nebuliser with the inhalation solution as per your doctor's instructions. Ensure that you do not exceed the maximum level.

3. 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).

4. To start the treatment, set ON/OFF switch ③ into the «I» position.

5. The mouthpiece gives you a better drug delivery to the lungs.

6. Choose between adult ⑧ or child face mask ⑨ and make sure that it encloses the mouth and nose area completely.

7. Use all accessories including the nose piece ⑫ as prescribed by your doctor.

8. 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.

9. 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.
10. 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.

4. 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 nebuliser ⑤ by turning the top counterclockwise and remove the medicine conduction cone. Wash the components of the disassembled nebuliser, the mouthpiece ⑦ and the nose piece ⑫ by using tap water; dip in boiling water for 5 minutes. Reassemble the nebuliser 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 tube with warm water.

Only use cold disinfecting liquids following the manufacturer's instructions.

Do not boil nor autoclave the air tube and masks.

5. 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 ¹³ 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!

6. 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 colored vaporiser head ⑤-a is placed correctly and not obstructed.
• Ensure the required medication has been added.

7. 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, 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.

8. 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 stan-

dard deviation): 0.73

RF (respirable fraction

< 5 μm): 63.3 %

Large particle range

(> 5 μm): 36.7 %

Maximum air pres-

sure: 2.2 bar

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

15 - 95 % relative maximum humidity

700 - 1060 hPa Atmospheric pressure

Storage and shipping -20 - +60 °C / -4 - +140 °F

conditions: 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 standards: EN 13544-1; EN 60601-1; EN 60601-2; 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 authorised representative (EC REP).

Vigilance contact point:

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

FR

RF (respirable fraction

< 5 μm): 63.3 %

Particules de grande

taille (> 5 μm): 36.7 %

Dimensions: 157.5 x 105 x 61.5 mm

Classe IP: IP21

Restate in salute – Microlife AG!

Indice

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

DE

www.microlife.com/support

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

TR

www.microlife.com/support

GSD (geometrik stan-

dart sapma): 0.73

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

ES

www.microlife.com/support

Volumen residual: 0.8 ml

Tamaño de partícula

(MMAD): 2.83 μm

GSD (desviación

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

PT

2. Important Safety Instructions

Volume residual: 0.8 ml

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

NL

Vigilance contact point:

https://ec.europa.eu/growth/sectors/medical-devices/contacts

Microlife NEB 410

GR

https://ec.europa.eu/growth/sectors/medical-devices/contacts

ON

OFF

IP21

C€0123

③

www.microlife.com/support

③

⑥

⑤

⑤

https://ec.europa.eu/growth/sectors/medical-devices/contacts

IP21

C€0123

EN 13544-1:2009

hPa 1060 - 700

hPa 1060 - 700

IP21

EN 13544-1; EN 60601-1

www.microlife.com/support

https://ec.europa.eu/growth/sectors/medical-devices/contacts