Ингалятор b well med 120 инструкция

Thank you for purchasing the Nebulizer* model MED-120/TH-130 B.Well.

The B.Well Nebulizer is a reliable device. It creates a stream of air that travels through clear tube to the nebulizer. When air enters the nebulizer, it will convert the prescribed medication into aerosol mist for easy inhalation.

The B.Well company guarantees this device was made of high-quality materials and meets national and international safety standards. The Nebulizer is a medical device therefore it should be used under the supervision of a licensed physician and/or a respiratory therapist.

Please, read this Instruction for Use carefully before use and follow the recommendations.

* Hereafter referred to as «inhaler», «device», consider the same.

WARNINGS AND SAFETY NOTES

Read this Instruction for Use carefully before use. Keep it for future reference during the life cycle of the device. Use the device only as described in this Instruction for Use and therefore as an aerosol 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.

• Before use, ensure that there is no visible damage to the device or accessories. If you have any doubts, do not use the device and contact the specified Customer Service address.
• In the event of device faults, please see Chapter «Troubleshooting».

Consult a doctor if

• The device is not a substitute for medical consultation and treatment. Always consult your doctor first if you are experiencing any pain or are suffering from an illness.
• If you have health concerns of any kind.
• Regarding the type of medication to use, the dosage, and the frequency and duration of inhalation.
• Only use medication prescribed or recommended by your doctor or pharmacist.

Please note

• If the device does not work properly, or you feel unwell or experience pain, stop using it immediately.
• Keep the device away from your eyes when it is in use, as the mist of medication could be harmful.
• Never use the device near flammable gases, oxygen or nitrogen oxide.
• Do not expose to harmful vapors or volatile substances.
• This device is not intended for use by children or people with restricted physical, sensory (e.g. reduced sensitivity to pain) or mental skills or a lack of experience and/or lack of knowledge, unless they are supervised by a person who is responsible for their safety or are instructed by such a person in how to use the device.
• The device must be switched off and the plug pulled out before every cleaning and/or maintenance procedure.
• Keep packaging material away from children (risk of suffocation).
• To avoid the risk of entanglement and strangulation, store cables and air lines out of the reach of small children.
• Do not use any additional parts that are not recommended by the manufacturer.
• The device must only be connected to the mains voltage that is specified on the type plate.
• Never submerge the device in water and do not use it in the bathroom. Under no circumstances may liquid enter the device.
• Protect the device from heavy impact.
• Never touch the micro USB cable with wet hands, as you could get an electric shock.
• Do not pull the mains adapter out of the socket using the micro USB cable.
• Do not crush or bend the micro USB cable, pull it over sharp-edged objects or leave it dangling down, and protect it from sources of heat.
• We recommend that the micro USB cable is completely unrolled to avoid dangerous overheating.
• If the micro USB cable or the mains adapter of this device is damaged, it must be disposed of it properly.
• Making modifications to the device or accessories is not permitted.
• If the device has been dropped, exposed to high levels of moisture or suffered any other damage, it must no longer be used. If in doubt, contact Customer Services or the retailer.
• The nebulizer may only be operated with nebulizer kit the appropriate recommended producer’s accessories. The use of nebulizer kit and accessories made by other companies may result in less efficient treatment and could damage the device.
• Keep the device and accessories out of the reach of children and pets.

Power cuts, sudden interference or other unfavourable conditions could lead to the device becoming inoperable.

• Should you require an USB-adapter or extension lead, this must meet the applicable safety requirements.
  The power limit and the maximum output specified on the adapter must not be exceeded.
• Do not store the device or the power cable near to sources of heat.
• Do not use the device in a room in which a spray has previously been used. Air the room before carrying out the inhalation.
• No modification of this equipment is allowed
• Never use the device if it is making an abnormal sound.
• For a hygiene reasons, recommended for users to use their own accessories.
• Always disconnect the mains adapter from the device after use.
• The device must be stored in the environmental conditions specified in this instruction manual.
• Protect batteries from excessive heat (for TH-130).
• Risk of explosion! Never throw the device into a fire.
• Do not disassemble, split or crush the rechargeable batteries (for TH-130).
• Only use chargers specified in this instruction for use (for TH-130).
• Batteries must be charged prior to use. The instructions from the manufacturer and the recommendations in these instructions for use regarding correct charging must be observed at all times (for TH-130).
• Fully charge the battery prior to initial use (for TH-130) (see Chapter 12).
• In order to achieve as long a battery service life as possible, fully charge the battery at least twice per year (for TH-130).

General notes

• The device is only to be used:
  • On humans
  • For the purpose for which indicated in these instructions for use.
• Any form of improper use can be dangerous.
• In the event of an acute emergency, the provision of first aid has top priority.
• Apart from the medication, only use distilled water or a saline solution. Other liquids may cause a fault in the nebulizer or nebulizer kit.

Prior to initial use

• Remove all packaging material before using the device.
• Protect the device against dust, dirt and humidity and never cover the device while it is in use.
• Do not operate the device in a very dusty area.
• Switch the device off immediately if it is faulty or not working properly.
• The manufacturer is not liable for damage resulting from improper or careless use.

Repairs

Note

• Under no circumstances should you open or repair the device yourself, as faultless functionality can no longer be guaranteed thereafter. Failure to comply these instruction manual will result in voiding of the warranty and removal of responsibility from the manufacturer.
• For repairs, please contact Customer Services.

INDICATION AND CONTRAINDICATION

Nebulizers model MED-120/TH-130 with accessories are intended for inhalation therapy aimed at the prevention and treatment of acute respiratory diseases, chronic respiratory diseases, for example, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchial asthma, pneumonia and other diseases of the respiratory system, both adult patients and children. Nebulizers MED-120/TH-130 with accessories can be used in the doctor’s practice in clinics, hospitals, as well as successfully used by patients at the outpatient stage for the prevention and treatment of exacerbations of diseases of the upper and lower respiratory tract.

Scope: prevention and treatment facility and personal use at home.

DESCRIPTION OF THE DEVICE AND ACCESSORIES

Overview of nebulizer

1. On/Off switch
2. Micro USB port
3. Battery status indicator (TH-130 only)
4. Hoseconnector
5. Filter cap
6. Holder for nebulizer kit
7. Сompressed air hose
8. Mouthpiece
9. Adult mask
10. Children’s mask
11. Nosepiece
12. Set of filters
13. USB power mains part
14. USB cable

Nebulizer kit

1. Nebulizer cup
2. Medication container
3. Diffusor

INITIAL USE

Setting up the device

Take the device out of the packaging. Place the device on a flat surface.

Before using the device for the first time

Note

• Clean and disinfect the nebulizer and accessories before using them for the first time. See «Cleaning and disinfection».
• Connect the compressed air hose to the bottom of the medication cup.
  
• Connect the other end of the compressed air hose to the nebulizer hose connection by turning it slightly.

Charging the nebulizer battery (for TH-130)

To charge the nebulizer battery:

• Plug the micro USB cable included in delivery into the micro USB port on the nebulizer as shown.
• Plug the other end of the micro USB cable into the USB port on the mains adapter and insert the mains adapter into the socket.

Note

1. For TH-130: During the charging procedure, between one (battery almost empty) and four (battery fully charged) LEDs on the battery status indicator [3] flash according to the battery charge status. As soon as the battery is fully charged, all four LEDs are permanently illuminated.
2. For MED-120: Connect the inhaler to the mains with the required voltage using the USB power mains part and the USB cable, after using to disconnect and remove the USB power mains part and the USB cable.

Switching on the nebulizer

To turn on the nebulizer, proceed as follows:

• Press the ON/OFF button on the nebulizer. The ON/OFF button illuminates blue. The nebulizer is now operational.
  Only for TH-130: The battery must be sufficiently charged for the nebulizer to function correctly.

Note The blue LEDs on the battery status indicator show the current battery state:

OPERATION

• For hygiene reasons, it is essential to clean the nebulizer and the accessories after each treatment and to disinfect them after the last treatment of the day.
• If the treatment involves inhaling several rent medications one after the other, please be aware that the nebulizer must be rinsed under warm tap water following every usage. See «Cleaning and disinfection».
• Please observe the notes on changing the filter in these instructions for use.
• Check that hose connectors are firmly attached to the nebulizer and the nebulizer before each use of the device.
• Before use, check the device is working correctly by briefly switching on the nebulizer (together with the connected nebulizer, but without medication). If air comes out of the nebulizer, the device is working.
• When using nebulizer do not close ventilation holes of the device.

Inserting the diffusor

• Open the nebulizer kit by twisting the top anticlockwise against the medication container. Place the diffusor into the medication container.
• Ensure that the cone for administering medication fits well on the cone for the air duct inside the nebulizer.

Filling the nebulizer kit

• Pour the medication directly into the medication cup. Avoid overfilling. The maximum recommended filling quantity is 6 ml.
• Use medication only as instructed by your doctor and ask about the appropriate inhalation period and quantity for you.
• If the prescribed quantity of medication is less than 2 ml, top this up to at least 2 ml with isotonic saline solution. Dilution is also necessary with viscous medications. Here too, please observe the instructions of your doctor.

Closing the nebulizer

Close the nebulizer by twisting the top clockwise against the medication container. Ensure that the connection is correct.

Connecting accessories to the nebulizer kit

Connect the nebulizer to the desired accessory (mouthpiece, mask, nosepiece)

Note
The most effective form of nebulization is by using the mouthpiece. Nebulization using a mask is only recommended if it is not possible to use a mouthpiece (e.g. for children who are not yet able to inhale medication using a mouthpiece).

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 as possible.

If you use the accessories for the first time, after long period of storage, and/or after every use cleaning and disinfection of the accessories should be performed! Make sure that all the components are properly disinfected and dried, and after that store it in clean place. If you are using the adult mask, you can secure it to your head with the adult mask strap. There is also a strap for the children’s mask.

• Before the treatment, pull the nebulizer upwards out of the holder.
• Start the nebulizer using the switch.
• Spray mist pouring out of the nebulizer indicates that the device is operating correctly.

Treatment

• When inhaling, sit upright and relaxed at a table and not in an armchair to avoid compressing the airways and therefore impairing the effectiveness of the treatment.
• Breathe in the atomized medication deeply.

The device is not suitable for continuous operation; after 30 minutes of operation it must be switched off for 30 minutes.

Note During the treatment, hold the nebulizer straight (vertically), otherwise the nebulization will not work and faultless functionality is not guaranteed.

The following is strictly forbidden to use as nebulizer therapy medicine:

• substances and solutions containing suspended particles (herbal infusions, suspensions, extracts, etc.) Suspended particles are significantly larger than the particles of respirable fraction. Using it in nebulizer can bring harm to health;
• oil-containing solutions (including ester oils). Oil particles form the finest films when entering lower
• respiratory tract and this increases the risk of the so called «oil pneumonia»;
• anaesthetic mixture inflammable with air, oxygen or nitrogen protoxide; flavoring substances

Stopping inhalation

Once the mist is only coming out in an irregular flow or if the sound changes when inhaling, you can stop the treatment.

• Switch the nebulizer after treatment using the On/Off switch and disconnect it from the mains.
• Place the nebulizer back in its holder after the treatment.

CHANGING THE FILTER

In normal operating conditions, the air filter must be replaced after approx. 100 operating hours or one year. Please check the air filter regularly (after 9–11 nebulization procedures). Replace the used filter if it is very dirty or clogged. If the filter has become damp, it must also be exchanged for a new filter.

• Do not attempt to clean the used filter and reuse it.
• Only use the manufacturer’s original filter, otherwise your nebulizer may become damaged and sufficiently effective treatment cannot be guaranteed.
• Do not repair or maintain the air filter while it is in use.
• Never operate the device without a filter.

To replace the filter, proceed as follows

• First switch the device off and disconnect it from the mains.
• Allow the device to cool down.

1. Pull the filter cap towards the front.
   Note If the filter remains in the device after the cap has been removed, take the filter out of the device, e.g. with tweezers or similar.
2. Re-insert the filter cap with a new filter.
3. Ensure that it is securely in place

CLEANING AND DISINFECTION

Nebulizer and accessories

Adhere to the following hygiene instructions to avoid health risks.

• The nebulizer and accessories are designed for multiple use. Please note that different areas of application involve different requirements in terms of cleaning and hygienic preparation.

Notes

• Do not clean the nebulizer or the accessories mechanically using a brush or similar device, as this could cause irreparable damage and it will mean that the best treatment results can no longer be guaranteed.
• Please consult your doctor about the additional requirements in terms of the hygienic preparation required (hand care, handling of medication/inhalation solutions) for high-risk groups (e.g. patients with cystic fibrosis).
• Ensure thorough drying after each cleaning or disinfection process. Residual moisture or wetness can represent an increased risk of bacterial growth.

Preparation

• Immediately after each treatment, all parts of the nebulizer and the accessories used must be cleaned of residual medication and contamination.
• To do this, dismantle the nebulizer into its individual parts.
• Remove the mouth piece, the mask or the nosepiece from the nebulizer.
• Dismantle the nebulizer by twisting the top anticlockwise against the medication container.
• Remove the nebulizer insert from the medication container.
• Reassembly is carried out in reverse order.

Cleaning

The device must be switched off disconnected from the mains and allowed to cool down each time before cleaning.

The nebulizer and the accessories used such as the mouthpiece, mask, etc. must be washed with hot but not boiling water after each use. Dry the parts carefully using a soft cloth. Put the parts together again when they are completely dry and place them in a dry, sealed container (depends on configuration) or disinfect them. When cleaning, ensure that any residue is removed. Never use any substances for cleaning that could potentially be toxic if they came into contact with the skin or mucous membranes, or if they were swallowed or inhaled.

Use soft, dry cloth and non-abrasive cleaning products to clean the device.

Do not use any abrasive cleaning products and never submerge the device in water.

• Ensure that no water gets inside the device.
• Do not clean the device or accessories in the dishwasher.
• Do not touch the device with wet hands when it is plugged in and do not allow water to spray on the device. Only operate the device if it is completely dry.
• Do not spray any liquid on device If liquid penetrates the device this could cause damage to the electrics or other nebulizer parts and lead to a malfunction

Condensation, hose care

Condensation may form in the hose depending on the ambient conditions. It is essential to remove the moisture to prevent bacterial growth and ensure proper treatment. To do so, proceed as follows:

• Remove the compressed air hose from the nebulizer.
• The hose must remain connected to the nebulizer.
• Operate the nebulizer until the moisture is removed by the air passing through.
• In the event of heavy contamination, replace the hose.

Disinfection

Please carefully observe the points below when disinfecting your nebulizer and accessories. We recommend disinfecting the individual parts on a daily basis after the last usage as a minimum measure.

After each use, flush the nozzles under running water. Disinfection of the nozzles is recommended to be carried out by placing them for 5-10 minutes in one of the listed solutions:

• alcohol solution,
• 3% hydrogen peroxide solution,
• 1% chlorhexidine solution.

After disinfection in solution, it is recommended to wash the nozzles with warm water. You can also use noncontact methods of cleaning and disinfection of attachments: in ultrasonic or ultraviolet cleaner.

Do not boil or autoclave the compressed air hose or the masks.

Always clean the nebulizer and its components from remaining drug and washing substances. Never leave cleansing solution in chamber, mouthpiece or aerosol tube! Nebulizer and its components should not be dried in microwave oven, with hair dryer and other household appliances.

• Put the parts together again when they are completely dry and place them in a dry, sealed container.
  Note
  Please ensure that the parts are completely dried after cleaning, otherwise the risk of bacterial growth is increased.
• Use cold disinfection solution in accordance with the manufacturer’s instructions.

Drying

• Place the individual parts on a clean, dry and absorbent surface and leave them to dry completely (at least 4 hours).

Durability of materials

• As with any plastic parts, nebulizers and their accessories are affected by a certain amount of wear and tear when used and hygienically prepared on a frequent basis. Over time, this can lead to a change in the aerosol, which can have a negative effect on the efficiency of the treatment. We therefore recommend that you replace the nebulizer and other accessories after a year.
• Only use a mild cleaning product or disinfectant.

STORAGE

• Do not store in damp conditions (such as in a bathroom) and do not transport with any damp items.
• When storing and transporting, protect from prolonged direct sunlight.
• Store the device in a dry place, ideally in the original packaging.

BATTERY AND DEVICE DISPOSAL

Remove battery from the device after life, before its disposal. Remember to protect your eyes and hands when removing the battery. Dispose of the battery separately from the device.

If you have any questions about removing the batteries from the electronic unit, please contact the service center or call the hotline.

The empty, completely flat rechargeable batteries must be disposed of through specially designated collection boxes, recycling points or electronics retailers.

You are legally required to dispose of the rechargeable batteries.

The codes below are printed on rechargeable batteries containing harmful substances:

Pb = Battery contains lead

Cd = Battery contains cadmium

Hg = Battery contains mercury

Environmental Protection and Recycling:

This device is equipped with lithium-ion rechargeable batteries (only TH-130).

Please ensure that the batteries are disposed of at an official collection point, if there is one in your country.

Do not disassemble or replace batteries to continue using the instrument.

Replace batteries only at an authorized service center.

The device should be disposed of in accordance with accepted standards and not disposed of with household waste.

TROUBLESHOOTING

Problem/question	Possible cause/remedy
The nebulizer produces no or too little aerosol	Too much or too little medication in the nebulizer. Minimum: 2 ml, Maximum: 6 ml. Check nozzle for blockages. Clean nozzle if necessary. Then start using the nebulizer again. Carefully pierce the fine holes from the underside of the nozzle only. Nebulizer not held vertically. Unsuitable medication fluid added for nebulization (e.g. too viscous). The medication fluid should be prescribed by the doctor.
The output is too low.	Kinked hose, clogged filter, too much inhalation solution.
There is inhalation solution residue in the nebulizer	This is normal and is due to technical reasons. Stop inhalation once the nebulizer starts to make a notably different sound. On infants and children, the mask should cover the mouth and nose to ensure effective inhalation. It is not a good idea to carry out nebulization on some- one who is sleeping, as in this case not enough of the medication will reach the lungs. Note Inhalation for child should only be carried out under the supervision of an adult and with their assistance and the child should not be left alone.

TECHNICAL SPECIFICATIONS

Model	МED-120 / ТН-130
Dimensions, mm (W x H x D)	(100 х 54 х 51) ± 10%
Weight, g	235 ± 10% – for MED-120; 208 ± 10% – for ТН-130
Operating pressure, bar	0,35 to 0,60
Nebulizer filling volume, ml	Min 2 Max 6
Residal volume, ml	1
Medication flow rate, ml/min	0,3
Sound pressure, dB	44
Mains connection Input	AC 100-240 V, 50-60 Hz; 0,5 A
Output	DC 5V, 2A
Expected service life, h	400
Operating conditions	Temperature: from +10°C to +40°C Relative humidity: from 10% to 95% Ambient pressure: 700 – 1060 kPa
Storage and transportation conditions	Temperature: from -20°C to +60°C Relative humidity: 10% to 95% Ambient pressure: 700 – 1060 kPa
Aerosol properties	RF: 71.1 % Particle size (MMAD): 2.90 μm
Battery (for ТН-130): Capacity Nominal voltage	2570 mAh 3,7 V
Complete set:	Nebulizer model MED-120/TH-130 in composition: Nebulizer – 1pc. Built-in accumulator – 1pc. (TH-130 only) Nebulizer kit – 1pc. Mouthpiece – 1 pc. Nosepiece – 1 pc. Compressed air hose – 1 pc. Adult mask – 1 pc. Children’s mask – 1 pc. Set of filters – 5 pcs. Instructional manual – 1 pc. Gift box – 1 pc. Accessories: USB power mains part USB cable Storage pouch

Particle size diagram

Measurements were performed using a sodium fluoride solution with a «Next Generation Impactor» NGI) The diagram may therefore not be applicable to suspensions or highly viscous medications. You can obtain more detailed information from the manufacturer of your medication.

WARRANTY INFORMATION

The device is covered by a warranty for five years from the date of purchase of the device.

The guarantee does not apply to the nozzles. Warranty does not apply to parts and consumables subject to wear (nebulizer, masks, mouthpiece, air hose, filters, nozzles, adapters, etc.), as well as a built-in battery, packaging, storage bag and storage pouch.

The service life of the device – 10 years.

EXPLANATION SYMBOLS FROM PACKAGING AND LABELS

The date of manufacture of the device is encrypted on the label of the device in the serial number «SN»: the first two digits are the production week, the second two digits are the year of manufacture.

B.Well Swiss AG,
Bahnhoffstrasse 24, 9443, Widnau, Switzerland.

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