Air Plus - Inhaler Medel - Free user manual and instructions

Brand	Medel
Model	Air Plus
Device type	Compressor inhaler / nebuliser
Dimensions (W x H x D)	166 x 141 x 148 mm
Weight	1.4 kg
Power supply	230 V~, 50 Hz ; 230 VA
Working pressure	approx. 0.8 – 1.45 bar
Nebuliser filling volume	2 ml (min) – 8 ml (max)
Medication flow rate	approx. 0.3 ml/min
Nasal douche volume	2 ml (min) – 10 ml (max)
Noise level	approx. 52 dBA (according to DIN EN 13544-1)
Operating / pause duration	30 minutes ON / 30 minutes OFF
Operating conditions	Temperature: +10°C to +40°C ; Humidity: 10 % to 95 % ; Pressure: 700 to 1060 hPa
Storage and transport conditions	Temperature: 0°C to +60°C ; Humidity: 10 % to 95 % ; Pressure: 500 to 1060 hPa
Particle size (MMAD)	3.07 μm
Expected service life	1000 hours
Warranty	5 years
Included accessories	Nebuliser, compressed air hose, mouthpiece, adult mask, child mask, nasal tip with comfort, nasal douche, replacement filter, storage bag, instruction manual
Safety class	Type BF device, safety class II, medical device
Cleaning and disinfection	Clean with hot water after each use; disinfect by boiling (except tube and masks); replace nebuliser and accessories after 1 year
Filter change	After approximately 200 hours of use or 1 year; check every 10-12 atomisations

Frequently Asked Questions - Air Plus Medel

What medications can I use with the Air Plus?

Only use medications prescribed or recommended by your doctor. Suitable inhalation solutions for nebulisers are appropriate. Avoid essential oils and cough syrups, as they may damage the device.

How should I clean the nebuliser after each use?

Disassemble the nebuliser and rinse all parts with hot (not boiling) water. Dry thoroughly with a soft cloth. For disinfection, boil the parts for 5 minutes (except tube and masks). Ensure parts are completely dry before reassembly.

How often should I change the air filter?

The filter should be changed after approximately 200 hours of use or one year. Check it every 10 to 12 uses; if dirty or damp, replace it. Never use the device without a filter.

Can I use essential oils with the inhaler?

No, essential oils, cough syrups and other viscous solutions are not suitable. They may damage the device and cause bronchospasm. Use only saline solutions or prescribed medications.

Is the device suitable for children?

Yes, the Air Plus is intended for children from 2 years old. Use the provided child mask. For babies (0-3 years), a specific mask is available as an option. Inhalation should always be supervised by an adult.

What should I do if the nebuliser does not produce aerosol?

Check the medication level (minimum 2 ml, maximum 8 ml). Make sure the nozzle is not blocked. Keep the nebuliser upright during use. If the problem persists, clean the nozzle or replace the nebuliser.

What is the warranty period?

The global warranty is 5 years from the date of purchase. It covers manufacturing defects, but not normal wear (batteries, accessories, etc.). Keep the invoice for any claims.

How do I use the nasal douche?

Fill the salt reservoir with a sodium chloride solution. Attach the lid, connect the tube, place the lid in a nostril and breathe through the nose. Press the reservoir button to start the spray. Do not use with medications.

Can I share the accessories with others?

For hygiene reasons, it is not recommended to share accessories. Each user should have their own nebuliser, mouthpiece and mask. Replace all accessories after one year of use.

Why do I need to replace the nebuliser regularly?

Over time, nozzle wear changes the particle size and reduces efficiency. Additionally, for hygiene reasons, it is recommended to replace the nebuliser every year to ensure optimal treatment.

USER MANUAL Air Plus Medel

Medical inhaler device with needle inserted into a coiled tube, no visible text or symbols on the device itself.

DE Inhalator

Instructions for use 25

FR Inhalateur

Mode d'emploi 36

ES Inhalador

Technical diagram of a portable air purifier with labeled components including a coiled cable and tubing.

Line drawings of two hands holding a tool, one with a pointed tip and the other with a pointed tip (no text or symbols)

Line drawing of a hand using a handheld device to lift a circular component, with a cable and wire nearby (no text or symbols)

Netzanschluss

Illustration of a hand holding a dropper with liquid droplets (no text or symbols)

i Hinweis

Diagram of a mechanical device with a numbered label '5' and a directional arrow, no readable text or symbols present.

Hinweis

Line drawings of two hands holding a tool, one with a pointed tip and the other with a small cap (no text or symbols)

Line drawing of a hand using a handheld device to lift a bowl, with a coiled cable nearby (no text or symbols)

Illustration of a hand holding a dropper with liquid droplets above (no text or symbols)

1. Getting to know your device ....25
2. Signs and symbols....25
3. Warnings and safety notes....26
4. Description of the device and accessories .....28
5. Initial use.....28
6. Operation....29
7. Changing the filter 31
8. Cleaning and disinfection....31
9. Disposal....33
10. Troubleshooting....33
11. Technical specifications ....33
12. Replacement parts and wearing parts .....34
13. Warranty/service....35

Included in delivery

See Description of the device and accessories, page 28.

• Nebuliser
• Atomiser
• Compressed air hose
• Mouthpiece
• Adult mask
• Children's mask
• Nosepiece with comfort attachment
• Nasal douche
• Replacement filter
• Storage bag
  • These instructions for use

1. Getting to know your device

Dear customer,

Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage and air.

Please read these instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.

With kind regards,

Your Medel team

Intended use

Medel AIR PLUS is an aerosoltherapy system suitable for domestic use.

Medel AIR PLUS 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, adolescent and adult patients.

Intended users: the user is an adult person without specific knowledge or professional ability. The patient is the intended operator except in case of children and patients that requires special assistance.

This nebuliser is an inhalation device for atomising liquids and liquid medication (aerosols) and for the treatment of the upper and lower airways.

By nebulising and inhaling the medication prescribed/recommended by your doctor, you can prevent diseases affecting the airways, or in the case that you contract such an illness, you can alleviate symptoms and speed up your recovery. Ask your doctor or pharmacist for further information about the potential applications.

The device is suitable for domestic use. Inhaler medication should only be used following instructions to do so from a doctor. Ensure you are calm and relaxed when inhaling the medication and breathe slowly and deeply to ensure that the medication reaches right down to the lower bronchi. Breathe out normally.

The device does not need to be calibrated.

Once it has been properly prepared, the device can be used again. Preparation involves replacing all the accessories, including the atomiser and air filter, and disinfecting the surface of the device using a standard disinfectant. Please note that all accessories should be replaced if the device is used by more than one person.

We recommend that you replace the atomiser and other accessories after one year.

2. Signs and symbols

The following symbols appear in these instructions for use.

Warning

Warning instruction indicating a risk of injury or damage to health.

Important

Safety note indicating possible damage to the device/accessory.

Note

Note on important information.

The following symbols are used on the packaging and on the type plate for the device and accessories.

	Application part, type BF
	Observe the instructions for use
	Protection class 2 device
	Manufacturer
I	On
O	Off
	Serial number
30 ON/30 OFF	30 minutes of operation, then 30 minutes break before operating again.
IP 21	Protected against foreign objects equal to or greater than 12.5 mm in diameter and against vertically falling drops of water
	CE labellingThis product meets the requirements of the applicable European and national guidelines
A	Marking to identify the packaging material.A = Material code,B = Material number:1-7 = Plastics,20-22 = Paper and cardboard
	Separate the packaging elements and dispose of them in accordance with local regulations
	Separate the product and packaging elements and dispose of them in accordance with local regulations
Storage/Transport	Permissible storage and transport temperature, humidity and ambient pressure
Operating	Permissible operating temperature, humidity and ambient pressure
	Authorised Representative in the European Community
	Medical device
	Distributor
	Date of manufacturing
	Article number
	Alternating current

3. Warnings and safety notes

Warning

- 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 your retailer or the specified Customer Services address.

• In the event of device faults, please see Chapter "10. Troubleshooting".
• The device is not a substitute for medical consultation and treatment. Consult your doctor first if you are experiencing any pain or are suffering from an illness.
• If you have health concerns of any kind, consult your GP.
• Please note the general hygiene measures when using the atomiser.
• You should always follow the instructions of your doctor 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:

For treatment, only use parts indicated by your doctor according to the particular diagnosis.

• The AIR PLUS is not indicated to use with quick-relief medications during life-threatening asthma attack.
• Check whether there are contraindications for use with the usual systems for aerosol therapy on the medication instruction leaflet.
• 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.
• 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.
• Check in the medicine package leaflet for possible contraindications for use with common aerosol therapy systems.
• 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 or other liquids 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 mains cable with wet hands, as you could get an electric shock.
• Do not pull the mains plug out of the socket using the mains cable.
• Do not crush or bend the mains cable, pull it over sharp-edged objects or leave it dangling down, and protect it from sources of heat.
• We recommend that the power cable is completely unrolled to avoid dangerous overheating.
• If the mains connection cable of this device is damaged, it must be disposed of. If it cannot be removed, the device must be disposed of.
• If the device is opened, there is a risk of electric shock. Disconnection from the power supply network is only guaranteed if the mains plug is unplugged.
• 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 AIR PLUS nebuliser may only be operated with compatible Medel atomisers and with the appropriate Medel accessories. The use of atomisers and accessories made by other companies may result in less efficient therapy and could damage the device.
• Keep the device and accessories out of the reach of children and pets.

Important

• Power cuts, sudden interference or other unfavourable conditions could lead to the device becoming inoperable. We therefore recommend that you obtain a replacement device or medication (the latter should be agreed with your doctor).
• Should you require an 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 therapy.
• Do not allow objects to get into the cooling vents.
• Never use the device if it is making an abnormal sound.

• For hygiene reasons, it is essential that every user uses their own accessories.

• Always disconnect the mains plug from the mains socket after use.

• Store the device in a location protected against climatic influences. The device must be stored in the environmental conditions specified.

PROTECTION

- The unit is fitted with an overcurrent protection device. This may only be replaced by authorized specialist personnel.

General notes

Important

- The device is only to be used:

- on humans

- for the purpose for which it is designed (aerosol inhalation) and in the manner specified 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 saline solution. Other liquids may cause a fault in the nebuliser or atomiser.
• This device is not intended for commercial or clinical use; it is designed exclusively for self-treatment in a private home.

Prior to initial use

Important

• Remove all packaging material before using the device.
• Protect the device against dust, dirt and humidity, never cover the device while it is in operation.
• 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 will result in voiding of the warranty.
• For repairs, please contact Customer Services or an authorised retailer.
• The device is maintenance-free.

4. Description of the device and accessories

Overview of nebuliser

Technical diagram of a portable air conditioner unit with labeled components including hose, bulb, and cable

1 Carrying handle
2 On/Off switch (back)
3 Mains connector cable
4 Hose connector
5 Filter cap with filter
6 Holder for atomiser

Overview of atomiser and accessories

8 9 11 13 10 12 14

7 Nasal douche
8 Compressed air hose
9 Atomiser
10 Atomiser insert
11 Valve
12 Medication container
13 Mouthpiece
14 Adult mask
15 Children's mask
16 Nosepiece with comfort attachment
17 Replacement filters

7 8 6 4 2

15

16

17

5. Initial use

Positioning the device

Take the device out of the packaging.

Place the device on a flat surface.

Make sure that the vents are free from obstructions.

Before using the device for the first time

i Note

• Clean and disinfect the atomiser and accessories before using them for the first time. See “Cleaning and disinfection” on page 31.
• Connect the compressed air hose [8] to the bottom of the medication container [12].

Line drawings of two hands holding a tool, one with a pointed tip and the other with a small cap (no text or symbols)

- Connect the other end of the compressed air hose [8] to the nebuliser hose connection [4] by turning it slightly.

Line drawing of a hand using a handheld device to lift a circular component, with a wire and cable nearby (no text or symbols)

Power supply

The device must only be connected to the mains voltage that is specified on the type plate.

• Insert the mains plug of the mains connector cable [3] into a suitable socket.
• To connect to the mains, fully insert the mains plug into the socket.

i Note

• Ensure that there is a mains socket close to the setup area.
• Arrange the mains connector cable so that no-one will trip over it.
• To disconnect the nebuliser from the mains after inhalation, first switch off the device and then pull the mains plug out of the socket.

6. Operation

Important

• For hygiene reasons, it is essential to clean the atomiser [9] and the accessories after each treatment and to disinfect them after the last treatment of the day.
• The accessories may be used only by one person; use by several people is not recommended.
• If the therapy involves inhaling several different medications one after the other, please be aware that the atomiser [9] must be rinsed under warm tap water following every usage. See “Cleaning and disinfection” on page 31.
• Please observe the notes on changing the filter in these instructions for use.
• Check that hose connectors are firmly attached to the nebuliser [4] and the atomiser [9] before each use of the device.
• Before use, check the device is working correctly, by briefly switching on the nebuliser (together with the connected atomiser, but without medication). If air comes out of the atomiser [9], the device is working.

6.1 Installing the atomiser insert

• Open the atomiser [9] by twisting the top anticlockwise against the medication container [12]. Place the atomiser insert [10] into the medication container [12].
• Ensure that the cone for administering medication fits well on the cone for the air duct inside the atomiser [9].

6.2 Filling the atomiser

• Fill with an isotonic saline solution or pour the medication directly into the medication container [12]. Avoid overfilling. The maximum recommended filling quantity is 8 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 4 ml with isotonic sa-

11 10 12

line solution. Dilution is also necessary with viscous medications. Here too, please observe the instructions of your doctor.

6.3 Closing the atomiser

- Close the atomiser [9] by twisting the top clockwise against the medication container [12]. Ensure that the connection is correct.

6.4 Inserting the valve

- Press the blue valve [11] into the opening intended for this purpose on the upper side of the atomiser [9].

i Note

The valve system ensures better delivery of the medication to the lungs. Only use the valve [11] with the mouthpiece [13], never with the masks [14, 15] or the nosepiece [16].

6.5 Connecting accessories to the atomiser

• Connect the atomiser [9] to the desired accessory (mouthpiece [13], adult mask [14], children's mask [15] or nosepiece [16]).
  In addition to the accompanying adult [14] and children's mask (from 2 years of age) [15], you also have the option of using baby mask (from ages 0-3 years) with your nebuliser. The baby mask is not included in delivery with the AIR PLUS. You can find an overview of all replacement items in chapter "12. Replacement parts and wearing parts".

i Note

The most effective form of nebulisation is by using the mouthpiece. Nebulisation 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).

If you are using the adult mask [14] you can secure it to your head with the adult mask strap. There is also a strap for the children's mask [15].

When using a mask to inhale, take care to ensure the mask fits well and the eyes are unobstructed.

• Before the treatment, pull the atomiser upwards out of the holder [6].
• Start the nebuliser using the On/Off switch [2].
• Spray mist pouring out of the atomiser indicates that the device is operating correctly.

6.6 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 atomised medication deeply.

Important

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 atomiser straight (vertically), otherwise the atomisation will not work and faultless functionality is not guaranteed.

Important

Essential oils, cough syrups, gargling solutions and drops to be used as a rub or in a steam bath are wholly unsuitable for inhalation using a nebuliser. These additions are often viscous and can impair the correct functioning of the device and therefore the effectiveness of the application in the long-term. For individuals with a hypersensitive bronchial system, medications containing essential oils may under certain conditions cause an acute bronchospasm (a sudden cramp-like restriction of the bronchi with shortness of breath). Consult your doctor or pharmacist in relation to this matter.

6.7 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 off the nebuliser after treatment using the On/Off switch [2] and disconnect it from the mains.
• Place the atomiser [9] back in its holder [6] after the treatment.

6.8 Nasal douche

19 20 21 22 19. Cover 20. Collection container for nasal secretion 21. Saline container 22. Cover hole (Starting the application)

You can use the nasal douche to clean your nasal cavities. The nasal douche creates a fine jet. We recommend using the nasal douche for colds, dryness inside the nose, dust exposure, pollen allergies, chronic inflammation of the sinuses or upon the advice of your doctor.

Warning

- Do not use the nasal douche in combination with other medication or essential oils.

Important

• The nasal douche should only be used with isotonic saline solutions.
• Replace the nasal douche after a year.

The maximum volume of the nasal douche is 10 ml. If you are unsure about the correct dilution of the saline solution, please consult your doctor.

6.9 Using the nasal douche

To use the nasal douche correctly, proceed as follows:

1. Twist the cover [19] 90° anticlockwise and remove it in an upward direction.2. Lift the collection container [20] out.
3. Fill the saline container [21] with saline solution.
4. Place the collection container [20] into the saline container [21].5. Place the cover [19] on the saline container [21]. Twist the cover [19] in a clockwise direction until it clicks firmly into place.
6. Connect the compressed air hose [8] to the saline container [21] from below.
7. Position the cover [19] carefully inside one of your nostrils. Breathe through the nose.

1. Press the On/Off switch [2] on the back of the nebuliser. To start the application, place one finger over the cover hole [22] on the container.

i Note

During the application, breathe slowly and evenly through the nose. Tilt your head slightly in the opposite direction to the nostril being treated so that the saline solution can flow deep into the nose.

1. To pause or stop the application, take your finger off the cover hole [22] on the saline container [21].

2. Once your nose feels clear again, you can stop the application. The application should be stopped at the latest once the maximum filling quantity has been used.

Illustration of a hand holding a dropper with liquid droplets (no text or symbols)

6.10 Cleaning

See "Cleaning and disinfection" on page 31.

7. Changing the filter

In normal operating conditions, the air filter must be replaced after approx. 200 operating hours or one year. Please check the air filter regularly (after 10-12 nebulisation 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.

Important

• Do not attempt to clean the used filter and reuse it.
• Use only the manufacturer's original filter, otherwise your nebuliser may become damaged and sufficiently effective therapy 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:

Important

• First switch the device off and disconnect it from the mains.

• Allow the device to cool down.

• Pull off the filter cap [5] towards the front.

Diagram of a mechanical device with a numbered label '5' and a directional arrow (no text or symbols beyond the number)

i 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.

1. Re-insert the filter cap [5] with a new filter.
2. Ensure that it is securely in place.

8. Cleaning and disinfection

Atomiser and accessories

Warning

Adhere to the following hygiene instructions to avoid health risks.

- The atomiser [9] 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 atomiser 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 needed (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 atomiser [9] and the used accessories must be cleaned of residual medication and contamination.
• To do this, dismantle the atomiser [9] and the nasal douche [7] into their individual parts.
• Remove the mouth piece [13], the mask [14, 15] or the nosepiece [16] from the atomiser.

- Disassemble the nosepiece if you have used it with the comfort attachment.

- Dismantle the atomiser by twisting the top anticlockwise against the medication container [12].

- Remove the atomiser insert [10] from the medication container [12].

- Remove the valve [11] by pulling it out of the atomiser [9].

- Reassembly is carried out in reverse order.

11 10 12

Cleaning

Important

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

The atomiser and the used accessories such as the mouthpiece, mask, nasal douche, 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 if they are completely dry and place them in a dry, sealed container 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 a 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.

Important

• Ensure that no water gets inside the device.
• The masks and air tube must be washed with warm water.
• Do not boil nor autoclave the air tube and masks.
• 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 into the vents. If liquid penetrates the device this could cause damage to the electrics or other nebuliser 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 the bacterial growth and ensure ideal therapy. To do so, proceed as follows:

• Remove the compressed air hose [8] from the atomiser [9].
• The hose must remain connected to the inhaler [4].
• Operate the nebuliser 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 atomiser and accessories. We recommend disinfecting the individual parts on a daily basis after the last usage as a minimum measure.

(All you need for this is a little white vinegar and distilled water.)

• First, clean the atomiser and accessories as described in the “Cleaning” section.
• Place the disassembled atomiser, nasal douche, mouthpiece and the disassembled nosepiece in boiling water for 5 minutes.
• Rinse the parts with water and dry carefully with a soft cloth.

Important

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

- Put the parts together again if 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.

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, atomisers 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 therapy. We therefore recommend that you replace the atomiser and other accessories after a year.
• The following point should be observed when selecting the cleaning product or disinfectant: only use a mild cleaning product or disinfectant in the concentration and volume prescribed by the manufacturer.

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.
• The accessories can be stowed securely in the accessory compartment. Store the device in a dry place, ideally in the original packaging.

9. Disposal

For environmental reasons, do not dispose of the device in the household waste.

Please dispose of the device in accordance

with EC Directive – WEEE (Waste Electrical and Electronic Equipment).

If you have any questions, please contact the local authorities responsible for waste disposal.

1. Troubleshooting

Problem/question	Possible cause/remedy
The atomiser does not produce any aerosol or produces too little aerosol.	1. Too much or too little medication in the atomiser. Minimum: 2 ml, Maximum: 8 ml.
	2. Check nozzle for blockages. Clean nozzle if necessary (e.g. by rinsing out). Then start the atomiser again. IMPORTANT: Carefully pierce the fine holes from the underside of the nozzle only.
	3. Atomiser not held vertically.
	4. Unsuitable medication fluid added for nebulisation (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.
What medications are suitable for inhaling?	Please consult your doctor in relation to this matter. As a rule, all medication that is suitable and approved for device inhalation, can be inhaled.
There is inhalation solution residue in the atomiser.	This is normal and is necessary for technical reasons. Stop inhalation once the atomiser starts to make a notably different sound.
What should be taken into account when using the device with infants and children?	1. On infants and children, the mask should cover the mouth and nose to ensure effective inhalation.

Problem/question	Possible cause/remedy
	2. On children, the mask should also cover both the nose and mouth. It is not a good idea to carry out nebulisation on someone who is sleeping, as in this case not enough of the medication will reach the lungs.
	Note: Inhalation should only be carried out under the supervision of an adult and with their assistance and the child should not be left alone.
Inhalation using the mask takes longer.	This is necessary for technical reasons. You breathe less medication per breath through the holes of the mask than via the mouthpiece. The aerosol is mixed with ambient air via the holes.
Why should the atomiser be replaced regularly?	There are two reasons for this:1. To ensure a therapeutically effective particle spectrum, the nozzle hole must not exceed a specific diameter. Due to mechanical and thermal stresses, the plastic is subject to a certain degree of wear. The atomiser insert [10] is particularly sensitive. This can also alter the composition of the aerosol droplets, which directly affects the effectiveness of the treatment.2. Regularly changing the atomiser is also recommended for hygiene reasons.
Should each person have their own atomiser?	Yes, this is absolutely essential for hygiene reasons.

1. Technical specifications

Model	AIR PLUS
Type	GCE828
Dimensions(W x H x D)	166 x 141 x 148 mm
Weight	1.4 kg
Operating pressure Approx.	0.8 to 1.45 bar
Atomiser filling volume	Min. 2 mlMax. 8 ml
Medication flow rate Approx. 0.3 ml/min
Filling volume	Min. 2 ml
Nasal douche	Max. 10 ml
Sound pressure	Approx. 52 dBA (acc. to DIN EN 13544-1 section 26)
Power supply	230 V~; 50 Hz; 230 VA UK: 240 V~; 50 Hz; 240 VA Saudi Arabia: 220 V~; 60 Hz; 220 VA
Expected service life 1000 h
Operating conditions	Temperature: +10°C to +40°C Relative humidity: 10% to 95% Ambient pressure: 700 to 1060 hPa
Storage and transportation conditions	Temperature: 0°C to +60°C Relative humidity: 10% to 95% Ambient pressure: 500 to 1060 hPa
Aerosol properties	1) Flow: 5.3 l/min2) Aerosol delivery: 0.11 ml3) Aerosol delivery rate: 0.07 ml/min4) Particle size (MMAD): 3.07 μm

The serial number is located on the device or in the battery compartment.

Subject to technical changes.

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.

1. Replacement parts and wea-ring parts

Designation Material REF
Year pack AIR PLUS Standard contains: Mouthpiece Nosepiece Adult mask Children's mask Nebulizer Compressed air hose Filter	PP/Silicone PP/Silicone PVC/Alu-minum PVC/Alu-minum PP/Silicone PVC PU	603.33
Yearpack AIR PLUS Kids contains: Mouthpiece Silicon children mask Silicone baby mask Angled fitting Nebulizer Compressed air hose Filter	PP/Silicone Silicone/PP Silicone/PP PPPP/Silicone PVC PU	603.34

i Note

If the device is not used according to the instructions specified, perfect functionality cannot be guaranteed! We reserve the right to make technical changes to improve and develop the product. This device and its accessories comply with the European standards EN60601-1, EN60601-1-2 (CISPR 11, IEC61000-3-2, IEC61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, EC61000-4-5, IEC61000-4-6, IEC61000-4-7, IEC61000-4-8, IEC61000-4-11) and EN13544-1 and are subject to particular precautions with regard to electromagnetic compatibility. This device meets the requirements of European Directive 93/42/EEC for medical products, as well as those of the Medizinproduktegesetz (German Medical Devices Act).

NOTES ON ELECTROMAGNETIC COMPATIBILITY

• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
• The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well

as the other devices must be monitored to ensure they are working properly.

- The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device's electromagnetic immunity; this can result in faulty operation.

13. Warranty/service

Medel International, via Villapizzone 26 / 20156, Milan (referred to as “Medel”) provides a warranty for this product, subject to the requirements below and to the extent described as follows.

The warranty conditions below shall not affect the seller's statutory warranty obligations which ensue from the sales agreement with the buyer.

The warranty shall apply without prejudice to any mandatory statutory provisions on liability. Medel guarantees the perfect functionality and completeness of this product.

The worldwide warranty period is 5 years, commencing from the purchase of the new, unused product from the seller. The warranty only applies to products purchased by the buyer as a consumer and used exclusively for personal purposes in the context of domestic use.

German law shall apply.

During the warranty period, should this product prove to be incomplete or defective in functionality in accordance with the following provisions, Medel shall carry out a repair or a replacement delivery free of charge, in accordance with these warranty conditions

If the buyer wishes to make a warranty claim, they should approach their local retailer in the first instance: see the attached “International Service” list of service addresses.

The buyer will then receive further information about the processing of the warranty claim, e.g. where they can send the product and what documentation is required. A warranty claim shall only be considered if the buyer can provide Medel, or an authorised Medel partner, with

- a copy of the invoice/purchase receipt, and

- the original product.

The following are explicitly excluded from this warranty:

- deterioration due to normal use or consumption of the product;

• accessories supplied with this product which are worn out or used up through proper use (e.g. batteries, rechargeable batteries, cuffs, seals, electrodes, light sources, attachments and nebuliser accessories);
• products that are used, cleaned, stored or maintained improperly and/or contrary to the provisions of the instructions for use, as well as products that have been opened, repaired or modified by the buyer or by a service centre not authorised by Medel;
• damage that arises during transport between manufacturer and customer, or between service centre and customer;
• products purchased as seconds or as used goods;
• consequential damage arising from a fault in this product (however, in this case, claims may exist arising from product liability or other compulsory statutory liability provisions).

Repairs or an exchange in full do not extend the warranty period under any circumstances.

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/

FRANÇAIS

Table des matières

Line drawings of two hands holding a pen and a tool, no text or symbols present

Illustration of a hand using a handheld device to interact with a circular tank, with a cable and wire nearby (no text or symbols)

Illustration of a hand holding a dropper with liquid droplets (no text or symbols)

6.10 Nettoyage

Diagram of a mechanical device with a circular component and a curved arrow, labeled with number 5 (no text or symbols beyond the label)

i Remarque

Point de contact vigilance: https://ec.europa.eu/growth/sectors/medical-devices/contacts/

ESPAÑOL

Índice

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Line drawing of a hand using a handheld device to interact with a circular tank, no text or symbols present

Potencia

IEC 60601-1-2:2014 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for Class B product

The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments and so on.

Warning: Don't near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

Warning: use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Warning: use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation."

Warning: portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MEDEL AIR PLUS including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

If any: a list of all cables and maximum lengths of cables (if applicable), transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE ORGANIZATION and that are likely to affect compliance of the ME EQUIPMENT or ME SYSTEM with the requirements of Clause 7 (EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES may be specified either generically (e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).

If any: he performance of the ME EQUIPMENT or ME SYSTEM that was determined to be ESSENTIAL PERFORMANCE and a description of what the OPERATOR can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need not be used).

1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer's declaration -electromagnetic emissions and Immunity.

Tab 1

Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test Compliance
RF emissionsCISPR 11	Group 1
RF emissionsCISPR 11	Class B
Harmonic emissionsIEC 61000-3-2	Class A
Voltage fluctuations/ flicker emissionsIEC 61000-3-3	Compliance

Tab 2

Guidance and manufacturer's declaration - electromagnetic Immunity
Immunity test IEC 60601-1-2 Test level		Compliance level
Electrostatic discharge (ESD) ±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air		±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrical fast transient/burst Power supply lines: ±2 kV100 kHz repetition frequency		Power supply lines: ±2 kV
SurgeIEC 61000-4-5	line(s) to line(s): ±1 kV.	line(s) to line(s): ±1 kV.100 kHz repetition frequency
Voltage dips, short interruptions and voltage variations on power supply input linesIEC 61000-4-11	0% 0.5 cycleAt 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315°0% 1 cycleAnd70% 25/30 cyclesSingle phase: at 00% 250 cycle	0% 0.5 cycleAt 0°, 45°, 90°, 135°, 180°, 225°, 270°and 315°0% 1 cycleAnd70% 25/30 cyclesSingle phase: at 00% 250 cycle
Power frequency magnetic fieldIEC 61000-4-8	30 A/m50Hz/60Hz	30 A/m50Hz/60Hz
Conduced RFIEC61000-4-6	150KHz to 80MHz: 3Vrms6Vrms (in ISM and amateur radio bands)80% Am at 1kHz	150KHz to 80MHz: 3Vrms6Vrms (in ISM and amateur radio bands)80% Am at 1kHz
Radiated RFIEC61000-4-3	10 V/m80 MHz – 2,7 GHz80 % AM at 1 kHz	10 V/m80 MHz – 2,7 GHz80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.

Tab 3

Guidance and manufacturer's declaration - electromagnetic Immunity
Radiated RFIEC61000-4-3(Test specifications forENCLOSURE PORTIMMUNITY toRF wireless communications equipment)	TestFrequency(MHz)	Band(MHz)	Service Modulation Modulation		(W)	Distance(m)	IMMUNITYTEST LEVEL(V/m)
	385 380 -	390	TETRA 400 Pulse modulation18 Hz		1.8 0.3 27
	450 430 -	470	GMRS 460,FRS 460		FM ± 5 kHz deviation1 kHz sine	2 0.3 28
	710 704 -	787	LTE Band13,17		Pulse modulation217 Hz	0.2 0.3 9
	745
	780
	810 800 -	960	GSM 800/900,TETRA 800,iDEN 820,CDMA 850,LTE Band 5		Pulse modulation18 Hz	2 0.3 28
	870
	930
	1720 1700	1990	GSM 1800;CDMA 1900;GSM 1900;DECT;LTE Band 1, 3,4, 25; UMTS		Pulse modulation217 Hz	2 0.3 28
	1845
	1970
	2450 2400	2570	Bluetooth,WLAN,802.11 b/g/n,RFID 2450,LTE Band 7		Pulse modulation217 Hz	2 0.3 28
	5240 5100	5800	WLAN 802.11a/n		Pulse modulation217 Hz	0.2 0.3 9
	5500
	5785

Manufacturer:

Globalcare Medical Technology Co., Ltd 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town 528415 Zhongshan City, Guangdong Province PEOPLE'S REPUBLIC OF CHINA Phone : [phone] http://www.globalcare.com.hk/contact/

EC REP

EC- Representative:

Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome / Italy https://www.donawa.com/wli/main/contatti.index

Distributed by:

Beurer GmbH Söflinger Str. 218 89077 Ulm, Germany

CE _0123