Compact - Inhaler Medel - Free user manual and instructions

USER MANUAL Compact Medel

Close-up of a white handheld device with a black lid and circular button (no visible text or symbols)

IT Inalatore

Instructions for use..... 35

DE Inhalator

Diagram of eight labeled mechanical components, including a battery and cable assembly

Illustration of a hand pressing down on a cylindrical object with a downward arrow (no text or symbols)

Simple line drawing of a camera connected to a cable with a small square object nearby (no text or symbols)

Diagram showing a hand pressing down on a cylindrical object with an arrow indicating motion (no text or symbols)

Illustration of a hand pressing down on a cylindrical object with an upward arrow indicating motion (no text or symbols)

Attenzione

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.

Dear customer,

Thank you for choosing a product from our range. Our name is synonymous with high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, body temperature, pulse, gentle therapy, massage, beauty and air.

Contents

1. Included in delivery.... 39
2. Signs and symbols.... 39
3. Proper use 41
4. Warnings and safety notes.... 43
5. Description of the device and accessories 49
6. Initial use .... 51
7. Usage 52
8. Cleaning and maintenance.... 55
9. Accessories and replacement parts.... 61
10. What if there are problems? 61
11. Disposal.... 64
12. Technical specifications 65
13. Warranty/service.... 68

1. Included in delivery

Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specified Customer Service address.

• Nebuliser
  • Cover for mesh atomiser
• Protective cap for mesh atomiser
• Mouthpiece
• Adult mask
• Children's mask
• Micro USB cable
  • These instructions for use

- Mesh atomiser with medication container (hereinafter referred to as “mesh atomiser”)

2. Signs and symbols

The following symbols appear in the instructions for use and on the device

Warning

Warning instruction indicating a risk of in-jury 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
	Manufacturer
	On/Off
	Serial number
	Protection class 2 device
	Do not use outdoors
IP22	Protected against foreign objects ≥ 12.5 mm and against water dripping at an angle
	This product satisfies the requirements of the applicable European and national directives.
	European Union representative
	Alternating current
PAP	Dispose of packaging in an environmentally friendly manner
Storage/Transport	Permissible storage and transport temperature and humidity
Operating	Permissible operating conditions
	Disposal in accordance with the Waste Electrical and Electronic Equipment EC Directive – WEEE

3. Proper use

Intended use

Nebulisers (including compressor, ultrasonic and mesh nebulisers) are medical devices for the nebulisation of liquids and liquid medication (aerosols). The aerosol treatment is suitable for treating 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.

Target group

In combination with inhalation solutions, the nebuliser can be used in the home environment for paediatric and adult patients.

Indication/clinical benefits

Inhalation is the most effective way to administer medication for most respiratory system conditions.

The benefits are:

• The medication is transported directly to the target organs
• The local bioavailability of the medication is significantly increased
  • Systemic diffusion is reduced substantially
• Only very low doses of the medication are required
• Quick and effective therapeutic effect
• Side effects are significantly reduced compared to systemic administration

Therefore, inhalation is indicated in the case of acute or chronic diseases of the respiratory organs or inflammation of the upper respiratory system.

Examples of upper respiratory system diseases include:

• Nasal mucosal inflammation
  • Allergic nasal mucosal inflammation
• Nasal sinus infection
• Pharyngitis
• Laryngitis

Examples of lower respiratory system diseases include:

• Bronchial asthma
• Bronchitis
  • COPD (chronic obstructive pulmonary disease)
• Bronchiectasis
• Acute tracheobronchitis
• Cystic fibrosis
• Pneumonia

The purpose/benefits of inhalation therapy are:

• Humidifying the airways
- Loosening of and making (bronchial) secretions more liquid

• Releasing bronchospasms (spasmolysis)
• Relieving swollen and inflamed bronchial mucosa
• Clearing secretions by coughing
  • Counteracting pathogens of respiratory infections

4. Warnings and safety notes

Contraindications

• This device must not be used by children under the age of 8 and by people with reduced physical, sensory (e.g. reduced sensitivity to pain) or mental skills or a lack of experience or knowledge, unless they are supervised or have been instructed on how to use the device safely, and are fully aware of the consequent risks of use.
• Do not use the device on persons who are ventilated and/or unconscious.
• Check whether there are contraindications for use with the usual systems for aerosol treatment on the medication instruction leaflet.
• If the device does not work properly, or you feel unwell or experience pain, stop using it immediately.

General warnings

- Once it has been properly prepared, the device can be used again. Preparation involves replacing all the components, including the atomiser and air filter, and disinfecting the surface of the device using a standard disinfectant. We recommend replacing the atomiser and other components after one year. For hygiene reasons, it is essential that each user uses their own components.

• Always follow your doctor's or pharmacist's instructions for the dosage, frequency and duration of inhalation for the type of medication to be used. In the event of use with medication/nebulisation of medication, the conditions and restrictions applicable to such medication must be adhered to. Please note: For treatment, only use parts indicated by your doctor according to the particular diagnosis.
• 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, consult your GP!
• Please note the general hygiene measures when using the nebuliser.
• Before use, ensure that there is no visible damage to the device or components. If you have any doubts, do not use it and contact your retailer or the specified Customer Service address.
• Changes to the device and the components are not permitted.
• Do not use any additional parts that are not recommended by the manufacturer.
• The nebuliser may only be operated with compatible Sanitas atomisers and with the appropriate Sanitas components. The use of atomisers and components made by other companies may result in less efficient treatment and could damage the device.
• Keep the device away from your eyes when it is in use, as the nebulised medication could be harmful.
• Do not use the device near flammable gases, oxygen or nitrogen oxide.

• Store the device and components out of the reach of children and pets.

• Keep packaging material away from children (risk of suffocation).

• The device must be switched off and the plug pulled out before every cleaning and/or maintenance procedure.
• Never submerge the device in water and do not use it in the bathroom. Under no circumstances may liquid enter the device.
• 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.
• 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).
• To avoid the risk of entanglement and strangulation, store the cable out of the reach of small children.
• The device must only be connected to the mains voltage that is specified on the type plate.
• 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 of this device is damaged, it must be disposed of. Please contact Customer Services or the retailer.

- If the device is opened, there is a risk of electric shock. Disconnection from power supply network is only guaranteed if there is no power connection via the micro USB cable.

General precautions

• Never 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 treatment.
• Do not use the device if it is making an abnormal sound.
• Store the device in a location protected against climatic influences. The device must be stored in the environmental conditions specified.
• Do not operate the device near electromagnetic transmitters.
• Protect the device from heavy impacts.
• 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 type plate must not be exceeded.
• Do not use any liquids with a viscosity of more than 5. This can irreparably damage the mesh.
• Do not use any powdered medication (including in a solution).

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 incorrect use.

Repairs

• Under no circumstances should you open or repair the device yourself, as faultless functionality can no longer be guaranteed thereafter. Failure to comply with this instruction will void the warranty.
• The device is maintenance-free.
• For repairs, please contact Customer Services or an authorised retailer.

Measures for handling batteries

• If your skin or eyes come into contact with fluid from a battery cell, flush out the affected areas with water and seek medical assistance.
• Choking hazard! Small children may swallow and choke on batteries. Therefore, store batteries out of the reach of small children.
• Protect batteries from excessive heat.
• Risk of explosion! Never throw batteries into a fire.
• Do not disassemble, split or crush the batteries.
• Only use chargers specified in the instructions for use.
• Batteries must be charged correctly prior to use. The instructions from the manufacturer and the specifications in these instructions for use regarding correct charging must be observed at all times.
• Fully charge the battery prior to initial use (see section 5).
• In order to achieve as long a battery service life as possible, fully charge the battery at least 2 times a year.

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.

- Failure to comply with the above can impair the performance of the device.

5. Description of the device and accessories

Accessories

Only use the accessories recommended for use by the manufacturer; safe function is only guaranteed when this requirement is met.

Important

Leakage protection

When pouring the medication into the medication container, ensure that you only fill it up to the maximum mark (10 ml). The recommended filling quantity is between 2 and 10 ml.

Nebulisation only occurs while the substance to be nebulised is in contact with the mesh. If this is not the case, the nebulisation is stopped automatically.

Therefore, please try to hold the device as vertically as possible.

Automatic switch-off

The device has an automatic switch-off function. When there is only a very small amount of medication or fluid left, the device switches off automatically to avoid causing damage to the mesh. Do not operate the device when the medication container is empty. The device switches off automatically if the substance to be nebulised is no longer in contact with the mesh.

Device

1 Cover for mesh atomiser
2 Mesh atomiser with medication container (hereinafter referred to as "mesh atomiser")
3 Protective cap for mesh atomiser
4 Housing
5 ON/OFF button incl. LED indicator
6 Button ("PRESS")
7 Micro USB port
8 Micro USB cable

Overview of accessories

10 Adult mask
11 Children's mask
12 Mouthpiece

Diagram of eight labeled components of a device, including zoomed-in parts and cable connectors

101112

6. Initial use

Before using the device for the first time

Note

- Clean and disinfect the mesh atomiser (2) and accessories before using them for the first time. See “Cleaning and maintenance” on page 54.

Installation

Take the device out of the packaging.

- Push the mesh atomiser (2) from above vertically into the guide provided in the housing (4) or the base of the device so that it audibly clicks into place.

Illustration of a hand pressing down on a cylindrical object with a downward arrow (no text or symbols)

Charging the nebuliser battery

To charge the nebuliser battery, proceed as follows:

• Open cover of the micro USB port on the housing (4).
• Connect the micro USB cable (8) included in delivery with the micro USB port (7) on the nebuliser and a computer that is

switched on. Alternatively, connect the micro USB cable (8) to the nebuliser and a USB mains adapter (not included in delivery). Insert the USB mains adapter into a suitable socket.

Simple line drawing of a camera connected to a power outlet (no text or symbols)

• Whilst charging, the LED indicator (5) flashes green. As soon as the battery is fully charged, the LED indicator lights up green.
• It usually takes approx. 1.5 hours to fully charge the battery.
• As soon as the battery is completely charged, remove the micro USB cable (8) from the computer or the socket and the USB mains adapter and from the micro USB port (7) on the nebuliser.
• When the battery is fully charged, the battery life is approx. 60 minutes. If the LED indicator (5) flashes blue five times, this indicates that the battery level is low.

7. Usage

1. Preparing the nebuliser

• For hygiene reasons, it is essential to clean the mesh atomiser (2) and the accessories after each treatment and to disinfect them after the last treatment of the day.
• If the therapy involves inhaling several different medications one after the other, please be aware that the mesh atomiser (2) must be rinsed under warm tap water following every usage. See “Cleaning and maintenance” on page 54.

2. Filling the atomiser

• Open the mesh atomiser cover (1) by turning it anti-clockwise and fill the medication container with an isotonic saline solution or pour the medication straight in. Avoid overfilling.
• The maximum recommended filling quantity is 10 ml.

Illustration of a hand pressing down on a cylindrical object with an arrow indicating motion (no text or symbols)

• 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 0.4 ml, it must be topped up with isotonic saline solution. Dilution is also necessary with viscous medications (viscosity > 5). Here too, please observe the instructions of your doctor.

3. Closing the mesh atomiser

- Close the cover of the mesh atomiser (1) by turning it clockwise.

4. Connecting an accessory

• Remove the protective cap (3) from the mesh atomiser (2).
• Firmly connect the desired accessory (mouthpiece, adult mask or children's mask) to the mounted mesh atomiser (2).
• Now place the device to your mouth and put your lips firmly around the mouthpiece. When using the mask(s), please place the mask over your nose and mouth.
• Ensure that you added fluid before switching on the device. Start the device using the On/Off button (5).
• The spray mist coming out of the device and the continuously lit blue LED (5) indicate that the device is operating correctly.

Note

The most effective form of nebulisation is by using the mouth-piece. 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 using a mouthpiece).

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

5. Inhaling correctly

Breathing technique

• It is important to use the correct breathing technique to ensure that the particles are distributed as widely as possible across the airways. To ensure that the particles reach your airways and lungs, you must breathe in slowly and deeply, then hold your breath briefly (5 to 10 seconds) and then breathe out quickly.
• Nebulisers should only be used for the treatment of respiratory diseases after consultation with your doctor. He or she will advise you about the selection, dosage and use of medications suitable for inhalation therapy.
• Certain medications are only available with a prescription.

Note

You should hold the device as vertically as possible. However, a slight angle will not affect the application, as the container is leak proof. For full functionality of the device, ensure when using it that the medication is in contact with the mesh.

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 additives 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. Stopping inhalation

• When you have finished the treatment, switch off the device using the On/Off button (5).
• The LED indicator (5) goes out.
• If the inhalant is nebulised, the device switches off automatically. This automatic switch-off is indicated by the control LED (5) flashing blue three times. For technical reasons, a small amount of medication remains in the medication container. Do not use this.
• After a treatment period of 10 minutes, the device switches off automatically. Immediately before the device switches off, the control LED (5) flashes blue 10 times.

7. Cleaning

See chapter 8. "Cleaning and maintenance".

8. Cleaning and maintenance

Warning

Adhere to the following hygiene instructions to avoid health risks.

- Mesh atomiser (2) and accessories are designed for multiple use. Please note that different areas of application involve different requirements in terms of cleaning and hygienic preparation.

Note

• Do not clean the mesh 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).

Cleaning

The mesh atomiser (2) and the accessories used such as the mouthpiece, mask, etc. must be washed with warm water of max. 40°C for approx. 5 minutes 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 or disinfect them.

• Remove the mouthpiece and the relevant accessory from the mesh atomiser (2).
• Pour 6 ml of clean water into the medication container (1) and switch the device on to first clean the mesh of any medication residue (please nebulise all of the liquid).

Disassembling

- First remove the cover of the mesh atomiser (1) by turning it anti-clockwise.

Diagram showing a hand pressing down on a cylindrical object with an upward arrow indicating motion (no text or symbols)

• Remove the mesh atomiser (2) by pressing the button (7) on the back of the device and pulling the unit upwards vertically.
• Reassembly is carried out in reverse order.

Important

Never hold the whole device under running water to clean it.

When cleaning, ensure that any residue is removed and dry all parts carefully.

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.

If required, clean the housing of the device using a slightly damp cloth, which you can moisten with a mild soapy solution.

• If there is any residue from medical solutions or contamination on the silver-coloured contacts of the device or mesh atomiser (2), clean with a cotton bud moistened with ethyl alcohol.
• Also clean the outer sides of the mesh and the medication container with a cotton bud moistened with ethyl alcohol.

Important

• The device must be switched off and allowed to cool down each time before cleaning.
• Do not use any abrasive cleaning products and never sub-merge the device in water.
• Ensure that no water gets inside the device!
• Do not clean the device or accessories in the dishwasher!
• Do not allow water to spray onto 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.

Important

We recommend carrying out inhalation without interruptions since the inhalant may clog the mesh atomiser (2) during a long pause in treatment, and the effectiveness of the application may be impaired as a result.

Disinfection

Please carefully observe the points below when disinfecting your mesh atomiser (2) and accessories. We recommend disinfecting the individual parts on a daily basis after the last usage as a minimum measure.

You can disinfect the SIH 52 and its accessories in two ways: using ethyl alcohol or boiling water.

First, clean the mesh atomiser (2) and accessories as described in the “Cleaning” section. Then continue with the disinfection.

Important

Make sure that you do not touch the mesh (2), as this can destroy it.

Disinfection with ethyl alcohol (70–75%)

• Pour 8 ml of ethyl alcohol into the medication container (1). Close the container. Leave the alcohol in the container for at least 10 minutes.
• For better disinfection, shake the unit gently from side to side.

• Once this is complete, pour the ethyl alcohol out of the container.

• Repeat the process, but this time using water.

• Position the medication container (1) so that you can drip a few drops of ethyl alcohol onto the mesh (2). Leave this to work for 10 minutes.
• Then clean all the parts again under running water.
• The same procedure applies to accessories such as masks, mouthpieces and protective caps.

Disinfection with boiling water

• The mesh atomiser (2), the cover (1) and the mouthpiece can be placed in boiling water for 15 minutes in order to disinfect them. Contact between the parts and the hot base of the pan should be avoided.
• You can also disinfect the mesh atomiser (2) and the mouth-piece using a commercially available steam steriliser. For more information, please see the instructions for use of the steam steriliser manufacturer.
• The mesh atomiser (2) must not be placed in the microwave.

Note

The masks must not be placed in hot water!

- We recommend disinfecting the masks using a standard disinfectant.

Drying

• Dry the parts carefully using a soft cloth.
• Shake the mesh atomiser (2) gently from side to side (5 to 10 times), so that the water inside the mesh is removed from the tiny holes.
• Place the individual parts on a clean, dry and absorbent surface and leave them to dry completely (at least 4 hours).

Note

Please ensure that the parts are completely dry after cleaning, otherwise the risk of bacterial growth is increased.

Put the parts together again if these are completely dry and place the parts in a dry, sealed container.

Ensure that the mesh atomiser (2) is completely dried off by the shaking. Otherwise, the nebulisation may not work after reassembling the device.

In this case, shake the mesh atomiser (2) again so that the water can escape. The nebuliser should then work as normal.

Durability of materials

- 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.

- As with any plastic parts, the medication container with mesh atomiser (2) and the 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 medication container with mesh atomiser (2) and the accessories after no more than a year.

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.

9. Accessories and replacement parts

To purchase accessories and replacement parts, please visit https://sanitas-online.de/en or contact the corresponding service address (according to the service address list) in your country. Accessories and replacement parts are also available from retailers.

Designation Material REF
Mouthpiece (PP), adult mask (PVC), children’s mask (PVC), mesh atomiser with medication container (PC)	PP/PVC/PC	602.10

10. What if there are problems?

Problem/question	Possible cause/remedy
The nebuliser produces no or too little aerosol.	1. Insufficient amount of medication in the mesh atomiser (2).
	2. Mesh atomiser (2) not held vertically.
	3. Unsuitable medication fluid added for nebulisation (e.g. too viscous. Viscosity must be less than 5).The medication fluid should be prescribed by the doctor.
	4. The battery is empty. Charge it.
The output is too low.	1. There are air bubbles in the medication container, which are preventing continuous contact with the mesh. Please check this and remove any air bubbles.
	2. Particles on the mesh are hindering output. In this case, you should pause the inhalation process and remove the mask or mouthpiece. In order to remove the dirt, you can pour in 2 to 3 drops of vinegar mixed with 3 – 6 ml of water and nebulise the entire mixture. Please do not inhale this mist and remember to clean and disinfect the medication container afterwards (see page 54).
	3. The mesh is worn. Replace the mesh atomiser (2).
What medications are suitable for inhaling?	Naturally, only your doctor can decide which medication should be used for treating your condition. Please consult your doctor in relation to this matter. With the SIH 52 you can nebulise medications with a viscosity of less than 5. Medications containing oil (particularly essential oils) should not be used, as these attack the material of the medication container, which can lead to faults.
There is inhalation solution residue in the mesh atomiser (2).	This is normal and is due to technical reasons. Stop the inhalation as soon as the atomiser starts to make a notably different sound or the device switches off automatically due to a lack of inhalant.
What should be taken into account when using the device with infants and children?	1. On infants, the mask should cover the nose and mouth to ensure effective inhalation.2. On children, the mask should also cover both the nose and mouth. It is not very useful to carry out nebulisation next to 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 due to 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.
Does every-one need their own accessories?	Yes, this is absolutely essential for hygiene reasons.

11. Disposal

Battery disposal

• The empty, completely flat batteries must be disposed of using specially designated collection boxes, recycling points or electronics retailers. You are legally required to dispose of the batteries.
• The codes below are printed on batteries containing harmful substances:

Pb = Battery contains lead

Cd = Battery contains cadmium

Hg = Battery contains mercury

Pb Cd Hg

General disposal

For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Dispose of the device at a suitable local collection or recycling point in your country. 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.

12. Technical specifications

Model FEELLIFE HEALTH INC: Air Pro III

Medel Compact 95280

Dimensions

(LxWxH) 54 x 40 x 92 mm

Weight 103 g

Mains connection Input: 100–240 V\~; 50–60 Hz; 35 A

Output: 5 V; 1 A

Expected product

life cycle 2 years

Filling volume Min. 0.4 ml

Max. 10 ml

Medication flow rate Approx. 0.3 ml/min

Vibration frequency 130 kHz ±10 kHz

Housing material ABS

Operating conditions Temperature: +5°C to +40°C

Relative humidity: < 80%

non-condensing

Ambient pressure: 860 hPa to 1060 hPa

Storage and Temperature: -20^ to +55^

transportation Relative humidity: < 80%

conditions non-condensing

Ambient pressure: 700 hPa to 1060 hPa

Battery:

Capacity	1000 mAh
Nominal voltage	2.4 V
Type designation	Lithium-ion

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

Subject to technical changes.

Wearing parts are excluded from the guarantee.

Particle size diagram

The measurements were carried out with a sodium chloride solution using a laser diffraction method.

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.

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 and EN60601-1-2 (in accordance with IEC61000-3-2, IEC61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-11) as well as EN13544-1 and is subject to particular precautions with regard to electromagnetic compatibility.

This device meets the requirements of European Directive for medical devices 9,342 wells 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 Srl 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 International guarantees the perfect functionality and completeness of this product.

The worldwide warranty period is 2 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 International shall carry out a repair or a replacement delivery free of charge, in accordance with these warranty conditions.

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 International, or an authorised Medel International 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 International;
• 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.

DEUTSCH

Diagram of eight labeled mechanical components, including a battery case and cable, with numbered parts 1 through 8.

101112

6. Inbetriebnahme

Illustration of a hand pressing down on a cylindrical object with a downward arrow (no text or symbols)

Simple line drawing of a camera connected to a cable with a small icon (no text or symbols)

Simple line drawing of a hand pressing down on a cylindrical object with an arrow indicating motion (no text or symbols)

Diagram showing a hand pressing down on a cylindrical object with an upward arrow indicating motion (no text or symbols)

Mesures relatives aux piles

Diagram of eight labeled mechanical components, including a cylindrical device and cable assembly

101112

6. Mise en service

Illustration of a hand pressing down on a cylindrical object with a downward arrow (no text or symbols)

Simple line drawing of a camera connected to a cable with a small icon nearby (no text or symbols)

Simple line drawing of a hand pressing down on a cylindrical object with an arrow indicating motion (no text or symbols)

Diagram showing a hand pressing down on a cylindrical object with an upward arrow indicating motion (no text or symbols)

Attention

Diagram of eight labeled mechanical components, including a cylindrical device and cable assembly

101112

6. Uruchomienie

Diagram showing a hand pressing down on a cylindrical object with a downward arrow (no text or symbols)

Simple line drawing of a camera connected to a cable with a small icon (no text or symbols)

Simple line drawing of a hand pressing down on a cylindrical object with an arrow indicating motion (no text or symbols)

Diagram showing a hand pressing down on a cylindrical object with an upward arrow indicating motion (no text or symbols)

Uwaga

P: call R: long form of print I: text in the Φ: app prints B: app prints

Three line drawings of abstract shapes with vertical lines, no text or symbols present

101112

1 pin and the pu shr phen

1.4610

Simple line drawing of a mechanical assembly with a downward arrow indicating motion (no text or symbols)

Simple line drawing of a camera with a curved cable and a small square object attached (no text or symbols)

Simple line drawing of a mechanical device with a roller and a moving part (no text or symbols)

Simple line drawing of a mechanical device with arrows indicating motion or force (no text or symbols)

T paoang

Technical line drawings of various electronic devices and components (no text or symbols)

الجهاز

غطاء البخاخ

الشبكي

البحاخ الشبكي مزود

بخزان للدواء

Simple line drawing of a megaphone (no text or symbols)

10

Simple line drawing of a megaphone (no text or symbols)

11

12

بدء التشفيل

قبل الاستخدام الأول

التوجيه

Diagram showing a mechanical assembly with a downward arrow indicating force or motion (no text or symbols present)

الجميع

Simple line drawing of a camera connected to a cable with a label (no text or symbols on the diagram itself)

Simple line drawing of a hand pressing down on a cylindrical object (no text or symbols)

Simple line drawing of a container with an arrow indicating upward motion, no text or symbols present

التفكيك

Model FEELLIFE HEALTH INC: Air Pro III (Model Medel Compact)

FEELLIFE HEALTH INC.

Room 1903, Building A,

No. 9 Furong Road, Tantou Community, Songgang Subdistrict, Bao'an District, Shenzhen 518104 Guangdong, China

Distributed by Medel International

Via Villapizzone 26

20156 Milano / Italy

Lotus NL B.V.

Koningin Julianaplein 10