BEURER IH 57 (01) PDF DOCUMENT

Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents are present. The following items are included with your BEURER IH 57:

• Nebuliser

• Mesh atomiser with medication container

• Mouthpiece

• PVC adult mask

• PVC children’s mask

• Micro USB cable

• Storage bag

• These instructions for use

WARNING: Indicates a potentially impending danger. If it is not avoided, there is a risk of death or serious injury.

CAUTION: Indicates a potentially impending danger. If it is not avoided, slight or minor injuries may result.

NOTICE: Indicates a potentially harmful situation. If it is not avoided, the device or something in its vicinity may be damaged.

Intended Use:

The BEURER IH 57 is a medical device for the nebulisation of liquids and liquid medication (aerosols). This device produces aerosols by combining an oscillating mesh with holes and a liquid medication. 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.

Intended users:

The nebuliser is only intended for medical care in a home environment and is not intended for health care in professional facilities. The nebuliser can be used on persons over 2 years of age under supervision; it can be used for self-treatment by persons over 12 years of age. When using a mask to inhale, take care to ensure the mask fits well and the eyes are unobstructed.

Clinical benefits:

• The medication is carried 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

• Humidification of the airways

• Loosening and making (bronchial) secretions more liquid

• Releasing bronchospasms (spasmolysis)

• Relieving swollen and inflamed bronchial mucosa

• Coughing up secretions

• Fighting viruses that affect the upper and lower airways

Indication:

The nebuliser can be used for diseases of the upper and/or lower airways. 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, Bronchiectasis, Acute tracheobronchitis, Cystic fibrosis, Pneumonia.

Contraindications:

• The atomiser is not intended for the treatment of life-threatening conditions.

• This device must not be used by children under the age of 12 and by people with reduced physical, sensory or mental abilities 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 resulting 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 if you feel unwell or experience pain, stop using it immediately.

Warnings:

• The atomiser is not intended for the treatment of life-threatening conditions.

• For hygiene reasons, it is essential that every user uses their own components. We recommend you replace the medication container and other components after one year at the latest.

• Always follow the instructions of your doctor or pharmacist regarding the type of medication, dosage, frequency, and duration of inhalation.

• Only use the medications 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 in the event of pain or illness.

• If the liquid you wish to use is not compatible with steel, PP, PC, silicone and PVC, do not use this liquid with the nebuliser. Examples of compatible liquids include salbutamol solution and sodium chloride solution.

• The particle size distribution curve, MMAD, aerosol delivery, and/or aerosol delivery rate may change if a different or highly viscous medication is used.

• Before use, ensure there is no visible damage to the device or components.

• Changes to the device and 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 Beurer atomisers and components.

• Keep the device away from your eyes when in use, as the mist of medication could be harmful.

• Never 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).

• Switch off the device and pull out the micro USB cable before every cleaning procedure.

• A 4-hour period is required for the device to cool down from maximum storage temperature or warm up from minimum storage temperature before use.

• Never submerge the device in water or use it in the bathroom.

• If the device is dropped or damaged, it must no longer be used.

• We recommend you obtain a replacement device or medication in case of power cuts or other conditions that make the device inoperable.

• To avoid entanglement and strangulation, store the cable out of the reach of small children.

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

• Never touch the micro USB cable with wet hands.

• Do not pull the mains adapter out of the socket using the micro USB cable.

• Do not crush, bend, or pull the micro USB cable over sharp-edged objects.

• If the device is opened, there is a risk of electric shock.

• Risk of explosion! Risk of fire! Always use the correct or supplied charging cable/charger/mains adapter for charging. Avoid continuous charging or overcharging. Do not throw the device or batteries into a fire.

Cautions:

• Never store the device near sources of heat.

• Do not use the device in a room where a spray has previously been used. Air the room before treatment.

• Never use the device if it is making an abnormal sound.

• Store the device in a location protected from climatic effects.

• Do not operate the device near electromagnetic transmitters.

• Protect the device from severe knocks.

• After the battery has been successfully charged, disconnect the device from the mains.

Device overview:

1. Cover for medication container

2. Mesh atomiser with medication container

3. Housing

4. On/Off switch

5. LED indicator

6. Button for unlocking the medication container (“PRESS”)

7. Micro USB port

8. Micro USB cable

Atomiser set overview:

9. PVC adult mask

10. PVC children’s mask

11. Mouthpiece

Before using the BEURER IH 57 for the first time, you must clean and disinfect the medication container and atomiser set. Then, assemble and charge the device.

Assembly:

Take the device out of the packaging. If the medication container (2) has not been assembled, slide it onto the housing (3) horizontally from the front.

Charging the nebuliser battery:

1. Connect the included micro USB cable (8) to the micro USB port (7) on the bottom of the nebuliser and a USB mains adapter (not included). The mains adapter should comply with protection class 2 and have been tested in accordance with European standard EN 60601-1.

2. Insert the USB mains adapter into a suitable socket. Lie the nebuliser flat on its back during the charging process.

3. While charging, the LED indicator (5) will light up continuously orange. Once fully charged, the LED indicator will stay on green. It takes approx. 4 hours to fully charge.

4. As soon as the battery is completely charged, remove the micro USB cable (8) from the socket and the nebuliser.

5. A fully charged battery provides approx. 4 hours of life. A low battery level is indicated by the LED indicator lighting up orange during use.

1. Preparing the nebuliser:

For hygiene reasons, clean and disinfect the medication container (2) and the atomiser set after each treatment. If multiple medications are used, rinse the medication container under warm tap water after each use.

2. Filling the medication container:

Open the cover of the medication container (2) by lifting the flap (1) on the rear. Fill it with an isotonic saline solution or pour the medication straight in. Avoid overfilling. The maximum recommended quantity is 8 ml. Use medication only as instructed by your doctor. If the prescribed quantity is less than 0.5 ml, top it up with isotonic saline solution.

3. Closing the medication container:

Close the cover of the medication container (2) by pressing the flap on the rear down and locking it.

4. Connecting the atomiser set:

Securely connect the desired part of the atomiser set (mouthpiece 11, adult mask 9, or children’s mask 10) to the medication container (2). If using a mask, you can attach one of the included straps.

5. Starting inhalation:

Move the device to your mouth and put your lips firmly around the mouthpiece. If using a mask, place it over your nose and mouth. Ensure you have added fluid before starting. Press the On/Off switch (4) to start. If the spray mist is flowing and the LED indicator (5) is lit up continuously blue, the device is operating correctly.

6. Adjusting medication flow rate:

The device is factory set to “high”. You can adjust the rate by pressing and holding the On/Off switch (4) for 3 seconds until the LED indicator (5) flashes blue. A continuously blue LED indicates a high nebulisation rate (≥ 0.4 ml/min); a slowly flashing blue LED indicates a low nebulisation rate (≥ 0.2 ml/min).

Breathing technique:

To ensure particles are distributed widely throughout the airways and reach your lungs, you must breathe in slowly and deeply, then hold your breath briefly (5 to 10 seconds) and then breathe out quickly.

Holding the device:

You should hold the BEURER IH 57 as vertically as possible. A slight angle will not affect usage as the container is leak proof. Ensure the medication is in contact with the mesh for the device to work properly.

Using a Mouthpiece vs. Mask:

The most effective way of nebulising is by using the mouthpiece. Using a mask is only recommended if a mouthpiece cannot be used (e.g., for children). When using a mask, ensure it fits well and the eyes are unobstructed.

You can stop inhalation with the BEURER IH 57 either manually or it will stop automatically.

a) Manually ending nebulisation:

When you have finished the treatment, switch off the device using the On/Off switch (4). The LED indicator (5) will go off.

b) Automatically ending nebulisation:

If the inhalant has been nebulised, the LED indicator (5) will flash blue quickly and the device will switch itself off. A small amount of medication will remain in the container for technical reasons; do not use this.

Automatic switch-off function:

The device has an automatic switch-off function. It will switch off automatically if there is very little fluid left or if the substance is no longer in contact with the mesh, to avoid damaging it. The device also switches off automatically after 15 minutes of nebulisation time. Do not operate the device when the medication container (2) is empty, as it will detect this and switch off automatically.

Disassembling the BEURER IH 57:

1. Hold the device with one hand. Press the button (6) on the rear with your thumb and horizontally pull off the medication container (2).

2. Remove the mouthpiece (11) or the mask (9 or 10) from the medication container (2).

3. Open the cover of the medication container (2) by lifting up the flap (1) on the rear.

Cleaning:

After each use, the medication container and used atomiser parts must be cleaned for approx. 5 minutes using warm water (ideally distilled) at a max. temperature of 40°C. To clean the medication container, follow the self-cleaning instructions.

Self-cleaning function:

1. Disassemble the device as described above.

2. Open the cover of the medication container (1) and pour out the remaining fluid.

3. Pour 3-6 ml of tap water into the medication container (2). Close the cover and shake slightly.

4. Open the cover again, pour out the liquid, and add fresh tap water.

5. Place the medication container on the housing (3).

6. Press and hold the On/Off switch (4) for 3 seconds while the device is switched off. The LED indicator (5) will flash orange quickly, and the device will enter self-cleaning mode for 3 minutes.

Disinfection with ethyl alcohol (70 – 75%):

1. Pour 8 ml of ethyl alcohol into the medication container (2). Close it and leave for at least 10 minutes.

2. Shake the unit gently back and forth.

3. Pour the ethyl alcohol out.

4. Repeat the process, but this time using water.

5. Position the medication container (2) to drip a few drops of ethyl alcohol onto the mesh from the outside. Leave for 10 minutes.

6. Finally, clean all parts again with water. This procedure is also used for the mouthpiece and masks.

Disinfection with boiling water:

The medication container (2), the cover (1), and the mouthpiece can be placed in boiling water for 15 minutes to disinfect them. Ideally, use distilled water. Avoid contact between the parts and the hot base of the pan. The medication container must not be placed in the microwave. The masks must not be placed in hot water.

Aerosol values according to EN 27427:2019 based on adult breathing patterns with salbutamol:

• Aerosol delivery: 0.90 ± 0.03 ml

• Aerosol delivery rate: 0.21 ± 0.01 ml/min

• Fill volume dispensed in percent per min.: 28.71 ± 3.12%

• Residual volume: 0.004 ± 0.001 ml

• Particle size (MMAD): 4.519 ± 0.09 μm

• GSD (geometrical standard deviation): 2.054 ± 0.04

• RF (respirable fraction < 5 μm): 55.04 ± 1.21%

• Large particle range (> 5 μm): 44.96 ± 1.21%

• Medium particle range (2 to 5 μm): 41.03 ± 0.46%

• Small particle range (< 2 μm): 14.01 ± 1.03%