IH 40 - Inhaler BEURER - Free user manual and instructions

USER MANUAL IH 40 BEURER

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, blood glucose, 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 ac

cessible to other users and observe the information they contain. With kind regards, Your Beurer team Application area This nebuliser is an ultrasonic atomiser for treating the upper and lower airways. The aerosol generated by the high-frequency vibra

tion has a predominant droplet size of 1 – 5 μm and is therefore very well suited for transporting the nebu

lised active agents directly to the lower airways. By nebulising and inhaling the medication prescribed/ recommended by your doctor, you can prevent dis

eases 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 phar

macist for further information about the potential ap- plications. The device is suitable for inhalation at home and can also be used on multiple occasions in one day when on the move. Inhaler medication should only be used following instructions to do so from a doctor. Ensure you are calm and relaxed when inhaling the medica

tion and breathe slowly and deeply to ensure that the medication reaches right down to the lower bronchi. Breathe out normally. Once it has been properly prepared, the device can be used again. Preparation involves replacing all the ac

cessories, including the 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 unit/accessory. Note Note on important information. The following symbols are used on the packaging and on the type plate for the device and accessories. Applied part, type BF Observe the instructions for use

anufacturer On /off Serial number Protection class 2 device Do not use outdoors ENGLISH

1. Getting to know your device .............................13

2. Signs and symbols ............................................13

3. Warnings and safety notes ................................14

4. Useful information regarding the device ............15

5. Description of nebuliser device and

12. Replacement parts and wearing parts ..............21

IP 22 Protected against foreign objects equal to or greater than 12.5 mm and against angular falling drops of water CE labelling This product satisfies the require

ments of the applicable European and national directives.

PAP Dispose of packaging in an environ- mentally friendly manner

3. Warnings and safety notes

Before use, ensure that there is no visible dam- age to the device or accessories. If you have any doubts, do not use the device and contact your re

The device is not a substitute for medical consulta- tion and treatment. Talk with your doctor first if you are experiencing any pain or are suffering from an illness.

If you are pregnant or if you suffer from a chronic disease or other condition, consult your doctor be

fore starting a course of inhalation therapy.

If you have health concerns of any kind, consult your GP!

Please note the general hygiene measures when using the nebuliser.

For hygiene reasons, every user should use their own set of accessories (medication container, hose, mask, mouthpiece).

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.

If the device does not work properly, or you feel un- well or experience pain, stop using it immediately.

Keep the device away from your eyes when it is in use, as the nebulised medication could be harmful.

Never leave the device unattended when it is switched on.

Do not remove the upper cover while the device is in operation (when the blue light is illuminated).

Do not operate the device in the presence of flam- mable gases.

Do not operate the device near electromagnetic transmitters.

This device is not intended for use by children or people with restricted physical, sensory (e.g. re

duced 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 responsi

ble for their safety or are instructed by such a per- son in how to use the device.

Check in the medicine package leaflet for possib- le contraindications for use with common aerosol therapy systems.

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

Do not use any additional parts that are not recom- mended by the manufacturer.

Never submerge the device in water or other liq- uids and do not use it in the bathroom. Under no circumstances may liquid enter the device. How

ever, if the device does fall into a liquid do not pull it out; instead, disconnect it from the power supply immediately.

Protect the device from heavy impacts.

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 Cus

The IH40 may only be operated with the desig- nated Beurer accessories. The use of accessories made by other companies may result in less effi

cient therapy and could damage the device.

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.

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.

Ensure that you only insert and remove the mains part with dry hands and that you only press the ON/OFF button with dry hands.

During operation, the mouthpiece or mask can reach a temperature of 43°C degrees within 15 minutes.

• If the nebuliser motor is blocked, this does not pose a safety risk to the user.

• The product has no Essential Performance whose absence or degradation would result in an unac

Power cuts, sudden interferences or other unfa- vourable conditions could lead to the device be- coming inoperable. We therefore recommend that you obtain a replacement device or medication (the latter should be agreed with your doctor).15

Do not use the device when the water tank or medication container is empty. Only add clean tap water or distilled water to the water tank. Other liquids could cause irreparable damage to the device.

Do not store the device 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 car

rying out the therapy.

Store the device in a location protected against cli- matic influences. The device must be stored in the environmental conditions specified.

Do not use any powdered medication (including in a solution).

Do not shake the atomiser as this may cause liquid to leak out and damage the device. Mains part Important

Only use the mains part supplied.

Ensure that the power supply socket does not come into contact with any liquids.

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.

Always unplug the mains part from the mains socket after use.

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

The device is only to be used: – on people, – 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.

nly use the medication with a saline solution.

This device is not intended for commercial or clini- cal 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 from dust, dirt and humidity.

Do not operate the device in a very dusty area.

Ensure the device and accessories are at room temperature before using them.

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 Important

Never open the device, modify it or repair it; oth- erwise proper operation can no longer be guaran- teed. Failure to comply with this instruction can be dangerous, and will also invalidate the warranty.

The device is maintenance-free.

For repairs, please contact Customer Services or an authorised retailer.

4. Useful information regarding the

device Accessories Only use the accessories recommended for use by the manufacturer; safe function is only guaranteed when this requirement is met. Automatic switch-off The device has an automatic switch-off function. When there is only a very small amount of medica

tion or fluid left, the device switches off automati- cally. The device switches off automatically after 15 minutes of operation. If you wish to continue the treatment, switch the device back on by pressing the ON/OFF button. Do not operate the device when the medication con

tainer or water tank is empty.16

5. Description of nebuliser device and accessories

Overview of nebuliser 1 Accessory connector 2 Cover 3 Medication container 4 Water tank 5 ON/OFF button 6 LED indicator for displaying the opera

ting status 7 Control dial for airflow 8 Housing 9 Water level fill line 10 Connector socket for the mains part plug 11 Filter cap with filter

Overview of atomiser and accessories 12 Connector for the masks 13 Adult mask 14 Children's mask 15 Mouthpiece 16 Hose 17 Mains part 18 Storage pouch 19 Replacement filter

Positioning the device Take the device out of the packaging. Place the de- vice on a hard, even surface. Make sure that the vents are free from obstructions. Remove the acces

sories from the packaging. Before using the device for the first time Note

Clean and disinfect the atomiser and accesso- ries before using them for the first time. See 10. “Cleaning and disinfection”.17

Before using them, always clean and disinfect the water tank, the cover, the connector for the masks, the extension hose, the mouthpiece and the masks, according to the instructions under section

10. “Cleaning and disinfection”.

If the therapy involves inhaling several different medi

cations one after the other, please be aware that the atomiser must be rinsed under warm tap water fol

lowing every usage. See section 10. “Cleaning and disinfection”.

Place the device on an even surface.

Ensure that there is a mains socket close to the set-up area.

Arrange the mains cable so that no-one will trip over it.

To disconnect the nebuliser from the mains after nebulisation, first switch off the device and then pull the mains plug out of the socket. Operating the mains part

Insert the mains part connector plug [17] into the provided connector socket [10] and fully insert the mains part [17] into a suitable mains socket.

illing the nebulisation chamber The tank capacity is 20ml. Fill the water tank [4] with clean water (preferably distilled water) up to the water fill line [9]. This water is used as the fluid through which the ultrasonic waves are guided to the medication. Do not pour medication directly into the water tank. Filling the medication container Place the medica- tion container in the water tank (image 2) and then fill it with the medication (im

age 3). Ensure that the maximum capac

ity of 8ml is not ex- ceeded. For this purpose, refer to the marker lines on the medication container (image 2.1). Adhere to the instructions for use and dosage instruc

tions for the medi- cation to be used. If it is necessary to dilute a medication with an isotonic so

Connecting an accessory Now connect the hose to the acces

sory connector [1] on the nebulisa

tion chamber (im- age 5). Now connect the accessory you wish to use (mask with connector or mouthpiece) to the hose. 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 mouth

piece (e.g. for children who are not yet able to inhale using a mouthpiece). If you are using the adult mask [13] you can secure it to your head with the adult mask strap. There is also a strap for the children’s mask [14]. When using a mask to inhale, take care to ensure the mask fits well and the eyes are unobstructed. When using a mask to inhale, take care to ensure the mask fits well and the eyes are unobstructed. Switch on the device by pressing the ON/OFF button. When the device is functioning correctly, a mist is then generated for inhalation. Airflow control dial You can adjust the airflow using the airflow control [7]. You can increase the airflow by turning the air

flow control to the left and decrease it by turning it to the right. Stopping inhalation

When you have finished the treatment, switch off the device using the ON/OFF button [5].

The LED indicator for the operating display [6] goes out.

If the inhalant is nebulised, the device switches off automatically. For technical reasons, a small amount of medication remains in the medication container [3].

Disconnect the mains part [17] from the power supply. Carry out cleaning

See 10. “Cleaning and disinfection”.

Do not tilt the device or position it at an angle.

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. Such additives are often viscous and can impair the correct functioning of the device and the effec

tiveness of the application in the long-term.

For individuals with a hypersensitive bronchial sys- tem, medications containing essential oils may un- der certain conditions cause an acute bronchos- pasm (a sudden cramp-like restriction of the bron- chi with shortness of breath). Consult your doctor or pharmacist in relation to this matter! Breathing technique

It is important to use the correct breathing tech- nique to ensure that the particles are distribut- ed 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 selec

tion, dosage and use of medications suitable for inhalation therapy.

Certain medications are only available with a pre- scription. When inhaling through the mouthpiece

Use the mouthpiece if you are suffering from a condition of the lower airways, such as a cough or a bronchial infection.

Connect the hose [16] to the accessory connector [1]. Then connect the mouthpiece [15] to the hose.

Place your lips around the mouthpiece.

Switch on the device by pressing the ON/OFF but- ton.

Breathe in slowly and deeply through your mouth and breathe out through your nose. After breathing in, hold your breath briefly to increase the effec

tiveness of the therapy. Remain calm and relaxed during the treatment. Take breaths at regular in

tervals and do not breathe too fast. If you want to pause the inhalation for a short time, switch off the device by pressing the ON/OFF button and take out the mouthpiece.

The inhalation mask is suitable for the treatment of the nasopharynx.

Connect the hose [16] to the accessory connec- tor [1]. Now connect the connector [12] to the hose and the mask to the connector.

Hold the mask pressed gently against your nose; the mask must cover your mouth and nose without squashing them.

Take deep and slow breaths in and out through your nose. After breathing in, hold your breath briefly to increase the effectiveness of the therapy. Remain calm and relaxed during the treatment. Take breaths at regular intervals and do not breathe too fast. If you want to pause the inhalation briefly, switch off the device by pressing the ON/OFF but

ton and remove the mask from your face for a mo- ment. To continue with the inhalation, place the mask back over your nose and mouth and switch on the device by pressing the ON/OFF button. Replacing the medication container The medication container should be replaced follow- ing usage every time inhalation treatment is carried out. This is to avoid deposits and chemical reactions due to medical products. In the package you will find 12 medication containers which can be used to re

place used containers. Additional containers can be obtained from the Customer Services address pro

9. Changing the filter

Check the filter regularly (e.g. after every tenth use). Replace the used filter if it is very dirty or blocked (but at the latest after 6 month). If the filter has be

come wet, it must also be replaced with a new one. Caution

• Do not try to clean and re-use the used filter!

Only use original filters supplied by the manufacturer. Otherwise, your nebuliser may become damaged or effective therapy can no longer be guaranteed

• Never operate the device without a filter. To replace the filter, proceed as follows: Caution

• First switch off the unit and unplug it.

• Allow the unit to cool

1. Remove the filter cap [11] in a

2. After replacing the old filter with a new one, repla

3. Ensure that it is securely in place.

10. Cleaning and disinfection

Warning Adhere to the following hygiene instructions to avoid health risks.

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

Please consult your doctor about the additional requirements in terms of the hygienic preparation needed (hand care, handling of medication/inha

lation solutions) for high-risk groups (e.g. patients with cystic fibrosis). Important

The device must be switched off and allowed to cool down each time before cleaning (the ultrason

ic transducer heats up considerably during usage).

Do not clean the ultrasonic transducer or the acces- sories 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.

Ensure that no water gets inside the device!

Do not clean the device or accessories in the dish- washer!

Do not touch the device with wet hands when it is switched on and do not allow water to spray on the device. The device may only be operated when it is completely dry (this excludes the liquids that are required to be used in the water tank and the medication container).

Do not spray any liquid into the vents! If liquid pen- etrates the device this could cause damage to the electronics or other nebuliser parts and lead to a malfunction. Cleaning When you have detached the device from the mains socket, remove the cover and if required remove any remaining residue from the medication container and the nebulisation chamber. The used accessories such as the mouthpiece, mask, adapter, etc. must be washed with hot water after each use. Dry the parts carefully using a soft cloth and place the parts in a dry, sealed container or disinfect them.

Clean the tank and the cover with a cloth soaked in water or vinegar.20

Clean the surface of the device using a damp cloth (water or a mild cleaning solution). Dry the device using a lint-free cloth.. 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 dangerous if they came into con

tact with the skin or mucous membranes, or if they were swallowed or inhaled. Disinfection Please carefully observe the points below when dis- infecting your atomiser and accessories. We recom- mend disinfecting the individual parts on a daily ba- sis after the last usage as a minimum measure. You can disinfect the IH40 and its accessories in two ways: using 70% ethyl alcohol or boiling water. First, clean the atomiser and accessories as de

scribed in the “Cleaning” section. Then continue with the disinfection.

Drop a few drops of ethyl alcohol onto the ultrason- ic transducer and leave this to work for 10 minutes

Place the used accessory parts in ethyl alcohol for 10 minutes or use an alcohol-based disinfection spray

Then clean all the parts again under running water. Disinfection with boiling water Important The facial masks and the hose must not be sub- merged in hot water!

We recommend disinfecting the masks and hose using commercially available alcohol-based disin

The mouthpiece can be disinfected in boiling water for 10 minutes.

Avoid touching the hot base of the pan in this case

You can also disinfect the mouthpiece using a commercially available vaporiser. For more infor

mation, please see the instructions for use of the vaporiser manufacturer. Drying

Dry the parts carefully using a soft cloth.

Place the individual parts on a clean, dry and ab- sorbent surface and leave them to dry completely (at least 4 hours). Note Please ensure that the parts are completely dried after cleaning and disinfection before they are used again or stored; otherwise the risk of bacterial growth is in

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

The following point should be observed when se- lecting the cleaning product or disinfectant: only use a mild cleaning product or disinfectant in the concentration and volume prescribed by the man

As with any plastic parts, atomisers and their ac- cessories 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 ac- cessories after no more than a year. Storage

Do not store in a room with a high level of dampness (such as a bathroom) and do not transport with any damp items.

When storing and transporting, protect from pro- longed direct sunlight. Troubleshooting Problem/ question Possible cause/remedy The atom

1. No water in the water tank.

2. Insufficient amount of medication

3. Do not hold the atomiser vertically.

4. Unsuitable medication fluid filled

for nebulisation (e.g. too viscous – viscosity must be less than 3). The medication fluid should be pre- scribed by the doctor. The output is too low. Check whether the control dial for the airflow is set correctly. What medica

tions are suit- able for inhal- ing? Naturally, only your doctor can decide which medication should be used for treating your condition. Please con- sult your doctor in relation to this matter. With the IH40 you can nebulise medications with a viscosity of less than 3.21 Problem/ question Possible cause/remedy There is inha

lation solution residue in the medication container. This is normal and is necessary for technical reasons. Stop the inhalation as soon as you can no longer detect nebulisation or the device switches off automatically due to a lack of inhalant. What should be taken into account when using the de

vice with in- fants and chil- dren?

On babies, the mask should cover the mouth and nose to ensure ef- fective inhalation.

2. On children, the mask should also

cover both the nose and mouth. It is not a good idea to carry out nebuli- sation on someone who is sleeping, as in this case not enough of the medication will reach the lungs. Note: Inhalation should only be car- ried out under the supervision of an adult and with their assistance and the child should not be left alone. Does inhala

tion using the mask take longer? This is necessary for technical rea- sons. 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. Should each person have their own at- omiser? Yes, this is absolutely essential.

portation conditions Temperature: -20 °C to +70 °C Relative humidity: < 95% non-con- densing 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

Cumulative Volumne (%) particle diameter (µm) The measurements were carried out with a sodium chloride solution using a laser diffraction method. The diagram may therefore not be applicable to sus- pensions or highly viscous medications. You can ob- tain more detailed information from the manufacturer of your medication.

12. Replacement parts and wea-

ring parts Replacement parts and wearing parts are available from the corresponding listed service address under the stated material number. Name Material REF Medication container PET

Year pack (contains mouthpiece, adult mask, children’s mask, connector for masks, 12 medication containers, hose, 2 re- placement filters)

PP, PVC, EVA, PET 601.07

Note If the device is not used according to the instructions specified, perfect functionality cannot be guaran

teed! 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 (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 ) and EN13544-1 and is 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 De

The device is suitable for use in all environments listed in these instructions for use, including do

mestic environments.

The use of the device may be limited in the pres- ence of electromagnetic disturbances. This could result in issues such as error messages or the fail

ure of the display/device.

Avoid using this device directly next to other devic- es 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 im

munity; this can result in faulty operation.

Failure to comply with the above can impair the performance of the device. Warning The use of accessories, transducers and cables other than those specified with the exception of transducers and cables sold by the manufacturer of IH40 as re

placement parts for internal components may result in increased emissions or decreased immunity of IH40.

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

vice in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities re

sponsible for waste disposal.

Warranty / Service Beurer GmbH, Söflinger Straße 218, 89077 Ulm, Ger- many (hereinafter referred to as “Beurer”) provides a warranty for this product, subject to the requirements below and to the extent described as follows. The warranty conditions below shall not aect 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. Beurer guarantees the perfect functionality and com

pleteness of this product. The worldwide warranty period is 5 years, commenc

ing 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, Beurer 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 Beurer, or an authorised Beurer partner, with - a copy of the invoice/purchase receipt, and - the original product. The following are explicitly excluded from this war

ranty: - 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. bat

teries, rechargeable batteries, cus, seals, elec- trodes, light sources, attachments and nebuliser accessories); - products that are used, cleaned, stored or main

tained 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 Beurer; - damage that arises during transport between manufacturer and customer, or between ser

vice 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 com