IH 21 - Inhaler BEURER - Free user manual and instructions

USER MANUAL IH 21 BEURER

Nosepiece with comfort attachment

These instructions for use

1. Getting to know your instrument

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 pres- sure, body temperature, pulse, gentle therapy, mas- sage 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 Area of application This nebuliser is a device used for the nebulisation of liquids and liquid medication (aerosols) and for the treatment of the upper and lower respiratory tract. The nebulisation and inhalation of medication pre- scribed or recommended by a doctor can prevent against diseases of the respiratory tract, treat the side effects of these disorders and accelerate healing. For more information on possible applications, consult your doctor or pharmacist. The device is suitable for inhalation at home. Medicines should only be inhaled when instructed by a doctor. Inhalation should be performed in a calm and relaxed atmosphere. Inhale slowly and deeply to enable the medicine to reach the small bronchi deep into the lungs. Exhale normally. 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. 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 nameplate of the device and accessories. Type BF applied part Read the instructions for use Device in protection class 2

Off Serial number 30 Min. ON / 30 Min. OFF 30 minute operation, followed by a 30 minute break before operation continues. IP 21 Protected against foreign objects equal to or greater than 12.5 mm in diameter and against vertically falling drops of water The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.

PAP Dispose of packaging in an environmen- tally friendly manner

1. Getting to know your instrument .......................13

4. Description of device and accessories..............15

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

3. Safety information and warnings

Before use, ensure that there is no visible damage to the unit or accessories. When in doubt, do not use the unit and contact your dealer or the customer service address provided.

In the event of device faults, please see Chapter "10. Troubleshooting".

Using the unit is not a substitute for consultation with or treatment from a physician. Whenever you have any pain or illness, always contact your physician first.

If you have health concerns of any kind, contact your general practitioner!

Always follow your doctor’s instructions regarding the type of medicine to be used and the dose, fre- quency, and duration of inhalation.

Only use medicines that have been prescribed or recommended by your doctor or pharmacist. Please note: For treatment, only use parts indicated by your doc- tor according to the particular diagnosis.

• Check whether there are contraindications for use with the usual systems for aerosol therapy on the medication instruction leaflet.

If the unit does not function correctly or if you begin to feel unwell or feel pain, stop using the unit im- mediately.

During use, hold the unit away from the eyes, as some nebulised medicines may cause damage to the eyes.

Do not operate the unit in the presence of flammable gases.

This device is not intended to be used by children or persons with restricted physical, sensory (e.g. insensitivity to pain) or mental abilities or persons lacking in the required experience or knowledge for safe operation of the device, unless supervised or instructed by a person responsible for their safety.

• 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 children away from packaging materials (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 attachments that are not recommended by the manufacturer.

Connect the unit only to the mains voltage listed on the type plate.

Do not dip the unit into water and do not use it in wet rooms. Do not allow any liquid to penetrate the unit.

Protect the unit from strong impacts.

Never touch the mains cable with wet hands, this can cause an electric shock.

Do not pull the mains plug from the socket by the cord.

Do not pinch or bend the mains cable, pull it over sharp objects, or allow it to hang freely, and protect it against 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 dam- aged, it must be replaced by the manufacturer, its customer service department or a simi-larly qualified person to avoid any risk.

Opening the unit carries a risk of electric shock. Dis- connection from the mains supply is only guaranteed if the mains plug has been removed from the socket.

Do not use the unit if it has fallen or been dropped on the floor, been exposed to extreme humidity or is otherwise damaged. In case of doubt, contact our customer service department or your local dealer.

The IH 21 nebuliser must only be used with suitable atomisers and with the appropriate accessories. The use of other atomisers and accessories can impair therapeutic efficiency and may damage the device. Important

Power cuts, sudden faults or other unfavourable conditions may render the unit unusable. You are therefore recommended to keep a spare device or replacement medicine (as agreed with the doctor).

If adapters or extensions are required, these must comply with the applicable safety regulations. The electrical capacity and the maximum capacity speci- fied on the adapter must not be exceeded.

The unit and the mains cable must be stored away from sources of heat.

Do not use the unit in a room in which a spray has previously been used. If this is the case, ventilate the room before commencing treatment.

Do not allow any objects to enter or obstruct the ventilation openings.

Do not use the device if you notice an unusual noise.

For hygiene reasons, each user must use his own accessories.

Always disconnect from the mains after use.

Store the device in a location protected against en- vironmental influences. The device must be stored in the specified ambient conditions.

The device contains an overload protection fuse. This must only be changed by authorised specialist personnel.15 General notes Important

for its intended purpose (aerosol inhalation) and in the manner described in these instructions for use.

In acute emergencies, first aid takes priority.

Apart from the medication, use only distilled water or a saline solution in the unit. Other liquids may cause defects to the nebuliser or atomiser.

This unit is not intended for commercial or clinical use, but only for individual, private household use! Before using the unit for the first time Important

Before you use the unit for the first time, remove all packaging materials.

Protect the unit against dust, dirt and moisture. Never cover the unit during operation.

Do not use the unit in very dusty environments.

Switch the unit off immediately if it is defective or malfunctioning.

The manufacturer shall not be held liable for damage or injuries caused by improper or incorrect use. Repairs Note

Never open or attempt to repair the unit yourself, as otherwise proper function is no longer guaranteed. Failure to observe this regulation shall void the war

The device is maintenance-free.

If you need to have the unit repaired, contact cus- tomer service or an authorised dealer.

4. Description of device and

accessories Overview of the nebuliser

1 Mains cable 2 Lid 3 On/off switch 4 Compartment for accessories 5 Filter cap with filter 6 Hose connection 7 Holder for atomiser Overview of atomiser and accessories 8 Compressed air hose 9 Atomiser 10 Atomiser insert 11 Valve 12 Medicine container 13 Mouthpiece 14 Adult mask 15 Child mask 16 Nosepiece with comfort attachment 17 Replacement filter

Setup Remove the unit from the packaging. Place it on a flat surface. Ensure that the ventilation slits are free. Fold open the lid [2] to access the accessories. Before using the unit for the first time Note

The atomiser and accessories must be cleaned and disinfected before they are used for the first time. For information about this, see “Cleaning and disinfec- tion” on page 16.

Attach the compressed-air hose [8] at the bottom of the medicine container [12].

Connect the other end of the hose [8] to the hose connector [6] on the nebuliser by lightly turning it. Mains connection Connect the unit only to the mains voltage listed on the type plate.

Insert the mains cable plug [1] into a suitable socket.

Push the plug completely into the mains socket. Note

Ensure that there is a socket near to where the unit will stand.

Lay the mains cable in such a way that no one can trip over it.

To disconnect the nebuliser from the mains after use, first switch off the device and then remove the plug from the socket.

For hygiene reasons, the atomiser [9] and the ac- cessories must be cleaned after each treatment and disinfected after the last treatment of the day.

The accessories may be used only by one person; use by several people is not recommended.

If several different medicines are to be inhaled in suc- cession during therapeutic use, the atomiser [9] must be rinsed under warm tap water after each use. For information about this, see “Cleaning and disinfec

Follow the instructions for changing the filter con- tained in these instructions.

Before each use, check that the hose connections on the nebuliser [6] and the atomiser [9] are tight.

Before use, check that the device is functioning cor- rectly. To do this, switch on the nebuliser (including the connected atomiser, but without any medication) for a short time. If the atomiser [9] expels air, the device is functioning correctly.

1. Inserting the nozzle attachment

• To open the atomiser [9], twist the upper section anti- clockwise against the medicine container [12]. Place the nozzle attachment [10] in the medicine container [12].

Ensure that the cone for administering medication fits well on the cone for the air duct inside the atomiser [9].

mended fill level is 8 ml !

• Use medication only on the advice of a physician, and check the ap- propriate inhalation duration and quantity for your needs.

If the required volume of medi- cation is less than 2 ml, top up this quantity to at least 4 ml using an isotonic saline solution. Viscous medicines may also require dilution. Always follow the instructions of your doctor.

• To close the atomiser [9], twist the upper section clockwise against the medicine container [12]. En- sure the parts are connected correctly.

Press the blue valve [11] into the opening intended for this purpose on the upper side of the atomiser [9]. Note The valve system ensures better delivery of the medi- cation to the lungs. Only use the valve [11] with the mouthpiece [13], never with the masks [14, 15] or the nosepiece [16].

5. Connecting the accessories to the atomiser

Connect the required accessory part (mouthpiece [13], adult mask [14], child mask [15] or nosepiece [16]) to the atomiser [9]. 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 inclu- ded in delivery with the IH 21. You can find an overview of all replacement items in chapter "12. Replacement parts and wearing parts". Note The most effective form of nebulisation is by using the mouthpiece. Nebulisation using a mask is only recom- mended if it is not possible to use a mouthpiece (e.g. for children who are not yet able to inhale medication using a mouthpiece). When using a mask to inhale, take care to ensure the mask fits well and the eyes are unobstructed.

Before commencing treatment, pull the atomiser upwards out of its holder [7].

A flow of spray from the atomiser indicates that the device is functioning properly.

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.

Inhale the nebulised medicine 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 treatment, hold the atomiser straight (vertical), otherwise the atomisation does not work and correct function cannot be guaranteed. Important Essential oils, cough medicines, solutions designed for gargling, and drops for application to the skin or for use in steam baths are wholly unsuitable for inha- lation using a nebuliser. These substances are often highly viscous and can impair the correct function of the device and hence affect the effectiveness of its application in the long term. In the case of oversensitivity of the bronchial system, medicines containing essential oils can sometimes cause acute bronchiospasm (a sudden, cramp-like tightening of the bronchi accompanied by breathless- ness). Always ask your doctor or pharmacist for advice!

7. End of inhalation

If the spray is only output sporadically or if the noise changes during inhalation, you can end the treatment.

• Switch off the nebuliser after treatment using the on/ off switch [3] and disconnect it from the mains.

After use, replace the atomiser [9] in its holder [7].

The nasal douche is not included in delivery with the IH 21. You can order the nasal douche using the item number 601.37. You can find an overview of all replace- ment items on page 21.

(Starting the application) You can use the nasal douche to clean your nasal cavi- ties. The nasal douche creates a fine jet of liquid for treating respiratory tract problems or for moistening the nasal mucous membranes. We recommend using the nasal douche for colds, dry- ness inside the nose, dust exposure, pollen allergies, chronic inflammation of the sinuses or upon the advice of your doctor.18 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.

Twist the cover [19] 90° anticlock- wise and remove it in an upward direction.

Lift the collection container [20] out.

Fill the saline container [21] with saline solution.

Place the collection container [20] into the saline container [21].

Place the cover [19] on the saline container [21]. Twist the cover [19] in a clockwise direction until it clicks firmly into place.

Connect the compressed air hose [8] to the saline container [21] from below.

Position the cover [19] carefully in- side one of your nostrils. Breathe through the nose.

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. 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.

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

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.

10. Clean the device

For information about this, see “Cleaning and disinfec- tion” on page 19.

7. Changing the filter

In normal operating conditions, the air filter must be replaced after approx. 500 operating hours or one year. Please check the air filter regularly (after 10-12 nebu- lisation procedures). If the filter is very contaminated or blocked, replace the used filter. If the filter has become 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.

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: Caution

First switch off the unit and unplug it.

Allow the unit to cool down.

1. Remove filter cap [5] upwards.

Note If the filter remains in the unit when the cap is removed, remove the filter from the unit using tweezers or similar.19

2. Replace the filter cap [5] containing the new filter.

3. Check that the filter cap is firmly in place.

8. Cleaning and disinfection

Atomiser and accessories Warning Observe the following hygiene instructions in order to avoid any health risks.

The atomiser [9] and accessories are intended for multiple use. Please note that cleaning requirements differ according to the different application areas. Notes:

The atomiser and accessories must not be me- chanically cleaned with brushes or similar as this can cause irreparable damage and the success of the treatment can no longer be guaranteed.

For additional requirements regarding the necessary hygienic preparations (hand washing, handling of medicines or inhalation solutions) in high-risk groups (e.g. cystic fibrosis patients), contact your doctor.

Ensure that all parts are properly dried following all cleaning and disinfection. Residual moisture or water droplets can result in an increased risk of bacterial growth. Preparation

Directly following each treatment, all parts of the atomiser [9] and any accessories used must be cleaned of medicine residues and contami- nation.

To do this, dismantle the atomiser [9] into its component parts.

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

Dismantle the atomiser by twisting the upper section anti-clockwise against the medicine container [12].

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

The nebuliser is later reassembled in the reverse order. Cleaning Important Before you clean the unit, always switch it off, unplug it and let it cool off. The atomiser and the used accessories such as the mouthpiece, mask, nozzle attachment, nasal douche, etc. must be cleaned with hot but not boiling water after each use. Carefully dry all components using a soft cloth. Once all components are fully dry, reassemble the atomiser and place the components in a dry, sealed container or carry out disinfection. When cleaning, ensure that all residues are removed. Never use any substances that may be poisonous when in contact with the skin or mucous membranes, or when swallowed or inhaled. Use a soft, dry cloth and non-abrasive cleaning prod

ucts to clean the device. Do not use abrasive detergents and never immerse the unit in water. Important

Ensure that no water penetrates inside the unit!

Do not put the device or accessories in a dishwasher.

Do not touch the unit with wet hands while it is plugged in; do not allow any water to be sprayed onto the unit. The unit must be operated only when it is completely dry.

Do not spray any liquids into the ventilation slots. Any liquid that penetrates into the unit can damage the electrical parts or other components of the nebuliser and impair the function of the device. Condensation, care of the hose Depending on the environmental conditions, con- densation may collect in the hose. To prevent against bacterial growth and to ensure effective therapeutic use, this moisture must always be removed. To remove moisture from the hose, proceed as follows:

Leave the hose plugged into the nebuliser [6].

Run the nebuliser until all the moisture has been dis- placed by the flow of air.

In the event of significant contamination, replace the hose. Disinfection Follow the steps listed below carefully in order to disin- fect your atomiser and the accessories. It is advisable to disinfect the individual components after the last time they are used each day at the latest. (For disinfection, you will simply require a small amount of clear vinegar and distilled water).

First clean the atomiser and the accessories as de- scribed under “Cleaning”.

Place the disassembled atomiser, nasal douche, mouthpiece and the disassembled nosepiece in boiling water for 5 minutes.

For the remaining accessories, use a vinegar solution consisting of ¼ vinegar and ¾ distilled water. Make

sure that the volume is sufficient to fully submerge the parts in the solution.

Leave the components in the vinegar solution for 30 minutes.

Rinse the parts with water and dry carefully with a soft cloth. Important Do not boil or autoclave the masks and air hose.

Once all components are fully dry, reassemble the atomiser and place the components in a dry, sealed container. Note Ensure that all parts are thoroughly dried during, and in particular after cleaning, otherwise there is an in- creased risk of bacterial growth. Drying

Place the individual components on a dry, clean and absorbent surface and allow to dry completely (for at least 4 hours). Material resistance

As with all plastic components, frequent use and cleaning of the atomiser and the accessories can lead to a certain amount of wear. Over time, this can alter the aerosol properties and may eventually affect the efficiency of therapy. We therefore recommend that you replace the atomiser once a year.

When choosing a cleaning or disinfecting agent, note the following: Only use mild cleaning or disinfect- ant agents in the quantities recommended by the manufacturer. Storage

Do not store the nebuliser in a damp atmosphere (e.g. in the bathroom) or transport it together with damp objects.

Store and transport the nebuliser away from direct sunlight.

The accessories can be safely stored in the acces- sories compartment [4]. Store the device in a dry place, if possible in its original packaging.

In the interest of environmental protection, do not dis- pose of the device in household waste. Please dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Elec- tronic Equipment). If you have any queries, please contact the appropriate local authorities.

1. Too much or too little medicine

in the atomiser. Minimum: 2 ml, Maximum: 8 ml.

2. Check that the nozzles are not

blocked If necessary, clean the nozzle (e.g. by rinsing). Use the atomiser again. CAUTION: Only poke imple

ments through the fine holes from the underside of the nozzle.

3. The atomiser is not held in an

4. The medicine solution is

unsuitable for nebulising (e.g. too thick). The medicine solution should be specified by the doctor. Output is too low. Hose kinked, filter blocked, too much inhalation solution. Which medicines are suitable for inhalation? Consult your doctor. Essentially all medicines that are suitable and approved for device-based inhalation can be inhaled. Some inhalation solution remains in the atomiser. This is normal and occurs for technical reasons. Stop inhala

tion if you hear a notable differ- ence in the noise of the atomiser. What special steps should be taken for babies and children?

1. In babies, the mask should

cover the mouth and nose to guarantee effective inhalation.

2. In children, the mask should

also cover the mouth and nose. Nebulisation next to a sleeping person is not suitable because insufficient medicine reaches the lungs. Note: Children should only use the device with help and under supervision of an adult. Never leave a child alone with the nebuliser. Inhalation with the mask takes longer. This is for technical reasons. Less medicine is inhaled per breath through the mask holes than using the mouthpiece. The aerosol is mixed with ambient air through the holes in the mask.21 Problem/ Question Possible Cause/Remedy Why do I need to replace the atomiser at regular inter

vals? There are two reasons for this:

1. To guarantee a therapeutically

effective particle spectrum, the nozzle holes should not exceed a certain diameter. Due to the thermal and me

chanical stresses, the plastic is subjected to a certain amount of wear. The nozzle attachment [10] is particularly susceptible to this wear. This can also cause changes to the droplet composition of the aerosol, which has a direct ef- fect on the effectiveness of the treatment.

2. You are also recommended

to replace the atomiser on a regular basis for hygiene reasons. Does each per

son need their own atomiser? This is absolutely necessary for hygiene reasons.

The serial number is located on the device or in the battery compartment. Subject to technical modifications. Particle size diagram Measurements were performed using a sodium fluo- ride solution with a "Next Generation Impactor" (NGI). This diagram may not be applicable for suspensions or highly viscous medicines. More information can be obtained from the relevant medicine manufacturer.

Replacement parts and wearing parts Designation Material REF Yearpack (contains Mouth

piece, Nosepiece, Adult mask, Child mask, Atomiser, Com- pressed air hose, Filter) PP/ PVC 601.22 Nasal douche PP 601.37 Baby mask PVC 601.31 Note If the unit is used outside of the specifications, proper function is no longer guaranteed! We reserve the right to make technical changes to im

prove and further develop the product. This device and its accessories comply with Eu- ropean standards EN60601-1 and 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), as well as EN13544-1, and is subject to special safety measures in terms of electromagnetic tolerance. The unit conforms to the requirements of the European Directive for Medical Products 93/42/EEC, the MPG (German Medical units Act).22

The device is suitable for use in all environments listed in these instructions for use, including domes- tic 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

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 per- sonal 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 accord- ance 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 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. batter- ies, rechargeable batteries, cus, seals, electrodes, light sources, attachments and nebuliser accesso- ries); - products that are used, cleaned, stored or main- tained improperly and/or contrary to the provi- sions of the instructions for use, as well as prod- ucts 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 man

ufacturer 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 aris- ing from product liability or other compulsory statu- tory liability provisions). Repairs or an exchange in full do not extend the war