IH 55 Emser Inhalator Compact Device for Asthma Bronchitis and Co Instruction Manual

June 12, 2024
EMS

IH 55 Emser Inhalator Compact Device for Asthma Bronchitis and Co

Product Information:

  • Product Name: Emser Inhalator Compact
  • Model: IH 55
  • Weight: 228 g (including batteries)
  • Battery Operation: Yes
  • Expected Product Lifespan: 5 years
  • Max. Medication Flow: > 0.25 ml/min
  • Sound Pressure: Approximately 37.5 dB(A)
  • Vibration Frequency: 100 kHz
  • Aerosol Properties: Mesh-Vernebler with PC material
  • Manufacturer: Emser

Product Usage Instructions:

  1. Getting to know your device:
    • Read the instructions for use carefully and keep them for future reference.
    • Make the instructions accessible to other users and ensure they observe the information provided.
  2. Signs and symbols:
    • Warning symbol indicates a risk of injury or damage to health.
    • Important safety note symbol indicates possible damage to the device/accessory.
    • Note symbol provides important information.
  3. Inhalator Purpose:
    • The Emser Inhalator Compact is designed for inhalation purposes.
  4. Warning and safety instructions:
    • Follow the warning instructions provided.
    • Pay attention to general notes and precautions before use.
    • Take note of battery handling instructions.
    • Do not attempt to repair the device yourself.
  5. Device Components:
    • Mesh-Vernebler
    • On/Off button with control LEDs (orange for battery replacement, violet for self-cleaning function) Battery compartment
  6. Initial Setup:
    • Prior to first use, refer to the provided instructions.
  7. Operation:
    • The device is operational when the control LEDs are illuminated in blue.
  8. Cleaning and Disinfection:
    • Follow the provided instructions for cleaning and disinfecting the device.
  9. Netzteil (Power Supply):
    • Use the power supply as indicated on the type plate of the device.
    • Connect the power supply to the designated socket on the device.
  10. Technical Specifications:
    • Model: Emser Inhalator Compact
    • Weight: 228 g (including batteries)
    • Battery Operation: Yes
    • Expected Product Lifespan: 5 years
    • Max. Medication Flow: > 0.25 ml/min
    • Sound Pressure: Approximately 37.5 dB(A)
    • Vibration Frequency: 100 kHz
    • Aerosol Properties: Mesh-Vernebler with PC material
  11. Disposal:
    • Follow general disposal guidelines for the device and its components.
  12. Warranty/Service:
    • For complaints or warranty inquiries, contact the provided customer service contact details.

Included in delivery

See Description of the device and accessories on

  • Inhalator
  • Mesh atomiser with medication container
  • Mouthpiece
  • Adult mask
  • Children’s mask
  • Power pack
  • 4 × 1.5 V LR6 AA batteries
  • These instructions for use
  • Storage bag

Getting to know your device

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

Application area

  • This inhalator is a mesh atomiser 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. Ask your doctor or pharmacist for further information about the potential applications.
  • The device is suitable for use at home and 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 medication 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 accessories, including the medication container, 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 mesh atomiser and other accessories after one year.

Signs and symbols

  • The following symbols appear in these instructions for use.
  • Warning Warning instruction indicating a risk of injury or damage to health.
  • Important Safety note indicating possible damage to the device/accessory.
  • Note on important information.
    The following symbols are used on the packaging and on the type plate for the device and accessories.

Intended use

This inhalator is an inhalation device for atomising liquids and liquid medication (aerosols). It is used for treatment of the upper and lower airways in cases of asthma and chronic bronchitis, and for supportive treatment of colds and other respiratory diseases.

Warnings and safety notes

Warning

  • Before use, ensure that there is no visible damage to the device or accessories. If you have any doubts, do not use the device and contact your retailer or the specified Customer Services address.
  • The device is not a substitute for medical consultation and treatment. Consult your doctor first if you are experiencing any pain or are suffering from an illness.
  • If you have health concerns of any kind, consult your GP!
  • Please note the general hygiene measures when using the inhalator.
  • 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. Also make sure to note the package leaflet of the medication.
  • If the device does not work properly, or you feel unwell or experience pain, stop using it immediately.
  • Keep the device away from your eyes when it is in use, as the nebulised medication could be harmful.
  • Do not operate the device in the presence of flammable 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. reduced sensitivity to pain) or mental skills or a lack of experience and/or lack of knowledge, unless they are supervised by a person who is responsible for their safety or are instructed by such a person in how to use the device.
  • Check in the medicine package leaflet for possible contraindications for use with common aerosol therapy systems.
  • Keep packaging material away from children (risk of suffocation).
  • Do not use any additional parts that are not recommended by the manufacturer.
  • Never submerge the device in water and do not use it in the bathroom. Under no circumstances may liquid enter the device.
  • Protect the device from heavy impact.
  • If the device has been dropped, exposed to high levels of moisture or suffered any other damage, it must no longer be used. If in doubt, contact Customer Services or the retailer.
  • The Emser® Inhalator Compact may only be operated with the appropriate accessories. The use of accessories made by other companies may result in less efficient therapy and could damage the device.
  • If the batteries are empty or you do not intend to use the device for longer periods, remove the batteries from the device. This prevents damage which could occur due to leakage. Always replace all batteries at the same time.

Important

  • Power cuts, sudden interference or other unfavorable 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).
  • 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 carrying out the therapy.
  • For hygiene reasons, every user should use their own set of accessories (mesh atomizer with medication container, mask, mouthpiece).
  • Store the device in a location protected against climatic influences. The device must be stored in the environmental conditions specified.
  • Do not use any liquids with a viscosity of more than 3.
  • This can irreparably damage the mesh.
  • Do not use any powdered medication (including in a solution).
  • Do not shake the atomizer as this may cause liquid to leak out and damage the device.
General notes

Important

  • The device is suitable only:
    • on humans
    • for the purpose for which it is designed (aerosol inhalation) and in the manner specified in these instructions for use.

Any form of improper use can be dangerous.

  • In the event of an acute emergency, the provision of first aid has top priority.
  • Only use the medication with a saline solution.
  • This device is not intended for commercial or clinical use; it is designed exclusively for self-treatment in a private home.
Prior to initial use

Important

  • Remove all packaging material before using the device.
  • Protect the device 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.

Notes on handling batteries

  • If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
  • Choking hazard! Small children may swallow and choke on batteries. Store the batteries out of the reach of small children.
  • Observe the plus (+) and minus (–) polarity signs.
  • If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
  • Protect batteries from excessive heat.
  • Risk of explosion! Never throw batteries into a fire.
  • Do not charge or short-circuit batteries.
  • If the device is not to be used for a relatively long period, take the batteries out of the battery compartment.
  • Use identical or equivalent battery types only.
  • Always replace all batteries at the same time.
  • Do not use rechargeable batteries.
  • Do not disassemble, split or crush the batteries.
Repairs

Note

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

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.

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 or water tank is empty. The device switches off automatically if the substance to be nebulised is no longer in contact with the mesh.

Description of the device and accessories

Overview

  1. Medication container

  2. Mesh atomiser

  3. On/Off button incl.
    LED indicators for the operating display: blue: device ready for operation
    orange: change batteries
    violet: start of self-cleaning function

  4. Housing

  5. Battery compartment
    Overview of accessories

  6. Adult mask

  7. Children’s mask

  8. Mouthpiece Storage bag

Initial use

Before using the device for the first time

Note

Clean and disinfect the atomiser and accessories before using them for the first time. See “Cleaning and disinfection” on page 17.

Installation
Take the device out of the packaging.

Push the medication container (1) with mesh atomiser (2) from the front horizontally into the guide provided in the housing (4) respectively the base of the device so that it audibly clicks into place.

Insert the batteries

  • Open the battery compartment (5) on the underside of the device by pressing gently and pulling at the same time, and folding open the battery compartment.
  • Insert four batteries (type AA, LR6).
  • Ensure that the correct battery polarity is observed (diagram inside battery compartment).
  • Close the battery compartment lid again.

Note

  • When replacing the batteries, ensure that the medication container is completely empty, otherwise, there is a risk of droplets leaking out.
  • As soon as the orange-colored LED indicators (3) light up, please change all four batteries, as the efficiency of the nebulization decreases significantly when the batteries are low.
  • With new alkaline batteries, you can operate the device for approx. 180 minutes.
  • This is sufficient for 5–9 applications with saline solution (depending on dosage and application period).

Operation

Preparing the atomiser

  • For hygiene reasons, it is essential to clean the atomizer 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 atomiser must be rinsed under warm tap water following every usage. See “Cleaning and disinfection” on page 17.

Filling the atomiser

  • Open the medication container (1) by releasing the clip 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.
  • Use medication only as instructed by your doctor and ask about the appropriate inhalation period and quantity for you.
  • If the prescribed quantity of medication is less than 2 ml, top this up to at least 4 ml with isotonic saline solution only. Dilution is also necessary with viscous medications.
    Here too, please observe the instructions of your doctor.

Closing the atomiser

Close the lid of the medication container (1) and fasten the clip.

Connecting an accessory

  • Firmly connect the desired accessory (mouthpiece, adult mask or children’s mask) to the outlet of the mesh atomiser (2) by inserting it.
  • 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.
  • Start the device using the On/Off button (3).
  • The spray mist pouring out of the device and the LEDs glowing blue (3) indicate that the device is operating correctly.

Note
For treatment of the lower airways, inhalation with the mouthpiece is most effective. If it is primarily the upper airways that are to be treated, use of a mask is advisable. Use of the mask is also 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.

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.
  • Inhalators 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 an inhalator. These additions are often viscous and can impair the correct functioning of the device and therefore the effectiveness of the application in the long- term.

For individuals with a hypersensitive bronchial system, medications containing essential oils may under certain conditions cause an acute bronchospasm (a sudden cramp-like restriction of the bronchi with shortness of breath). Consult your doctor or pharmacist in relation to this matter.

Stopping inhalation

  • When you have finished the treatment, switch off the device using the On/Off button (3).
  • The LED indicators (3) go out.
  • If the inhalant is nebulised, the device switches off automatically.
  • For technical reasons, a small amount of medication remains in the medication container (1).
  • Do not use this.

Carry out cleaning
See “Cleaning and disinfection” on page 17.

Cleaning and disinfection

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

The atomiser 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 with container and the used accessories such as mouthpiece, mask, etc. must be washed with hot water after each use. Dry the parts carefully using a soft cloth. Put the parts together again if they are completely dry and place them in a dry, sealed container or disinfect them.

  • Remove the mouth piece and the relevant accessory from the atomiser.
  • 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).
  • Remove the batteries.
  •  Remove the add-on parts such as the mesh atomiser or the medication container and the cover from the device.

Disassembling

  • Remove the medication container (1) with mesh atomiser (2), by pressing the button on the back of the device and pulling the unit off horizontally towards the front.
  • 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 atomiser, 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 submerge 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 inhalators parts and lead to a malfunction.

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

Self-cleaning function
To completely remove medication residue and eliminate any blockages, you can use the device’s self-cleaning function.

To do this, proceed as follows:

  1. Pour 0.5 to 1.0 ml of tap water or distilled water mixed with vinegar (1/4 vinegar and 3/4 distilled water) into the opening of the mesh atomiser (2). To avoid leakage through the lateral openings, please do not overfill.

  2. Press and hold the On/Off button (3) until the LED indicator (3) briefly lights up violet.
    The cleaning liquid is now drawn out of the opening in the mesh atomiser into the medication container (reverse mode) During this process, it is possible for droplets of this liquid to leak out of the medication container. Therefore, place some protection under the inhalator if necessary.

  3. Once there is no cleaning liquid left in the opening of the mesh atomiser, switch the inhalator off again by pressing the On/Off button (3).

Note

The inhalator does NOT switch off automatically when the self-cleaning function is activated.

Disinfection
Please carefully observe the points below when disinfecting your atomiser and accessories. We recommend disinfecting the individual parts on a daily basis after the last usage as a minimum measure. You can disinfect the Emser® Inhalator Compact and its accessories in two ways: using ethyl alcohol or boiling water. First, clean the atomiser 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.

Disinfection with boiling water

  • The medication container with mesh atomiser should be placed with the lid open into bubbling, boiling water together with the mouthpiece for 15 minutes. Contact between the parts and the hot base of the pan should be avoided.
  • You can also disinfect the medication container with mesh atomiser and the mouthpiece using a standard steriliser. For more information, please see the instructions for use of the steriliser manufacturer.
  • The atomiser 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 (5–10 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.
If this is the case, shake the mesh atomiser (2) again so that the water can escape. The inhalator 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 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 therapy.
  • We therefore recommend that you replace the medication container with mesh atomiser 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.

Troubleshooting

Problem/ question Possible cause/remedy
The atomiser produces no or too little aerosol. 1. Too little medication in

the atomiser.
2. Atomiser not held vertically.
3. Unsuitable medication fluid added 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.| 1. The batteries are empty. Replace the batteries and try again.
2. There are air bubbles in the medica- tion container, which are preventing continuous contact with the mesh. Please check this and remove any air bubbles.
3. Particles on the mesh are hindering output. In such cases, you can re- move the dirt by pouring in 2–3 drops of vinegar mixed with 3–6 ml of wa- ter and nebulising the entire mixture. Please do not inhale this mist and remember to clean and disinfect the medication container afterwards (see page 17).

Alternatively, you can use the de- vice’s self-cleaning function.

If the output is still not improved, re- place the medication container with

mesh atomiser.

4. The mesh is worn.
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.
Problem/ question| Possible cause/remedy
---|---
 | With the Emser® Inhalator Compact you can nebulise medications with a viscosity of less than 3.

Medications containing oil (particularly essential oils) should not be used, as these attack the material of the medica-

tion container, which can lead to faults.

There is inha- lation solution residue in the atomiser.| This is normal and is necessary for technical reasons. Stop the inhala- tion 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 de- vice with in- fants and chil- dren?| 1. On infants, the mask should cover the nose and mouth to ensure effec- tive inhalation.

2. On children, the mask should also cover both the nose and mouth. It is not a good idea to carry out nebulisa- tion on someone who is sleeping, as in this case not enough of the medi- cation 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.

Inhalation us- ing the mask takes 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.
Does everyone need their own accessories?| Yes, this is absolutely essential for hy- giene reasons.

Mains part

Important

  • The device must only be used with the mains part described here.
  • 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.

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

  • Power supply: 100–240 V~; 50–60 Hz; 0.15 A

  • Insert the mains part connector plug

  • (A) into the provided connector socket

  • (B) and fully insert the mains part into a suitable socket.
    Note

  • Ensure that there is a mains socket close to the setup area.

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

  • To disconnect the device from the mains after inhalation, first switch the device off and then pull the mains plug out of the socket.

  • The batteries do not need to be removed during operation with the mains part.

  • The mains part cannot be used for charging batteries.

Technical specifications

Model: Emser Inhalator Compact
Type: IH 55

Dimensions

  • (L×W×H) 146 × 51 × 85 mm

  • Weight 228 g incl. batteries

  • Battery-operated 4 × 1.5 V type AA, Mignon (LR6)
    Expected product

  • life cycle 5 years

  • Filling volume Max. 10 ml

  • Medication flow rate > 0.25 ml/min

  • Sound pressure Approx. 37.5 dB(A) (according to DIN EN 13544-1 section 26)

  • Vibration frequency 100 kHz

  • Housing material ABS

  • Operating conditions: Temperature: +10 °C to +40 °C Relative humidity: < 93% non-condensing Atmospheric pressure: 860 to 1060 hPa

  • Storage and transportation conditions
    Temperature: -10 °C to +45 °C
    Relative humidity: < 93% non-condensing
    Atmospheric pressure: 860 to 1060 hPa

  • Aerosol properties

      1. Aerosol delivery: 0.33 ml
      1. Aerosol delivery rate: 0.05 ml/min
      1. Particle size (MMAD): 4.81 μm
      1. RF value (proportion of particles < 5 μm): 52,8 %
        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

Measurements were performed using a sodium fluoride solution with a ”Next Generation Impactor“ (NGI).
The diagram may therefore not be applicable to suspensions or highly viscous medications. You can obtain more detailed information from the manufacturer of your medication.

Note

If the device is not used according to the instructions specified, perfect functionality cannot be guaranteed! We reserve the right to make technical changes to improve and develop the product.

This device and its accessories comply with the European standards EN60601-1, EN60601-1-2 (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 are subject to particular precautions with regard to electromagnetic compatibility. This device meets the requirements of European Directive 93/42/EEC for medical devices, as well as those of the Medizinproduktegesetz (German Medical Devices Act).

Notes on electromagnetic compatibility•
The device is suitable for use in all environments listed in these instructions for use, including domestic environments.

  • The use of the device may be limited in the presence of electromagnetic disturbances. This could result in issues such as error messages or the failure of the display/ device.
  • Avoid using this device directly next to other devices or stacked on top of other devices, as this could lead to faulty operation. If, however, it is necessary to use the device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
  • The use of accessories other than those specified or provided by the manufacturer of this device can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic immunity; this can result in faulty operation.

Disposal

Battery disposal

  • Empty, completely flat batteries must be disposed of through 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.

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. 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.

Replacement parts and wearing parts

Replacement parts and wearing parts are available from the corresponding listed service address under the stated material number.

Designation Material REF

Mouthpiece (PP), adult mask (PVC), children’s mask (PVC), mesh atomizer with medica- tion container (PC)| PP/PVC/PC| 602.11
Mesh atomiser with medica- tion container (PC)| PC| 163.899

Warranty/service

In case of a claim under the warranty please contact your local dealer or the local representation which is mentioned in the list “service international”.
In case of returning the unit please add a copy of your receipt and a short report of the defect.

The following warranty terms shall apply:

  1. The warranty period for EMSER products is either 5 years or- if longer- the country specific warranty period from date of Purchase.
    In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.

  2. Repairs (complete unit or parts of the unit) do not extend the warranty period.

  3. The warranty shall not be valid for damages because of

    • a. improper treatment, e.g. nonobservance of the user instructions.
    • b. repairs or tampering by the customer or unauthorised third parties.
    • c. transport from the manufacturer to the consumer or during transport to the service centre.
    • d. The warranty shall not be valid for accessories which are subject to normal wear and tear (cuff, batteries etc.).
  4.  Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim.

  • Sidroga Gesellschaft für Gesundheitsprodukte mbH Postfach 1262, 56119 Bad Ems, Germany www.emser.de · Tel.: +49 2603 – 9604 710
  • WellKang Ltd (www.CE-marking.eu) Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE Northern Ireland
  • Foshan Gaunying Electronics Co., Ltd. 2nd Floor, Building 5, No. 1, Hua Bao South Road Chan Cheng District, 528000 Foshan, Guangdong province, P.R.C.
  • MedEnvoy Switzerland, Gotthardstrasse 28, CH-6302 Zug
  • Sidroga AG, Weidenweg 15, CH-4310 Rheinfelden

References

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