medisana IN 155 Child Friendly Inhaler Instruction Manual

medisana IN 155 Child Friendly Inhaler

Device and controls

Explanation of symbols

This instruction manual belongs to this device. The instruction manual includes important information on the initial start-up and handling. Read this instruction manual completely. Failure to follow these instructions may result in serious injury or damage to the device.

WARNING: These warnings must be followed to prevent possible injury to the user.

NOTICE: These instructions must be followed to prevent possible injury to the device.

NOTE: These instructions provide you with useful additional information regarding installation or operation.

• Information about protection type against foreign objects and water.
• This product is subject to European Directive 2012/19/EU on waste electrical and electronic equipment and is marked accordingly.
• Protection class II
• Catalogue number
• Device classification: Type BF
• Importer
• LOT number
• Serial number
• Temperature range
• Humidity range
• Manufacturer
• Date of manufacture

Authorized EU representative

• Alternating current

• On /Off

• Medical device

• Distributer

• Ambient pressure limitation

• Single patient multiple use (for accessories only)

IMPORTANT INFORMATION! KEEP IN A SAFE PLACE

Please read this instruction manual carefully, in particular the safety instructions, before using the device. Keep the instruction manual in a safe place for later reference. If you pass the device on to a third party, this instruction manual must remain with the device.

Safety instructions

• This device must only be used for the purpose described in these instructions. The manufacturer is not liable for damage resulting from improper use.
• Do not use the device in the presence of flammable anaesthetic mixtures with oxygen or nitrous oxide (laughing gas).
• This device is not suitable for the anaesthesia and ventilation of the lungs.
• This device may only be used with the original accessories, which are listed in these instructions.
• Do not use the device, if you spot damage or you notice something unusual.
• Never open the device.
• This device consists of delicate components and must be handled with care. Observe the storage and operating conditions in the chapter “Technical Data”.
• Protect the device from: – water and moisture, – extreme temperatures, – knocks and drops, – dirt and dust, – strong sunlight, – heat and cold
• Adhere to the safety regulations applicable to electrical appliances, in particular the following: – Never touch the device with wet or moist hands. – Position the device on a level and stable surface during use. – Do not pull the power cable or the device to remove the plug from the socket. – The power cable plug is used to disconnect the device from the power supply, it must therefore always remain accessible during use.
• Before connecting the device, make sure that the electrical data on the label on the bottom of the device match the data of the mains.
• In case the mains plug of the device does not fit into the socket, contact qualified personnel to replace the mains plug. In general, the use of adapters and extension cables is advised against. If it is essential to use them, then they must meet the safety regulations. In this case, however, the permitted limit values, which are specified on the adapters and extension cables, must always be adhered to.
• Do not leave the device plugged in when not in use; remove the plug from the socket when the device is not being used.
• The installation must be carried out in accordance with the manufacturer’s specifications. Incorrect installation can cause damage to people, animals and objects, for which the manufacturer cannot be held liable.
• Do not replace the power cable of this device. In the case of a faulty cable, contact a technical assistance centre approved by the manufacturer.
• The power cable should always be fully unwound to avoid dangerous overheating.
• Before every cleaning or maintenance operation, the device must be switched off and the power cable removed from the socket.
• Only use the medicine prescribed to you by your doctor and follow the instructions of your doctor regarding dosage, duration and frequency of the therapy.
• Only use the parts specified by the doctor in accordance with your specific illness.
• Only use the nose piece if expressly instructed to do so by your doctor. Make sure that the tubes are NEVER inserted into the nose, but are only held as near as possible in front of the nose.
• Check on the package insert of the medicine, whether there are contraindications for use with the usual systems for inhalation therapy.
• When positioning the device, make sure that the On/Off switch can be easily reached.
• For reasons of hygiene, do not use the same accessories for more than one person.
• Do not tilt the nebuliser by more than 60°.
• Do not use the device near strong electromagnetic fields such as mobile phones or radio equipment. Keep a minimum distance of 0.3 m to such devices when using this device.
• Make sure that children do not use the device unsupervised; some parts are so small that they could be swallowed. Tubes and lines of the device must be laid in such a way, that there is no risk of tripping, they are not kinked and the risk of strangulation is eliminated.
• The use of this device is not a replacement for visiting the doctor.

Please report any serious incident that has occurred in relation to the device injury or adverse event to the local competent authority and to the Manufacturer or to the European Authorised Representative (EC REP).

Vigilance contact point: https://ec.europa.eu/growth/sectors/medical- devices/contacts/

Intended use

The compressor nebulizer IN 155 from medisana is an aerosoltherapy system suitable for domestic use.

Preparing the device

Before the first use, we recommend cleaning all components – as described in the chapter ”Cleaning and disinfection”.

Application

1. Assembe the nebuliser set w. Make sure that all parts are complete.
2. Fill the nebuliser with the inhalation solution prescribed by your doctor. Ensure that the maximum level is not exceeded.
3. Connect the nebuliser 7 via the air tube 6 to the connector 3 on the compressor and plug the power cable into the electrical outlet (230V 50 Hz AC).
4. To start treatment, turn the On/Off button 4 to the “I” position.
   • The mouthpiece guarantees better delivery of the medicine into the lungs.
   • Choose between the adult 9 and child resp. baby face mask 0 (use adapter 0a herewith) and make sure that the mask fully covers the mouth and nose area.
   • Use all accessories including the nose piece 5 as prescribed by your doctor.
5. Whilst inhaling, sit upright and in a relaxed position at a table (not in an armchair), so as not to compress the airways and therefore not impair the effectiveness of the treatment. Do not lie down whilst inhaling. Stop the inhalation if you feel unwell.
6. After you have finished inhaling for the amount of time recommended by your doctor, switch the On/Off switch 4 to the “O” position, in order to switch off the device and remove the plug from the electrical outlet.
7. Empty the remaining inhalation solution from the nebulizer and clean the device as set out in the chapter “Cleaning and disinfection”.
   • This device was developed for operation in 30 minutes on / 30 minutes off mode. Please switch off the device after 30 minutes and wait a further 30 minutes, before you continue the treatment.
   • The device does not require calibration. Modification of the device is not permitted.

Use of the nasal shower 13

1. Remove cover: Turn the cover 90° (anticlockwise)
2. Fill container with rinsing solution (adhere to manufacturer’s instructions!)
3. Screw cover back on (clockwise).
4. Connect the nasal shower to the tube 6. The other end of the tube should already be connected to the main device at position 3 .
5. Place the nose piece onto the nostril and breath through the nose.
6. Switch the inhaler on 4 and guide your finger over the small opening on the lower part of the nasal shower to begin with the treatment.

During use, you should breath in and out slowly through the nose and tilt your head slightly to the opposite side of the affected nostril, so that the salt spray can flow deep into your nostril. You can pause or stop the wash by removing your finger from the opening.

Empty the remaining rinsing solution from the nasal shower after the treatment and clean the device as set out in the chapter “Cleaning and disinfection”.

Scope of delivery

• 1 medisana Inhaler IN 155 (1 position of the air filter, 2 holder for the nebuliser set, 3 connector for the air tube, 4 On/Off switch)
• 1 Instruction manual
• Accessories: 5 nose piece, 6 2 air tubes, 7 nebuliser, 7a atomiser head (w assembling the nebuliser set), 8 mouthpiece, 9 adult face mask, 0 Children and baby face mask (with adapter 0a), q air filter (replacement on position 1), storage bag, e nasal shower.

WARNING

• Make sure that children do not get hold of the packaging films.
• There is a risk of suffocation!

Cleaning and disinfection

• Clean all accessories thoroughly after each treatment in order to remove residues of medicinal product and possible impurities.
• Use a soft, dry cloth and a non-abrasive cleaning agent to clean the compressor.
• Make sure that there is no ingress of liquids into the device and the power cable is disconnected.

Cleaning and disinfection of the accessories

Follow the instructions for cleaning and disinfecting the accessories exactly, as they are fundamental for the performance of the device and the therapeutic success.

Before and after each application

1. Turn the upper part of the nebuliser 7 anticlockwise in order to open the nebuliser and remove the atomiser head 7a.
2. Wash all parts of the nebuliser, the mouthpiece 8 , the nose piece 5 and the nasal shower e under running water. After that, dip in boiling water for 5 minutes (15 minutes for the nasal shower).
3. Wash the masks and the air tube with warm water.
4. Assemble the nebuliser parts again and connect the nebuliser to the air tube.
5. Switch the device on and leave in use for 10-15 minutes.

Use only cold sterilisation solutions in accordance with the manufacturer’s instructions. Do not boil or autoclave masks and air tube.

Maintenance and care

Replacement of the nebuliser

Replace the nebuliser 7 after a relatively long period of non-use, if it has deformations or cracks or if the atomiser head 7a is blocked by a dried-up medicine, dust, etc. We recommend replacing the nebuliser after 6 to 12 months depending on use. Only use the original nebuliser!

Replacement of the air filter

Under normal conditions of use, the air filter q should be replaced after about 200 working hours or after each year. We recommend regularly checking (10-12 applications) and replacing the air filter, if it is discoloured grey or brown or if it feels moist. Remove the air filter (Position 1) replace it with a new one. Do not try to clean the filter for reuse. The air filter must not be repaired or maintained, whilst it is being used by a patient. Only use original filter! Do not use the device without filter!

Malfunctions and countermeasures

The device cannot be switched on

• Make sure that the power cable is correctly plugged into the electrical output.
• Make sure that the On/Off switch 4 is in the “I” position.
• Make sure that the device has been operated within the operating period specified in these instructions (30 min. on / 30 min. off).

The device is only misting a little or not at all

• Make sure that the air tube 6 is properly attached on both ends.
• Make sure that the air tube 6 is not compressed, bent, dirty or blocked. If necessary, replace it with a new one.
• Make sure that the nebuliser 7 is completely assembled and the coloured atomizer head 7a has been correctly positioned and is not blocked.
• Make sure that the required inhalation solution has been poured in.

Technical data

• Name: medisana Inhaler IN 155, Type: GCE847
• Power supply: 230 V~ 50 Hz
• Nebulisation amount (average):  0.35 ml/min.
• Particle size: 3.07 μm
• max. pressure: 2.3 bar
• Noise level: 52 dBA, 1 m
• Nebuliser fill quantity: min. 2 ml; max. 8 ml
• Residual amount: 1.68 ml
• Operating period: 30 min. on / 30 min. off
• Expected service life: 1000 hours
• Operating conditions: 10 – 40 °C / 50 – 104 °F
  • 10 – 95 % relative maximum humidity
  • 700 – 1060 hPa air pressure
• Storage and transport conditions: -25 – +70 °C / -13 – +158 °F
  • 10 – 95 % relative maximum humidity
  • 700 – 1060 hPa air pressure
• Weight: 1450 g
• Dimensions: 18 x 14 x 9.4 cm
• Length of the power cable: 180 cm
• IP class: IP 21
• Reference to standards: EN 13544-1; EN 60601-1; EN 60601-2; EN 60601-1-6;
  • IEC 60601-1-11
• Item number: 54555
• EAN number: 40 15588 54555 9

This device meets the requirements of the Directive concerning medical devices 93/42/EEC. Device in Class II in relation to protection against electric shocks. Nebuliser, mouthpiece and masks are applied parts of type BF.

This device must not be disposed of with domestic waste. All users are obliged to bring all electrical or electronic devices to a collection point in their town/city or to a retailer, whether the devices contain any hazardous materials or not, so that they can be disposed of in an environmentally responsible manner. Please contact your local authority or retailer with regard to disposal procedures.

In the course of constant product improvements, we reserve the right to make technical and design changes without prior notice. The current version of this instruction manual can be found at www.medisana.com

Warranty and repair conditions

In case of warranty please contact your specialist shop or the service centre directly. If you need to return the device, please indicate the defect and enclose a copy of the purchase receipt. The following warranty conditions apply

1. All medisana products are guaranteed for 3 years from the date of purchase. The date of purchase is to be proven in case of warranty by the purchase receipt or invoice.
2. Defects due to material or manufacturing defects shall be repaired free of charge within the warranty period.
3. A warranty service does not extend the warranty period for either the device or for replaced components.
4. The following are excluded from the warranty:
   • Any damage caused by improper handling, e.g. by non-observance of the instruction manual.
   • Damage due to repair or intervention by the purchaser or unauthorized third parties.
   • Transport damage that has occurred on the way from the manufacturer to the consumer or when sending it to the service center.
   • Accessories that are subject to normal wear and tear.
5. Liability for direct or indirect consequential damage caused by the device is also excluded when the damage on the device is recognized as a warranty claim.

Globalcare Medical Technology Co., Ltd.

• 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, 528415 Zhongshan City, Guangdong Province, PEOPLE’S REPUBLIC OF CHINA
• Phone: +86 760 22589901
• http://www.globalcare.com.hk/contact/

Donawa Lifescience consulting Srl,

• Piazza Albania, 10, 00153 Rome, Italy
• https://www.donawa.com/wli/main/contatti.index

References

• Contact – Globalcare
• Home page medisana – Your health in good hands

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