medisana IN 165 Inhaler Device Instruction Manual

medisana IN 165 Inhaler Device

Instruction manual Inhaler IN 165

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.

• IP21 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

• REF Catalogue number

• Device classification: Type BF

• Importer

• LOT LOT number

• Serial number

• Temperature range

• Humidity range

• Manufacturer

• Date of manufacture

• Authorized EU representative

• Alternating current

• I / O On / Off

• MD 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 anesthetic mixtures with oxygen or nitrous oxide (laughing gas).
• This device is not suitable for the anesthesia 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 re-move the plug from the socket. – The power cable plug is used to disconnect the device 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 emulations. 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 charging cable of this device. In the case of a faulty cable, contact a technical assistance center approved by the manufacturer.
• The charging 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 nebulizer 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 ad-verse event to the local competent authority and to the Manufacturer or to the European Authorized Representative (EC REP).
Vigilance contact point: https://ec.europa.eu/growth/sectors/medical- devices/contacts/

Intended use
The compressor nebulizer IN 165 from medicine is an aerosol therapy 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”. In between, you can charge the device with the USB cable w and USB charging adapter e included. To do this, connect the larger of the two connectors of the cable to the USB charging adapter and plug the other end of the cable into the charging socket 3 of the inhaler. The charge level is displayed with the 4 LEDs 2.

Application

• Open the nebulizer 8 by turning the cover anticlockwise.
• Make sure the atomizer head is properly seated on the cylindrical head of the nebulizer.
• Fill the nebulizer with the inhalation solution prescribed by your doctor. Make sure that the maximum level (6 ml) is not exceeded.
• Close the nebulizer 8 by turning the cover clockwise.
• Insert the air tube 7 into the nebulizer 8 and connect the other end of the tube to the inhaler (Position 5).
• Insert the mouthpiece or nosepiece or mask directly into the nebulizer (put on the child and baby mask q with the help of the adapter qa).

You have two options for the power supply of your inhaler:
Charge the device as described in ‚Preparing the device‘ (for example for use while travelling) or use the cable and adapter as a direct power supply.
To start the treatment, briefly press the On/Off button 1.
While inhaling, sit upright and in a relaxed position at a table (not in an armchair), so as not to com-press the airways and therefore not to impair the effectiveness of the treatment. Do not lie downdating the inhalation. Stop the inhalation if you feel unwell.
After you have finished inhaling for the amount of time recommended by your doctor, press the On/Off
button 1 in order to switch off the device and remove the plug from the electrical socket.
Empty the remaining inhalation solution from the nebulizer and clean the device as described 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.

Scope of delivery

• 1 medicine Inhaler IN 165 (1 On/Off button, 2 Charging indicator, 3 Micro-USB port (charging socket), 4 Position of the air filter, 5 Connection for the air tube)
• 1 Instruction manual
• Accessories: 6 Nosepiece, 7 2 Air tubes, 8 Nebulizer, 9 Mouthpiece, 0 Adult face mask, q Child face mask & Baby face mask without illustration (with adapter qa), w Micro-USB cable (charging cable), e USB charging adapter, r 5 x Air filter (replacement at position 4), Storage bag (without illustration)
  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 intrusion 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 success of the therapy.

Before and after each application

1. Turn the upper part of the nebulizer 8 anticlockwise in order to open the nebulizer and remove the atomizer head.
2. Wash all parts of the nebulizer, the mouthpiece 9 and the nosepiece 6. Then place in boiling water for 5 minutes.
3. Wash the masks and the air tube with warm water.
4. Assemble the nebulizer parts again and connect the nebulizer to the air tube.
5. Switch the device on and leave in use for 10-15 minutes.
   Use only cold sterilization solutions in accordance with the manufacturer’s instructions. Do not boil or autoclave masks and the air tube.

Maintenance and care

Replacement of the nebulizer
Replace the nebulizer 8 after a longer period of non-use, if it has deformations or cracks or if the atomizer head is blocked by dried-up medicine, dust, etc. We recommend replacing the nebulizer after 6 to 12 months depending on use. Only use the original nebulizer!

Replacement of the air filter
Under normal conditions of use, the air filter 4/r should be replaced after about 500 hours of use or once a year. We recommend regularly checking (10-12 applications) and replacing the air filter, if it is discolored grey or brown or if it feels moist. Remove the air filter (Position 4) replace it with a new one. Do not try to clean the filter for reuse. The air filter must not be repaired or maintained, while it is being used by a patient.
Only use original filters! Do not use the device without a filter!

Malfunctions and countermeasures

The device cannot be switched on

• Make sure the charging cable is properly plugged in/Charge the battery.
• 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 7 is properly attached on both ends.
• Make sure that the air tube 7 is not compressed, bent, dirty or blocked. If necessary, replace it with a new one.
• Make sure that the nebulizer 8 is completely assembled and the atomizer head has been correctly positioned and is not blocked.
• Make sure that the required inhalation solution is filled in the correct amount (up to 6 ml).

Technical data

• Name medisana Inhaler IN 165, type: GCE845

• Power supply Input: 100-240 V~ 50-60 Hz; Output: 5V DC, 2A

• Nebulisation amount (average) 0.25 ml/min.

• Particle size 2.9 μm

• max. pressure 1.1 bar

• Noise level 45 dBA

• Nebuliser fill quantity min. 2 ml; max. 6 ml

• Operating period 30 min. on / 30 min. off

• Expected service life 400 hours

• Operating conditions
  10 – 40 °C / 50 – 104 °F
  10 – 95 % relative maximum humidity
  700 – 1060 hPa air pressure

• Storage and transport conditions
  -20 – +60 °C / -4 – +140 °F
  10 – 95 % relative maximum humidity
  700 – 1060 hPa air pressure

• Weight 240 g

• Dimensions 10.8 x 7.2 x 4.4 cm

• Length of the power cable 150 cm

• IP class IP 21

• Reference to standards EN 60601-1; EN 60601-2; 93/42/EWG

• Item number 54556

• EAN number 40 15588 54556 6

• Aerosol properties according to EN 13544-1 APPENDIX CC

• Aerosol emission: 0.51 ml

• Aerosol emission rate: 0.16 ml/min.

• Particle size (MMAD): 2.9 μm

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. Nebulizer, 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 center 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 medicine 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:

5. Any damage caused by improper handling, e.g. by non-observance of the instruction manual.

6. Damage due to repair or intervention by the purchaser or unauthorized third parties.

7. Transport damage that has occurred on the way from the manufacturer to the consumer or when sending it to the service center.

8. Accessories that are subject to normal wear and tear.

9. 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, Xiao an Town, 528415 Zhongzheng 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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