medisana IN 500 Inhalator Instruction Manual

medisana IN 500 Inhalator Instruction Manual

Product Overview

Device and controls

Compressor unit

1. Connection for air tube

2. Air filter (with cover)

3. On/Off-Switch

4. Carry handle

5. Ventilation slots

6. Nebulizer kit holder
   Nebulizer kit

7. Connection for air tube (on nebulizer)

8. Nebulizer tank

9. Nozzle

10. Vaporizer head

11. Inhalation top

12. Connection tube for mouthpiece and nose adaptor

13. Air tube

14. Adult mask with mask connection tube

15. Child mask with mask connection tube

16. Nose adaptor for adults

17. Nose adaptor for children

18. Mouthpiece

19. Replacement air filter

Explanation of symbols

This instruction manual belongs to this device.
It contains important information about starting up and operation. Read the instruction manual thoroughly. Non-observance of these instructions can result in serious injury or damage to the device.

WARNING
These warning notes must be observed to prevent any injury to the user

CAUTION
These notes must be observed to prevent any damage to the device.

NOTE
These notes give you useful additional information on the installation or operation.

Device classification: type BF
Protection class II
LOT number
Manufacturer
Keep dry
Alternating current
Serial number
Date of manufacture

Intended use

• The medisana Inhalator IN 500 is suitable for the temporary oral or nasal inhalation therapy with nebulised medication in private households. The unit must only be used by patients, who became familiar with the usage of the device with a recommended or prescribed (by a doctor or pharmacist) liquid medication.
• The user needs to read and understand these instructions of use and needs to understand the general machine operation.
• Always pay attention to the notes in the accompanying information for the medication to be inhaled and follow the instuctions of your doctor or pharmacist.

Contraindications

• The medisana Inhalator IN 500 is only designed to be used by patients, who are able to breath by themselves and are conscious.
• The appliance is not suitable for patients, who breathe through a surgical opening in the windpipe (tracheostoma).

IMPORTANT INFORMATION! RETAIN FOR FUTURE USE

Read the instruction manual carefully before using this device, especially the safety instructions, and keep the instruction manual for future use. Should you give this device to another person, it is vital that you also pass on these instructions for use.

Safety Information

• Use the device only according to its intended purpose as specified in the instruction manual. The warranty will be invalidated if used for purposes other than those for which it is intended.

• Any application other than the herewith described is improper and therefore considered dangerous. If the appliance is not used according to the instructions, the user is liable for the safe operation of the unit.

• A single inhalation application should not exceed 20 minutes.

• Only use genuine accessories and spare parts provided by the manufacturer.

• Use only liquid medications that have been approved for use in inhalation therapy. Before starting therapy, discuss the length, dosage, frequency of use and the selection of the medication with your doctor or pharmacist.

• Do not use only water in the nebulizer for nebulizing purposes.

• This device is not designed to be used by persons (including children) with limited physical, sensory or mental abilities, or by persons with insufficient experience and/or knowledge, unless under observation by a person responsible for their safety, or unless they have been instructed in the use of the device.

• Children must be supervised to ensure that they do not play with the device.

• Small parts (e.g. the air filter) can be swallowed. Therefore keep and dispose of all small parts out of reach of children.

• Do not use or store the appliance, where it may be exposed to noxious fumes or volatile substances.

• Do not operate the device in the vicinity of anaesthetic mixtures, that are inflammable in air or oxygen.

• Avoid contact with pointed or sharp objects.

• Do not block the ventilation slots 5. Never place the device where the ventilation slots may be obstructed during operation.
  Do not cover the compressor with a blanket or towel etc, during use.

• Do not block the air filter cover 2.

• Do not insert objects or parts of the body (fingers etc.) into the intertior of the unit.

• Do not run the appliance on carpets or in very dusty environments (e.g. under the bed).

• The nebulizer is not suitable for using in respiration systems for anaesthesia or for artificial respiration systems.

• Never use the device whilst taking a bath or shower.

• Do not use the device at temperatures over +40°C.

• Do not leave the device outside or in a humid environment. The device is not protected against the ingress of liquids.

• Store and operate the appliance only in places where a solid stand is given and where the unit cannot fall. There is a danger of hurts or fractures to anyone or anything below if it falls.

• Do not operate the device in the vicinity of high-frequency electromagnetic transmitters.

• Never touch the mains cable with wet hands.

• Do not operate the unit with a damaged cord or plug.

• To completely isolate the unit from the power source unplug the plug from the power source.

• Hoses and wirings of the device need to be laid in that way, that there is no risk of stumbling, that these are not bended and that the risk of strangulation is completely excluded.

• Do not run the power cord over sharp edges or allow it to be pinched; do not run the appliance nearby heat sources.

• To avoid the risk of electric shock, immediately pull out the plug from the power source:

  • if a malfunction occurs during operation
  • after each use
  • before each cleaning or maintenance.

• Do not wind the power cord around the main unit.

• If the mains cable is damaged, it may only be replaced by medisana, an authorized dealer or suitably qualified service personnel.

• Take care to ensure that no water gets inside the device. In case the unit comes in contact with humidity, immediately unplug the power plug and contact the service centre.

• When cleaning, do not hold the device under running water.

• Do not attempt to repair the device yourself in the event of a malfunction. Repairs should only be carried out by authorised service centres.

• Do not carry or leave the nebulizer kit while the nebulizer tank contains medication.

• Avoid shocks and do not drop the unit.

• Do not use the appliance on animals.

• Never use the appliance if you are feeling tired or dizzy.

• Consult your family doctor before using the device if you have diabetes or other illnesses.

• Pregnant women should observe the necessary precautions and their personal circumstances; consult your doctor if necessary.

• Do not use the device if the application will come into contact with bruises, burns, inflammations, rashes, wounds or sensitive areas. The treatment should be pleasant. Stop using the device and consult your doctor if you feel pain or using the device is unpleasant.
  WARNING
  Danger of infection from contaminated nebulizer! Follow the hygiene regulations (e.g. thoroughly washing the hands) before each use and make sure that the nebulizer has been cleaned and disinfected before first and after each use according to point „Cleaning and maintenance“

• Disinfect all parts of the nebulizer kit including mouthpiece and mask before first use, after each use and after a long period of non-usage (see „Cleaning and maintenance“).

• After disinfection, all parts of the nebulizer kit need to be rinsed with clear, boiled water.

• Check before each use, if the case, the power cord, the plug, the air tube 13 and the air tube connections ( 1 and 7 ) are intact and if the appliance is working normally.

• If the unit is visibly damaged or if you assume a defect, do not use the appliance, unplug the power plug and contact the service centre.

• Before connecting the device to your power supply, please ensure that the supply voltage stated on the rating plate is compatible with your mains supply. Do not use multi sockets or extension cables.

• Do not fill more than 10 ml of a suitable inhalation liquid into the nebulizer tank.

• Before using the device, make sure that all parts are correctly assembled.

• Make sure that the air filter 2 is clean.If the air filter has changed colour, or has been used on average for more than 60 days, replace it with a new one. Make sure, it is correctly mounted.

• In order to avoid that the air tube looses during use, make sure that the air tube 13 is securely attached to the compressor (main unit) and nebulizer kit through the respective connections ( 1 and 7 ). Twist the airtube plug slightly when inserting it into the connectors.

during use

• Always use fresh medication each time.
• Do not block the openings of the inhalation top q.
• Hold the device as upright as possible and do not shake it while in use.
• When using this device, there will be some noise and vibration caused by the the compressor. This is normal and does not indicate a malfunction.

after use

• Never dry the appliance in microwave ovens or with a hairdryer.
• Store the device and all parts only in completely dry and empty state in a dry and clean location.
• Always dispose of any remaining medication after use. All parts have to
• be cleaned and disinfected thoroughly, please refer to chapter „Cleaning and maintenance“.
• Do not store the device with a creased or twisted air tube  13

Items supplied and packaging

Please check first of all that the unit is complete and is not damaged in any way. If in doubt, do not use the appliance. Send it to a service point. The following parts are included:

• 1 medisana Inhalator IN 500 with nebulizer kit and air tube, 1 mouthpiece, 1 nose adaptor for adults, 1 nose adaptor for children, 1 adult mask and 1 child mask
• 5 replacement air filters
• 1 Instruction manual

The packaging can be reused or recycled. Please dispose properly of any packaging material no longer required. If you notice any transport damage during unpacking, please contact your dealer without delay

WARNING
Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation

Preparing for inhalation

WARNING
Clean and disinfect the nebulizer kit as described under „Cleaning and maintenance“ in order to avoid a possible infection by contaminated parts! Additionally general hygiene regulations (e.g. thoroughly washing the hands, hygienic handling of the medication) must be observed.

NOTE
Before starting therapy, discuss the length, dosage and frequency of use with your doctor.
The method of use should be appropriate to the aim of the therapy (e.g. lung treatment = use of mouthpiece and treatment of the nasal-pharyngeal area = use of mask). Consult your doctor about this aspect as well

1. Rotate the inhalation top 11 counterclockwise to remove it from the nebulizer tank 8.
2. Place the vaporizer head 10 on the nozzle 9.
3. Fill in the correct amount (min. 2 ml and max. 10 ml) of prescribed medication into the nebulizer tank 8. If you have overfilled the tank, pour all the liquid out and clean the nebulizer kit as described in „Cleaning and maintenance“.
4. Rotate the inhalation top 11 clockwise to properly fix it on the nebulizer tank 8.
5. a. Plug either the mouthpiece 18, or a nose adaptor (16 or 17) with the connection tube for mouthpiece and nose adaptor w onto the inhalation top. Therefore the connection tube 12 needs to be put onto the nozzle on the upper part of the inhalation top 11 with the longer end. Then the mouthpiece 18 or the nose adaptor (16 or 17) needs to be connected to the shorter end of the connection tube 12 .
   b. Alternatively, you may use the adult or child mask (14 oder 15) for the inhalation. Therefore you need the mask connection tube instead of the connection tube 12. Make sure, the power switch 3 is turned off („O“). Connect the power plug to the mains outlet and place one end of the air tube 13 firmly over the connection for air tube 7 of the compressor. Place the other end over the appropriate connection for air tube 7 of the nebulizer kit.

NOTES

• Make sure that all parts are firmly connected to each other. The air tube needs to be securely attached to the compressor (main unit) and nebulizer kit.
• Take care not to spill any medication.
• Use the nebulizer kit holder 6 as a temporary holder for the nebulizer kit.

Perform inhalation
Sit as upright as possible.

a) Inhalation using the mouthpiece:
Enclose the mouthpiece 18 completely with your lips. Switch on the device by pressing the ON/OFF switch 3 („I“). The nebulizer starts to generate a visible nebulization (aerosol). Now breathe in slowly and deeply through your mouth and out through your nose. If you need a break, stop using the device for a short time and take the mouthpiece 18 out of your mouth. Then put it into your mouth again (lips enclosing it tightly) and breathe slowly in and out again.

b) Inhalation using the mask resp. the nose adaptor:
Alternatively, a child inhalation mask 15, an adult inhalation mask 14 and nose adaptors (16 and 17) are supplied with the device. These can be used for inhaling aerosol through the nose (preferrably for the upper respiratory tract). This method is particularly suitable for children.
Mask: Hold the mask pressed lightly over your nose. Make sure, that the mask seals around the nose without being too tight.
Nose adaptor: Carefully guide the two tubings into the nose and hold there throughout the whole inhalation use.

Switch on the device by pressing the ON/OFF switch 3 („I“). The nebulizer starts to generate a visible nebulization (aerosol).
Now breathe in slowly and deeply through your nose. Afterwards, breathe out again slowly.

NOTES

• Hold the nebulizer kit as upright as possible. A slight tilt does not affect its use (leakage proof). However, take care during inhalation not to tilt the device more than 45° in any direction.
• You can improve the effectiveness of the therapy, if you hold your breath for a short time after breathing in. However, this is not necessary for general success of the therapy. It is only important that you keep quiet and relaxed while breathing in and out regularly.
  Do not inhale too fast. If you need a break, stop using the device for a short time.

WARNING

• An inhalation application should not exceed 20 minutes. Do not leave the compressor on for a long period of time. This could result in the compressor overheating or malfunctioning. After use, wait at least 40 minutes for the device to cool down.
• Do not block the ventilation slots or the air filter on the compressor.

Finish inhalation
After terminating the inhalation, switch off the device by pressing the ON / OFF switch 3 („O“), even if you have not used up all the inhalant. Pour out the rest of the inhalant. Do not use it again. Clean the device immediately after each use (also refer to „Cleaning and maintenance“).

NOTES

• A larger amount of aerosol remains on the mucosa of the nasal pharynx when using the mask resp. the nose adaptor than when using the mouthpiece.
• Once you have used the mouthpiece for a certain time, several drops of inhalant solution may gather in the attachment pipe. However, this does not affect the operation and function of the device. Wipe off the drops with a soft cloth after use.

Cleaning and maintenance
Follow the below steps for cleaning and disinfection before first use, after each use and if the device has not been used for a longish period of time (approx. 4 weeks).

Cleaning

1. Make sure that the unit is switched off and the power plug is unplugged from the outlet.
2. Remove the air tube 13 from the nebulizer kit and disassemble the nebulizer kit. Empty out any residue in the nebulizer tank. In order to help reduce water pollution, do not dispose of the medication residue in the waste water system. Wipe it up with tissues and dispose of the tissues with non-recyclable waste.
3. Rinse all parts of the nebulizer kit with warm water (approx. 40°C) and some detergent. Afterwards rinse all parts with warm water (approx. 40°C without any detergent) again. The nebulizer parts now need to be disinfected – please refer to the chapter „Disinfection“.
4. Clean the compressor case with a soft, damp cloth. Do not use any aggressive substances for cleaning, such as scouring cream or other detergents, as these may damage the surfaces.

Disinfection

1. Before disinfecting the nebulizer parts, follow the steps under „Cleaning“.
2. To disinfect, you can use alcohol or other common alcohol-based disinfectant sprays. Make sure that no disinfectant residues are left behind on the attachments to ensure safe inhalation when next used.
3. Allow all parts to dry thoroughly for about 4 to 5 hours. Additionally the nebulizer unit should be agitated several times to remove remaining drops of water.

WARNING
Always make sure that all parts are properly dried out, before you assemble them. Lay all parts on a dry, clean and absorbent cloth after disinfection and allow them to dry thoroughly.

Care of the air tube

1. After each use, check the air tube 13 for condensation.
2. Is condensation present, pull the air tube off the nebulizer and let the compressor run, until all moisture has been removed by the airstream (but not longer than 20 minutes!). In this way you avoid a bacterial contamination caused by residual moisture.
3. Do not clean the air tube with cleaning or disinfecting solutions. If the outside of the air tube is dirty, wipe it clean with a soft cloth moistened with water or mild detergent. If the inside of the air tube shows soilings, it must be replaced.

Filter replacement

In case of visible soilings (e.g. color deviances) or humidity, but latest every 60 days, the air filter 2 should be changed.
Therefore please proceed as follows:

1. Remove the air filter cover 2.
2. Remove the old air filter, e.g. with a new toothpick.
3. Insert the new air filter and put the air filter cover back into its place.

WARNING

• Only use original air filters from medisana, which are suitable for this device.
• Do not wash out the filter.

Life cycle:

If the device is used 10 times a day with each 20 minutes of inhalation at room temperature (25°C), the expected life cycle of the compressor is 3 years. The accessories show a different expected life cycle:
Nebulizer unit: 100 days / Mouthpiece & Nose adaptor: 3 months / Air tube: 1 year / Air filter: 2 months / Mask: 1 year

Troubleshooting

Problem: Device is not working after switching on.
Possible cause: The plug is not correctly connected to the mains outlet.
Solution: Switch off the device („O“) and connect the mains plug to a corresponding outlet. Do not use extension cords etc. Switch on the device.

Problem: No nebulization.
Possible cause: Vaporizer head 0 is missing or no / resp. too less medication in the nebulizer tank.
Solution: Assemble the nebulizer kit in the correct way. Fill in medication (min. 2 ml / max. 10 ml) into the nebulizer tank

Problem: No nebulization or low nebulization rate.
Possible cause: The nebulizer kit is not correctly assembled or is tilted at an incorrect angle. The air tube is not correctly attached or is folded or damaged.
Solution: Follow the instructions in chapter „Preparing for inhalation“. Pay attention, that the device is not tilted at an angle greater than 45° in any direction. Check the correct connection of the air tube on the compressor unit and on the nebulizer kit.
The air tube must not be folded, kinked or bent. Replace the air tube if damaged.

Problem: The device gets very hot.
Possible cause: The device is covered or has been used for more than 20 minutes.
Solution: Do not cover the device. Allow the device to cool down for at least 40 minutes.

Directives / norms

This inhalation device meets the requirements of the EU standard 93/42/EWG (medical device directive) and of the standard EN 13544-1: 2007 Respiratory therapy equipment – Part1: Nebulising systems and their components. Electromagnetic compatibility: The device complies with the EN 60601-1-2 standard for electromagnetic compatibility. You can find details on this measurement data on the seperate enclosure.

Disposal

This product must not be disposed of together with domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner. Consult your municipal authority or your dealer for information about disposal.

Technical specifications

• Name and model: medisana Inhalator IN 500
• Power supply: 230V~ 50Hz.
• Current consumption: 0,6A
• Jet flow: 4 – 7 l/min
• Max. filling volume: 10 ml
• Particle size: ≤ 5 μm
• Min. nebulizing output: 0.2 ml/min.
• Sound level: ≤ 65 dB
• Compressor pressure range: > 205 kPa
• Operation pressure range: 100 – 190 kPa
• Operating conditions: +10°C – +40°C, rel. humidity ≤ 85 %
• Storage conditions: -10°C – +40°C, rel. humidity ≤ 95 %
• Weight approx.: 1.3 kg
• Dimensions LxWxH approx.: 19.5 x 13.5 x 9.2 cm
• Article no.: 54520
• EAN number: 4015588 54520 7
• Spare parts: Art. 54524 Connection tube for mouthpiece and nose adaptor
  Art. 54525 Air filter and nebulizer unit
  Art. 54526 Mouthpiece and nose adaptor
  Art. 54527 Air tube
  Art. 54528 Child mask
  Art. 54529 Adult mask

In accordance with our policy of continual product improvement, we reserve the right to make technical and optical changes without notice.

The current version of this instruction manual can be found under www.medisana.com

Warranty and repair terms

Please contact your dealer or the service centre in case of a claim under the warranty. If you have to return the unit, please enclose a copy of your receipt and state what the defect is.

The following warranty terms apply:

1. The warranty period for medisana products is three years 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. Defects in material or workmanship will be removed free of charge within the warranty period.
3. Repairs under warranty do not extend the warranty period either for the unit or for the replacement parts.
4. The following is excluded under the warranty:
   • a. All damage which has arisen due to improper treatment, e.g. nonobservance of the user instructions.
   • b. All damage which is due to repairs or tampering by the customer or unauthorised third parties.
   • c. Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
   • d. Accessories which are subject to normal wear and tear.
5. 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.

The service centre address is shown on the attached leaflet.

References

• Home page medisana – Your health in good hands

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>