IN 500 Compact - Facial sauna MEDISANA - Free user manual and instructions

USER MANUAL IN 500 Compact MEDISANA

1 Safety Information 2 Useful Information 3 Operating 4 Miscellaneous 5 Warranty

Nebulizer kit Connection for air tube (on main unit) Air filter (with cover) On/Off-Switch Carry handle Latch for storage compartment lid Storage compartment Ventilation slots Nebulizer kit holder Mains cable compartment lid Storage compartment lid Connection for air tube (on nebulizer) Nebulizer tank Nozzle Vaporizer head (blue, particle size 3.5 -

Inhalation top Connection tube for mouthpiece and nose adaptor Air tube Adult mask with mask connection tube Child mask with mask connection tube Nose adaptor for adults Nose adaptor for children Mouthpiece Replacement air filter Replacement fuses (only art.no. 54530) Vaporizer head (red, particle size 4.5 -

6.0 µm, only art.no. 54530)

Vaporizer head (yellow, particle size 3.0 -

5 Garantie14 1 Safety Information This instruction manual belongs to this device. It contains important information about starting upand operation. Read the instruction manual thoroughly.Non-observance of these instructions can result inserious injury or damage to the device.WARNINGThese warning notes must be observed to preventany injury to the user.CAUTIONThese notes must be observed to prevent any damage to the device. NOTE These notes give you useful additional informationon the installation or operation. Lot number Serial number Manufacturer Explanation of symbolsDate of manufacture Device classification: type BFProtection class II Alternating current 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.

Keep dry1 Safety Information

Safety Information Intended use The MEDISANA inhalator IN 500 Compact / IN 550 Pro is suitable for the temporary oral or nasal inhalation therapy with nebulised medi- cation 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 Compact / IN 550 Pro 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).

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. g 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. g A single inhalation application should not exceed 20 minutes. g Only use genuine accessories and spare parts provided by the manufac- turer. g Use only liquid medications that have been approved for use in inhala- tion therapy. Before starting therapy, discuss the length, dosage, fre- quency of use and the selection of the medication with your doctor or pharmacist. g Do not use only water in the nebulizer for nebulizing purposes. g This device is not designed to be used by persons (including children) with limited physical, sensory or mental abilities, or by persons with in- sufficient 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. g Children must be supervised to ensure that they do not play with the device. g Small parts (e.g. the air filter) can be swallowed. Therefore keep and dispose of all small parts out of reach of children. g Do not use or store the appliance, where it may be exposed to noxious fumes or volatile substances. g Do not operate the device in the vicinity of anaesthetic mixtures, that are inflammable in air or oxygen. g Avoid contact with pointed or sharp objects. g Do not block the ventilation slots . 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 . g Do not insert objects or parts of the body (fingers etc.) into the intertior of the unit. g Do not run the appliance on carpets or in very dusty environments (e.g. under the bed). g The nebulizer is not suitable for using in respiration systems for anaesthesia or for artificial respiration systems. g Never use the device whilst taking a bath or shower. g Do not use the device at temperatures over +40°C. g Do not leave the device outside or in a humid environment. The device is not protected against the ingress of liquids. g 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 frac- tures to anyone or anything below if it falls. g Do not operate the device in the vicinity of high-frequency electromag- netic transmitters. g gNever touch the mains cable with wet hands. Do not operate the unit with a damaged cord or plug. g To completely isolate the unit from the power source unplug the plug from the power source. g 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. g Do not run the power cord over sharp edges or allow it to be pinched; do not run the appliance nearby heat sources. g To avoid the risk of electric shock, immediately pull out the plug from the power source: g - if a malfunction occurs during operation g - after each use g - before each cleaning or maintenance. g Do not wind the power cord around the main unit. g If the mains cable is damaged, it may only be replaced by MEDISANA, an authorized dealer or suitably qualified service personnel. g 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. g When cleaning, do not hold the device under running water. g Do not attempt to repair the device yourself in the event of a malfunction. Repairs should only be carried out by authorised service centres. g Do not carry or leave the nebulizer kit while the nebulizer tank contains medication. g Avoid shocks and do not drop the unit. g Do not use the appliance on animals. g Never use the appliance if you are feeling tired or dizzy. g Consult your family doctor before using the device if you have diabetes or other illnesses. g Pregnant women should observe the necessary precautions and their personal circumstances; consult your doctor if necessary. g 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. 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 "4.1 Cleaning and maintenance". WARNING before use Disinfect all parts of the nebulizer kit including mouthpiece and mask be- fore first use, after each use and after a long period of non-usage (see point "4.1 Cleaning and maintenance"). g After disinfection, all parts of the nebulizer kit need to be rinsed with clear, boiled water. g Check before each use, if the case, the power cord, the plug, the air tube and the air tube connections ( and ) are intact and if the app- liance is working normally. g 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. f 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. g Do not fill more than 10 ml of a suitable inhalation liquid into the nebuli- zer tank. g Before using the device, make sure that all parts are correctly assembled. Make sure that the air filter 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. g In order to avoid that the air tube looses during use, make sure that the air tube is securely attached to the compressor (main unit) and ne- bulizer kit through the respective connections ( and ). Twist the airtube plug slightly when inserting it into the connectors. during use Always use fresh medication each time. g Do not block the openings of the inhalation top . g 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 malfunc- tion. g

Never dry the appliance in microwave ovens or with a hairdryer. g Store the device and all parts only in completely dry and empty state in a dry and clean location. g Always dispose of any remaining medication after use. All parts have to be cleaned and disinfected thoroughly, please refer to chapter 4.1 Clea- ning and maintenance. g Do not store the device with a creased or twisted air tube . after use

1 MEDISANA Inhalator IN 500 Compact or IN 550 Pro 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 2 additional vaporizer heads (red & yellow, only for art. 54530) 2 replacement fuses (only for art. 54530) 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. G Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation!

Items supplied and packaging Thank you very much Thank you for your confidence in us and congratulations on your purchase! You have acquired a quality product with your purchase of the MEDISANA Inhalator IN 500 Compact / IN 550 Pro. To ensure the best results and long-term satisfaction with your MEDISANA Inhalator unit, we recommend that you read the following operating and maintenance instructions carefully. 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: G

Important information about inhalation therapy Living = breathing / Breathing = living G Often, diseases of the respiratory system or the lung are lengthy, painful and life restricting. Timely, effective therapies such as inhalation therapy with aerosols can be of great help and assistance. G A gas + particle mixture is defined as an aerosol; mist is an example of a natural aerosol. Aerosol therapy delivers medicines in an "air transported" form (e.g. nebulized) which are inhaled. The great advantage of this therapy (unlike taking tablets for example) is that the medicines are ad- ministered at the precise point where they will have greatest effect (via the oro-nasalpharyngeal cavity into the lung) without passing through other organs: G

1. The effect is noticeably rapid.

2. There is no (significant) effect or side effect on other organs.

3. Small quantities of medicines are used.

WARNING Clean and disinfect the nebulizer kit as described under "4.1 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.

Preparing for inhalation 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.

5a. 5b. Fill in the correct amount (min. 2 ml and max. 10 ml) of prescribed medication into the nebulizer tank . If you have overfilled the tank pour all the liquid out and clean the nebulizer kit as described under point "4.1 Cleaning and maintenance". g Rotate the inhalation top clockwise to properly fix it on the nebulizer tank . g Plug either the mouthpiece , or a nose adaptor ( or ) with the connection tube for mouthpiece and nose adaptor onto the inhalation top. Therefore the connection tube needs to be put onto the nozzle on the upper part of the inhalation top with the longer end. Then the mouthpiece or the nose adaptor ( or ) needs to be connected to the shorter end of the connection tube . g Alternatively, you may use the adult or child mask ( or ) for the inhalation. Therefore you need the mask connection tube instead of the connection tube . Make sure, the power switch is turned off ("O"). Connect the power plug to the mains outlet and place one end of the air tube firmly over the connection for air tube of the compres- sor. Place the other end over the appropriate connection for air tube f of the nebulizer kit.

Rotate the inhalation top counterclockwise to remove it from the nebulizer tank . g Place the vaporizer head on the nozzle . NOTE The are two additional vaporizer heads included in the scope of delivery of model IN 550 Pro (art.no. 54530). You have the possi- bility to use one of totally 3 heads (blue , red or yellow ) on the nozzle . This allows a more targeted application. Particle sizes of approx. 4.5 to 6.0 µm (red vaporizer head) are ideal for use on mouth and throat (e.g. laryngitis). Particle sizes of approx. 3.5 to 4.5 µm (blue vaporizer head) are ideal for use on the respiratory tract and upper lungs (e.g. bronchitis) and smaller particle sizes of approx. 3.0 to 4.0 µm (yellow vaporizer head) are ideal for the deeper areas of the lung (e.g. asthma). Consult your physician to find out, which particle size is ideal for your personal situation. r g h

NOTES - Hold the nebulizer kit as upright as possible. A slight tilt does not affect its use (leakage proof). However, take care during inhala- tion 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 impor- tant 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.

Perform inhalation Sit as upright as possible. G a) Inhalation using the mouthpiece: g Enclose the mouthpiece completely with your lips. Switch on the de- vice by pressing the ON/OFF switch ("I"). The nebulizer starts to generate a visible nebulization (aerosol). Now breathe in slowly and deep- ly 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 out of your mouth. Then put it into your mouth again (lips enclosing it tightly) and breathe slowly in and out again.

Alternatively, a child inhalation mask , an adult inhalation mask g and nose adaptors ( and ) 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 child- ren. Mask: Hold the mask pressed lightly over your nose. Make sure, that the mask seals around the nose without being too tight. G Nose adaptor: Carefully guide the two tubings into the nose and hold there throughout the whole inhalation use. G

p a b) Inhalation using the mask resp. the nose adaptor: Switch on the device by pressing the ON/OFF switch ("I"). The nebu- lizer starts to generate a visible nebulization (aerosol). Now breathe in slowly and deeply through your nose. Afterwards, breathe out again slowly.

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 as a temporary holder for the nebulizer kit. 83 Operating / 4 Miscellaneous

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. 4 Miscellaneous

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). G Cleaning

Make sure that the unit is switched off and the power plug is unplugged from the outlet. G Remove the air tube from the nebulizer kit and disassemble the ne- bulizer 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. G 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". G 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. G

Finish inhalation After terminating the inhalation, switch off the device by pressing the ON / OFF switch ("O"), even if you have not used up all the inhalant. g Pour out the rest of the inhalant. Do not use it again. Clean the device immediately after each use (also refer to "4.1 Cleaning and maintenance").

Before disinfecting the nebulizer parts, follow the steps under "Cleaning" To disinfect, you can use alcohol or other common alcohol-based dis- infectant sprays. Make sure that no disinfectant residues are left behind on the attachments to ensure safe inhalation when next used. G 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. G 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 com- pressor.4 Miscellaneous

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

After each use, check the air tube for condensation. G 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 con- tamination caused by residual moisture. G 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. G

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

WARNING - Only use original air filters from MEDISANA, which are suitable for this device. - Do not wash out the filter. Remove the air filter cover in direction of the arrow: Remove the old air filter, e.g. with a new toothpick. Insert the new air filter and put the air filter cover back into its place.

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: E

Trouble- shooting Problem Possible cause Solution Device is not working after switching on The plug is not correctly connected to the mains outlet. Switch off the device ("O") and connect the mains plug to a corresponding outlet. Do not use extension cords etc. Switch on the device. No nebulization Vaporizer head is missing or no resp. too less medication in the nebulizer tank. Assemble the nebulizer kit in the correct way. Fill in medication (min. 2 ml / max. 10 ml) into the nebulizer tank. No nebulization or low nebulization rate The nebulizer kit is not correctly assembled or is tilted at an incorrect angle. Follow the instructions in chapter 3.1 Preparing for inhalation. Pay attention, that the device is not tilted at an angle greater than 45° in any direction. No nebulization or too less nebulization rate The air tube is not correctly attached or is folded or damaged. 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. The device gets very hot The device is covered or has been used for more than 20 minutes. Do not cover the device. Allow the device to cool down for at least 40 minutes.4 Miscellaneous

This inhalation device meets the requirements of the EU standard 93/42/ EWG (medical device directive) and of the standard EN 13544-1: i 2007 Respiratory therapy equipment - Part1: Nebulising systems and their components.

Directives / norms 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 sepe- rate enclosure.

Replace the fuses (for art. 54530 IN 550 Pro only) Inside the compressor unit of IN 550 Pro two fuses (type T1AL, 250V~) are present to protect the electrical components. Make sure, that the app- liance is only connected to mains outlets, which are corresponding to the specifications mentioned in chapter 4.8 Technical specifications. If it is necessary to replace the fuses, follow the below steps:

Open the mains cable com- partment lid on the rear side of the compressor. g By turning the fuse cover counterclockwise (e.g. with a screwdriver) and im- pressing it at the same time (see alongside mar- king), you can open the fuse chambers. Rear view of compressor IN 550 Pro Replace the old fuses by new ones of the same type and close the lid again.

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 commer- cial collection point so that they can be disposed of in an environmentally acceptable manner. Consult your municipal authority or your dealer for in- formation about disposal. E

Disposal4 Miscellaneous

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

5 Warranty Warranty and repair terms MEDISANA GmbH Jagenbergstraße 19 41468 NEUSS Germany eMail: info@medisana.de Internet: www.medisana.de The service centre address is shown on the attached leaflet. 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. non- observance 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.1 Consignes de sécurité