medisana IN 520 Steam Inhaler Instruction Manual

: June 4, 2024
: medisana

Table of Contents

Device and controls
Safety instructions
Technical data
References
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INSTRUCTIONS FOR USE
Inhaler IN 510/520

Device and controls

medisana IN 520 Steam Inhaler

Legend

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

IP21

| Information about protection types against foreign objects and water
| Protection class II

LOT

| LOT number
****| Manufacturer
| Date of manufacture

O/I

| Off/on
| Authorized EU representative
| Serial number of the device

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 only 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 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 matches 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 center 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 nosepiece 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, and 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 3.3 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.

Intended use
The medicine inhaler IN 510/520 is an aerosol therapy system for home use. This device is designed for the nebulization of liquids and liquid medicines (aerosols) and for the treatment of the upper and lower airways.
Preparing the device
Before the first use, we recommend cleaning all components – as described in the chapter ”Cleaning and disinfection”.
Application

Assembling the nebulizer set w. Make sure that all parts are complete.
Fill the nebulizer with the inhalation solution prescribed by your doctor. Ensure that the maximum level is not exceeded.
Connect the nebulizer 7 via air tube 6 to connector 3 on the compressor and plug the power cable into the electrical outlet (230V 50 Hz AC).
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 face mask 0 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.
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.
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.
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 (only IN 520)

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

medisana IN 520 Steam Inhaler - FIG 1

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 medicine inhaler IN 510/520 (1 position of the air filter, 2 holders for the nebulizer set, 3 connectors for the air tube, 4 On/Off switches)
1 Instruction manual
Accessories: 5 nose pieces, 6 air tubes (IN 520: two air tubes), 7 nebulizers, 7 a atomizer heads ( 12 assembling the nebulizer set), 8 mouthpieces, 9 adult face masks, 10 (IN 520: child face masks), 11 air filter (replacement on position 1 ), storage bag, ( 13 IN 520: 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 the 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 that 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 therapeutic success.
Before and after each application

Turn the upper part of the nebulizer 7 anticlockwise in order to open the nebulizer and remove the atomizer head 7 a.
Wash all parts of the nebulizer, the mouthpiece 8 , the nose piece 5 , and the nasal shower 13 under running water. After 5 minutes (15 minutes for the nasal shower), place in boiling water.
Wash the masks and the air tube with warm water.
Assemble the nebulizer parts again and connect the nebulizer to the air tube.
Switch the device on and leave it 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 air tubes.
Maintenance and care
Replacement of the nebulizer
Replace the nebulizer 7 after a relatively long period of non-use, if it has deformations or cracks or if the atomizer head 7 a is blocked by a dried-up medicine, dust, etc. We recommend replacing the nebulizer after 6 to 12 months depending on use. Only use the original nebuliser!
Replacement of the air filter
Under normal conditions of use, air filter 11 should be replaced after about 500 hours of use or one year. We recommend regularly checking (10-12 applications) and replacing the air filter, if it is discolored grey, brown or if it feels moist. Remove the air filter (Position 1 ) and 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 the original filter! Do not use the device without a 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 air tube 6 is properly attached on both ends.
Make sure that air tube 6 is not compressed, bent, dirty, or blocked. If necessary, replace it with a new one.
Make sure that the nebulizer 7 is completely assembled and the colored atomizer head 7 a has been correctly positioned and is not blocked.
Make sure that the required inhalation solution has been poured in.

Technical data

Name	medicine inhaler IN 510/520
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	0.8 ml
Operating period	30 min. on / 30 min. off
Expected service life	1000 hours
Operating conditions	10 – 40 °C / 50 – 104 °F

30 – 85 % 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| 54547/54548
EAN number:| 40 15588 54547 4/40 15588 54548 1

This device meets the requirements of the Directive concerning medical devices 93/42/EEC.
The device in Class II is in relation to protection against electric shocks. Nebulizers, mouthpieces, 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:

All medicinal 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.
Defects due to material or manufacturing defects shall be repaired free of charge within the warranty period.
Warranty service does not extend the warranty period for either the device or for replaced components.
The following are excluded from the warranty:
a. Any damage caused by improper handling, e.g. by non-observance of the instruction manual.
b. Damage due to repair or intervention by the purchaser or unauthorised third parties.
c. Transport damage that has occurred on the way from the manufacturer to the consumer or when sending it to the service center.
d. Accessories that are subject to normal wear and tear.
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.