Arianne series, Hi-Neb and Meganeb series Operating Manual Aug 2014

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• Do not use the appliance if the appliance housing or power supply cable are damaged; • Never leave the appliance and all its parts, including packaging, within the reach of children, uncapable people, domestic animals or insects. latEX • The elastic bands (optional) can include latex (LATEX).Latex can produce allergic reactions. • Do not use the appliance with wet or damp hands or while taking a bath; Do not wet the appliance with water or other liquids; do not use the appliance if it has accidentally become wet; • Keep the appliance and the power supply cable away from sources of heat; The appliance is not suitable for use in the presence of inflammable substances; • Do not use the appliance in rooms where sprays have just been used; air the room well before proceeding with the therapy; • Do not block or obstruct the appliance air openings and do not place it on a soft surface such as a bed or settee; • Do not insert any objects into the cooling openings; Do not use the appliance in cases where it makes unusual noises; • To guarantee the performances, functionalities and safety of the appliance, only use Norditalia original accessories and spare parts. • We recommend personal use of the accessories; In order to reduce the risk of infection, we recommend to sterilize the accessories before each use. • Do not pull the power supply cable or the appliance to remove the plug from the power supply socket. Always remove the plug after use. In case of detacheable cable always remove the plug from the wall socket before detaching the cable from the appliance. • Do not leave the appliance exposed to atmospheric agents; store it in the environmental conditions indicated. • Do not wrap the tube or the power cable around your neck. • The appliance include some small parts which can be dangerous if inhaled or swallowed. • Do not operate the appliance in combination with other appliances and accessories not described in the present manual. • Do not operate the device if stored in dirty places. RESPONSIBILITY The manufacturer, his representative, or the importer shall only be considered responsible in terms of safety, performance and reliability if: - the assembly technique, calibration, repairs or amendments have been performed by persons authorised by them; - the electrical system complies with the standards in force; - the operating instructions have been respected; The manufacturer declines all responsibility for damage deriving from improper, erroneous and unreasonable use. By the time the product may deteriorate. After 10 years have passed from the manufacturing date stated on the data plate label the product is no more usable and the manufacturer cannot be held responsible for damages or incidents caused by the product. SAFETY FUSE A safety fuse is housed within the appliance and it may be replaced if it blows. As for all other possible repairs, the replacement operation must be performed by the manufacturer or by personnel authorised by the same. ELECTROMAGNETIC COMPATIBILITY The appliance is compliant with the electromagnetic compatibility standards currently in force and is suitable for use in all buildings, including those for residenial / domestic use. The RF emissions from the appliance are very low and are not likely to cause any interference with nearby appliances. In any case, we recommend that you avoid positioning it on top of or near other appliances. If it does appear to be interfering with your electrical appliances, move it or connect it to a different electrical socket. Radio appliances may affect the functioning of the appliance, keep them at least 3 m. away. OPERATING INSTRUCTIONS 1. Position the appliance on a stable surface. 2. When using the appliance for the first time, clean the accessories as indicated in the “cleaning the accessories” section. 3. Connect the tube (1) to the appliance and make it work for 1 minute to release any humidity. Connect the nebulizing ampoule (2) to the appliance, using the tube (1). 4. Connect one of the desired accessories to the nebulizing ampoule: mouthpiece (4), nosepiece (5) or mask (6), as indicated in the accessory connection diagram on page 2. 5. Insert the medication into the nebulizing ampoule according to the filling limits indicated in the accessories connection diagram. 6. Insert the plug into the power supply socket after having checked that the power supply voltage corresponds to the rated voltage indicated on the label located under the appliance. 7.

Start the appliance using the switch, bearing in mind that it may be tested for intermittent operation; The operating times are indicated in the table on page 3. The emission of vapour from the ampoule confirms correct functioning. When the appliance is new it is normal for the compressor and accessories to have a peculiar smell which leaves after few uses. 8. Inhale the nebulized medicine until exhaustion. It is normal for a certain amount of medicine (approximately 0.5 ml.) not to be nebulized. The not nebulizing quantity, such as the nebulization speed, depend on the medicine characteristics. For example, drugs highly viscous or producing foam may be more difficult to nebulize. 9. Once the application has been completed, switch the appliance off and remove the plug from the power supply. 10.To avoid the risk of infection, clean the appliance and the accessories as indicated below.

Fig. A

Fig. B

Attention: the nosepiece can only be used with the plug (3) inserted in the ampoule. CLEANING THE APPLIANCE All cleaning operations must be performed with the plug of the appliance removed from the power supply socket. To avoid anomalous appliance operation and the inhalation of undesired substances, clean the appliance and the accessories immediatelyafter performing the

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Important instructions about using the nebulizing ampoule. The plastic Neboplus ampoule (2) can be used in two different ways: • with the plug (3) inserted, for slow nebulization (Fig. A); • with the plug (3) open, for standard nebulization (Fig. B).

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treatment. The appliance and the accessory storage area must be cleaned using a cloth slightly moistened with denatured alcohol. After cleaning the appliance, wait until the alcohol completely evaporates before re-use. Do not use other liquids or substances. Do not use excessively wet cloths, if liquids come into contact with the electrical parts of the appliance, operating defects or irreparable damage may be caused. CLEANING THE ACCESSORIES After use, and if necessary, before use, wash the accessories (not including the tube) carefully with tepid water and dry them with a cloth. Then put the accessories into a clean storage area. When cleaning, ensure that all residue is removed and that the accessories are dried properly. Under no circumstances should you use substances that may be toxic if they come into contact with the skin or mucous, if ingested or inhaled. If it is necessary to disinfect or sterilize the accessories, adopt the methods approved by the regulations in force and in compliance with the resistance of the material. Any residual humidity in the tube may be removed by leaving the aerosol on without the ampoule connected for a few minutes. If the tube is dirty it should be replaced. The accessories (not including the tube) may be sterilized using specific products such as the MILTON® method: they should be rinsed to remove all traces of disinfectant, dried and stored in a dry and clean environment. The accessories may be sterilized in boiling water (100°C) for at least 40’ or in an autoclave (120°C) for at least 20’. Do not boil the tube or the masks. Do not put weights on the accessories and do not bend them; do not exceed the temperatures indicated; After sterilization, store in suitable sterile bags. PVC accessories will lose their transparency in water or vapour; this phenomenon will disappear after a few days in a dry environment and will not affect usability. All the accessories may be sterilized up to a maximum of 100 times, following which they should be replaced. The frequency and interval between one sterilization session and another should be established according to the discretion of the doctor and/or the clinic and according to the pathology. The accessories should normally be sterilized prior to each change of patient. Do not wash accessories in a washing machine In case of use onto high-risk groups (e.g. cystic fibrosis patients), consult your doctor who will prescribe specific precautions. REPLACING THE FILTER The appliance is fitted with a filter, which eliminates any impurities from the air sucked in by the compressor. On a periodical basis, or if the appliance is no longer efficient, check the conditions of the filter, if it is very dirty it should be replaced. For checking or replacement, lift up the plug of the filter-holder compartment. If necessary, extract the filter using some tweezers. (See diagram on page 2). PERIODIC CHECKS To preserve the efficiency of the appliance we recommend replacing the nebulizing ampoule every 12 months (every 6 months for frequent use – 3 applications per day). Damaged accessories should be replaced. Although a correctly used appliance can last a very long time, we recommend to replace it after no more than 10 years or a thousand working hours from the manufacturing date. Periodically, or in case of doubt about the performances of the appliance, verify for the “Amount nebulized” with open plug (3) not to decrease below 50% of declared value. The test have to be performed using 4 ml of physiological solution. If the performances would be not compliant try replacing all the accessories and the filter or get another appliance. WASTE DISPOSAL Dispose of the appliance and its accessories in compliance with the regulation in force. Do not dispose of this appliance in the environment. In case of doubt please call your local authorities. GUARANTEE CONDITIONS This appliance is guaranteed for the period indicated in the table on page 3, except where otherwise indicated or for different local regulations. The guarantee is only valid if the device is returned to the stockist, together with its receipt as proof of the date of purchase. The guarantee covers the appliance for any fabrication defects, on condition that the same has not been tampered with by the user or by persons other than the authorised maintenance service personnel. For service or for reporting abnormal operation please contact the manufacturer or your local distributor. The guarantee does not include: - faults or defects caused by improper use, or failure to comply with the operating instructions; - interventions for presumed defects, checks on request, ordinary maintenance and components subject to natural wear and tear; - accidental damage such as shocks, falls, etc. NB. For repairs or overhauls, return the appliance to the stockist in clean condition. LEGENDA 1. 2. 3. 4.

Tube “Neboplus” nebuliser Plug for ampoule Mouthpiece

5. Nosepiece 6. Mask 7. Joint (optional) 13. Filter

Environmental Conditions for use / storage

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Temperature

5 ÷ 40 °C / -40 ÷ 70 °C

14. Filter cap 15. Bottom of nebuliser 16. Pixper 17. Selector

18. Upper part of nebuliser

Relative Humidity

Atmospheric Pressure

10 ÷ 93% / 10 ÷ 100%

500 ÷ 1060 hPa

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