Titelseite LC SPRINT SINUS PARI GmbH Spezialisten für effektive Inhalation, 023D1006-C 09/12

Transcription

1 Titelseite LC SPRINT SINUS 2012 PARI GmbH Spezialisten für effektive Inhalation, 023D1006-C 09/12

2 de en es fr it nl pt Gebrauchsanweisung... 3 Instructions for use Instrucciones de uso Notice d'utilisation Istruzioni per l'uso Gebruiksaanwijzing Manual de instruções nl

3 Instructions for use en Information as of: We reserve the right to make technical changes. IMPORTANT INFORMATION General Information about the instructions for use Structure of safety instructions Before a treatment Treatment of babies, children and anyone who requires assistance Hygiene PRODUCT DESCRIPTION Components Material information Product combinations Intended use Mode of action in inhalation therapy of the upper respiratory tract Operating life INHALATION Assembling the nebuliser Filling with medication Connecting the tubes Performing the inhalation CLEANING AND DISINFECTION Preparation Care of the pressure hose and bolus tube Cleaning Disinfection Drying and storage... 38

4 MISCELLANEOUS Disposal Contact Technical data REPLACEMENT SETS, SPARE PARTS AND ACCESSORIES... 40

5 en 1 IMPORTANT INFORMATION 1.1 General read these instructions for use... 2 Please read these instructions for use carefully and completely. Do not discard, so you can consult them at a later date. If you fail to comply with the instructions for use, injury or damage to the device cannot be ruled out. These instructions for use are intended for the user at home. Separate instructions for use are available for technical personnel on the internet at (on the respective product page) or as a hard copy on request from PARI GmbH. symptoms persist... If symptoms persist or if your condition worsens, discontinue the inhalation treatment and contact your doctor immediately. 1.2 Information about the instructions for use All instructions for use can be retrieved on the internet at (on the respective product page), or they are available in hardcopy form on request from PARI GmbH. Check for updated versions of all instructions for use at regular intervals. 1.3 Structure of safety instructions Safety-critical warnings are categorised according to hazard levels in these instructions for use: The signal word WARNING is used to indicate hazards which, without precautionary measures, can result in serious injury or even death. The signal word CAUTION is used to indicate hazards which, without precautionary measures, can result in minor to moderate injury or impair treatment. The signal word NOTE is used to indicate general precautionary measures which are to be observed to avoid damaging the product during use.

6 1.4 Before a treatment You must always have a medical examination before treating illnesses. You must only use medication that has been prescribed or recommended by your doctor. Patients who respond to the treatment with adverse reactions must stop the therapy. Following surgery or where inflammation of the middle ear is present, a risk/benefit assessment for vibrating aerosols must be carried out by the doctor before the start of treatment. 1.5 Treatment of babies, children and anyone who requires assistance Babies, children and anyone who requires assistance must be supervised constantly by an adult during inhalation therapy. This is the only way to ensure safe and effective treatment. Individuals in this group often underestimate the hazards involved (e.g. strangulation with the tubing), thus resulting in a risk of injury. The product contains small parts. Small parts can block the respiratory tract and lead to a choking hazard. Therefore, make sure that you always keep the compressor, the nebuliser and the accessories out of the reach of babies and infants. The nebulisers are only designed for patients who are able to breathe by themselves and are conscious. This is the only way to ensure effective treatment and avoid a choking hazard.

7 en 1.6 Hygiene use nebulisers and accessories... Only use nebulisers and accessories that have been cleaned, disinfected and dried as described in chapter 4 for inhalation therapy. Contamination and residual moisture encourage the growth of bacteria, so increasing the risk of infection Therefore, please observe the following hygiene instructions: Each nebuliser must only be used at home by a single patient for hygiene reasons. Before every use and cleaning wash your hands thoroughly. Clean, disinfect and dry your nebuliser and accessories. Make absolutely sure you also carry out cleaning, disinfection and drying before using the device for the first time. For cleaning and disinfection always use fresh tap water of drinking water quality. Make sure all components are dried properly whenever you have performed cleaning or disinfection. Do not keep the nebuliser or accessories in a damp environment or together with damp objects.

8 PRODUCT DESCRIPTION 2.1 Components that all... Check that all components of your PARI product are contained in your package. If anything is missing, please notify the dealer from whom you purchased the PARI product immediately. (1) PARI LC SPRINT SINUS nebuliser (2) Nose plug (3) Nasal joining piece (4) Knee (5) Bolus tube for vibration (6) Pressure hose (7) Connector

9 2.2 Material information en Polypropylene Silicone Thermoplastic elastomer Nebuliser, knee, connector, nasal joining piece Nose plug Nebuliser 2.3 Product combinations The PARI LC SPRINT SINUS nebuliser can only be operated with a PARI SINUS compressor. 2.4 Intended use The PARI LC SPRINT SINUS nebuliser (with orange nozzle attachment) is a medication nebuliser that is intended for use with the PARI SINUS compressor for inhalation therapy of the upper respiratory tract. Each nebuliser must only be used at home by a single patient for hygiene reasons. Each application generally takes between 5 and 10 minutes, but in no case more than 20 minutes (depending on the quantity of medication). Only medication that has been approved for inhalation treatment must be used. This is generally determined by the doctor. Take note of any restrictions in the instructions for use of the medication in question. The frequency of application depends on the clinical picture and the medication used. The nebulisers are only designed for patients who are able to breathe by themselves and are conscious. Please read and follow the instructions for use of the PARI SINUS compressor.

10 Mode of action in inhalation therapy of the upper respiratory tract The treatment of acute and chronic inflammations of the nasal sinuses (sinusitis) using inhaled medications is subject to particular requirements. The aim is to apply the medication through the ostia (connections between the main nasal cavity and nasal sinuses) directly to its site of action, the nasal sinuses. To achieve this aim, the appliance generates a "vibrating aerosol" that is conveyed much more easily through the ostia to the nasal sinuses. The advantage of such topical (local) therapy over oral, systemic application (e.g., in tablet form) is that less medication is required. Thus it can be expected that there is a reduction in the occurrence of side effects. It also moistens the mucous membranes of the nose. The treatment must not... The treatment must not be performed when the nose is blocked. Before starting the treatment, make sure that the nose is decongested, e.g., by flushing with the PARI MONTESOL nasal douche and the PARI MONTESOL nasal rinse. If necessary, use products designed to reduce swelling prescribed or recommended by a doctor. 2.6 Operating life Replace the nebuliser after a year at the latest as changes can occur in the material of the nebuliser over time. This might impair the effectiveness of the treatment.

11 3 INHALATION 3.1 Assembling the nebuliser Check all nebuliser en CAUTION Check all nebuliser components and the accessories before each use. Replace any broken, misshapen or seriously discoloured parts. Please also follow the instructions for assembly given below. Damaged components and/or an incorrectly assembled nebuliser may impair functioning of the nebuliser and thus treatment as well: Gently push the nozzle attachment (1b) as far as it will go onto the nozzle in the nebuliser lower section (1c) of the nebuliser. The arrow on the nozzle attachment must point upwards. Place the nebuliser upper section (1a) on the nebuliser lower section and turn it clockwise to lock the two parts together. Fit the pressure hose (6) onto the nebuliser. Connect the nasal joining piece to the knee and then connect both to the nebuliser.

12 Filling with medication NOTICE Take care to ensure that the cap only moves in the direction allowed by the hinge. Otherwise the nebuliser cap might snap off. Release the closure on the nebuliser upper section by pressing your thumb against the underside of the cap. Insert the nebuliser in the holder on the compressor intended for this purpose. Pour the quantity of medication prescribed by your doctor into the nebuliser chamber. Ensure that the medication is filled no higher than the upper scale marking (max. level 8 ml). Overfilling can greatly impair the nebulisation of medication. Close the cap of the nebuliser. Make sure that the cap snaps into place. If you are to inhale several medications one after the other in one application, rinse out the nebuliser with tap water between inhalations. Remove excess water by shaking the nebuliser and then fill with medication as described.

13 3.3 Connecting the tubes Insert the bolus tube (5) in the connector (7). Insert the connector in the nebuliser upper section. Connect both tubes to the PARI SINUS compressor. To do this, follow the instructions for use of the compressor en Check carefully, to ensure... WARNING Make quite sure that the other ends of the tubes connected to the compressor are attached to the PARI nebuliser. When several tubing systems are present, there is a possible threat to life if different connection options are confused with each other. This applies particularly in the case of patients in need of constant care who must receive artificial nutrition or other infusion treatments.

14 Performing the inhalation Sit in an upright position and relax. Take the nebuliser out of its holder and hold it upright. Position the nasal joining piece against one nostril so the nostril is closed tightly. Close the other nostril using the nose plug. The nose plug has a small opening that creates a defined resistance when breathing. Switch the compressor on. Open your mouth and close your soft palate (to learn how to close your soft palate, please see the end of this section). NOTICE The aerosol is automatically conveyed into the nasal sinuses. During therapy do not breathe in or out either through the nose or the mouth. To breathe, take short pauses and breathe through the nose or mouth. After breathing in and out, close the soft palate again and continue with the therapy as described. Therapy is complete after approx. 5 minutes (if possible, treat left and right nostril for approx. 2.5 minutes each).

15 en Replace the nebuliser in the holder as soon as you have finished inhaling. Switch the compressor off. To ensure successful therapy it is important that the nose is tightly closed by the nasal joining piece during treatment, the other nostril is closed with the nose plug and the soft palate remains closed. Check The soft palate is closed when the edge of the nostril in which the nose plug is inserted vibrates slightly, and air escapes via the opening in the nose plug. If you find the pressure resistance produced during inhalation unpleasant or too great, you can reduce it: Push out the inside of the nose plug and cut off the tip at the edge indicated using a pair of scissors. Push the inside of the nose plug back in. Tips for closing soft palate If you open your mouth very wide, the soft palate will close automatically. If you do not want to open your mouth so wide, you have to press your tongue up against the roof of the mouth at the back in order to close the soft palate. If you say the letter "K" but pause as you are making the sound, so that the tongue remains pressed against the roof of your mouth at the back, the soft palate also closes automatically.

16 CLEANING AND DISINFECTION The nebuliser and the... The nebuliser and the accessories used must be cleaned after each application and disinfected at least once a day. The PARI SINUS tube system must not be cleaned or disinfected. 4.1 Preparation Detach the pressure hose and the bolus tube together with the connector from the nebuliser. Disconnect the connector from the bolus tube. Dismantle the nebuliser into its individual parts. Open the cap of the nebuliser. 4.2 Care of the pressure hose and bolus tube Leave the pressure hose (6) connected to the compressor. Leave the compressor running until any condensation in the tubing has been removed by the air-flow. Detach the pressure hose from the compressor. Connect the bolus tube (5) with the right end to the compressed air connection of the compressor and proceed as described above until any condensation has been removed from this tube too. 4.3 Cleaning Thoroughly clean all components (except the PARI SINUS tube system) in warm tap water and dishwashing liquid for about 5 minutes. If necessary, use a clean brush to remove loose dirt (the brush must be reserved exclusively for this purpose).

17 Rinse all parts thoroughly under warm running water. You can remove excess water more quickly by shaking all parts. Remember to hold the cap of the nebuliser upper section, otherwise the hinge may be damaged by shaking. 4.4 Disinfection en After cleaning, disinfect the dismantled nebuliser and accessories used (except the PARI SINUS tube system) (effective disinfection is only possible if the nebuliser has been cleaned). A damp environment may encourage the growth of bacteria... CAUTION A damp environment may encourage the growth of bacteria. Therefore, remove all parts from the pot or disinfector as soon as disinfection has finished. Dry the parts. The risk of infection is reduced when the parts are dried completely. In boiling water Place all the individual parts in boiling water for at least 5 minutes. Use a clean pot and fresh drinking water. If your water is very hard... If your water is very hard, scale may be deposited on the plastic parts as a milky coating. This can be prevented by using softened water. Plastic will melt... NOTICE Plastic will melt if it comes into contact with the hot base of the pot. Therefore, make sure there is plenty of water in the pot. This way you will avoid damaging the components.

18 Using a standard thermal disinfector for baby bottles (not a microwave oven) Disinfection must last at least 15 minutes. Regarding disinfection and the quantity of water required for this, it is essential to follow the instructions for use of the disinfector you are using. Always check carefully that it is clean and fully functional. 4.5 Drying and storage You can remove excess water more quickly by shaking all parts. Remember to hold the cap of the nebuliser upper section, otherwise the hinge may be damaged by shaking. Place all parts on a dry, clean and absorbent surface and let them dry completely. When drying, between applications, and in particular during long breaks, wrap the nebuliser in a clean, lint-free cloth (e.g. a tea-towel) and keep in a dry, dust-free environment. During storage, make sure the nebuliser and accessories are protected from continuous exposure to direct sunlight.

19 en 5 MISCELLANEOUS 5.1 Disposal All product components can be disposed of with domestic waste unless this is prohibited by the disposal regulations prevailing in the respective member countries. 5.2 Contact all product information... For all product information and in the event of defects or questions about usage, please contact our Service Center: Tel.: +49 (0) (German-speaking) +49 (0) (international) 5.3 Technical data Operating gases Minimum flow Corresponding minimum operating pressure Maximum flow Corresponding maximum operating pressure Minimum fill volume Maximum fill volume Air, oxygen 3.0 l/min. 0.5 bar / 50 kpa 6.0 l/min. 2.0 bar / 200 kpa 2 ml 8 ml data according... Aerosol data according to DIN EN is available on request from PARI GmbH or on the internet at (under "Technical data" on the respective product page).

20 REPLACEMENT SETS, SPARE PARTS AND ACCESSORIES Description Item no. Replacement sets: PARI LC SPRINT SINUS Year Pack (PARI LC SPRINT 023G2860 SINUS nebuliser, PARI SINUS tube system, filter) Spare parts and accessories: PARI LC SPRINT SINUS nebuliser (PARI LC SPRINT 023G2800 SINUS nebuliser, knee, connector, nasal joining piece, nose plug) PARI LC SPRINT SINUS application set (knee, 023G2840 connector, nasal joining piece, nose plug) PARI SINUS tube system 041B4570 PARI SINUS nasal joining piece 041E0573 PARI SINUS nose plugs, pack of 3 041B0576

21 Rückseite 2012 PARI GmbH Spezialisten für effektive Inhalation, 023D1006-C 09/12 PARI GmbH Moosstrasse Starnberg Germany Tel.: +49 (0) Fax: +49 (0) info@pari.de