Gima HAPPYNEB III NEBULIZER User guide

HAPPYNEB III
GUARANTEED
3
YEARS
NEBULIZZATORE
PROFESSIONAL
NEBULIZER INHALATOR NÉBULISEUR NEBULIZADOR
HAPPYNEB III
Via Marziale Cerutti 90/F, Loc. S. Tomaso
3A HEALTH CARE S.R.L.
25017 Lonato (BS) - ITALY
Ph. +39 030 9133177
Fax +39 030 9919114
www.3-a.it
SIMBOLOGIA - SYMBOLS - SYMBOLIQUE - VERWENDETE SYMBOLE - SIMBOLOGÍA
Apparecchio di classe II/Class II/Appareil de classe II/Schutzklasse II/Aparato de clase II.
Apparecchio di tipo BF/Type BF device/Appareil de type BF/Geräteyp BF/Aparato de tipo BF.
Interruttore spento/Switch “OFF”/Interrupteur éteint/Ein-Ausschalter ausgeschaltet/Interruptor apagado.
Interruttore acceso/Switch “ON”/Interrupteur allumé Ein-Ausschalter eingeschaltet/Interruptor encendido.
Corrente alternata/Alternating current/Courant alternatif/Wechselstrom/Corriente alterna.
Non utilizzare l’apparecchio mentre si fa il bagno o la doccia/Never use the unit while having a bath or shower/Ne pas utiliser l’appareil pendant le bain ou la douche/Das Gerät darf nicht während des Badens oder in der/No utilizar el aparato mientras se hace el baño o la ducha.
Leggere attentamente le istruzioni prima di utilizzare questo dispositivo/ Carefully read the instructions before using this device/ Veuillez lire attentivement les instructions avant d’utiliser le dispositif/Vor dem Gebrauch dieser Vorrichtung die Anleitung aufmerksam lesen/ Leer detenidamente las instrucciones antes de utilizar este dispositivo.
3
6
EN
PROFESSIONAL PISTON COMPRESSOR NEBULISER
1 Piston compressor 2 Power cord 3 ON/OFF Switch
Dear Customer, this nebuliser is a high quality device for inhalation the-rapy for asthma, chronic bronchitis, and other respiratory illnesses. This medical device generates aerosols with variable characteristics to adapt to the patient’s respiratory pathology and generating a medicinal mist of particles that are small enough to reach even the deepest regions of your lungs and be of maximal benefit.The operation and usage of the device is very straightforward. All common liquid medication can be used for inhalation therapy. Please read through these instructions carefully so that you understand all functions and safety information. We want you to be happy with your Happyneb III product. For any further questions you may have, please ask your chemist or usual retailer.
IMPORTANT SAFETY INSTRUCTIONS
This device may only be used for the purposes described in this booklet. The manufacturer cannot be held liable for damage caused by incorrect application. This device is not suitable for anaesthesia and lung ventilation.This device should only be used with original accessories as shown in these instructions. Do not use the device if you think it is damaged or notice anything unusual. Never open the device. This device comprises sensitive components and must be treated with caution. Observe the storage and operating conditions described in the «Technical Specifications» section. Protect it from: - water and moisture - ex­treme temperatures - impact and dropping - contamination and dust - direct sunlight - heat and cold. Only use the medication prescribed for you by your doctor and follow your doctor’s instructions with regard to dosage, duration and frequency of the therapy. All accessories should only be used by one person. Never bend the nebuliser over 60°.
- The unit should not be used in the presence of anesthetic mixture inflammable with air, oxigen or nitrous oxide.
- Device not protected against splashes.
Ensure that children do not use the device unsupervised some parts are small enough to be swallowed.
Use of this device is not intended as a substitute for consultation with your physician.
PREPARATION AND USAGE OF THIS DEVICE
Prior to using the device for the first time, we recommend cleaning it as described in the section «Cleaning and Disinfecting».
1 Assemble the nebuliser kit 12 Ensure that all parts are complete. 2 Fill the nebuliser with the inhalation solution as per your doctor’s instructions. Ensure that you do not exceed the maximum level. 3 Connect the nebuliser with the air hose 6 to the compressorm 1 and plug the power cord 2 into the socket. 4. Switch the
ON/OFF switch 3 to position «I» to turn on the device and place the mouthpiece 7 in the mouth or fit one of the face masks over mouth and nose. The mouthpiece gives you a better drug delivery to the lungs. Choose between adult 8 or child face mask 9 and make sure that it encloses the mouth and nose area completely. 5. Breathe in and out calmly during the therapy. Sit in a relaxed position with the upper body upright. Do not lie down while inhaling. Stop inhalation if you feel unwell. 6 After completing the inhalation period recommended by your doctor, switch the ON/OFF switch 3 to position «O» to turn off the device and unplug it from the socket. 7 Empty the remaining medication from the nebuliser and clean the device as described in the section «Cleaning and Disinfecting».
CLEANING AND DISINFECTING
Thoroughly clean all components to remove medication residuals and possible impurities after each treatment. The compressor 1 and the air hose 6 should be cleaned with a clean, moist cloth.
Always wash your hands well before cleaning and disinfecting the accessories. Do not expose the compressor to water or heat. Replace the air hose for each treatment with a new patient or in case of impurities.
Unplug the device before cleaning.
Cleaning with water Wash all nebuliser components (except air hose) under warm tap water (max 60 °C) for about 5 minutes adding
if necessary a small quantity of detergent following dosage and use limitations as provided by detergent manufacturer. Rinse thoroughly making sure that all deposits are washed away and leave to dry.
4 Air filter compartment 5 Nebjet Nebulizer 6 Air hose
7 Mouthpiece 8 Adult face mask 9 Child face mask
10 Nosepiece 11 Replacing air filter 12 Assembling nebuliser kit
7
Disinfecting
All nebuliser components (except air hose) can be disinfected with chemical disinfectants following dosage and use limitations as provided by disinfectant manufacturer. Disinfectants are usually available at pharmacies.
Sterilizing with steam All nebuliser components (except air hose and masks) can be heat steam sterilized up to 121 °C (20 min.) or 134 °C (7 min.). EN554/ISO11134.The sterilization packaging must conform to EN868/ISO11607 and be suitable for steam sterilization. After sterilization always let all components cool down to ambient temperature before further use. Do not repeat sterilization cycle when components are still warm.
MAINTENANCE, CARE, AND SERVICE
Order all spare parts from your dealer or pharmacist.
It is advisable replace nebulizer after some 100 to 120 treatments on single patient or after about 20 sterilization cycles. Check the filter continually for cleanliness and replace it if dirty, or after a maximum of 3 months use. Spare filters are provided with the device. To replace the filter, open the air filter compartment 4 marked «Filter» and change the filter 11
MALFUNCTIONS AND ACTIONS TO TAKE
The device cannot be switched on
Ensure the power cord 2 is correctly plugged into the socket. Ensure the ON/OFF switch 3 is in the position «I». The device has automatically switched off due to overheating. Wait until it has cooled down and try again.
The nebuliser functions poorly or not at all
Ensure the air hose 6 is correctly connected at both ends. Ensure the air hose is not squashed, bent, dirty or blocked. If ne­cessary, replace with a new one. Ensure the nebuliser 5 is correctly assembled 12. Ensure the required medication has been added.
GUARANTEE
This device is covered by a 3 year guarantee from the date of purchase. The guarantee is valid only on presentation of the guarantee card completed by the dealer (see back) conforming date of purchase or the receipt.The guarantee covers only the compressor. The replaceable components like nebuliser, masks, mouthpiece, air hose, and filters are not included. Opening or altering the device invalidates the guarantee.The guarantee does not cover damage caused by improper handling, accidents or non compliance with the operating instructions.
TECHNICAL DATA
Piston electrocompressor with thermal cut Nominal voltage: see data label Dimensions: 310x130x220 mm Weight: 2.0 Kg approx. Temporary use: 30/30 min. I/O MDD 93/42/EEC - Class of risk IIa Maximum pressure: 250 kPa Air flow: 14 Lt/min Noise level: 56 dBA (EN13544-1) Neb rate: 0.45 ml/min (con soluzione NaCl0.9%) Operating pressure: 90 kPa (0.9bar) Operating flow: 6 l/min MMAD: 2.38 μm GSD: 2.84 Aerosol Output: 160 μl Output Rate: 100 μl/min
3A HEALTH CARE S.R.L.
Via Marziale Cerutti 90/F, 25017 Lonato (BS) - ITALY
0434
GUARANTEED
CERTIFICATO DI GARANZIA
Valevole 36 mesi dalla data di vendita
3
YEARS
Data di vendita Date of purchase
La presente garanzia non è valida se non “unitamente allo scontrino fiscale dell’apparecchio” e all’appa­recchio difettoso. Sono esclusi dalla garanzia danni causati da usi impropri, incidenti o mancanza di cure opportune./ This warranty certificate is valid only if returned to your dealer along with Receipt and Faulty Unit. Warranty does not cover damages caused by misuse, crashes or lack of attention.
AVVERTENZE PER IL CORRETTO SMALTIMENTO DEL PRODOTTO AI SENSI DELLA DIRETTIVA EUROPEA 2002/95CE - 2002/96CE ­2003/108CE. Il simbolo del cassonetto barrato riportato sull’apparecchiatura indica che il prodotto alla fine della propria vita utile deve essere raccolto separatamente dagli altri rifiuti. L’utente dovrà, pertanto, conferire l’apparecchiatura giunta a fine vita agli idonei centri di raccolta diffe­renziata dei rifiuti elettronici ed elettrotecnici, oppure riconsegnarla al rivenditore al momento dell’acquisto di una nuova apparecchiatura di tipo equivalente, in ragione di uno a uno. L’adeguata raccolta differenziata per l’avvio successivo dell’apparecchiatura dismessa al riciclaggio, al trattamento e allo smaltimento ambientalmente compatibile contribuisce ad evitare possibili effetti negativi sull’ambiente e sulla salute e favorisce il riciclo dei materiali di cui è composta l’apparecchiatura. Lo smaltimento abusivo del prodotto da parte dell’utente comporta l’applicazione delle sanzioni amministrative di cui al dlgs. n. 22/1997” (art. 50 e seguenti del dlgs. n. 22/1997). WARNING REGARDING DISPOSAL OF THIS AP­PLIANCE IN COMPLIANCE WITH THE PROVISIONS OF 2002/95CE – 2002/96CE – 2003/108CE EUROPEAN DIRECTIVESThe crossed-out wheeled bin symbol on this equipment means that this product must be collected separately from normal wastes at the end of its useful lifespan.At the end of the appliance useful lifespan, users must therefore take it to an authorised disposal centre for the recycling of electronic and electro-technical waste or they should take it back to the retailer upon purchase of a new, similar appliance, on a one-to-one basis.An adequate separate waste collection system for later recycling, treatment and environmentally-friendly disposal of the appliance avoids a negative impact on the environment and health, as well as it facilitates the recycling of the product’s different components.Users who dispose of products in an unauthorised manner shall be liable for administrative penalties in compliance with Article 50 of the Legislative Decree No. 22/1997 and the following articles. AVERTISSE­MENT CONCERNANT L’ÉLIMINATION CORRECTE DU PRODUIT AUX TERMES DE LA DIRECTIVE EUROPÉENNE 2002/95CE - 2002/96CE
- 2003/108CELe symbole d’une poubelle barrée présent sur l’appareil indique que, à la fin de sa vie utile, il doit être traité séparément des autres déchets.L’utilisateur devra donc remettre l’appareil usé aux centres de collecte et tri des déchets électroniques et électrotechniques correspondants, ou le rendre au revendeur au moment d’acquérir un nouvel appareil du même type, à raison d’un par un.La collecte et le tri appropriés de l’appareil rejeté - destiné par la suite au recyclage, au traitement et à l’élimination compatibles du point de vue écologique - contribue à éviter de possibles effets négatifs sur l’environnement et sur la santé, et favorise le recyclage des matériaux composant l’appareil.L’élimination abusive du produit de la part de l’utilisateur entraîne l’application des sanctions administratives conformément au décret législatif nº 22/1997 (art. 50 et successifs) HIIN­WEIS FÜR DIE ENTSORGUNG DES PRODUKTES GEMÄSS DER EUROPÄISCHEN RICHTLINIEN 2002/95 EG – 2002/96 EG – 2003/108 EGDas auf der Anlage angebrachte durchgestrichene Containersymbol weist darauf hin, dass das Produkt am Ende seiner Lebensdauer gesondert entsorgt werden muss.Das heißt, der Benutzer muss die Anlage am Ende ihrer Nutzungsdauer an einen für elektrische und elektrotechnische Abfälle befugten Entsorger übergeben, oder sie bei der Anschaffung einer neuen bzw. ähnlichen Anlage bei dem Händler abgeben.Die für das spätere Recycling, Behandlung und umweltfreundliche Entsorgung angemessene selektive Abfallsammlung der Anlage trägt dazu bei, mögliche negative Auswirkungen auf die Umwelt und für die Gesundheit zu vermeiden und das Recycling der Materialien der Anlage zu fördern.Die unbefugte Pro­duktentsorgung seitens des Benutzers führt zur Verhängung der in der Gesetzverordnung N.22/1997 (Paragraph 50ff der Gesetzverordnung N. 22/1997) aufgeführten Verwaltungsstrafen. ADVERTENCIAS PARA LA ELIMINACIÓN DEL PRODUCTO CONFORME A LA DIRECTIVA EUROPEA 2002/95CE – 2002/96CE – 2003/108CEEl símbolo del contenedor tachado presente en el equipo indica que el producto, cuando finaliza su vida útil, se debe recoger en forma separada del resto de los residuos.Por lo tanto, cuando finaliza la vida útil del equipo, el usuario debe entre­garlo a los centros de recogida selectiva de residuos electrónicos y electrotécnicos idóneos, o bien, entregarlo al revendedor cuando se adquiere un nuevo equipo similar, en razón de uno a uno.La recogida selectiva apropiada para el posterior reciclado, tratamiento y eliminación ambiental compatible del equipo, contribuye a evitar posibles efectos negativos en el ambiente y en la salud, y favorece el reciclado de los materiales que conforman el equipo.La eliminación no autorizada del producto por parte del usuario implica la aplicación de las sanciones administrativas descri­tas en el Decreto Legislativo n. 22/1997 (Art. 50 y sucesivos del Decreto Legislativo n. 22/1997).
WARRANTY CERTIFICATE
Validity 36 months from date of purchase
Rivenditore(timbro e firma) Dealer(Stamp and signature)
DESCRIZIONE GUASTO/ FAULT DESCRIPTION
3A HEALTH CARE S.R.L.
Via Marziale Cerutti 90/F, 25017 Lonato (BS) - ITALY
3A1415 rev.03 - 11/2012
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