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OPERATING INSTRUCTIONS                                                                                                          

Before each use, wash your hands accurately and clean the device as described in the 

paragraph “CLEANING SANITISATION DISINFECTION STERILISATION”.

The nebuliser cup and accessories are for personal use only to avoid potential risks 

of transmitting infection.

During application, it is advisable to suitably protect yourself from any dripping.

1. Assemble the nozzle as indicated in the “Connection diagram” in point 15.2 Insert the 

complete nozzle in the bottom part (15.1). Insert the Double action inspiratory valve 

(15.4) in the upper part (15.3) as shown in the “Connection diagram” in point 15.

2. Pour the medication prescribed by the physician into the lower part (15.1). Close the 

AEROSOL THERAPY NEBULIZER

Congratulations on your purchase and thank you for choosing our unit.

Our goal is to fully satisfy customers by offering them cutting-edge systems for the treat-

ment of respiratory tract ailments.

Carefully read this instruction manual and store it for future reference. Only use the 

accessories as described in this manual. This is a medical device intended to nebu-

lize and administer medications prescribed or recommended by a doctor. 

Visit our Internet site 

www.flaem.it

 to view the whole range of Flaem products.

ACCESSORIES THAT CAN BE USED 

WITH THIS NEBULIZER 

NEBULIZER 

1 - Child nasal inhaler

2 - Adult nasal inhaler

3 - Child bi-material face mask

4 - Adult bi-material face mask

5 - Polyethylene (PE) face mask

6 - Medical PVC child face mask

7 - Medical PVC adult face mask

8 - Mouthpiece with valve

    8.1 - Expiratory valve

9 - Non-invasive nasal prong

10 - Baby mask set (see its instruction manual)

11 - Nebulisation  manual control

12 - Connector

13 - 1 or 2 m Connection hose

14 - RF6 Plus with ambient contamination pre-

vention set (see its instruction manual)

15 - RF6 Plus NEBULISER

   15.1 - Lower part    

   15.2 - Complete nozzle

   15.3 - Upper part with valve-holder

   15.4 - Double action inspiratory valve

WARNINGS                                                                                                                                         

-   This is a medical device (compliant with Dir. 93/42/EEC) and may only be used with 

medication prescribed or recommended by a doctor. Before using the accessories, 

consult the instruction manual of the device. It is important that the patient reads and 

understands the information on how to use the device and the nebulizer. Contact your 

retailer or nearest service center for any questions.

-   When used very frequently, we recommend that the nebuliser be replaced every 6 

months (or earlier if it becomes clogged), in order to guarantee the maximum thera-

peutic effect.

-   Children and disabled persons should always use the nebulizer under strict supervi-

sion of an adult who has read this manual.

-   The nebulizer contains small parts that may be swallowed by children; keep therefore 

the nebulizer out of the reach of children

Summary of Contents for RF6 Plus

Page 1: ...6 Plus nebulizer with valve system and dual velocity function Mode d emploi du n buliseur RF6 Plus avec syst me valves et fonction double vitesse Gebruikershandleiding vernevelaar RF6 Plus met kleppen...

Page 2: ...HEMA DI COLLEGAMENTO ASSEMBLY DIAGRAM SCH MA DE CONNEXION AANSLUITSCHEMA ANSCHLUSSSCHEMA ESQUEMA DE CONEXI N SCHEMAT PO CZENIA 1 2 3 4 5 6 7 8 9 15 11 12 11 13 14 8 1 10 15 15 2 15 3 15 2 15 1 15 4 1...

Page 3: ...enti 1 Montate l ugello come indicato nello Schema di collegamento nel punto 15 2 Inserite l ugello completo nella parte inferiore 15 1 Inserite la valvola espiratoria 15 4 nella AMPOLLA PER AEROSOLTE...

Page 4: ...atoria la linguet ta che funge da Limitatore di Dispersione si piega verso l in terno della mascherina Nella fase espiratoria la linguetta che funge da Limitatore di Di spersione si piega verso l este...

Page 5: ...alle istruzioni di seguito riportate PULIZIA IN AMBIENTE DOMESTICO SANIFICAZIONE E DISINFEZIONE SANIFICAZIONE Prima e dopo ogni utilizzo sanificate l ampolla e gli accessori scegliendo uno dei metodi...

Page 6: ...on detergente delicato per piatti non abrasivo metodo B Sanificate gli accessori 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 in lava stoviglie con ciclo a caldo DISINFEZIONE Gli accessori disinfettabi...

Page 7: ...imi Conservazione Conservare i componenti sterilizzati come da istruzioni d uso del sistema o imballaggio a barriera sterile scelti La procedura di sterilizzazione convalidata in conformit alla ISO 17...

Page 8: ...N BE USED WITH THIS NEBULIZER NEBULIZER 1 Child nasal inhaler 2 Adult nasal inhaler 3 Child bi material face mask 4 Adult bi material face mask 5 Polyethylene PE face mask 6 Medical PVC child face mas...

Page 9: ...w greater sedimentation of medication in the patient and also limit dispersion Soft biocompatible material Dispersion Limiting Vent USAGE INSTRUCTIONS FOR THE RF6 PLUS NEBULISER WITH VALVE SYSTEM AND...

Page 10: ...es shake them vigorously and place them on a paper towel Alternatively dry them with a jet of hot air for example a hair dryer DISINFECTION After sanitising the nebuliser cup and the accessories disin...

Page 11: ...ant must be an electrolytic chloroxidizer active principle sodium hypochlorite specific for disinfecting which is available in any pharmacy Implementation Fill a container big enough to hold all of th...

Page 12: ...pressure min 69KPa max 106KPa follow the instructions in the instruction manual FLAEM compressor range Operating pressure MMAD m 2 BREATHABLE FRACTION 5 m FPF 2 DELIVERY ml min 1 approx open valve hol...

Page 13: ...ISEUR 1 Neusinhalator voor kinderen 2 Neusinhalator voor volwassenen 3 Kindermasker van bimateriaal 4 Volwassenenmasker van bimateriaal 5 Masker van PE 6 Kindermasker van medisch PVC 7 Volwassenenmask...

Page 14: ...a ventilation du compres seur cette op ration permet d viter la prolif ration de moisissures l int rieur du tube MODE D EMPLOI DU NEBULISEUR RF6 PLUS AVEC SYSTEME A VALVES ET FONC TION DOUBLE VITESSE...

Page 15: ...ond sire galementD SINFECTER suivrelesindicationsduparagrapheD SINFECTION Apr s avoir assaini les accessoires les secouer nergiquement et les poser sur une serviette en papier ou les faire s cher au...

Page 16: ...issant l une des m thodes d crites ci apr s m thode A Laver les accessoires 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 sous l eau chaude potable environ 40 avec un d tergent d licat pour la vaisselle...

Page 17: ...onnant une temp rature de 134 C et une dur e de 10 minutes Conservation Conserver les composants st rilis s comme indiqu par les instructions d utilisation du syst me ou emballage barri re st rile La...

Page 18: ...assenen 3 Kindermasker van bimateriaal 4 Volwassenenmasker van bimateriaal 5 Masker van PE 6 Kindermasker van medisch PVC 7 Volwassenenmasker van medisch PVC 8 Mondstuk met ventiel 8 1 Uitademklep 9 N...

Page 19: ...dient als Dispersie Begrenzer naar de binnenkant van het masker In de exhalatiefase vouwt het lipje dat dient als Dispersie Begrenzer naar de buitenkant van het masker Zacht materiaal biocompatibel Di...

Page 20: ...ssoires het water er goed afschudden en ze op keukenpapier leggen Ze kunnen ook met warme lucht worden gedroogd met een haardroger bij voorbeeld DESINFECTIE Na het saneren de ampul en de accessoires m...

Page 21: ...cessoires 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 onder warm kraanwater circa 40 C met behulp van een mild afwasmiddel niet schurend methode B Saneer de accessoires 1 2 3 4 5 6 7 8 9 11 12 15 1 15...

Page 22: ...us uit volgens de gebruiksaanwijzingen van het apparaat en selecteer een temperatuur van 134 C en een tijd van 10 minuten Bewaring Bewaar de gesteriliseerde onderdelen zoals aangeduid wordt in de gebr...

Page 23: ...ske f r Kinder aus Bimaterial 4 Maske f r Erwachsene aus Bimaterial 5 Maske aus PE 6 Maske f r Kinder aus medizinischem PVC 7 Maske f r Erwachsene aus medizinischem PVC 8 Mundst ck mit Ventil 8 1 Atmu...

Page 24: ...t aus ACHTUNG Sollte sich nach der Therapie eine deutliche Ablagerung von Feuchtigkeit im Inneren des Schlauchs 13 bilden ziehen Sie den Schlauch aus dem Spr hger t und trock nen Sie ihn mit dem Gebl...

Page 25: ...gung mit DESINFEKTION ausf hren wollen gehen Sie auf den Abschnitt DESINFEKTION ber Nach der Entkeimung sch tteln Sie die Zubeh rteile kr ftig und legen Sie sie auf eine Papierserviette oder trocknen...

Page 26: ...entkeimen Sie die Ampulle und Zubeh rteile indem Sie eine der nachfolgend beschriebenen Methoden w hlen Methode A Entkeimen sie die Zubeh rteile 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 unter warm...

Page 27: ...ie sich auf dessen spezifische Bedienungsanleitung TECHNISCHE CHARAKTERISTIKEN Zerst uber RF6 Plus In bereinstimmung mit der Richtlinie 93 42 CEE Min Heilmittel Fassungsverm gen 2 ml Max Heilmittel Fa...

Page 28: ...co nasal adulto 3 Mascarilla pedi trica de bimaterial 4 Mascarilla adulto de bimaterial 5 Mascarilla de PE 6 Mascarilla pedi trica de PVC m dico 7 Mascarilla adulto de PVC m dico 8 Aplicador bucal con...

Page 29: ...erap utica se forma un dep sito evidente de humedad en el tubo 13 desenganche este ltimo del nebulizador y s quelo con la ventilaci n del compresor esta acci n evita la proliferaci n de moho en el tub...

Page 30: ...una servilleta de papel o s quelos con un chorro de aire caliente por ejemplo con un secador de pelo DESINFECCI N Despu s de haber higienizado la ampolla y los accesorios desinf ctelos eligiendo uno d...

Page 31: ...s accesorios 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 en lavavajillas con ciclo caliente DESINFECCI N Los accesorios que se pueden desinfectar son 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 Utilic...

Page 32: ...de 10 minutos primero Conservaci n Conserve los componentes esterilizados siguiendo las instrucciones de uso del sistema o del embalaje de barrera est ril seleccionado El procedimiento de esterilizac...

Page 33: ...31 Flaem www flaem it 1 2 3 4 5 PE 6 7 8 8 1 9 10 11 12 13 1 2 14 RF6 Plus c 15 RF6 Plus 15 1 15 2 15 3 15 4 93 42 6...

Page 34: ...32 SOFTTOUCH SoftTouch 1 15 2 15 1 15 4 15 3 15 2 15 1 15 3 3 4 5 13 RF6 PLUS RF6 Plus RF6 Plus RF6 Plus 5 8 10 14 1 2 3 4 5 6 7 8 9...

Page 35: ...33 15 3 15 2 15 3 15 2 A 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 40 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 50 50 40 C 11 11...

Page 36: ...5 2 15 3 15 4 1 2 3 4 8 9 11 12 15 1 5 2 15 3 15 4 10 C 1 2 3 4 8 9 11 12 15 1 15 2 15 3 15 4 6 A 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 40 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 1 2 3 4 5...

Page 37: ...17665 1 10 14 RF6 Plus 93 42 2 8 F 1 2 3 4 5 6 7 8 9 10 14 10 40 10 95 69 106 25 70 10 95 69 FLAEM v MMAD m 2 5 m FPF 2 1 F700 F1000 0 8 bar 3 2 73 0 42 0 26 F2000 1 2 bar 2 8 76 0 54 0 31 1 Flaem I29...

Page 38: ...yczka nosowa dla doros ych 3 Maska dla dzieci z bimateria u 4 Maska dla doros ych z bimateria u 5 Maska z polietylenu PE 6 Maska dla dzieci z PCV medycznego 7 Maska dla doros ych z PVC medycznego 8 Us...

Page 39: ...wilgo nale y od czy przew d od nebulizatora i osuszy go wykorzystuj c wentylacj samej spr arki dzia anie to pozwoli unikn ewentualnego rozmna ania si ple ni wewn trz przewodu SPOS B U YCIA INHALATORA...

Page 40: ...DEZYNFEKCJA Po odka eniu akcesori w nale y nimi energicznie potrz sn i u o y je na papierowym r czniku lub osuszy strumieniem ciep ego powietrza np za pomoc suszarki do w os w DEZYNFEKCJA Po odka eniu...

Page 41: ...le y odkazi w jeden z ni ej opisanych sposob w metoda A Odkazi akcesoria 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 stosuj c cie p wod pitn oko o 40 C i delikatny p yn do naczy nie tr cy metoda B Odk...

Page 42: ...obs ugi CHARAKTERYSTYKITECHNICZNE Nebulizator RF6 Plus Zgodny z dyrektyw 93 42 EWG Minimalna ilo leku 2 ml Maksymalna ilo leku 8 ml CZ CI STOSOWANE Stosowane cz ci typu BF to akcesoria pacjenta 1 2 3...

Page 43: ...41 1 15 2 15 1 Flaem www flaem it 1 2 3 4 5 PE 6 PVC 7 PVC 8 8 1 9 10 11 12 13 1 2 m 14 RF6 Plus 15 RF6 Plus 15 1 15 2 15 3 15 4 93 42 CEE 6...

Page 44: ...42 SOFTTOUCH SoftTouch 15 4 15 3 15 2 15 1 15 3 3 4 5 13 RF6 PLUS RF6 Plus RF6 Plus RF6 Plus 5 ml 2 8 10 14 1 2 3 4 5 6 7 8 9...

Page 45: ...2 15 3 15 2 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 40 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 50 50 40 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3...

Page 46: ...8 9 11 12 15 1 15 2 15 3 15 4 10 C 1 2 3 4 8 9 11 12 15 1 15 2 15 3 15 4 6 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 40 C 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 1 2 3 4 5 6 7 8 9 11 12 15 1 15...

Page 47: ...4 5 6 7 8 9 10 14 min 10 C max 40 C min 10 max 95 min 69KPa max 106KPa min 25 C max 70 C min 10 max 95 min 69Kpa max 106KPa FLAEM MMAD m 2 5 m FPF 2 ml min 1 MAX MIN F700 F1000 0 8 bar 3 2 73 0 42 0 2...

Page 48: ...46 Flaem www flaem it CEE 93 42 6 15 2 1 15 15 3 15 4 15 1 15 1 2 15 3 3 4...

Page 49: ...47 SOFTTOUCH SoftTouch 4 13 11 11...

Page 50: ...2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 C 40 50 50 1 2 3 4 5 6 7 8 9 11 12 15 1 15 2 15 3 15 4 10 1 2 3 4 8 9 11 12 15 1 15 2 15 3 15 4 1 2 3 4 8 9 11 12 15 1 15 2 15 3 15 4 C 6 1 2 3 4 5 6 7 8 9 1...

Page 51: ...a 106 KPa 69 BF 1 2 3 4 5 6 7 8 9 10 14 1 2 3 4 8 9 12 15 1 15 2 15 3 15 4 EN 13060 EN 11607 134 10 ISO 17665 1 10 14 FPF 5 2 MMAD FLAEM 0 42 73 3 2 0 8 F700 F1000 0 54 76 2 8 1 2 F2000 Products GmbH...

Page 52: ...MEMO MEMORANDUM NOTIZEN NOTAS...

Page 53: ...MEMO MEMORANDUM NOTIZEN NOTAS...

Page 54: ...52 MEMO MEMORANDUM NOTIZEN NOTAS...

Page 55: ...FISCALE FATTURAOANALOGODOCUMENTOCHENECOMPROVILADATADIACQUISTO PROVADIAVVENUTOPAGAMENTO SE ACQUISTATO ON LINE TRAMITE SITI INTERNET Condizioni di Garanzia The warranty terms here specified are valid on...

Page 56: ...de Europese Norm EN 10993 1 Biologische evaluatie van medische hulpmiddelen en de Europese Richtlijn 93 42 EEG Medische Hulpmiddelen Ftalaat vrij In overeenstemming met Reg EG n 1907 2006 In bereinst...

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