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9

bubbles on the parts. Leave the parts immersed for the amount of time indicated on the 

packaging of the disinfectant associated with the concentration chosen for the solution.

-   Remove the disinfected parts and rinse abundantly with warm potable water.

-  Dispose of the solution following the instructions provided by the disinfectant 

manufacturer.

method B: 

Disinfect the accessories 

1-2-3-4-8-9-11-12-15.1-15.2-15.3-15.4 

by boiling 

them in water for 10 minutes; use demineralised or distilled water to prevent calcium 

deposits.

method C:

 Disinfect the accessories 

1-2-3-4-8-9-11-12-15.1-15.2-15.3-15.4 

with a hot 

steam steriliser for baby-bottle (not the microwave type). Perform the process faithfully 

following the instructions of the steriliser. To ensure that the disinfection is effective, 

choose a steriliser with an operating cycle of at least 6 minutes.

After having disinfected the accessories, shake them vigorously and place them on a 

paper towel. Alternatively, dry them with a jet of hot air (for example, from a hair dryer).

CLEANING IN A CLINICAL OR HOSPITAL SETTING - DISINFECTION AND STERILISATION

Before disinfection or sterilisation, sanitise the nebuliser cup and the accessories, choosing 

one of the methods described below. 

method A: 

Sanitise accessories  

1-2-3-4-5-6-7-8-9-11-12-15.1-15.2-15.3-15.4 

under 

potable hot water (approximately 40°C) with a gentle, non abrasive dish detergent.

method B: 

Sanitise accessories 

1-2-3-4-5-6-7-8-9-11-12-15.1-15.2-15.3-15.4   

  in the 

dishwasher with a hot cycle. 
DISINFECTION
Accessories 

1-2-3-4-5-6-7-8-9-11-12-15.1-15.2-15.3-15.4 

 can be disinfected.

The disinfectant 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 the parts to disinfect with a solution of potable 

water and disinfectant, according to the proportions indicated on the packaging of the 

disinfectant.

-   Completely immerse each part in the solution, taking care to avoid the formation of air 

bubbles on the parts. Leave the parts immersed for the amount of time indicated on the 

packaging of the disinfectant associated with the concentration chosen for the solution.

-   Remove the disinfected parts and rinse abundantly with warm potable water.

-  Dispose of the solution following the instructions provided by the disinfectant 

manufacturer.

If you want to also perform the STERILISATION, jump to the STERILISATION paragraph.

After having disinfected the accessories, shake them vigorously and place them on a 

paper towel. Alternatively, dry them with a jet of hot air (for example, from a hair dryer). 

STERILISATION 
Accessories 

1-2-3-4-8-9-12-15.1-15.2-15.3-15.4 

 can be sterilised.

Device: Fractionated vacuum overpressure steam steriliser in accordance with EN 13060.

Implementation:

 Wrap every single part to be treated with a sterile barrier system or 

packaging in accordance with Norm EN 11607. Place the packed components in the steam 

steriliser. Run the sterilisation cycle according to the operating instructions of the device by 

selecting a temperature of 134 °C and a time of 10 minutes first.

Storage: 

Store the sterilised parts as per the instructions for use of either the sterile barrier 

system or packaging.

The sterilisation procedure is validated in its conformity to ISO 17665-1.

For the “

CLEANING SANITISATION DISINFECTION STERILISATION” 

of accessories 10-14 

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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