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CLEANING SANITISATION DISINFECTION STERILISATION                        

Switch off the device before any cleaning procedure and unplug the power cable from 

the socket.

DEVICE AND TUBING EXTERIOR (B)

Use only a damp cloth with antibacterial soap (non-abrasive and with no solvents of any 

sort).

ACCESSORIES

Open the nebuliser by turning the upper part (13.3) anticlockwise, remove the nozzle 

(13.2) from the upper part (13.3). Disassembly by pressing as shown by the 2 arrows in the 

“Connection diagram” in point 13.2.

Then proceed according to the following instructions.

CLEANING AT HOME - SANITISATION AND DISINFECTION

SANITISATION

Before and after each use, sanitise the nebuliser cup and the accessories, choosing one of 

the methods described below. 

method A: 

Sanitise accessories 

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4     

under po-

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

method B:

 Sanitise accessories 

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4   

 in the dish-

washer with a hot cycle.

method C:

 Sanitise accessories 

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4   

 by immers-

ing them in a solution of 50% water and 50% white vinegar, then rinse thoroughly under 

potable hot water (approximately 40 °C).

If you want to also perform the cleaning for DISINFECTION, jump to the DISINFECTION 

paragraph.

After having sanitised the accessories, 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, disinfect them choosing one of the 

methods described below. 

method A: 

Accessories 

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4

 can be disinfected.

The disinfectant must be an electrolytic chloroxidizer (active principle: sodium hypochlo-

rite) 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 manufac-

turer.

method B: 

Disinfect the accessories 

1-2-3-4-8-10-11-13.1-13.2-13.3-13.4 

by boiling 

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

posits.

method C:

 Disinfect the accessories 

1-2-3-4-8-10-11-13.1-13.2-13.3-13.4 

with a hot 

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

lowing 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 pa-

per 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  

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 

under pota-

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

method B: 

Sanitise accessories 

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 

in the dish-

washer with a hot cycle. 
DISINFECTION
Accessories 

1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 

 can be disinfected.

The disinfectant must be an electrolytic chloroxidizer (active principle: sodium hypochlo-

rite) 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 manufac-

turer.

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 pa-

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

STERILISATION 
Accessories 

1-2-3-4-8-11-13.1-13.2-13.3-13.4 

 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.

At the end of each use store the accessories in a dry place away from dust.

For the “

CLEANING SANITISATION DISINFECTION STERILISATION” 

of accessories 9 fol-

low the instructions in the instruction manual.

USE OF NEBULIZATION MANUAL CONTROL 

To achieve continuous nebulisation action you should not use the manual nebulisation 

control (10), especially in the case of children or persons with reduced physical, sensory, 

or mental capabilities. The manual nebulisation control is useful for limiting dispersion of 

the medication in the surrounding environment.

To start nebulizing close with a 

finger the hole of the nebulizer 

manual control (10) and breathe 

in gently; we recommend to 

hold your breath for a moment 

so that the inhaled aerosol drop-

lets can be deposited,

  meanwhile, to disable nebuliz-

ing, remove your finger from the 

hole of the nebulizer manual 

control to avoid the waste of 

drug, optimizing its acquisition. 

Then exhale slowly.

Содержание PF6 Basic2

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Страница 2: ...DIAGRAM SCH MA DE CONNEXION AANSLUITSCHEMA ANSCHLUSSSCHEMA ESQUEMA DE CONEXI N SCHEMAT PO CZENIA IS Pr co ZI ris di tal de pr da 1 2 o i d so c AC 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 13 10 11...

Страница 3: ...a la diluizione con soluzione fisiologica adatta secondo prescrizione medica Durante l applicazione consigliato proteggersi adeguatamente da eventuali gocciolamenti 1 Montate l ugello come indicato ne...

Страница 4: ...edi manuale istruzioni d uso dello stesso Inspirate dolcemente a fondo si consiglia dopo l inspirazione di trattenere il respiro per un istante in modo che le goccioline di aerosol inalate possano dep...

Страница 5: ...AMBIENTE DOMESTICO SANIFICAZIONE E DISINFEZIONE SANIFICAZIONE Prima e dopo ogni utilizzo sanificate l ampolla e gli accessori scegliendo uno dei metodi come di seguito descritto metodo A Sanificate g...

Страница 6: ...3 3 13 4 Procurarsi un disinfettante di tipo clorossidante elettrolitico principio attivo ipoclorito di sodio specifico per disinfezione reperibile in tutte le farmacie Esecuzione Riempire un contenit...

Страница 7: ...azione possono variare in funzione della capacit respiratoria del paziente 2 Caratterizzazione in vitro eseguita da T V Rheinland Italia srl in collaborazione con l Universit di Parma in conformit all...

Страница 8: ...me medical device to nebulise and administer medication prescribed or recom mended by your doctor upon assessing the patient s general conditions Visit our Internet site www flaem it to view the whole...

Страница 9: ...e mask During the expiratory phase the tab acting as a Dispersion Limiting De vice bends outwards from the mask SoftTouch masks have an outer edge made of soft bio compatible material that ensures exc...

Страница 10: ...l Alternatively dry them with a jet of hot air for example a hair dryer DISINFECTION After sanitising the nebuliser cup and the accessories disinfect them choosing one of the methods described below m...

Страница 11: ...rinciple sodium hypochlo rite 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 w...

Страница 12: ...ed mode F400 0 60 3 06 73 97 0 25 0 32 F700 F1000 0 80 3 32 71 91 0 32 0 42 1 Data shown is in accordance with Flaem Nuova internal procedure I29 P07 5 Dispensing speed values may vary according to th...

Страница 13: ...ts prescrits ou recommand s par un m decin qui a valu les conditions g n rales du patient Visitez notre site Internet www flaem it pour voir la gamme compl te des produits Flaem ACCESSOIRES QUI PEUVEN...

Страница 14: ...conseill de retenir la respiration un instant de sorte que les petites gouttes d a rosol inhal es puissent se d poser Puis expirer lentement 5 Une fois l application termin e teindre l appareil ATTENT...

Страница 15: ...R 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 moyen d un jet d air chaud p...

Страница 16: ...un d tergent d licat pour la vaisselle non abrasif m thode B Laver les accessoires 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 en lave vaisselle sur le cycle chaud D SINFECTION Les accessoires qu il est...

Страница 17: ...ccessoires 9 reportez vous leur mode d emploi Apr s chaque utilisation ranger le accessoires dans un endroit sec l abri de la poussi re Famille com presseurs FLAEM Pression de service bar MMAD m 2 FRA...

Страница 18: ...volen zijn door de arts die de algemene condities van de pati nt beoordeelde Het volledige productaanbod van Flaem is te zien op de website www flaem it COMPATIBELE ACCESSOIRES VERNEVELAAR 1 Neusinhal...

Страница 19: ...een buitenrand van zacht biocompatibel materiaal dat een optimale aansluiting op het gezicht garandeert De maskers zijn daarnaast voorzien van een innovatieve Dispersie Begrenzer Deze onderscheidende...

Страница 20: ...beeld DESINFECTIE Na het saneren de ampul en de accessoires met een van de hierna beschreven methoden ontsmetten methode A De accessoires die u kunt desinfecteren zijn 1 2 3 4 5 6 7 8 10 11 13 1 13 2...

Страница 21: ...t desinfecteren zijn 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 Het te gebruiken ontsmettingsmiddel is ge lektrolyseerd bleekwater werkzame stof natriumhypochloriet specifiek voor de desinfectie en ver...

Страница 22: ...geborgen worden op een droge plaats die bescherming tegen stof biedt Compressor familie FLAEM Bedrijfs druk bar MMAD m 2 INHALEERBAAR DEEL 5 m FPF 2 DISTRIBUTIE ml min 1 ca Standaard High speed F400 0...

Страница 23: ...uben und zu verabreichen Wir erinnern Sie daran dass Sie sich auf der Homepage www flaem it ber die gesamte Produktpalette von Flaem informieren k nnen PASSENDES ZUBEH R ZERST UBER 1 Nasenst ck f r K...

Страница 24: ...s Ger ts Langsam tief einatmen es wird empfohlen nach der Inhalation den Atem f r einen Augenblick zu halten so dass sich die inhalierten Aerosoltr pfchen ablagern k nnen Atmen Sie dann langsam aus 5...

Страница 25: ...Strahl warme Luft z B mit einem F n DESINFEKTION Nach dem Entkeimen der Ampulle und Zubeh rteile m ssen sie desinfiziert werden dazu eine der nachfolgend beschriebenen Methoden w hlen Methode A Die Zu...

Страница 26: ...Vorgehensweise F llen Sie ein entsprechend gro es Gef in das alle einzelnen zu desinfizierenden Ger teteile passen mit einer L sung aus Trinkwasser und Desinfektionsmittel wobei die auf der Verpa cku...

Страница 27: ...SORGUNG ml min 1 ungef hr Modalit t Standard Modalit t High Speed F400 0 60 3 06 73 97 0 25 0 32 F700 F1000 0 80 3 32 71 91 0 32 0 42 1 Daten erfasst in internem Vorgang Flaem I29 P07 5 Die Abgabegesc...

Страница 28: ...uministrar medicamentos prescritos o recomendados por su m dico despu s de evaluar las condiciones generales del paciente Le recordamos que toda la gama de productos Flaem puede visualizarse en el Sit...

Страница 29: ...el accesorio para la nariz la mascarilla o el kit para reci n nacidos 4 Ponga en funcionamiento el aparato v ase el manual de instrucciones de uso Inspire suavemente y a fondo tras la inspiraci n se a...

Страница 30: ...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 de los m todos que se describen a continuaci n m todo...

Страница 31: ...11 13 1 13 2 13 3 13 4 en lavavajillas con ciclo caliente DESINFECCI N Los accesorios que se pueden desinfectar son 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 Utilice un desinfectante de tipo cloro ox...

Страница 32: ...Italia S r l en colaboraci n con la Universidad de Parma y de acuerdo con las Normativas Europeas para equipos de terapia respiratoria Norma EN 13544 1 2007 A1 M s informaci n disponible bajo solicitu...

Страница 33: ...31 Flaem www flaem it 1 2 3 4 5 PE 6 7 8 9 10 11 12 1 2 13 RF6 Basic2 13 1 13 2 13 3 13 4 93 42 1 6 d po so os...

Страница 34: ...32 SOFTTOUCH SoftTouch 1 13 2 13 1 13 4 13 3 13 2 13 1 13 3 3 4 5 12 13 1 2 3 4 3 4 RF6 Basic2 RF6 Basic2 5 2 high speed...

Страница 35: ...13 2 13 3 13 2 A 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 40 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 50 50 40 C A 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3...

Страница 36: ...4 10 C 1 2 3 4 8 10 11 13 1 13 2 13 3 13 4 6 A 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 40 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 8 11 13 1 13...

Страница 37: ...5 69 106 25 70 10 95 69 FLAEM bar MMAD m 2 5 m FPF 2 1 high speed F400 0 60 3 06 73 97 0 25 0 32 F700 F1000 0 80 3 32 71 91 0 32 0 42 1 Flaem I29 P07 5 2 in vitro T V Rheinland Italia S r l EN 13544 1...

Страница 38: ...ych b d zalecanych przez Waszego lekarz kt ry oceni og lny stan pacjenta Przypominamy i ca a gama produkt w Flaem znajduje si na stronie internetowej www flaem it AKCESORIA NEBULIZATOR 1 Wtyczka nosow...

Страница 39: ...i nosowej b d zestawu dla no worodk w 4 W czy urz dzenie patrz instrukcja obs ugi Wdycha aerozol swobodnie i g boko za leca si aby po wdechu wstrzyma oddech na chwil aby krople wdychanego aerozolu mog...

Страница 40: ...niku lub osuszy strumieniem ciep ego powietrza np za pomoc suszarki do w os w DEZYNFEKCJA Po odka eniu pojemnika i akcesori w nale y je zdezynfekowa w jeden z ni ej opisanych sposob w metoda A Akceso...

Страница 41: ...4 stosuj c ciep wod pitn oko o 40 C i delikatny p yn do naczy nie tr cy metoda B Odkazi akcesoria 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 w zmywarce sto suj c cykl z wod ciep DEZYNFEKCJA Akcesoria p...

Страница 42: ...rza min 10 max 95 Ci nienie atmosferyczne min 69KPa max 106KPa Warunki przechowywania Temperatura min 25 C max 70 C Wilgotno powietrza min 10 max 95 Ci nienie atmosferyczne min 69KPa max 106KPa 1 2 3...

Страница 43: ...41 1 ys ne cj mi y Flaem 1 2 3 4 5 PE 6 PVC 7 PVC 8 9 10 11 12 1 2 m 13 RF6 Basic2 13 1 13 2 13 3 13 4 93 42 CEE 1 6...

Страница 44: ...42 SOFTTOUCH SoftTouch 13 2 13 1 13 4 13 3 13 2 13 1 13 3 3 4 5 10 11 RF6 Basic2 2 RF6 Basic2 5 ml 2...

Страница 45: ...13 2 13 3 13 2 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 40 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 50 50 40 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13...

Страница 46: ...4 10 C 1 2 3 4 8 10 11 13 1 13 2 13 3 13 4 6 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 40 C 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 8 11 13 1 13 2 1...

Страница 47: ...max 95 min 69KPa max 106KPa min 25 C max 70 C min 10 max 95 min 69Kpa max 106KPa FLAEM bar MMAD m 2 5 m FPF 2 ml min 1 F400 0 60 3 06 73 97 0 25 0 32 F700 0 80 3 32 71 91 0 32 0 42 1 Flaem I29 P07 5...

Страница 48: ...46 www flaem it Flaem 13 2 1 13 3 13 4 13 1 13 10 13 RF6 Basic2 13 1 13 2 13 3 13 4 dir 93 42 EEC 6...

Страница 49: ...47 1 SOFTTOUCH SoftTouch 13 1 2 13 3 3 4 4 10 RF6 Basic2 RF RF6 Basic2 5...

Страница 50: ...3 3 13 3 13 2 13 2 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 40 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 C 50 50 40 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4...

Страница 51: ...10 1 2 3 4 8 10 11 13 1 13 2 13 3 13 4 C 6 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 40 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 5 6 7 8 10 11 13 1 13 2 13 3 13 4 1 2 3 4 8 11 13 1 13 2 13 3...

Страница 52: ...5 95 10 KPa 106 KPa 69 BF 9 8 7 6 5 4 3 2 1 CEE CE 93 42 LOT EN10993 1 93 42 EEC CE 1907 2006 FLAEM MMAD 2 5 FPF 2 1 F400 0 60 3 06 73 97 0 25 0 32 F700 F1000 0 80 3 32 71 91 0 32 0 42 Flaem I29 P07 5...

Страница 53: ...MEMO E...

Страница 54: ...MEMO...

Страница 55: ......

Страница 56: ...p A o che sia stato utilizzato in modo diverso dalla sua destinazione d uso La garanzia copre inoltre la sostituzione o la riparazione dei componenti con vizi di fabbricazione Sono esclusi dalla prese...

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