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Primo.Neb

Mod. P0403EM F400

AEROSOL THERAPY DEVICE

Congratulations on your purchase and thank you for choosing our unit.  Our goal is to 

fully satisfy our customers by offering them cutting-edge products for treating ailments 

of the respiratory system. 

Please read these instructions carefully and keep them 

handy for future reference. Use this device only as described in this manual. This 

is a home medical device for the nebulization and administration of medication 

prescribed or suggested by your doctor. 

Please visit 

www.flaem.it

 to see our entire 

range of Flaem products.

THIS DEVICE COMES EQUIPPED WITH:                                                                    

A -

Aerosol Therapy Device

A1 - Switch

A2 - Air outlet port

A3 - Air filter

A4 - Nebulizer port

A5 - Power cord

C - 

Accessories

C1 - RF7 Dual Speed Nebulizer

  

 C1.1 - Bottom piece

        C1.2 - Nozzle

        C1.3 - Top piece

     C1.4 - Speed selector 

C2 - Mouthpiece

C3 - SoftTouch

 

adult mask

B - 

Connection tube (main unit / 

nebulizer)

        IMPORTANT SAFEGUARDS                                                                                  

• Before using the device for the first time and periodically during the product’s life, 

check the integrity of its structure and of the power cable, making sure that there is no 

damage; if it is damaged, do not insert the plug and take the product immediately to an 

authorised FLAEM technical assistance centre or to your local dealer.

• The average life span of accessories is 1 year; however, we recommend you replace 

the nebulizer every 6 months in intensive use (or earlier, if the nebulizer is blocked) to 

always ensure maximum therapeutic effect.

•  Children and disabled persons should always use the unit under strict supervision of an 

adult who has read this manual.

•  Several parts of the device are small enough to be swallowed by children; therefore 

keep the device out of reach of children.

•  Do not use the tubes and the cords of the device for purposes other than those specified 

as they may cause strangulation hazard; utmost attention must be paid to children 

and persons with special needs; usually, such persons are not capable of assessing the 

hazard correctly.

•  The unit should not be used in the presence of anaesthetic mixture inflammable with 

air, oxygen or nitrous oxide. 

•  Keep the cord away from heated surfaces.

• Keep the power supply cord away from animals (for example rodents) as they may 

damage the insulation of the power supply cord.

•  Do not handle the unit with wet hands. Do not use the device in humid environments 

(e.g. while taking a bath or shower). Do not immerse the device in water; should this 

accidentally occur, unplug the device immediately. Do not remove or touch the device 

immersed in water before pulling out the plug. Take the device immediately to an 

authorized service center or to your local dealer.

•  Only use the device in dust-free environments; otherwise, therapy may be compromised.

•  The casing of this unit is not protected against the penetration of liquids.  Do not wash 

the device under running water or submerge in water. Keep away from splashing water 

or other liquids.

•  Do not expose the device to high temperatures.

•  Do not put the device  near heat sources, direct sunlight, or in hot environments.

•  Do not obstruct or insert any objects in the filter or in its housing.

•  Do not obstruct the air vents placed on both sides of the unit.

•  During use, always place the unit on a firm surface clear of obstacles.

•  Check that there is no material obstructing the air vents before each use.

•  Do not place any objects inside the air vents.

• The average duration provided for compressor ranges is: F400: 400 hours, F700: 700 

hours, F1000: 1000 hours, F2000: 2000 hours.

•  Repairs must be performed by authorized personnel only. Any unauthorized repairs will 

void the warranty and may pose a safety hazard for the user.

  WARNING: Do not modify this equipment without authorization of the manufacturer

•  The Manufacturer, the Retailer and the Importer are responsible for the safety, reliability 

and performance of the device only if: a) the device is used in accordance with the 

operating instructions b) the electrical system of the premises where the device is used 

is in compliance with current laws.

•  Interactions: The materials used that come into contact with medications have been 

tested with a wide range of medications. However, due to the variety and continuous 

evolution of medication, the possibility of a chemical interaction cannot be excluded. 

We recommend that once the medication has been opened you should use it as soon 

as possible and avoid prolonged contact of the medication with the nebulizer.

• The manufacturer should be contacted for reporting problems and/or unexpected 

events related to device operation.

OPERATING INSTRUCTIONS                                                                                              

Before each use, clean hands thoroughly and clean the device as described in the 

section on “CLEANING SANITIZATION DISINFECTION". During use, it is advisable to 

protect yourself from any dripping. It is recommended that each person use their 

own nebulizer cup and accessories to prevent risk of infection due to contamination.

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

1.  Plug the power cord (A5) into a power socket corresponding to the voltage of the unit. 

This must be positioned so that it is not difficult to make the disconnection from the 

mains.

2.  Insert the nozzle (C1.2) in the upper part (C1.3) pressing as shown by the 2 arrows in 

the “Connection diagram” in point C1. Insert the Speed selector (C1.4) in the upper part 

(C1.3) as shown in the “Connection diagram” in point C1.  Pour the medication prescribed 

by the doctor into the lower part (C1.1). Close the nebuliser by turning the upper part 

(C1.3) clockwise.

3.  Connect accessories as indicated in the “Connection diagram” on the cover. 

4.  Sit comfortably holding the nebuliser in your hand, place 

the mouthpiece onto your mouth or alternatively use the 

nose piece or mask. Should you opt for the mask accessory, 

place it on your face as shown in the picture (with or 

without using the elasticated strap).

5.  Turn on the device using the switch (A1) and then breathe 

in and exhale deeply.

6.  When the treatment is finished, shut off the device and 

unplug the power cord.

WARNING: 

If after the therapy session moisture accumulates 

in the tube (B), remove the tube from the nebulizer and dry it using the device’s 

ENGLISH

8

9

Summary of Contents for P0403EM F400

Page 1: ...agram Sch ma de montage Verbindingsschema Anschlussschema Croquis de conexiones ITALIANO Pag 1 ENGLISH pg 8 FRAN AIS Pag 15 NEDERLANDS Pag 22 CTp 43 ESPA OL P G 36 DEUTSCH Pag 29 50 B A3 A2 A4 C1 4 C1...

Page 2: ...Si ob ist de e LA A B P la ch d d L l a se In za A g N tr p co a Te Te ta N ti n l a a...

Page 3: ...vita media prevista degli accessori di 1 anno comunque consigliabile sostituire l ampolla ogni 6 mesi negli utilizzi intensivi o prima se l ampolla ostruita per garantire sempre la massima efficacia...

Page 4: ...lettrico dell ambiente in cui l apparecchio viene utilizzato e a norma ed e conforme alle leggi vigenti Interazioni i materiali utilizzati a contatto con i farmaci sono stati testati con una vasta gam...

Page 5: ...endere pi veloce la terapia inalatoria posizionate il tasto selettore di velocit C1 4 premendo con un dito sulla scritta MAX Per rendere pi efficace la terapia inalatoria premete con il dito sull iscr...

Page 6: ...metodi come di seguito descritto metodo A Gli accessori disinfettabili sono C1 1 C1 2 C1 3 C1 4 C2 C3 Procurarsi un disinfettante di tipo clorossidante elettrolitico principio attivo ipoclorito di so...

Page 7: ...di che essi vengano installati e o utilizzati in accordo a quanto specificato dal costruttore Rischio di potenziale interferenze elettromagnetiche con altri dispositivi in particolare con altri dispos...

Page 8: ...BF Interruttore funzionale spento Corrente alternata Interruttore funzionale acceso Pericolo folgorazione Conseguenza Morte E vietato utilizzare il dispositivo mentre si fa il bagno o la doccia In con...

Page 9: ...ne Pressione Max Portata aria al compressore Rumorosit a 1 m Funzionamento 230V 50Hz 130VA 1 8 0 3 bar 9 l min approx 54 dB A approx Continuo Condizioni d esercizio Temperatura Umidit aria Pressione a...

Page 10: ...ntensive use or earlier if the nebulizer is blocked to always ensure maximum therapeutic effect Children and disabled persons should always use the unit under strict supervision of an adult who has re...

Page 11: ...n as possible and avoid prolonged contact of the medication with the nebulizer The manufacturer should be contacted for reporting problems and or unexpected events related to device operation OPERATIN...

Page 12: ...pressing on MAX with your finger To increase the effectiveness of the inhalation therapy press with your finger on the wording MIN of the speed selector C1 4 In this position the speed selector acts a...

Page 13: ...d 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 wa...

Page 14: ...ation of Medical Devices and European Di rective 93 42 EEC Medical Devices Phthalate free In accordance with Reg EC n 1907 2006 IP21 Enclosure protection rating IP21 Protected against solid bodies ove...

Page 15: ...Pa max 106KPa Dimensions W x D x H Weight 14 5x14x10 5 cm 1 300 Kg APPLIED PARTS Type BF applied parts are patient accessories C2 C3 RF7 Dual Speed nebulizer Medication minimum capacity Medication max...

Page 16: ...tive 2012 19 EC of the European member state or of the country in which the product is disposed of ELECTROMAGNETIC COMPATIBILITY This device has been designed to meet the current requirements for elec...

Page 17: ...vendeur local La vie moyenne pr vue des accessoires est d 1 an on conseille quoi qu il en soit de remplacer l ampoule tous les 6 mois dans les utilisations intensives ou plus t t si l ampoule est bouc...

Page 18: ...possible d exclure l ventualit d une interaction consid rant la vari t et la constante volution des m dicaments Nous conseillons de consommer le m dicament le plus rapidement possible une fois qu il e...

Page 19: ...ires basses Pour rendre la th rapie inhalatrice plus rapide positionnez la touche s lecteur de vitesse C1 4 en appuyant avec un doigt sur l inscription MAX Pour rendre la th rapie par inhalation plus...

Page 20: ...avoir lav l ampoule et les accessoires les d sinfecter en choisissant l une des m thodes d crites ci apr s m thode A Les accessoires qu il est possible de d sinfecter sont C1 1 C1 2 C1 3 C1 4 C2 C3 Ut...

Page 21: ...ier durantl installationetl utilisation concernantlesexigences CEM il est donc demand que ces dispositifs soient install s et ou utilis s en accord avec ce qui a t sp cifi par le fabricant Risque d in...

Page 22: ...appareil pendant le bain ou la douche Interrupteur fonctionnel allum En conformit Norme Europ enne EN 10993 1 valuation biologique des dispositifs m dicaux et la Directive Europ enne 93 42 EEC Disposi...

Page 23: ...106KPa Dimensions L x P x H Poids 14 5 x 14 x 10 5 cm 1 300 Kg PARTIES APPLIQUEES Les parties appliqu es de type BF sont C2 C3 Ampoule RF7 Dual Speed Capacit minimum m dicament Capacit maximum m dica...

Page 24: ...ijk naar een geautoriseerd servicecentrum van FLAEM of naar uw dealer brengen De accessoires hebben een gemiddelde levensduur van 1 jaar Desondanks raden we u aan de vernevelaar bij intensief gebruik...

Page 25: ...anwijzing gebruikt wordt b het elektrische circuit in de ruimte waar het apparaat gebruikt wordt aan de van kracht zijnde normen voldoet Interacties de materialen die met de geneesmiddelen in aanrakin...

Page 26: ...aats voor een snellere inhalatietherapie de snelheidsschakelaar C1 4 op MAX door met de vinger op de tekst te drukken Plaats de snelheidsschakelaar C1 4 met een vinger op MIN om de inha latietherapie...

Page 27: ...hierna beschreven methoden ontsmetten methode A De accessoires die u kunt desinfecteren zijn C1 1 C1 2 C1 3 C1 4 C2 C3 Het te gebruiken ontsmettingsmiddel is ge lektrolyseerd bleekwater werkzame stof...

Page 28: ...overheid daarvoor ingesteld is of het toestel overhandigen aan de verkoper waar een nieuw gelijkaardig toestel aangeschaft wordt De gescheiden vuilinzameling en de daaropvolgende behandeling terugwinn...

Page 29: ...douche of in bad Elektrocutiegevaar Gevolg Dood Functieschakelaar aan Conform De Europese Norm EN 10993 1 Biologische Beoordeling van medische apparatuur en de Europese Richtlijn 93 42 EEG Medische A...

Page 30: ...gepaste onderdelen Toegepaste onderdelen type BF C2 C3 Vernevelaar RF7 Dual Speed Minimum inhoud geneesmiddel Maximum inhoud geneesmiddel Bedrijfsdruk met vernevelaar 2 ml 8 ml 0 65 bar Snelheidsschak...

Page 31: ...Besch digungen vorliegen falls Besch digungen vorhanden sein sollten den Stecker nicht einstecken und das Ger t sofort zu einem autorisierten Kundendienstzentrum von FLAEM oder zu Ihrem Vertrauensh n...

Page 32: ...ehmigung des Herstellers vornehmen Der Hersteller der Verk ufer und der Importeur haften nur dann f r die Sicherheit Zuverl ssigkeit und Leistungsf higkeit des Apparats wenn a er gem der Gebrauchsanle...

Page 33: ...ssionell und schnell geeignet f r die Verabreichung aller Arzneimittel einschlie lich der teuersten auch f r Patienten mit chronischen Atemwegserkrankungen Dank der Geometrie der Kan le des Verneblers...

Page 34: ...d beschriebenen Methoden w hlen Methode A Die Zubeh rteile die desinfiziert werden k nnen sind C1 1 C1 2 C1 3 C1 4 C2 C3 Zum Desinfizieren muss ein elektrolytisches Chloroxidationsmittel verwendet wer...

Page 35: ...werden muss Deswegen muss der Verbraucher das Altger t an die von den lokalen Verwaltungen zur Verf gung gestellten R ckgabe und Sammelstellen abgeben oder abgeben lassen oder das Altger t beim Kauf e...

Page 36: ...fahr Stromschlag Folge Tod Nie das Ger t beim Baden oder Duschen verwenden Funktionsschalter ein In Konformit t mit der Europ ischen Norm EN 10993 1 Biologische Beur teilung von Medizinprodukte und de...

Page 37: ...x H Gewicht 14 5x14x10 5 cm 1 300 Kg Zubeh rteile Zubeh rteile des Typs BF sind C2 C3 Vernebler RF7 Dual Speed Mindestmenge Arzneimittel H chstmenge Arzneimittel Druck bei Betrieb mit Spr hvorrichtun...

Page 38: ...mentaci n alejado de animales por ejemplo roedores de lo contrario estos animales podr an da ar el aislamiento del cable de alimentaci n No tocar el alimentador con las manos mojadas y no utilizar el...

Page 39: ...aparato es utilizado cumple la norma y es conforme a las leyes vigentes Interacciones los materiales utilizados que est n en contacto con los f rmacos han sido testados con una amplia gama de f rmacos...

Page 40: ...en la posici n MAX Para hacer m s eficaz la terapia de inhalaci n colocar el bot n para se leccionar la velocidad C1 4 apretando con un dedo en MIN en este caso se obtendr una suministraci n perfecta...

Page 41: ...n 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 A Los accesorios que se pue...

Page 42: ...r o hacer depositar dicho desecho que deber llevarse a centros de recogida selectiva pertenecientes a las administraciones locales o bien entregarlo a su distribuidor en el momento de compra de un nue...

Page 43: ...aparato mientras se toma un ba o o una ducha Peligro electrocuci n Consecuencia Muerte Interruptor de funcionamiento encendido Conforme a Norma Europea EN 10993 1 Evaluaci n Biol gica de dispositivos...

Page 44: ...es A x P x H Peso 14 5x14x10 5 cm 1 300 Kg PIEZAS MONTADAS Las piezas montadas de tipo BF son C2 C3 Nebulizador RF7 Dual Speed Capacidad m nima de f rmaco Presi n de funcionamiento con nebulizador Ope...

Page 45: ...x FLAEM 1 6 c Primo Neb P0403EM F400 Flaem www flaem it A A1 A2 A3 A4 A5 C C1 RF7 Dual Speed C1 1 C1 2 C1 3 C4 4 C C2 C3 B 43...

Page 46: ...F400 400 F700 700 F1000 1000 F2000 2000 b _ 1 2 3 4 5 6 44...

Page 47: ...00 b 2 C1 2 C1 3 2 C1 C1 4 C1 3 C1 C1 1 C1 1 3 4 5 1 6 B RF7 DUAL SPEED RF7 Dual Speed C1 4 MAX MIN C1 4 45...

Page 48: ...SOFTTOUCH SoftTouch C1 3 C1 2 C1 4 C1 3 C1 A C1 1 C1 2 C1 3 C1 4 C2 C3 40 C C1 1 C1 2 C1 3 C1 4 C2 C3 C C1 1 C1 2 C1 3 C1 4 C2 C3 50 50 40 C A C1 1 C1 2 C1 3 C1 4 C2 C3 46...

Page 49: ...C1 1 C1 2 C1 3 C1 4 C2 C3 10 C C1 1 C1 2 C1 3 C1 4 C2 C3 6 3 Flaem 47...

Page 50: ...RF7 Dual Speed ACO461P ACO462P 1 ACO35 2 ACO439 T V EN 60601 1 3 Ed EN 60601 1 11 93 42 II F 10993 1 93 42 EEC 1907 2006 IP21 IP21 12 1 2 M 2 1 2 EN 60601 1 2 2007 EMC RF www flaemnuova it Flaem 48...

Page 51: ...max 40 C min 10 max 95 69 106 25 C 70 C 10 95 69 106 a L x P x H 14 5 x 14 x 10 5 cm 1 300 F C2 C3 RF7 Dual Speed 2 8 0 65 C C1 4 Max Min 1 0 55 0 25 2 MMAD 4 58 m 3 78 m 2 5 m FPF 54 4 63 1 Flaem I29...

Page 52: ...FLAEM 7 Primo Neb P0403EM F400 www flaem it Flaem RF7 C1 C1 1 C1 2 C1 3 C1 4 C2 SoftTouch C3 C 50...

Page 53: ...FLAEM A5 1 C1 3 C1 2 2 C1 3 C1 4 C1 C1 1 C1 C1 3 3 4 A1 5 6 B 51...

Page 54: ...SoftTouch SoftTouch C1 4 MAX MIN C1 4 Dual Speed RF7 Dual Speed RF7 A3 Flaem 52...

Page 55: ...C1 3 C1 C1 3 C1 4 C3 C2 C1 4 C1 3 C1 2 C1 1 A 40 C3 C2 C1 4 C1 3 C1 2 C1 1 B C3 C2 C1 4 C1 3 C1 2 C1 1 C 50 50 40 C3 C2 C1 4 C1 3 C1 2 C1 1 A C3 C2 C1 4 C1 3 C1 2 C1 1 B 10 C3 C2 C1 4 C1 3 C1 2 C1 1 C...

Page 56: ...ACO461P Dual Speed RF7 ACO462P ACO35 1 ACO439P 42 93 CEE CE II 1 EN10993 EEC 42 93 2006 1907 CE n FB IP21 12 IP21 EN 60601 1 11 EN 60601 1 3 T V M 54...

Page 57: ...1 40 10 95 10 KPa 106 KPa 69 70 25 95 10 KPa 106 KPa 69 18x14x13 x x 1 300 C1 C2 BF Dual Speed Ampolla RF7 2 8 0 65 C1 4 Max C1 4 Min 1 0 55 0 25 MMAD 2 m 4 58 m 3 78 m 5 2 FPF 54 4 63 Flaem I29 P07 5...

Page 58: ...2 2007 1 60601 60 EN EMC RE Flaem www flaemnuova it CE 19 2012 CE 19 2012 56...

Page 59: ......

Page 60: ...to Le spese postali di spedizione e riconsegna dell apparecchio sono a carico del Centro di Assistenza Tecnica Autorizzato nel caso di operativit della garanzia Nel caso in cui il Centro di Assistenza...

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