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        IMPORTANT WARNINGS                                                                                      

•  Before using the product for the first time, and periodically during its lifetime, check 

the integrity of the device structure and of the power cable to make sure there is no 

damage. In the event of damage, do not plug in the cable and immediately take the 

product to an authorised FLAEM service centre or to your trusted dealer.

• The expected medical life of the accessories is 1 year. It is, however, advisable to 

replace the nebuliser cup every 6 months in the event of intense use (or earlier if the 

cup is obstructed) to always guarantee maximum therapeutic efficacy.

•  Children and people who are not self-sufficient must use the device under the close 

supervision of an adult who has read this manual.

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

keep the device out of the reach of children.

•  Do not use the supplied tubing and cables for anything other than their intended 

use. These parts could cause a strangling hazard: pay close attention to children and 

persons with particular difficulties as they are often unable to accurately evaluate 

danger.

•  The apparatus is unsuitable for use in presence of flammable anaesthetic mixture 

with air, oxygen or nitrous oxide.

•  Always keep the power supply cable away from hot surfaces.

•  Keep the power cable away from animals (for example, rodents) which could damage 

the insulation. 

• Do not handle the device with wet hands. Do not use the device in damp 

environments (for example, while taking a bath or shower). Do not immerse the 

device in water; in the event of immersion immediately disconnect the plug. Do not 

MISTRAL PLUS

Mod. P0106EM F400

AEROSOL THERAPY APPARATUS

We are pleased you have purchased our product and we thank you for your trust 

in us. Our goal is to fully satisfy consumers by offering them cutting-edge systems 

for the treatment of respiratory tract ailments. Carefully read these instructions and 

keep them in a safe place for future reference. Read these instructions carefully 

and retain them for future reference. Only use the accessory as described in 

this manual. This is a medical device to nebulise and administer medication 

prescribed or recommended by your doctor.  Please note that the full range of 

products is visible on the website www.flaemnuova.it

STANDARD EQUIPMENT INCLUDES:                                                                          

A -

Aerosol apparatus

(main unit)

A1 - On/Off switch

A2 - Air intake

A3 - Air filter

A4 - Nebuliser holder

A5 - Handle for transport

A6 - Power cable

A7 - Socket for power cord

C -

Accessories

C1 - RF8 Nebuliser

  C1.1 - Lower part

  C1.2 - Upper part 

  C1.3 - Drugsaver 

C2 - Mouthpiece

C3 - Pediatric nose piece

C4 - Pediatric face mask

C5 - Adult face mask

B -

Connection tube

(main unit / nebuliser)

Summary of Contents for MISTRAL PLUS P0106EM F400

Page 1: ...C1 1 C1 3 C1 C1 2 A5 A3 A4 A2 A1 A6 A7 A4 C A B C5 C4 C2 C3 C1 I MANUALE ISTRUZIONI D USO GB INSTRUCTION FOR USE MANUAL Schema di collegamento Assembly diagram MISTRAL PLUS ...

Page 2: ......

Page 3: ...anestetica infiammabile con aria o con ossigeno o con protossido d azoto Tenete sempre il cavo di alimentazione lontano da superfici calde Teneteilcavodialimentazionelontanodaglianimali adesempio roditori altrimenti tali animali potrebbero danneggiare l isolamento del cavo di alimentazione Non maneggiate l apparecchio con le mani bagnate Non usate l apparecchio in MISTRAL PLUS Mod P0106EM F400 APP...

Page 4: ...TENZIONE Non modificare questo apparecchio senza l autorizzazione del fabbricante Il Fabbricante il Venditore e l Importatore si considerano responsabili agli effetti della sicurezza affidabilità e prestazioni soltanto se a l apparecchio è impiegato in conformità alle istruzioni d uso b l impianto elettrico dell ambiente in cui l apparecchio viene utilizzato e a norma ed e conforme alle leggi vige...

Page 5: ...ll innovativo Limitatore di Di spersione Questi caratteristici elementi che ci contraddistinguono consentono una maggiore sedimentazione del farmaco nel paziente ed an che in questo caso ne limita la dispersione Nella fase inspiratoria la linguetta che funge da Limitatore di Di spersione si piega verso l inter no della mascherina Nella fase espiratoria la linguetta che funge da Limitatore di Di sp...

Page 6: ...itico principio attivo ipoclorito di sodio specifico per disinfezione reperibile in tutte le farmacie Esecuzione Riempire un contenitore di dimensioni adatte a contenere tutti i singoli componenti da disinfettare con una soluzione a base di acqua potabile e di disinfettante rispettando le proporzioni indicate sulla confezione del disinfettante stesso Immergere completamente ogni singolo componente...

Page 7: ...rticale di gocce d acqua Temperatura ambiente minima e massima Umidità aria minima e massima Pressione atmosferica minima e massima COMPATIBILITÀ ELETTROMAGNETICA Questo apparecchio è stato studiato per soddisfare i requisiti attualmente richiesti per la compatibilità elettromagnetica EN 60601 1 2 2007 I dispositivi elettromedicali richiedono particolare cura in fase di installazione ed utilizzo r...

Page 8: ...many in conformità allo Standard Europeo per apparecchi da aerosolterapia Norma EN 13544 1 Maggiori dettagli sono disponibili a richiesta SMALTIMENTO DELL APPARECCHIO In conformità alla Direttiva 2012 19 CE il simbolo riportato sull apparecchiatura indica che l apparecchio da smaltire è considerato come rifiuto e deve essere quindi oggetto di raccolta separata Pertanto l utente dovrà conferire o f...

Page 9: ...s keep the power supply cable away from hot surfaces Keep the power cable away from animals for example rodents which could damage the insulation Do not handle the device with wet hands Do not use the device in damp environments for example while taking a bath or shower Do not immerse the device in water in the event of immersion immediately disconnect the plug Do not MISTRAL PLUS Mod P0106EM F400...

Page 10: ...d current laws Interactions the materials used in contact with medication have been tested with a vast range of medications However in view of the variety and continuous evolution of pharmaceuticals interactions cannot be ruled out We recommend using the medication as soon as possible once it has been opened and preventing prolonged exposure in the nebuliser cup The manufacturer must be contacted ...

Page 11: ...he 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 SoftTouch masks have an outer edge made of soft biocompatible material tha...

Page 12: ...2 C1 3 C2 C3 by boiling them in water for 10 minutes use demineralised or distilled water to prevent calcium deposits method C Disinfect the accessories C1 1 C1 2 C1 3 C2 C3 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 ...

Page 13: ...ertically dripping water Minimum and maximum ambient temperature Minimum and maximum humid ity Minimum and maximum air pressure ELECTROMAGNETIC COMPATIBILITY This device was designed to satisfy the currently required requisites for electromagnetic compatibility EN 60601 1 2 2007 Electro medical devices require particular care during installation and use relative to EMC requirements Users are there...

Page 14: ...PARTS Type BF applied parts are patient accessories C2 C3 C4 C5 RF8 nebuliser Medication minimum capacity Medication maximum capacity Operating pressure with neb 2 ml 8 ml 0 8 bar DEVICE DISPOSAL In compliance with the Directive 2012 19 EC the symbol printed on the device shows that the device to be disposed of is considered waste and must therefore be an item of differentiated collection Conseque...

Page 15: ...15 ...

Page 16: ...EM NUOVA S p A Via Colli Storici 221 25015 S MARTINO DELLA BATTAGLIA Brescia ITALY Tel 39 030 9910168 r a Fax 39 030 9910287 www flaemnuva it 2017 FLAEM NUOVA All right reserved cod 17586 Rev 01 2017 TÜV 4 ...

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