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SOFTTOUCH FACE MASKS

Soft

biocompatible

material

Dispersion 

Limiting  Vent

CLEANING SANITISATION DISINFECTION                                                                    

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

socket.

DEVICE AND TUBING EXTERIOR

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 (C1.2) anticlockwise, remove the upper 

part (C1.2 and C1.3) as shown in the “Assembly diagram” in point C1. 

Then proceed according to the following instructions.

SANITISATION

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

of the methods described below. 

method A: Sanitise accessories C1.1-C1.2-C1.3-C2-C3-C4-C5  under potable hot 

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

method B: Sanitise accessories C1.1-C1.2-C1.3-C2-C3-C4-C5   in the dishwasher with 

a hot cycle.

method C: Sanitise accessories C1.1-C1.2-C1.3-C2-C3-C4-C5 by immersing 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 

SoftTouch masks have an outer edge made of soft 

biocompatible material that ensures excellent 

adherence to the face, and is also equipped with 

an innovative Dispersion Limiting Device. These 

distinctive elements that distinguish it allow great-

er sedimentation of medication in the patient and 

also limit dispersion.

During the inspiratory phase, 

the  tab, acting as a Dispersion 

Limiting Device, bends inwards 

towards the mask.

During the expiratory phase, the 

tab, acting as a Dispersion Lim-

iting Device, bends outwards 

from the mask.

deeply in and out. After inhaling, we recommend holding your breath for an instant 

to allow the inhaled drops of aerosol to deposit. Then exhale slowly.

6. Upon completing application, switch off the device and unplug it.

ATTENTION: If after the therapy session an evident deposit of moisture forms within 

the pipe (B), detach the pipe from the nebuliser and dry it with the very ventilation 

from the compressor; this operation prevents possible blooms of mould inside the 

pipe.

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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