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ΚΙΝΔΥΝΟΣ ΗΛΕΚΤΡΟΜΑΓΝΗΤΙΚΩΝ ΠΑΡΕΜΒΟΛΩΝ ΚΑΙ ΠΙΘΑΝΕΣ ΛΥΣΕΙΣ

Η ενότητα αυτή περιλαμβάνει πληροφορίες για τη συμμόρφωση της συσκευής με το EN 60601

-1-

2. Η συσκευή θεραπείας

αερολύματος KIWI Plus είναι ένα ηλεκτρικό ιατροτεχνολογικό προϊόν για το οποίο απαιτούνται ειδικές προφυλάξεις ως προς

την ηλεκτρομαγνητική συμβατότητα και πρέπει να εγκαθίσταται και να χρησιμοποιείται σύμφωνα με τις πληροφορίες που

ορίζονται στα συνοδευτικά έγγραφα. Οι φορητές και κινητές συσκευές επικοινωνιών με ραδιοσυχνότητες (κινητά τηλέφωνα,

πομποδέκτες, κ.λπ.) μπορεί να παρεμβάλλουν στο ιατροτεχνολογικό προϊόν και δεν πρέπει να χρησιμοποιούνται σε μικρή

απόσταση, δίπλα ή πάνω στο ιατροτεχνολογικό προϊόν. Εάν η συγκεκριμένη χρήση είναι απαραίτητη και αναπόφευκτη, θα

πρέπει να λαμβάνονται ειδικές προφυλάξεις ώστε το ηλεκτρικό ιατροτεχνολογικό προϊόν να λειτουργεί σωστά με την

προβλεπόμενη διαμόρφωση λειτουργίας του (για παράδειγμα, συνεχής και οπτικός έλεγχος

για την απουσία ανωμαλιών και

δυσλειτουργιών).

Οι ακόλουθοι πίνακες περιλαμβάνουν πληροφορίες σχετικά με τα χαρακτηριστικά ΗΜΣ (Ηλεκτρομαγνητική

συμβατότητα) του ηλεκτρικού ιατροτεχνολογικού προϊόντος.

Οδηγίες και δήλωση κατασκευαστή

Ηλεκτρομαγνητικές εκπομπές

Η συσκευή αερολύματος KIWI Plus προορίζεται για χρήση στο παρακάτω προδιαγραφόμενο ηλεκτρομαγνητικό

περιβάλλον. Ο πελάτης ή/και ο χρήστης της συσκευής αερολύματος KIWI Plus πρέπει να διασφαλίζεται ότι η

συσκευή χρησιμοποιείται σε τέτοιο περιβάλλον

Δοκιμή εκπομπών

Συμμόρφωση

Οδηγίες για το ηλεκτρομαγνητικό περιβάλλον

Ακτινοβολούμενες / Αγώγιμες

Εκπομπές CISPR11

Μονάδα 1

Η συσκευή θεραπείας με αερόλυμα KIWI Plus

χρησιμοποιεί ενέργεια ραδιοσυχνοτήτων μόνο για την

εσωτερική της λειτουργία. Ως εκ τούτου, οι εκπομπές

των ραδιοσυχνοτήτων της είναι πολύ ασθενείς και δεν

προκαλούν οποιαδήποτε παρεμβολή σε οποιαδήποτε

παρακείμενη ηλεκτρονικό συσκευή.

Ακτινοβολούμενες

/ Αγώγιμες

Εκπομπές CISPR11

Κατηγορία [B]

Η συσκευή θεραπείας αερολύματος KIWI Plus είναι

κατάλληλη για χρήση

σε κάθε περιβάλλον,

περιλαμβανομένου του οικιακού, και σε αυτά που

συνδέονται με το δημόσιο δίκτυο διανομής που παρέχει

τροφοδοσία σε περιβάλλοντα που χρησιμοποιούνται για

οικιακούς σκοπούς.

Αρμονικές EN 61000

-3-2

Κατηγορία [A]

Διακυμάνσεις τάσης /

τρεμόσβησμα EN 61000

-3-3

Συμμορφώνεται

Содержание KIWI Plus

Страница 1: ...1...

Страница 2: ...IONE COMPRENDE a b c d e f g h i a Main Unit Unit Principale b Medication Chamber Camera porta farmaco con Mesh c S Pediatric Mask S Maschera Pediatrica S d L Adult Mask L Maschera Adulti L e Masks co...

Страница 3: ...100 240V 50 60 Hz Medical Grade Alimentatore DC universale 100 240V 50 60 Hz di Grado Medicale l Instruction Manual Manuale PARTS DESCRIPTION DESCRIZIONE DEI COMPONENTI 1 Medication Chamber Camera po...

Страница 4: ...arica 6 LED Operating LED Indicatore LED di funzionamento 7 Button to remove Medication Chamber Pulsante rimozione camera porta farmaco 8 AC AC adapter inlet with splashguard Connettore alimentatore A...

Страница 5: ...zione La presenza di piccole componenti e batterie comporta il rischio di soffocamento per ingestione da parte di bambini o animali domestici si raccomanda quindi di conservare prodotto sue componenti...

Страница 6: ...6 KIWI Plus MESH PC 200 0 1 ml 93 MMAD 1 51 m CA MI 1 2 3...

Страница 7: ...7 4 5 6 KIWI Plus 7 8 9 ISO 10993 1 10 EN 60601 1 11 12 13 14...

Страница 8: ...8 15 93 42 EEC...

Страница 9: ...9 1 8 ml 8 cc 12 ml 8 ml...

Страница 10: ...10 2 4 L S...

Страница 11: ...iu Technology Co Ltd HNEL050100WE 100 240 V 0 2 A 50 60 Hz 5 V 1 A Shenzhen Huoniu Technology Co Ltd HNBI050100WE 100 240 V 0 2 A 50 60 Hz 5 V 1 A Shanghai Sucheng Electronic Co Ltd SC06W 0501000V 100...

Страница 12: ...12 3 2 100 220 28 1 1 2 5 ml NaCl 0 9 300 1 100 3 2 1 DC 4 100 1 300...

Страница 13: ...13 LED 4 20 90...

Страница 14: ...14 1 1 1...

Страница 15: ...15 2 1 2 5 3 30 4 Y 10...

Страница 16: ...16 KIWI Plus SP 0279 Soft Touch K L SP 0281 Soft Touch K S SP 0282 Soft Touch K SP 0283 SP 0263 K SP 0284 AC DC SP 0262 AC DC SP 0262 01 EVO KIWI Plus SP 0280 12 350...

Страница 17: ...17 2 180 5 2 1 0 3 2 3 4 5 1 2 3 4 5...

Страница 18: ...2 0 W 220 14 2 1 1 2 5 ml NaCl 0 9 4 300 100 2 0 1 ml MMAD 100 laser 4 5 m 100 0 25 ml min 2ml NaCl 0 9 MMAD EN 13544 1 1 51 m GSD EN 13544 1 1 75 EN 13544 1 1 58 ml EN 13544 1 0 22 ml min 1 min 0 30...

Страница 19: ...19 8 ml 10 40 C 30 85 700 1 060 hPa 20 50 C 30 80 795 1 013 hPa 100 MMAD Mass Median Aerodynamic Diameter Marple Marple Personal Cascade Impacter GSD 100 EN 13544 1 EN 13544 1 m...

Страница 20: ...20 CA MI Srl 24 CA MI srl CA MI srl 93 42 BF II AC DC...

Страница 21: ...21 IPX2 1 2 15 2006 66 2012 19...

Страница 22: ...22 EN 60601 1 2 KIWI Plus KIWI Plus KIWI Plus CISPR11 1 KIWI Plus CISPR11 B KIWI Plus EN 61000 3 2 A EN 61000 3 3...

Страница 23: ...ARRYING CASE BEFORE EACH USE GENERAL WARNINGS 16 When opening the package check the integrity of the device and the power supply Pay particular attention to any damage to the plastic parts which may e...

Страница 24: ...er supply unattended in places accessible to children and or people not in full possession of their mental faculties as there is a risk of strangulation with the electric cable 24 The medical device m...

Страница 25: ...s have been performed or any of its parts have been damaged by accident improper use and or abuse Any unauthorised intervention even minimally on the device voids the warranty immediately and in any c...

Страница 26: ...appropriate safety lever with your fingers B Insert the prescribed drug s in compliance with the instructions of your doctor and the drug manufacturer ATTENTION The drug chamber is equipped with a gra...

Страница 27: ...missing good connection If the chamber has been properly engaged by pressing the ON OFF button the button operation BLU light flash slow cycle of 4 sec and permanently until the end of treatment and...

Страница 28: ...d potentially hazardous conditions overheating accidental drops and or damages we recommend disconnecting the power supply from the socket immediately after having finished using the device Do not lea...

Страница 29: ...level of charge of the battery With fully discharged batteries the full charge time lasts approximately 4 hours 100 charge C The recharging will stop if the device is turned on for nebulization during...

Страница 30: ...duct must be operated until the drug is fully used up until steam output has completely stopped Completely empty the chamber if treatment is stopped before its entire contents have been used In either...

Страница 31: ...or about 1 hour to cleanse these and or to remove residues and deposits DO NOT CLEAN THE MAIN UNIT USING WATER AVOID CONTACT WITH WET SURFACES AND EXPOSURE TO POSSIBLE SPLASHES DO NOT CLEAN THE DEVICE...

Страница 32: ...sinfected by boiling in water for about 10 minutes or using hot steam sterilising devices commonly used to disinfect accessories and components for children and infants Once boiled disinfected leave t...

Страница 33: ...ecay Minimum Expected service life 2 Years for main unit and power supply MAX 180 operating hours for drug chamber in accordance with the standard test and operation conditions Shelf life max 5 years...

Страница 34: ...tent with the technical and safety specifications of the device to which the manual refers The stated technical specifications are updated to the date of the publication of this document and only appl...

Страница 35: ...temperature 10 40 C Relative humidity 30 85 RH non condensing Atmospheric pressure 700 1060 hPa STORAGE CONDITIONS AND OF TRANSPORT Room temperature 20 50 C Relative humidity 30 80 RH non condensing...

Страница 36: ...to perform repair in the shortest possible time The warranty with the exclusion of liability for direct or indirect damage is limited only to material or workmanship defects and is not valid when the...

Страница 37: ...vice with Class of Insulation II if used with the provided AC DC power supply Alternating current Direct Current IPX2 Degree of protection of an electrical device against accidental or intentional pen...

Страница 38: ...ble negative effects on the environment and human health and allows the recovery of materials of which it is composed in order to obtain significant savings in energy and resources The symbol on the d...

Страница 39: ...ted Conducted Emissions Unit 1 The KIWI Plus aerosol uses RF energy only for its internal operation Therefore its RF emissions are very low and do not cause any interference with any nearby electronic...

Страница 40: ...TO CONTATTARE IL SERVIZIO TECNICO DEL DISTRIBUTORE E O SERVIZIO TECNICO CA MI PRIMA DI OGNI UTILIZZO TOGLIERE L APPARECCHIO DALLA VALIGETTA DI TRASPORTO AVVERTENZE GENERALI 1 All apertura dell imballo...

Страница 41: ...positivo KIWI Plus deve essere installato e utilizzato lontano da apparecchi di comunicazione RF mobili e portatili telefoni cellulari ricetrasmettitori ecc che potrebbero influenzare lo stesso dispos...

Страница 42: ...la camera porta farmaco Potrebbero risultarne danneggiati in modo irreversebile o creare pericolo di scossa elettrica Fabbricante e Distributore non possono essere ritenuti responsabili di danni accid...

Страница 43: ...ACO FIG A FIG B FIG C A Aprire il coperchio della camera porta farmaco sganciando con le dita l apposita leva di sicurezza B Inserire i il farmaci o prescritti o in ottemperanza alle istruzioni del pr...

Страница 44: ...nciata e in tal caso premendo il pulsante ON OFF il controllo elettronico di cui dotato il dispositivo attiver per alcuni secondi la retroilluminazione del pulsante stesso che constatata la mancanza d...

Страница 45: ...ectronic Co Ltd SC06W 0501000V Input 100 240V 0 15 AMax 50 60Hz Output 5V 1A A Il connettore DC situato nella parte inferiore del dispositivo Sganciare il coperchio di protezione verde come illustrato...

Страница 46: ...e alla presa di corrente per avviare il ciclo di ricarica B Una volta collegato l alimentatore alla presa di corrente si accender una luce GIALLA sul fondo del dispositivo per indicare che il ciclo di...

Страница 47: ...ne interrompendo di conseguenza il flusso di nebulizzato Per evitare l otturazione e o il danneggiamento della mesh il prodotto deve essere fatto funzionare sino ad esaurimento completo del farmaco si...

Страница 48: ...le anche immergere camera portafarmaco e accessori maschere con relativo connettore accessorio nasale e boccaglio in una soluzione 1 1 di acqua e aceto bianco per circa 1 ora per detergere e o rimuove...

Страница 49: ...BOCCAGLIO possono essere disinfettati utilizzando alcool denaturato o soluzione a base di ipoclorito facilmente reperibile in farmacia Prima di riutilizzare tali accessori necessario risciacquare in a...

Страница 50: ...ne e contaminazione microbica si consiglia un uso personale degli accessori e della camera porta farmaco e il rispetto delle procedure di sterilizzazione indicate in questo manuale consultare sempre i...

Страница 51: ...ta Pulire i contatti rimuovendo la causa del contatto elettrico scarso Rimuovere il liquido dai contatti Sostituire la Mesh con una nuova Sostituire la Mesh con una nuova 3 Il dispositivo si accende p...

Страница 52: ...erando 2 terapie di nebulizzazione complete 1 terapia 1 nebulizzazione totale di 2 5ml di fisiologica NaCl 0 9 TEMPO DI RICARICA MAX Circa 4 ore VITA UTILE DELLA BATTERIA 300 CICLI di carica completa...

Страница 53: ...er assicurare il rispetto dei parametri ottenuti secondo procedura della norma EN 13544 1 GRAFICO DISTRIBUZIONE PARTICELLARE COME DA EN 13544 1 N B Le misure e le curve non sono valide in caso di farm...

Страница 54: ...di tipo commerciale e le relative caratteristiche di carica potrebbero essere deteriorate in funzione della loro data di fabbricazione delo loro stoccaggio e del tempo di permanenza a magazzino quind...

Страница 55: ...r l ambiente e per la salute derivanti da un suo smaltimento inadeguato e permette di recuperare i materiali di cui composto al fine di ottenere un importante risparmio di energie e di risorse Il simb...

Страница 56: ...1 Gruppo 1 L aerosol KIWI Plus utilizza energia RF solo per la sua funzione Interna Per tanto le sue emissioni RF sono molto basse e non causano alcuna interferenza in prossimit di alcun apparecchio e...

Страница 57: ...57...

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