NORME GENERALI DI SICUREZZA

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2 I Il dispositivo in questione è consigliato per la prevenzione delle piaghe da decubito di I stadio, in terapie a lungo termine e terapie domiciliari. L alternarsi dei punti di contatto con l epidermide effettua un delicato massaggio che consente un buon flusso di sangue e una buona ossigenazione dei tessuti, prevenendo la formazione di ulcere da decubito. La manopola di regolazione controlla il livello di uscita della pressione. Ruotandola in senso orario aumenta la pressione, al contrario la pressione diminuisce. Di semplice installazione, utilizzo e manutenzione con la possibilità di regolare la pressione in funzione del peso del paziente. Il materassino, realizzato in PVC atossico, viene gonfiato grazie all apposito compressore, e sostiene il soggetto disteso. DESTINAZIONE D 'USO La pompa e il materasso sono destinate a ridurre l'incidenza delle ulcere da pressione, ottimizzando il comfort del paziente. NORME GENERALI DI SICUREZZA 1. Il dispositivo medico necessita di particolari precauzioni per quanto concerne la compatibilità elettromagnetica e deve essere installato e utilizzato secondo le informazioni fornite con i documenti di accompagnamento. 2. All apertura dell imballo, verificare l integrità dell apparecchio, prestando particolare attenzione alla presenza di danni alle parti plastiche che possono rendere accessibili parti interne dell apparecchio sotto tensione. In tali casi non collegare la pompa alla presa elettrica. Effettuare tali controlli prima di ogni utilizzo. 3. Prima di collegare l apparecchio verificare sempre che i dati elettrici indicati sull etichetta dati e il tipo di spina utilizzato, corrispondano a quelli della rete elettrica a cui si intende connetterlo. 4. Nel caso la spina in dotazione all apparecchio sia incompatibile con la presa della rete elettrica, rivolgersi a personale qualificato per la sostituzione della spina con altra di tipo adatto. In generale, è sconsigliabile l utilizzo di adattatori, semplici o multipli e/o prolunghe. Qualora il loro utilizzo fosse indispensabile, è necessario utilizzare tipi conformi alle norme di sicurezza, facendo comunque attenzione a non superare i limiti massimi di alimentazione sopportati, che sono indicati sugli adattatori e sulle prolunghe. 5. Rispettare le norme generali di sicurezza e in particolare: Il dispositivo non deve essere utilizzato da bambini e / o incapaci senza la sorveglianza di un adulto in possesso delle piene facoltà mentali; Non esporre il dispositivo a temperature estreme, polvere e / o raggi del sole diretti. Maneggiare con cura il dispositivo Nel caso di rotture non cercare di riparare il dispositivo. Contattare il servizio tecnico CA-MI. L alterazione di una parte qualsiasi del dispositivo sollevano il fabbricante da qualsiasi responsabilità per danni al prodotto, a cose, persone e / o animali. NON UTILIZZARE il dispositivo in ambienti in cui siano presenti miscele anestetiche infiammabili: potrebbero essere causa di esplosione Non rimuovere la copertura (sul retro) in quanto potrebbe essere causa di scossa elettrica. Non utilizzare mai questo prodotto con il cavo di alimentazione o la spina danneggiati, se non funziona bene, se è stato danneggiato o è caduto oppure se è caduto in acqua. Riportare il dispositivo al centro servizi per il controllo o la riparazione. Tenere il cavo lontano da superfici incandescenti. 6. Il dispositivo deve essere destinato esclusivamente all uso per il quale è stato progettato. Ogni utilizzo diverso per il quale l apparecchio è stato progettato è da considerarsi improprio e quindi potenzialmente pericoloso e per tale motivo il fabbricante e il distributore non possono essere considerati responsabili per danni causati al prodotto, cose, persone e / o animali derivanti da un improprio, erroneo e / o utilizzo irragionevole. 7. Lo smaltimento degli accessori e del dispositivo medico deve essere eseguito secondo le specifiche legislazioni vigenti in ogni paese; 8. Il mancato rispetto di quanto riportato qui sopra può compromettere la sicurezza del dispositivo. PRIMA DI UTILIZZARE L APPARECCHIO CONSULTARE ATTENTAMENTE IL MANUALE D USO NON SMONTARE MAI IL DISPOSITIVO. PER QUALSIASI INTERVENTO CONTATTARE IL SERVIZIO TECNICO CA-MI S.r.l. EVITARE CHE BAMBINI E / O INCAPACI POSSANO UTILIZZARE IL DISPOSITIVO MEDICO SENZA LA DOVUTA SORVEGLIANZA DI UN ADULTO IN POSSESSO DELLE PIENE FACOLTÀ MENTALI 2

3 I AVVERTENZE PER IL CORRETTO SMALTIMENTO DEL PRODOTTO AI SENSI DELLA DIRETTIVA EUROPEA 2012/19/UE- RAEE: Alla fine della sua vita utile il prodotto non deve essere smaltito insieme ai rifiuti urbani. Può essere consegnato presso gli appositi centri di raccolta differenziata predisposti dalle amministrazioni comunali, oppure riconsegnarlo al distributore all atto dell acquisto di un nuovo apparecchio dello stesso tipo ed adibito alle stesse funzioni. Smaltire separatamente il prodotto consente di evitare possibili conseguenze negative per l ambiente e per la salute derivanti da un suo smaltimento inadeguato e permette di recuperare i materiali di cui è composto al fine di ottenere un importante risparmio di energie e di risorse. Il simbolo posto all interno dell etichetta dati indica la raccolta separata delle apparecchiature elettriche ed elettroniche. Attenzione: Uno smaltimento non corretto di apparecchiature elettriche ed elettroniche potrebbe comportare sanzioni. CARATTERISTICHE STANDARD Facile da utilizzare Portatile e leggero Il materassino contiene 130 celle a bolle d aria CARATTERISTICHE TECNICHE Tipologia Dispositivo Medico Classe I COMPRESSORE MATERASSINO Alimentazione: 230V~ / 50Hz Dimensioni: 3000(L)mm x 900 (W)mm x 65(H)mm Emissione dell aria: 4.5 l/min Numero celle: 130 celle a bolla d aria Variazione della pressione: 30 mmhg 110 mmhg Materiale: PVC (EN-71, bassa tossicità) Tempo del ciclo: 10 min. Spessore PVC: 0.30 mm Potenza Assorbita: 5W Colore: beige Fusibile: 1A Kit per la riparazione incluso Dimensioni: 240(L)mm x 120 (W)mm x 95(H)mm Senza bocchette di ventilazione e con le linguette finali Peso: 1.4 Kg Condizioni di Esercizio Temperatura ambiente: 10 C 35 C (50 F 90 F) Percentuale umidità ambiente: 20 80% RH Condizioni di Conservazione e di Trasporto Temperatura ambiente: -15 C 50 C (5 F 122 F) Percentuale umidità ambiente: 10 90% RH MADE IN CHINA 3

4 I SIMBOLOGIA ADOTTATA SULL APPARECCHIO Marchio di conformità alla direttiva 93/42/CEE e successive modifiche intervenute. Fabbricante: CA-MI S.r.l. Via Ugo La Malfa Pilastro (PR) Italia Avvertenze generali e / o specifiche Consultare le istruzioni d uso Conservare in luogo fresco ed asciutto Temperatura di immagazzinamento Apparecchio di tipo BF Fusibile ~ Corrente alternata Hz Frequenza ON ACCESO OFF SPENTO Si considerano responsabili in materia di sicurezza, prestazioni ed affidabilità il fabbricante, il montatore, l installatore o l importatore solamente se l impianto elettrico al quale l apparecchio viene collegato è costruito secondo D.L.46/90. PULIZIA E MANUTENZIONE Il dispositivo non ha alcuna parte che necessiti di manutenzione. Occorre tuttavia effettuare alcuni semplici controlli per la verifica della funzionalità e della sicurezza dell apparecchio prima di ogni utilizzo. Estrarre l apparecchio dalla scatola e controllare sempre che non siano presenti danni visibili; verificare inoltre l integrità del cavo di alimentazione che potrebbe essere stato danneggiati durante l utilizzo precedente. Collegare quindi il cavo alla rete elettrica e accendere l interruttore. Prima di utilizzare l apparecchio sulle persone pulire accuratamente il materasso con detergente neutro. Non immergere o bagnare il compressore. Asciugare il materasso dopo ogni lavaggio. MATERASSO: Una prima pulizia del materasso può essere fatta utilizzando un panno umido ed un disinfettante di uso comune. Non Utilizzare panni abrasivi e / o superfici taglienti che potrebbero danneggiare la superficie del materasso. COMPRESSORE: Pulire il compressore con panno umido e ben pulito. Non versare liquidi direttamente sul compressore. Controllare periodicamente che i connettori dell aria non siano ostruiti da polvere. ATTENZIONE: Tutte le operazioni di pulizia e manutenzione devono essere fatte dopo aver spento il compressore e staccato l alimentazione dalla rete elettrica. NON IMMERGERE LA POMPA IN ACQUA NON UTULIZZARE IN AUTOCLAVE A GETTO DI VAPORE O A CALORE 4

5 I RISCHI DI INTERFERENZA ELETTROMAGNETICA E POSSIBILI RIMEDI Questa sezione contiene informazioni riguardanti la conformità del dispositivo con la norma EN MAT-130 è un dispositivo elettromedicale che necessita di particolari precauzioni per quanto riguarda la compatibilità elettromagnetica e che deve essere installato e messo in servizio in accordo alle informazioni specificate nei documenti accompagnatori. Dispositivi di radiocomunicazione portatili e mobili (telefoni cellulari, ricetrasmettitori, ecc..) possono influenzare il dispositivo medico e non dovrebbero essere utilizzati in vicinanza, in adiacenza o sovrapposti con il dispositivo medico. Se tale utilizzo è necessario e inevitabile, dovranno essere prese particolari precauzioni affinché il dispositivo elettromedicale funzioni correttamente nella sua configurazione d utilizzo prevista (ad esempio verificando costantemente e visivamente l assenza di anomalie o malfunzionamenti). L uso di accessori, trasduttori e cavi diversi da quelli specificati, con l eccezione di trasduttori e cavi venduti dal costruttore dell apparecchio e del sistema come parti sostitutive, può risultare in un incremento delle emissioni o in una diminuzione delle immunità del dispositivo o sistema. Le tabelle seguenti forniscono informazioni riguardanti le caratteristiche EMC (Compatibilità Elettromagnetica) di questo apparecchio elettromedicale. Guida e dichiarazione del costruttore Emissione Elettromagnetiche Il dispositivo modello MAT-130 è utilizzabile nell ambiente elettromagnetico di seguito specificato. Il Cliente e/o l utente del dispositivo MAT-130 devono assicurarsi che l apparecchio sia utilizzato in tale ambiente Test di Emissioni Conformità Guida all ambiente elettromagnetico Emissioni Irradiate / Condotte CISPR11 Emissioni Irradiate / Condotte CISPR11 Armoniche EN Fluttuazioni di tensione / Flicker EN Gruppo 1 Classe [B] Classe [A] Conforme Il dispositivo MAT-130 utilizza energia RF solo per la sua funzione Interna. Per tanto le sue emissioni RF sono molto basse e non causano alcuna interferenza in prossimità di alcun apparecchio elettronico. Il dispositivo MAT-130 è adatto per essere usato in tutti gli ambienti, inclusi quelli domestici e quelli connessi direttamente alla rete di distribuzione pubblica che fornisce alimentazione ad ambienti utilizzati per scopi domestici. Guida e dichiarazione del costruttore immunità elettromagnetica Il dispositivo modello MAT-130 è utilizzabile nell ambiente elettromagnetico di seguito specificato. Il Cliente e/o l utente del dispositivo modello MAT-130 devono assicurarsi che l apparecchio sia utilizzato in tale ambiente Prova di Immunità Livello di test Livello di Ambiente Elettromagnetico Guida Scariche elettrostatiche (ESD) EN Electrical fast transient/burst EN Surge EN Buchi di tensione, brevi interruzioni e variazioni di tensione EN /-6kV contatto +/-8kV aria +/-2kV per alimentazione +/-1kV per conduttori di segnale +/-1 kv modo differenziale +/-2 kv modo comune <5% UT (>95% buco in UT ) per 0,5 ciclo 40 % UT (60% buco in UT ) per 5 cicli 70 % UT (30% buco in UT ) per 25 cicli Conformità L apparecchio non modifica il suo stato. L apparecchio non modifica il suo stato L apparecchio non modifica il suo stato I pavimenti devono essere in legno, calcestruzzo o in ceramica. Se i pavimenti sono ricoperti di materiale sintetico, l umidità relativa dovrebbe essere almeno del 30%. L alimentazione dovrebbe essere quella tipica di un ambiente commerciale o ospedale. L alimentazione dovrebbe essere quella tipica di un ambiente commerciale o ospedale. -- L alimentazione dovrebbe essere quella tipica di un ambiente commerciale o ospedale o ambienti alimentati da batterie. Se l utente del dispositivo MAT-130 richiede che l apparecchio operi in continuazione, si raccomanda di utilizzarlo sotto un gruppo di continuità. Campo Magnetico a frequenza di rete (50/60 Hz) EN <5 % UT (>95% buco in UT ) per 5 s 3A/m Nota UT è il valore della tensione di alimentazione L apparecchio non modifica il suo stato I campi magnetici a frequenza di rete dovrebbero avere livelli caratteristici di installazioni in ambienti commerciali o ospedalieri. 5

6 I Guida e dichiarazione del costruttore immunità elettromagnetica Il dispositivo modello MAT-130 è utilizzabile nell ambiente elettromagnetico di seguito specificato. Il Cliente e/o l utente del dispositivo modello MAT-130 devono assicurarsi che l apparecchio sia utilizzato in tale ambiente Prova di Immunità Livello indicato Livello di Ambiente Elettromagnetico - Guida Immunità Condotte EN Immunità Irradiate EN dalla EN Vrms 150kHz to 80MHz (per apparecchi che non sono lifesupporting) 3V/m 80MHz to 2.5GHz (per apparecchi che non sono lifeequipment) conformità V1 = 3 V rms E1 = 3 V / m Gli apparecchi di comunicazione a RF portatili e mobili non dovrebbero essere usati più vicino a nessuna parte del dispositivo MAT-130, compresi i cavi, della distanza di separazione calcolata dall equazione applicabile alla frequenza del trasmettitore. Distanze di separazione raccomandate d = [3,5 / V1] d = [12 / E1] d = [23 / E1] P P da 80 MHz a 800MHz P da 800 MHz a 2,5 GHz Dove P e la potenza massima nominale d uscita del trasmettitore in Watt (W) secondo il costruttore del trasmettitore e d e la distanza di separazione raccomandata in metri (m). Le intensità del campo dai trasmettitori a RF fissi, come determinato in un indagine elettromagnetica del sito a), potrebbe essere minore del livello di conformità di ciascun intervallo di frequenza b). Si può verificare interferenza in prossimità di apparecchi contrassegnati dal seguente simbolo: Nota 1: A 80 MHz e 800 MHz si applica l intervallo della frequenza più alta. Nota 2: Queste linee guida potrebbero non applicarsi in tutte le situazioni. La propagazione elettromagnetica e influenzata dall assorbimento e dalla riflessione di strutture, oggetti e persone. a) Le intensità di campo per trasmettitori fissi come le stazioni di base per radiotelefoni (cellulari e cordless) e radiomobili terrestri, apparecchi di radioamatori, trasmettitori radio in AM e FM e trasmettitori TV non possono essere previste teoreticamente e con precisione. Per stabilire un ambiente elettromagnetico causato da trasmettitori RF fissi, si dovrebbe considerare un indagine elettromagnetica del sito. Se l intensità di campo misurata nel luogo in cui si usa l apparecchio, supera il livello di conformità applicabile di cui sopra, si dovrebbe porre sotto osservazione il funzionamento normale dell apparecchio stesso. Se si notano prestazioni anormali, possono essere necessarie misure aggiuntive come un diverso orientamento o posizione dell apparecchio. b) L intensità di campo su un intervallo di frequenze da 150 khz a 80 MHz dovrebbe essere minore di 3 V/m. 6

7 I Distanze di separazione raccomandate tra apparecchi di radiocomunicazione portatili e mobili ed il monitor Il dispositivo modello MAT-130 è previsto per funzionare in un ambiente elettromagnetico in cui sono sotto controllo i disturbi irradiati RF. Il cliente o l operatore del dispositivo MAT-130 possono contribuire a prevenire interferenze elettromagnetiche assicurando una distanza minima fra apparecchi di comunicazione mobili e portatili a RF (trasmettitori) e l apparecchio MAT-130 come sotto raccomandato, in relazione alla potenza di uscita massima degli apparecchi di radiocomunicazione. Potenza di uscita nominale massima Distanza di separazione alla frequenza del trasmettitore m del trasmettitore 150 khz a 80 MHz 80 MHz a 800 MHz 800 MHz a 2,5 GHz W d = [3,5/V1] P d = [12/E1] P d = [23/E1] P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7, Per i trasmettitori con potenza nominale massima di uscita sopra non riportata, la distanza di separazione raccomandata d in metri (m) può essere calcolata usando l equazione applicabile alla frequenza del trasmettitore, ove P e la potenza massima nominale d uscita del trasmettitore in Watt (W) secondo il costruttore del trasmettitore. Nota 1: A 80 MHz e 800 MHz si applica la distanza di separazione per l intervallo di frequenza più alta. Nota 2: Queste linee guida potrebbero non applicarsi in tutte le situazioni. La propagazione elettromagnetica è influenzata dall assorbimento e dalla riflessione di strutture, oggetti e persone. RISOLUZIONE DEI PROBLEMI: PROBLEMA Il compressore non si accende Il materasso non prende la forma SOLUZIONE Verificare il corretto collegamento della spina alla presa elettrica. Verificare che non sia saltato un fusibile. Controllare che la base del materasso sia attaccata fermamente agli elementi Controllare che il materasso sia attaccato fermamente al letto. PRODUCT FUNCTIONS Pompa La funzione della pompa viene descritta qui di seguito Interruttore ON/OFF L'interruttore ON/OFF è situato nella parte anteriore della pompa Accendere l interruttore sulla posizione ON, la pompa inizia a funzionare Pressione regolare la manopola Ruotare la manopola del regolatore di pressione per avere un livello confortevole di pressione Materasso Il MAT-130 è dotato oltre che dalla pompa da un materasso ad aria (materiale nylon / PVC). 7

8 I ISTRUZIONI PER L USO 1. Posizionare la pompa su una superficie orizzontale e fissarla all estremità del letto (lato dei piedi) tramite i ganci; 2. Posizionare il materassino sulla parte superiore del letto con le due prese aria dei tubi in corrispondenza della pompa. 3. Collegare i tubi aria alla pompa e al materasso. Le estremità dei tubi con i raccordi si collegano al materasso. 4. Assicurarsi che i tubi non siano annodati o attorcigliati sotto il materasso. 5. Connettere il cavo di alimentazione, regolare la pressione tramite manopola regolatore, e accendere l interruttore sulla posizione ON. L interruttore verde acceso indica che la pompa è in funzione. 6. Attendere 20 minuti per il gonfiaggio completo del materassino 7. Coprire con un lenzuolo e rimboccare senza stringere 8. Regolare la pressione per il massimo confort del paziente GARANZIA La garanzia sul prodotto è valida per il tempo di 24 mesi dalla data di fornitura CA-MI Durante il periodo di validità della garanzia si provvederò alla riparazione e / o sostituzione gratuite di tutte le parti difettose per cause di fabbricazione ben accertate. Sono esclusi dalla garanzia i componenti soggetti ad usura come le parti in PVC ed altri ancora. Inoltre la sostituzione o riparazione effettuata durante il periodo della garanzia non hanno l effetto di prolungare la durata della garanzia. La garanzia non è valida in caso di: riparazione effettuata da personale non autorizzato o con pezzi di ricambio non omologati da CA-MI S.r.l., avarie o vizi causati da negligenza, botte, uso anormale dell apparecchio o errori di installazione. La garanzia decade se il numero di matricola e / o lotto produttivo risulti essere asportato, cancellato o alterato. CA-MI S.r.l. non può essere ritenuta responsabile di danni accidentali o indiretti, qualora siano state effettuate modifiche al dispositivo, riparazioni e / o interventi tecnici non autorizzati, o una qualsiasi delle sue parti siano state danneggiate per incidente, uso e / o abuso improprio 8

9 GB This device is recommended for the prevention of basic bedsores in long-term and home therapy. Skin is delicately massaged at alternating points of contact for improved blood flow and tissue oxygenation to prevent the formation of bedsore ulcers. It is easy to install, use and maintain and offers pressure adjustment based on patient weight. This non-toxic PVC mattress is inflated with its own compressor and supports patients lying down. Check the correct functioning of the regulator by turning the knob form MIN to MAX. INTENDED USE The pump and mattress are intended to reduce the incidence of pressure ulcers while optimizing patient comfort. It also provides the following: Individual home care setting and long-term care Pain management as prescribed by a physician IMPORTANT SAFETY RULES 1. Particular precautions must be made concerning electromagnetic compatibility. The medical device must be installed and used according to information supplied with the accompanying documents; 2. On opening the packaging, check the integrity of the appliance, paying particular attention to the presence of damage to the plastic parts, which may make access possible to internal live parts and also to breakage and / or peeling of the power supply cable. In these cases don t connect the plug to the electric socket. Carry out these controls before each use; 3. Before connecting the appliance always check that the electric data indicated on the data label and the type of plug used, correspond to those of the mains electricity to witch it s to be connected; 4. If the plug supplied with the appliance is incompatible with the mains electricity socket, contact qualified staff for replacement of the plug with a suitable type. The use of simple or multiple and / or extension adapters is not generally recommended. Whenever their use is indispensable, use those in compliance with safety regulations, however paying attention not to exceed the maximum power supply limits, which are indicated on the adapters and extensions; 5. Respect the safety regulations indicated for electrical appliances and particularly: Use original components and accessories provided by the manufacturer CA-MI S.r.l. to guarantee the highest efficiency and safety of the device; Never immerge the appliance into water; Preserve and use the medical device in environments protected from atmospheric factors and at a distance from heat sources; Keep off the reach of children or not capable people without supervision; Don t leave the appliance connected to the power supply socket when not in use; Don t pull the power supply cable to disconnect the plug remove the plug from the mains socket correctly; Preserve and use the medical device in environments protected from atmospheric factors and at a distance from heat sources; DO NOT use in presence of flammable anesthetics, it may cause explosions. Due to the risk of electric shock, do not remove the cover (back). In case of failure and / or malfunction please contact immediately the technical service CA-MI S.r.l. Failure to comply with the above can jeopardise the safety of the device; None of electric or mechanical parts have been designed to be repaired by customers or end-users. Don t open the device, do not mishandle the electric / mechanical parts. Always contact CA-MI technical assistance 6. This medical device must be destined exclusively for the use for witch it has been designed ad described in this manual. Any different use must be considered incorrect and therefore dangerous; the manufacturer cannot be considered liable for damage caused by improper, incorrect and / or unreasonable use or if the appliance is used in electrical plants that are not in compliance with the regulations in force; 7. Instrument and accessories discharging must be done following current law regulations in every country of use. 8. Using the device in environmental conditions different than those indicated in this manual may harm seriously the safety and the technical characteristics of the same. READ INSTRUCTION MANUAL CAREFULLY BEFORE USE THE INSTRUMENT MUST NOT BE DISASSEMBLED. FOR A TECHNICAL SERVICE ALWAYS CONTACT CA-MI S.r.l. KEEP OFF REACH OF CHILDREN OR NOT CAPABLE PEOPLE WITHOUT SUPERVISION 9

10 GB IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC DIRECTIVE 2012/19/UE-WEEE: The symbol on the device indicates the separated collection of electric and electronic equipment. At the end of life of the device, don t dispose it as mixed solid municipal waste, but dispose it referring to a specific collection centre located in your area or returning it to the distributor, when buying a new device of the sample type to be used with the same functions. This procedure of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential effects on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the same Caution: The wrong disposal of electric and electronic equipment may involve sanctions. TECHNICAL CHARACTERISTICS Typology Medical Device Class I PUMP MATTRESS Power supply: 230V~ - 50Hz Size: 3000(L)mm x 900 (W)mm x 65(H)mm Air output: 4.5 liter/min. 130 bubble cells Pressure range: 30 mmhg 110 mmhg Material: PVC (EN-71, low toxic) Cycle time: 10 min. PVC thickness: 0.30 mm Power consumption: 5W Color: beige Fuse: 1A Repair kit included Size: 240(L)mm x 120 (W)mm x 95(H)mm Without vents and with end flaps Weight: 1.4 Kg Working Condition Room temperature: 10 C 35 C (50 F 90 F) Humidity: 20 80% RH Conservation condition and transport Room temperature: -15 C 50 C (5 F 122 F) Humidity: 10 90% RH MADE IN CHINA SYMBOLOGY CE marking in conformity with EC directive 93/42/EEC and subsequent changes. General warnings and/or specifications Consult the instruction manual Manufacturer: CA-MI S.r.l. Via Ugo La Malfa nr Pilastro (PR) Italia To preserve in place coolness and dry land Conservation temperature Type BF equipment Fuse ~ Alternate Current Hz Mains Frequency ON ON OFF OFF 10

11 GB STANDARD FEATURES Simple to operate. Portable and lightweight. Pad consists of 130 bubble cells. PRODUCT FUNCTIONS Pump The function of the pump are described below. Please refer to the figures Power Switch The Power Switch is at the front side of the pumps Turn ON / OFF the power, the pump will start / stop operation Pressure adjust knob Turn the soft / firm knob to set a comfortable pressure level Mattress The MAT-130 come with air mattress made of the material Nylon / PVC provided optionally with the pump. CLEANING AND MAINTENANCE The medical device does not need maintenance or lubrication. Before use always check correct functioning and safety of the device. Unpack the instrument and always check integrity of plastic parts and feeding cable, they might have been damaged during previous use. Connect cable to electrical network and turn switch on. Before using the device on people carefully clean the mattress with neutral detergent. Never immerge the compressor into water. Drain the mattress after each wash. MATTRESS: A first cleaning of the mattress can be made using a damp cloth. Do not use abrasive cloths and / or cutting surfaces that might damage the surface of the mattress. COMPRESSOR: Cleaning the compressor with damp cloth and very clean. Never immerge the compressor into water. Check periodically that the connectors are not clogged by dust. WARNING: All the cleaning and maintenance operation must be made after disconnected the compressor from the electrical network. DO NOT IMMERSE THE PUMP IN WATER DO NOT HEAT OR STEAM IN AUTOCLAVE TROUBLESHOOTING: The compressor will not turn. PROBLEM The mattress doesn t take the form SOLUTION Verify the plug may be misplaced in the wall socket Check that you have not missed a fuse. Check that the basis of the mattress is firmly attached to the items. Make sure the mattress is firmly attached to the bed. 11

12 GB OPERATING INSTRUCTIONS 1. PIace pump on a flat surface and hook it to the bed edge (foot side) 2. PIace the mattress on top of bed mattress with the 2 air connectors nearby the pump. 3. Connect the air hoses to the pump and mattress. The hose ending with connectors shall fit into the mattress. 4. Make sure the air hoses are not positioned or twisted underneath the mattress. 5. For operation, plug in the power cord, adjust the pressure with the knob and switch it on. The green light indicates correct operation. 6. Allow 20 minutes for pad to inflate fully. 7. Cover with a sheet and tuck loosely. 8. Adjust the pressure for patient comfort. WARRANTY The product has a 24-month warranty, valid from the date it is delivered by CA-MI S.r.l. During the guarantee period free repair and / or replacement of any defective parts due to faulty manufacture will be given, labour, postal, transport and packaging charges etc. are not included. The guarantee therefore excludes components subject to wear and tear such as parts in rubber or PVC, etc. Furthermore replacement or repairs effected during the guarantee period do not lengthen the duration of the guarantee. This guarantee is void in the event of: repairs effected by unauthorised persons or with spare parts not approved by CA-MI, damage or defects caused by negligence, blows, abnormal use of the appliance or faulty installation. CA-MI S.r.l. cannot be held liable for accidental or indirect damages should the device be modified, repaired without authorization or should any of its component be damaged due to accident or misuse. The guarantee will be invalidated if the registration number has been removed, cancelled or altered. RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES This section contains information regarding the conformity of the compliance with the EN Standard. The device MAT-130 is an electro-medical device that requires particular precautions regarding electro-magnetic compatibility and which must be installed and commissioned according to the electro-magnetic compatibility information supplied. Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may interfere with the medical device and should not be used in close proximity with, adjacent to or on top of the medical device. If such use is necessary and unavoidable, special precautions should be taken so that the electro-medical device functions properly in its intended operating configuration (for example, constantly and visually checking for the absence of anomalies or malfunctions). The use of accessories, transducers and cables different to those specified, with the exception of transducers and cables sold by the appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of the device or system. The following tables supply information regarding the EMC (Electromagnetic Compatibility) characteristics of the electro-medical device. Guidance and manufacturer s declaration Electromagnetic Emissions The device mod. MAT-130 is intended for use in the electromagnetic environment specified below. The customers or the user of the device MAT-130 should assure that it s used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance Irradiated / Conducted emissions CISPR11 Irradiated / Conducted emissions CISPR11 Harmonic emissions EN Voltage fluctuations / flicker emissions EN Group 1 Class [B] Class [A] Complies The device MAT-130 only used RF energy only for its internal functioning. Therefore its RF emissions are very low and are not cause interference in proximity of any Electronic appliances. The device MAT-130 can be used in all environments, including domestic and those connected directly to the public mains distribution that supplies power to environments used for domestic scopes or hospital 12

13 GB Guidance and manufacturer s declaration Immunity Emissions The device MAT-130 is intended for use in the electromagnetic environment specified below. The customers or the user of the device MAT-130 should assure that it s used in such an environment. Immunity Test Level indicated by Compliance Electromagnetic environments - guidance Electrostatic discharge (ESD) EN Electrical fast transient / burst EN Surge EN Loss of voltage, brief voltage interruptions and variations EN Magnetic field EN the EN ± 6kV on contact ± 8kV in air ± 2kV power supply lines ± 1kV for input / output lines ± 1kV differential mode 5%UT (>95% dip UT) for 0.5 cycle 40%UT (>60% dip UT) for 5 cycle 70%UT (>30% dip UT) for 25 cycle <5%UT (>95% dip UT) for 5 sec 3A/m Note UT is the value of the power supply voltage Level The device doesn t change its state The device doesn t change its state The device doesn t change its state Floors should be wood, conceret or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial environment or hospital Mains power quality should be that of a typical commercial environment or hospital - Mains power quality should be that of a typical commercial environment or hospital If the user of the MAT-130 device request that the appliance operates continuously, the use of a continuity unit is recommended. The device doesn t change its state The power frequency magnetic field should be measured in the intended installation location to assure that it s sufficiently low. Guidance and manufacturer s declaration Immunity Emissions The device MAT-130 is intended for use in the electromagnetic environment specified below. The customers or the user of the device MAT-130 should assure that it s used in such an environment. Immunity Test Level indicated by Compliance Electromagnetic environments - guidance Conducted Immunity EN Radiated Immunity EN the EN Vrms 150kHz to 80Mhz (for non lifesupporting devices) 3V/m 80MHz to 2.5GHz (for non lifesupporting devices) level V1 = 3 V rms E1 = 3 V / m The portable and mobile RF communication devices, including cables, must not be used closer to the device MAT-130, than the separation distance calculated by the equation applicable to the transmitter frequency. Recommended separation distance d = [3.5 / V1] d = [12 / E1] d = [23 / E1] P P from 80 MHz to 800MHz P from 800 MHz to 2.5 GHz Where P is the maximum nominal output voltage of the transmitter in Watt (W) depending on the manufacturer of the transmitter and the recommended separation distance in metres (m). The intensity of the field from the fixed RF transmitters, as determined by an electro-magnetic study of the site a), could be lower than the level of conformity of each frequency interval b). It is possible to check for interference in proximity to devices identified by the following symbol: Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by reflection from buildings, objects and people. a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial mobile radio, amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and accurately foreseen. To establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic study of the site should be considered. If the field intensity measured in the place where the device will be used surpasses the above mentioned applicable level of conformity, the normal functioning of the device should be monitored. If abnormal performance arises, additional measures such as changing the device's direction or positioning may be necessary. b) The field intensity on an interval frequency of 150 khz to 80 MHz should be less than 3 V/m. 13

14 GB Recommended separation distance between portable and mobile radio-communication devices and the monitor The device MAT-130 is intended to operate in an electro-magnetic environment where RF irradiated interferences are under control. The client or operator of the MAT-130 device can help prevent electro-magnetic interference by keeping a minimum distance between the portable and mobile RF communication devices (transmitters) and the MAT-130 device, as recommended below, in relation to the radio-communication maximum output power. Maximum nominal Separation distance from the frequency transmitter (m) output power of 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz the Transmitter W d = [3.5 / V1] P d = [12/E1] P d = [23/E1] P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7, For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres (m) can be calculated using the equation applicable to the transmitter frequency, where P is the maximum nominal output power of the transmitter in Watt (W) depending on the transmitter's manufacturer. Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by the reflection from buildings, objects and people. 14

15 D Das Produkt wird zur Vorbeugung von Dekubitusgeschwüren 1. Grades bei Langzeit- und häuslicher Pflege empfohlen. Die wechselnden Berührungspunkte mit der Haut massiert diese leicht, ermöglicht gute Durchblutung und Sauerstoffversorgung des Gewebes und beugt so der Bildung von Dekubitusgeschwüren vor. Das Einstellrad steuert den Druckpegel. Wird es im Uhrzeigersinn gedreht, erhöht sich der Druck, anders herum nimmt er ab. Einfacher Aufbau, Gebrauch und Wartung, mit Einstellmöglichkeit für den Luftdruck in Abhängigkeit vom Gewicht des Patienten. Die aus ungiftigem PVC hergestellte Matratze wird mit der dafür bestimmten Druckluftpumpe aufgepumpt und trägt die liegende Person. VORGESEHENE VERWENDUNG Pumpe und Matratze sollen die Häufigkeit von Druckgeschwüren verringern und den Komfort des Patienten verbessern. ALLGEMEINE SICHERHEITSVORSCHRIFTEN 1. Das Medizingerät erfordert besondere Vorsichtsmaßnahmen bezüglich der elektromagnetischen Verträglichkeit und darf nur entsprechend den Angaben in der Begleitdokumentation installiert und verwendet werden. 2. Kontrollieren Sie beim Öffnen der Verpackung, dass das Gerät vollständig und intakt ist. Achten Sie besonders auf eventuelle Schäden an den Plastikteilen, die unter Spannung stehende Bauteile im Inneren des Gerätes freilegen könnten. 3. In diesen Fällen die Pumpe nicht an die Steckdose anschließen. Diese Kontrollen müssen vor jedem Gebrauch ausgeführt werden. 4. Bevor Sie das Gerät anschließen, kontrollieren Sie immer, dass die auf dem Datenschild angegebenen Versorgungsdaten und der verwendete Stecker mit dem Stromnetz übereinstimmen, an das es angeschlossen werden soll. 5. Falls der mitgelieferte Verbindungsstecker am Gerät nicht mit der Steckdose des elektrischen Versorgungsnetzes kompatibel ist, wenden Sie sich an qualifiziertes Personal, um ihn auswechseln zu lassen. Im Allgemeinen ist es nicht ratsam, Adapter, Mehrfachstecker und/oder Verlängerungskabel zu verwenden. Falls dies jedoch unbedingt erforderlich ist, müssen diese den Sicherheitsrichtlinien entsprechen und die zugelassenen Höchstwerte für die Stromversorgung, die auf den Adaptern und Verlängerungskabeln aufgedruckt sind, dürfen nicht überschritten werden. 6. Die Sicherheitsvorschriften müssen beachtet werden, besonders diese: Das Gerät darf von Kindern oder behinderten Personen nur unter Aufsicht eines Erwachsenen benutzt werden, der im Vollbesitz seiner geistigen Fähigkeiten ist. Setzen Sie das Produkt keinen Extremtemperaturen, Staub und/oder direkter Sonneneinstrahlung aus. Gehen Sie vorsichtig mit dem Gerät um. Versuchen Sie nicht, das Gerät zu reparieren, falls es beschädigt ist. Wenden Sie sich an den CA-MI-Kundendienst. Werden Veränderung an irgend einem Bauteil des Gerätes vorgenommen, entbindet dies den Hersteller von jeder Verantwortung für Schäden am Produkt, an Gegenständen, Tieren und/oder Personen. Das Gerät NICHT in einer Umgebung benutzen, in der sich brennbare Anästhesielösungen befinden: diese könnten explodieren Die Abdeckung (auf der Rückseite) nicht entfernen, da dies Stromschlägen verursachen kann. Das Gerät nie benutzen, wenn Stromkabel oder Stecker beschädigt sind, oder wenn das Gerät selbst nicht richtig funktioniert, beschädigt wurde oder zu Boden oder ins Wasser gefallen ist. Bringen Sie in diesem Fall das Gerät zur Kontrolle oder Reparatur zum Kundendienst. Halten Sie das Kabel fern von heißen Oberflächen. 7. Das Gerät darf nur für den Zweck verwendet werden, für den es entwickelt wurde. Jede hiervon abweichende Verwendung muss als Missbrauch betrachtet werden und ist daher potenziell gefährlich. Aus diesem Grund können Produktions- und Vertriebsunternehmen nicht für Schäden am Produkt, an Gegenständen, Tieren oder Personen verantwortlich gemacht werden, die durch Missbrauch, oder fehlerhafte bzw. unvernünftige Verwendung entstanden sind. 8. Die Entsorgung der Zubehörteile und des Gerätes darf nur gemäß der geltenden Gesetzgebung im Anwendungsland erfolgen. 9. Werden die oben genannten Regeln nicht befolgt, kann die Sicherheit des Gerätes beeinträchtigt sein LESEN SIE VOR DEM GEBRAUCH AUFMERKSAM DAS HANDBUCH. DAS GERÄT NIE AUSEINANDERBAUEN WENDEN SIE SICH FÜR JEDE ART VON EINGRIFF AN DEN KUNDENDIENST VON CA-MI S.r.l. LASSEN SIE KINDER ODER PERSONEN, DIE DAZU NICHT IN DER LAGE SIND, DAS MEDIZINGERÄT NICHT BENUTZEN, OHNE DASS SIE VON EINEM ERWACHSENEN BEAUFSICHTIGT WERDEN, DER IM VOLLBESITZ SEINER GEISTIGEN FÄHIGKEITEN IST 15

16 D ENTSORGUNGSVERFAHREN (DIR. 2012/19/UE-WEEE): Das Symbol auf dem Boden des Geräts gibt die getrennte Müllsammlung der elektrischen und elektronischen Ausrüstungen an. Am Ende der Lebensdauer vom Gerät es nicht als gemischter faster Gemeindenabfall, sondern es bei einem spezifischen Müllsammlungszentrum in Ihrem Gebiet entsorhen ode res dem Händler zurückgeben, wenn Sie ein neues Gerät desselben Typ mit denselben Funktionen kaufen. Diese Prozedur getrennter Müllsammlung der elektrischen und elektronischen Ausrüstungen wird im Hinblick auf eine zukünftige gemeinsame europäische Umweltschutzpolitik vorgenommen, welche darauf zielen wird, die Umwelt zu schützen und sichern, als auch die Umweltqualität zu verbessern und potentielle Wirkungen auf die menschliche Gesundheit wegen der Anwesenheit von gefährlichen Stoffen in diesen Vorrichrungen oder Missbrauch derselben oder von Teilen derselben zu vermeiden. Vorsicht! Die fehlerhafte Entsorgung von elektrischen und elektronishen Vorrichtungen könnte Sanktionen mit sich bringen. STANDARDMERKMALE Einfache Anwendung Tragbar und leicht Die Matratze besteht aus 130 Luftkammern TECHNISCHE MERKMALE Typ PUMPE Stromversorgung: 230V~ / 50Hz Luftlieferleistung: 4.5 l/min Druckeinstellung: 30 mmhg 110 mmhg Zyklusdauer: 10 min. Aufnahmeleistung: 5W Sicherung: 1A Abmessungen: 240(L)mm x 120 (B)mm x 95(H)mm Gewicht: 1,4 kg Betriebsbedingungen: Lager- und Transportbedingungen MADE IN CHINA Medizintechnisches Gerät Klasse I MATRATZE Abmessungen 3000(L)mm x 900 (B)mm x 65(H)mm Anzahl der Kammern: 130 Luftkammern Material: PVC (EN-71, niedrige Toxizität) Stärke des PVC: 0.30 mm Farbe: beige Reparatursatz im Lieferumfang enthalten Ohne Entlüfterstutzen und mit den Endlaschen Umgebungstemperatur: 10 C 35 C (50 F 90 F) Luftfeuchtigkeit der Umgebung: 20 80% rel. Luftfeuchtigkeit Umgebungstemperatur: -15 C 50 C (5 F 122 F) PRODUKTFUNKTIONEN Pumpe Die Funktion der Pumpe wird hier im Folgenden beschrieben Schalter ON/OFF Der Schalter ON/OFF befindet sich auf der Vorderseite der Pumpe Wenn der Schalter in die Position ON gebracht wird, setzt sich die Pumpe in Betrieb Druck: mit dem Drehknopf einstellen Den Drehknopf der Druckregelung drehen, bis ein angenehmer Druck in der Matratze erreicht wird Matratze Das MAT-130 umfasst außer der Pumpe auch eine Luftmatratze (aus Nylon/PVC). 16

17 D AM GERÄT ANGEBRACHTE SYMBOLE Zertifizierung der Konformität zur Direktive 93/42/EWG und den nachfolgend vorgenommenen Änderungen. Allgemeine und/oder spezielle Hinweise Im Handbuch nachlesen Hersteller: CA-MI S.r.l. Via Ugo La Malfa Nr Pilastro (PR) Italien An einem kühlen und trockenen Ort aufbewahren Lagertemperatur Gerät vom Typ BF Sicherung ~ Wechselstrom Hz AUS ON ON OFF OFF REINIGUNG UND WARTUNG Das Gerät hat keine Teile, die gewartet werden müssen. Vor jedem Gebrauch müssen trotzdem einige einfache Kontrollen durchgeführt werden, um die Funktionen und die Sicherheit des Gerätes zu prüfen. Nehmen Sie das Gerät aus dem Karton und kontrollieren Sie immer, dass keine sichtbaren Schäden vorhanden sind. Prüfen Sie außerdem, dass das Stromkabel intakt ist, denn es könnte beim letzten Gebrauch beschädigt worden sein. Schließen Sie dann das Kabel an die Stromversorgung an und betätigen Sie den Schalter. Reinigen Sie die Matratze gründlich mit einem milden Reinigungsmittel, bevor sie in Kontakt mit Personen kommt. Die Druckluftpumpe nicht nass werden lassen oder in Wasser tauchen. Trocknen Sie die Matratze nach jeder Reinigung ab. MATRATZE: Eine Erstreinigung der Matratze kann auch mit einem feuchten Lappen und einem handelsüblichen Desinfektionsmittel vorgenommen werden. Keine Scheuerschwämme oder Ähnliches benutzen, da sie die Oberfläche der Matratze beschädigen könnten. DRUCKLUFTPUMPE: Die Pumpe mit einem sauberen, feuchten Tuch reinigen. Keine Flüssigkeiten direkt auf die Pumpe gießen. Kontrollieren Sie regelmäßig, dass die Luftanschlüsse nicht durch Staub verstopft sind. ACHTUNG: Alle Maßnahmen zur Reinigung und Instandhaltung dürfen nur ausgeführt werden, nachdem die Pumpe ausgeschaltet und von der Stromversorgung getrennt wurde. DIE PUMPE NICHT INS WASSER TAUCHEN. NICHT FÜR STERILISATION IM DAMPFDRUCKAUTOKLAV ODER HEISSLUFTSTERILISATOR GEEIGNET. 17

18 D PROBLEMLÖSUNG PROBLEM Die Druckluftpumpe lässt sich nicht einschalten Die Matratze bläst sich nicht auf LÖSUNG Prüfen, ob der Netzstecker richtig an die Steckdose angeschlossen ist. Sicherstellen, dass keine Sicherung ausgelöst hat. Prüfen, dass das Unterteil der Matratze fest mit den Elementen verbunden ist GEBRAUCHSANLEITUNG 1. Stellen Sie die Pumpe auf eine waagerechte Fläche und befestigen Sie sie mit den Haken am Fuß des Bettes. 2. Legen Sie die Matratze auf das Bett. Die beiden Lufteinlässe müssen sich in der Nähe der Pumpe befinden. 3. Verbinden Sie die Luftschläuche mit der Pumpe und der Matratze. Die Schlauchenden mit den Verbindungsstücken werden an die Matratze angeschlossen. 4. Achten Sie darauf, dass die Schläuche nicht unter der Matratze verknotet oder verwirrt sind. 5. Schließen Sie das Stromkabel an, regulieren Sie den Druck mit dem Drehschalter und schalten Sie den Schalter auf die Position ON. Wenn der Schalter grün leuchtet, ist die Pumpe in Betrieb. 6. Warten Sie 20 Minuten, bis die Matratze vollständig aufgeblasen ist 7. Legen Sie ein Bettlaken darüber und schlagen Sie die Matratze damit locker ein 8. Regeln Sie den Druck so, wie es für den Patienten am bequemsten ist GARANTIE Die Garantie des Produkts gilt 24 Monate ab der Lieferung durch CA-MI. Innerhalb der Garantiezeit werden alle aufgrund nachgewiesener Materialfehler defekten Teile kostenlos repariert oder ausgetauscht. Von der Garantie nicht abgedeckt werden Verschleißteile, wie z.b. die Bestandteile aus PVC. Während der Garantiezeit ausgeführte Reparaturen oder Ersetzungen verlängern nicht die Geltungszeitraum der Garantie. Die Garantie gilt nicht in folgenden Fällen: von nicht autorisierten Personen ausgeführte Reparaturen, Einbau von nicht mit CA-MI S.r.l. abgestimmten Ersatzteilen, Störungen oder Defekte, die durch Fahrlässigkeit, Schläge, unsachgemäßen Gebrauch oder Installationsfehler entstanden sind. CA-MI S.r.l. kann nicht für zufällige oder indirekte Schäden verantwortlich gemacht werden, falls Änderungen, Reparaturen und/oder nicht autorisierte technische Eingriffe am Gerät ausgeführt wurden oder ein irgend ein Teil von ihm durch einen Unfall, unsachgemäßen Gebrauch und/oder Missbrauch beschädigt wurde. Die Garantie verfällt, wenn die Seriennummer und/oder Produktionslosnummer entfernt, unkennbar gemacht oder verändert werden. 18

19 D RISIKEN DURCH ELEKTROMAGNETISCHE INTERFERENZEN UND MÖGLICHE ABHILFE Dieser Abschnitt enthält Informationen bezüglich der Konformität des Gerätes mit der Norden EN Das Modell MAT-130 ist eine elektromedizinische Vorrichtung, bei der bezüglich der elektromagnetischen Kompatibilität besondere Vorsichtsmaßnahmen berücksichtigt werden müssen; es muss gemäß den erteilten Informationen bezüglich elektromagnetischer Kompatibilität installiert und in Betrieb genommen werden. Tragbare und mobile Kommunikationsgeräte mit Funkfrequenz (Mobiltelefone, Sende- und Empfangsgeräte usw.) können das Medizinprodukt beeinflussen und sollten nicht in der Nähe, angrenzend oder überlagert mit der medizinischen Vorrichtung verwendet werden. Sollte eine solche Positionierung erforderlich sein, müssen besondere Vorsichtsmaßnahmen getroffen werden, damit das elektromedizinische Gerät korrekt gemäß seiner vorgesehenen Gebrauchskonfiguration funktioniert (indem beispielsweise durch eine konstante Sichtprüfung die Abwesenheit von Anomalien und Störungen sichergestellt wird). Der Gebrauch von Zubehör, Wandlern und Kabeln, die von den empfohlenen abweichen, kann zu einem Zuwachs der Emissionen bzw. zu einer Verminderung der Störfestigkeit der Vorrichtung oder des Systems führen (nur die vom Hersteller des Gerätes und des Systems als Ersatzteile verkaufte Wandler und Kabel sind zulässig). In der nachfolgenden Tabelle werden Informationen bezüglich der EMC (Elektromagnetische Verträglichkeit) dieses elektromedizinischen Gerätes geliefert. Angaben und Erklärung des Herstellers Elektromagnetische Emissionen Das Gerät Modell MAT-130 kann in der im Folgenden beschriebenen elektromagnetischen Umgebung verwendet werden. Der Kunde bzw. Benutzer des Geräts MAT-130 muss sicherstellen, dass das Gerät in so einer Umgebung benutzt wird. Emissionstests Konformität Elektromagn. Umgebung Ausgestrahlte / weitergeleitete Emissionen CISPR 11 Ausgestrahlte / weitergeleitete Emissionen CISPR11 Oberschwingungen EN Spannungsschwankungen / Flimmern EN Gruppe 1 Klasse [B] Klasse [A] Konform Das Gerät MAT-130 benutzt Hochfrequenzenergie nur für seine internen Funktionen. Daher sind seine Hochfrequenzemissionen sehr niedrig und verursachen in der Nähe elektronischer Geräte keine Interferenzen. Das Gerät MAT-130 eignet sich für den Gebrauch in jeder Umgebung, einschließlich zu Hause und in Einrichtungen im öffentlichen Verteilnetz für Nahrungsmittel (für den Haushalt). Anleitung und Erklärung des Herstellers zur Elektromagnetischen Emission Das Gerät Modell MAT-130 kann in der im Folgenden beschriebenen elektromagnetischen Umgebung verwendet werden. Der Kunde bzw. Benutzer des Geräts MAT-130 muss sicherstellen, dass das Gerät in so einer Umgebung benutzt wird. Emissionstests Durch die IEC angezeigtes Konformitätsniveau Elektromagnetisches Umfeld - Leitfaden Elektrosatische Entladungen (ESD) IEC/EN Schnelle Wanderwellen / Burst EN Überspannung EN Spannungsabfall, kurze Unterbrechungen und Spannungsschwankungen EN Magnetfeld EN Niveau ± 6kV bei Kontact ± 8kV in der Luft Das Gerät nicht seinen Zustand ändern ± 2kV Einspeisung Das Gerät nicht seinen Zustand ändern ± 1kV Differentialmodus 5%UT bei 0.5 Zyklus 40%UT bei 5 Zyklen 70%UT bei 25 Zyklen <5%UT für 5 Sek. 3A/m Anmerkung: UT ist der Wert der Einspeisungsspannung Das Gerät nicht seinen Zustand ändern Der Boden muss aus Holz, Beton oder Keramik sein. Wenn auf dem Boden synthetisches Material verlegt ist, muss die relative Luftfeuchtigkeit mindestens 30% betragen. Die Stromversorgung sollte die in Gewerberäumen oder Krankenhäusern übliche sein oder durch Batterien erfolgen. Die Stromversorgung sollte die in Gewerberäumen oder Krankenhäusern übliche sein oder durch Batterien erfolgen. -- Die Stromversorgung sollte die in Gewerberäumen oder Krankenhäusern übliche sein oder durch Batterien erfolgen. Wenn der Benutzer das Gerät MAT-130 im Dauerbetrieb verwenden will, sollte eine unterbrechungsfreie Stromversorgung vorgeschaltet werden. Das Gerät nicht seinen Zustand ändern Magnetfelder mit Netzfrequenz sollten Werte haben, die für Gewerberäume oder Krankenhäuser oder bei Versorgung über Batterien üblich sind 19

20 D Anleitung und Erklärung des Herstellers Das Gerät Modell MAT-130 kann in der im Folgenden beschriebenen elektromagnetischen Umgebung verwendet werden. Der Kunde bzw. Benutzer des Geräts MAT-130 muss sicherstellen, dass das Gerät in so einer Umgebung benutzt wird. Test Störfestigkeit Test Störfestigkeit Test Test Störfestigkeit Immunität gegen leitungsgeführte Störgrößen EN Immunität gegen gestrahlte Störgrößen EN Vrms 150kHz bis 80MHz (für Geräte, die nicht lebenserhaltend sind) 3V/m 80MHz bis 2.5GHz (für Geräte, die nicht lebenserhaltend sind) Störfestigkeit V1 = 3 V rms E1 = 3 V / m Mobile und tragbare Funk-Kommunikationsgeräte sollten nicht näher an Bestandteilen des Gerätes MAT- 130, einschließlich der Kabel, verwendet werden, als der Wert für den Mindestabstand angibt, der anhand der Sendefrequenz mit der Formel berechnet wird. Empfohlener Abstand d = [3.5 / V1] d = [12 / E1] d = [23 / E1] P P von 80 MHz bis 800MHz P von 800 MHz bis 2.5 GHz Wobei P der vom Hersteller des Senders angegebene Maximalwert für die Ausgangs-Nennspannung des Senders in Watt (W) ist und d der empfohlene Mindestabstand in Metern (m). Die vor Ort erhobene a) Intensität des Feldes von festen Funksendern könnte unter dem Konformitätsgrad jedes Frequenzbereichs liegen b).die Interferenz kann in der Nähe von Apparaten gemessen werden, die dieses Symbol tragen: Anmerkung 1: Bei 80 MHz und 800 MHz wird der jeweils höhere Frequenzbereich verwendet. </cf> Anmerkung 2: Die Leitlinien könnten nicht auf alle Situationen anwendbar sein. Die Ausbreitung des elektromagnetischen Feldes ist von der Absorption und Reflexion durch Räumlichkeiten, Gegenstände und Personen abhängig. a) Die Intensität des Magnetfeldes von festen Sendern, wie Basisstationen für Funktelefone (Handys und schnurlose Telefone) und Mobilfunk, Amateurfunkgeräte, AM- und FM-Radiosendemasten und Fernsehsendemasten kann nicht präzise theoretisch vorhergesagt werden. Um durch feste Funkgeräte erzeugten Elektromagnetismus in der Umgebung feststellen zu können, müsste eine elektromagnetische Studie vor Ort vorgenommen werden. Sollte die Stärke des gemessenen Feldes am Aufstellungsort des Geräts höher liegen als gemäß den genannten Vorschriften zulässig, sollte die normale Funktionsweise des Gerätes selbst beobachtet werden. Sollten Anomalien auftreten, könnte es notwendig werden, zusätzliche Vorsichtsmaßnahmen vorzunehmen, wie eine andere Ausrichtung oder Änderung der Position des Gerätes. b) Die Stärke des Feldes bei einem Frequenzbereich von 150 khz bis 80 MHz sollte unter 3 V/m liegen. Empfohlener Abstand zwischen tragbaren und mobilen Kommunikationsgeräten mit Funkfrequenz und dem Monitor Das Gerät MAT-130 ist für den Gebrauch in einer elektromagnetischen Umgebung vorgesehen, in der die Störstrahlung kontrolliert wird. Das Kundenunternehmen und das Bedienpersonal des Gerätes MAT-130 können dazu beitragen, elektromagnetische Störungen zu verhindern, indem der unten je nach maximaler Ausgangsleistung der Kommunikationsgeräte empfohlene Mindestabstand zwischen tragbaren und mobilen Kommunikationsgeräten mit Funkfrequenzen (Sendern) und dem Gerät MAT-130 eingehalten wird. Nominale Ausgangsleistung des Senders W 150 khz bei 80 MHz P Abstand zur Frequenz des Sendegeräts m 80 MHz bei 800 MHz 800 MHz bei 2.5 GHz d = [3.5 / V1] d = [12/E1] d = [23/E1] 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7, Für Sendegeräte mit einer maximalen nominalen Ausgabeleistung, die über der angegebenen liegt, kann der empfohlene Abstand in Metern (m) mithilfe der Gleichung der Frequenz des Sendegeräts berechnet werden, wenn P laut Hersteller die maximale Nominalleistung in Watt (W) in der Ausgabe des Sendegeräts ist. Anmerkung 1: Bei 80 MHz und 800 MHz wird der Abstand für den jeweils höheren Frequenzbereich verwendet. Anmerkung 2: Die Leitlinien könnten nicht auf alle Situationen anwendbar sein. Die Ausbreitung des elektromagnetischen Feldes ist wird von der Absorption und Reflexion durch Räumlichkeiten, Gegenstände und Personen beeinflusst. P P 20

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