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21

Manufacturer’s guide and declaration – electromagnetic emissions

INN-011 is intended to be used in the electromagnetic environment specified below.  The 
patient or use of INN-011 should assure it’s used in this environment. 

Emission test

Compliance

Electromagnetic environment

Emissions at RF CISPR 11

Group1

INN-011 uses radiofrequency 
energy only for its internal functio-
ning. As a result, its RF emissions 
are very low and are unlikely to 
cause any interference in nearby 
electronic devices. 

Emissions at RF CISPR 11

Class B

INN-011 is suitable for use in all 
domestic markets and connected 
directly to the public power 
voltage grid.  

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emis-
sions IEC 61000-3-3

Compliant

The product is designed to work with a rating up to an altitude of 3000 m. The electro-
medical device requires special precautions regarding EMC (Electromagnetic Compatibi-
lity) and must be installed and put into service in accordance with the EMC information 
contained in the accompanying documents.
Portable and mobile radiocommunication equipment can affect the operation of the 
EUT (Equipment under test).
The use of accessories, transducers and cables other than those specified, with the 
exception of those sold by the manufacturer as spare parts for internal components, 
may cause an increase in emissions and a decrease in immunity.
The appliance or system must not be used near other appliances and, if it is necessary 
to use it near other appliances, the electro-medical device must be observed to check 
normal functioning in the configuration in which it is used.
The electro-medical device has been tested and found to comply with the emission and 
immunity limits of electromedical equipment according to IEC60601-1-2: 2014. These 
limits are designed to provide adequate protection against harmful interference in a 
typical medical installation. However, there is no guarantee that interference will not 
occur in a particular installation.
If the electro-medical device, interacting with another device, causes or receives detec-
table interference, the user is invited to limit interference by adopting one or more of 
the following measures:

1. reorient or relocate the receiving device;
2. increase the distance between the appliances;
3. connect the equipment to an outlet on a circuit different from the device (s) causing 

the interference;

4. contact the manufacturer or local technician for assistance

Summary of Contents for INN-011

Page 1: ...AEROSOL A PISTONE INN 011 MANUALE D USO USER MANUAL...

Page 2: ...lla destinazione d uso per cui previsto ovvero apparecchio per aerosolterapia Il produttore non responsabile per un uso improprio Non usare accessori diversi da quelli originali indicati inquestomanua...

Page 3: ...are mai durante il sonno o in stato di assopimento dormiveglia Nonutilizzaremaiprolungheoadattatori Tenereilcavolontanodasuperficicalde Nonmaneggiaremailaspinaconlemanibagnateenonusareil prodottomentr...

Page 4: ...il boccaglio sotto supervisione devono utilizzare la maschera Utilizzare con il dispositivo solo gli accessori originali forniti per questoprodotto Non aprire n disassemblare il compressore per nessun...

Page 5: ...aragrafo PULIZIA E MANUTENZIONE 3 Pulire l unit principale dopo ogni trattamento non sufficiente Tubi e accessori devono essere puliti accuratamente dopo l uso per prevenire malattie e disturbi causat...

Page 6: ...6 I ILLUSTRAZIONE ACCESSORI BOCCAGLIO MASCHERA ADULTI COME COLLEGARE GLI ACCESSORI FIG 1 1 tubo collegamento aria 4 top ampolla 2 coppa ampolla 5 maschera adulti 3 inserto ampolla 6 boccaglio...

Page 7: ...e e inserire quello di ricambio Infine inserire il coperchietto portafiltro nell apposita sede facendolo aderire bene sulla superficie Per prolungare la vita utile del compressore si consiglia di far...

Page 8: ...muovere il filtro e sostituirlo con uno nuovo Inserire nuovamente il coperchietto NOTE Non tentare di lavare e riutilizzare il filtro Non utilizzare filtri diversi da quelli originali in dotazione pot...

Page 9: ...rnato 20 min ON 40 min OFF Classe di rischio IIa Pressione massima 3 bar Flusso libero 6 9 l min Capacit ampolla 6 c c MMAD m 2 8 0 1 Residuo non nebulizzato 0 5 1 3 c c Valore massimo di pressione so...

Page 10: ...installazione medica Non esiste comunque nessuna garanzia che non si verifichino interferenze in una particolare installazione Se l apparato elettromedicale interagendo con un altro dispositivo causa...

Page 11: ...commerciale o ospedaliero Sovratensioni IEC 61000 4 5 0 5 1kV tra le fasi 0 5 1kV tra le fasi La qualit della tensione di rete dovrebbe essere quella di un tipico ambiente commerciale o ospedaliero Bu...

Page 12: ...01 Livello di conformit Distanza di separazione raccomandata d RF Condotta IEC 61000 4 6 3 Veff da 150kHz a 80 MHz 6 Veff nelle bande ISM e amatoriali tra 150 KHz e 80 MHz 3 Veff 6Veff d 30 cm RF Irra...

Page 13: ...important that the patient reads and understands the informationprovidedfortheuseoftheunit Donotusethedevice for other use than Nebulizer for Aerosoltherapy Manufacturer will not be held responsible f...

Page 14: ...wethands andnotusetheproduct while bathing Never submerge the unit into water should this occur unplug immediately Do not reach for a product that has fallenintowater unplugitfirst Afterremovingthepro...

Page 15: ...ndavoidoperatingthecompressorcloseto anyofthesetransmitters c Turnoffthepowerifthecompressorisnotgoingtobeusedfor anylengthoftime d Beawarethataddingaccessoriesorcomponentsormodifying thecompressormay...

Page 16: ...diminish or eliminate the effectiveness of the treatment if clogging occurs replace with the same model 5 Close supervision is necessary when this product is used by or near children and physically o...

Page 17: ...17 GB ACCESSORIES MOUTH PIECE ADULT MASK HOW TO CONNECT THE ACCESSORIES PICTURE 1 1 air tube 4 top of nebulizing bulb 2 medicine cup 5 adult mask 3 inner insert 6 mouth piece...

Page 18: ...t the filter support lid into its seat making it adhere well to the surface In order to lengthen the life of the nebulizer do not use it continuosly for more than 20 minutes Always wait 40 minutes bef...

Page 19: ...air filter ensure the compressor is off open the air filter cover take out the air filter and replace it with a new one Place the cap back into the socket and snap the filter cover back to place NOTE...

Page 20: ...ss of risk IIa Maximum pressure 3 bar Air flow 6 9 l min Capacity of Medicine cup 6 c c MMAD m 2 8 0 1 Drug residues 0 5 1 3 c c Maximum sound pressure value 64 dBA Aerosol output ml 1 98 0 01 Aerosol...

Page 21: ...he EUT Equipment under test The use of accessories transducers and cables other than those specified with the exception of those sold by the manufacturer as spare parts for internal components may cau...

Page 22: ...l environment Overvoltage IEC 61000 4 5 0 5 1kV between phases 0 5 1kV between phases The quality of the mains voltage should be that of a typical com mercial or hospital environment Voltage dips brie...

Page 23: ...separation distance d Conducted RF IEC 61000 4 6 3 Veff from 150kHz to 80 MHz 6 Veff in ISM amateurs bands between 150 KHz and 80 MHz 3 Veff 6Veff d 30 cm Irradiated RF IEC 61000 4 3 10 V m from 80 M...

Page 24: ...Innoliving Spa Via Merloni 2 B 60131 Ancona Italy Tel 071 2133550 www innoliving it MADE IN CHINA Rev 12_07 2021...

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