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Warranty

Product: Mediblink Ultrasonic Nebulizer M480

Manufactured for (also EU importer):

Mediblink d.o.o., Gubčeva cesta 19,

8210 Trebnje, Slovenia; [email protected]; www.mediblink.com

Sellers name, address, signature and stamp*:

Date of extradition/sales*:

*If the invoice is accompanied by this warranty, and if all above information can be seen from the invoice, it is not necessary to fill in this field.

WARRANTY TERMS

Dear customers!
The warranty period is

3 years

and starts from the day of product purchase. The warranty

period on spare parts: masks, mouthpiece, tube and filters is

1 year

. In case of product

claim, you have to show the invoice. We kindly ask you to save the invoice!

Unfortunately, wrong handling with the device is a reason for 95% of customer

complains. You can easily avoid any problem, by getting useful information provided by

our special service department. To reach our service department, you can call or send

e-mail to Mediblink local distributor.
Before sending the product back to retailer, we kindly ask you to call our service

department, to get help about how to use the device to save you with unneeded trips.
The manufacturer guarantees free elimination of all imperfections due to defects in

material or manufacturing procedure by repairing or replacing the product. In case that

the product can not be repaired or replaced, the customer will get the money refund.

The guarantee is not valid in case of the force majeure, accidents or unexpected events

(such as lightning, water, fire etc.), incorrect use or incorrect transport, non-compliance

with safety and maintaining regulations or in case of unprofessional product intervention.

Traces of every day product usage (scratches, abrasions) and not subject to claim. The

warranty does not eliminate the customer rights, which originate from seller responsibility

for product flaws. By accepting the claimed product by the service department, the service

department does not take responsibility for loss of saved data or settings on the product.

All product repairs, which are performed out of product warranty period, have to be paid

by customer by prior notice.

The manufacturer guarantees the product quality and flawless product operation in the

warranty period, which starts with the day of product purchase. If the product can not be

repaired in 45 days, the product will be replaced with a new one. In case that the product

can not be replaced, the money will be refunded to the customer.
In case of product claim, call or send e-mail to Mediblink local distributor.

Any serious incident that has occurred in relation to the device should be reported to the

manufacturer (Foshan City Shunde Toplife Electronic Technology Co., Ltd), company

Mediblink d.o.o. and the competent authority of the Member State in which the user and/

or patient is established.

Содержание M480

Страница 1: ...abo izdelka v celoti preberete navodila za uporabo EN Mediblink Ultrasonic nebulizer M480 INSTRUCTIONS FOR USE Please read this guidebook completely before operating this unit HRV Mediblink Ultrazvu n...

Страница 2: ...5 Accessories 6 Device Components 7 Warnings 8 Aerosol output of NaF 9 Symbol use 13 Instructions 14 Cleaning and maintenance 17 Filter change 17 Technical features 18 Troubleshooting 18 EMC Declarati...

Страница 3: ...deli inhalatorja 27 Opozorila 28 Izhod razpr ila NaF 29 Uporabljeni simboli 33 Navodila 34 i enje in vzdr evanje 37 Menjava filtra 37 Tehni ne lastnosti 38 Odpravljanje te av 38 Izjava o elektromagne...

Страница 4: ...elovi ure aja 47 Upozorenja 48 Izlaz aerosola NaF 49 Upotreba simbola 53 Upute 54 i enje i odr avanje 57 Zamjena filtra 57 Tehni ka svojstva 58 Rje avanje problema 59 Izjava o elektromagnetskoj kompat...

Страница 5: ...s for deeper penetration of the medicine in the respiratory tract ensured by the perfect size of the aerosol particles Warning This product must be assembled maintained and handled by an adult Never l...

Страница 6: ...Item no Material Quantity 1 Adult mask PNEMAD 180 S08MZ7 PVC PP 1 2 Pediatric mask PNEMIN 180 S09MZ8 PVC PP 1 3 Medicine cup PNEBCAM3 XC S02YB PVC 10 4 Sealed ring PNEBUANL 180 G02DQ Silicon 3 5 Exten...

Страница 7: ...k M480 system for aerosol therapy Picture 2 Nebulizer Components 1 Atomizing nozzle or Blue Connector 2 Medicine Cup 3 Sealed ring 4 Sensor for water level 5 Body of the device with water tank 6 Switc...

Страница 8: ...treatment The medical conditions to be treated The device is intended for use in the treatment of asthma COPD and other respiratory ailments in which an aerosolized medication or saline solution is re...

Страница 9: ...nebulizer and the user 10 Never use the unit if it has damaged parts including the power cord or if it has been dropped or submerged in water Send it immediately to technical assistance for tests and...

Страница 10: ...ollected on each stage of the Marple impactor Figure A Plot of the cumulative size distribution of the results in table 2 Aerosol output of NaF 2 NaF minimum speed test results Table 1 Summary of the...

Страница 11: ...speed test results Table 3 Summary of the test results for the proposed device M480 Table 4 Mass fraction of the drug collected on each stage of the Marple impactor Figure B Plot of the cumulative siz...

Страница 12: ...of the cumulative size distribution of the results in table 6 4 NaF maximum speed test results Table 5 Summary of the test results for the proposed device M480 Table 6 Mass fraction of the drug colle...

Страница 13: ...atmospheric pressure limitation This way up Fragile handle with care Keep dry Stacking limit of 6 Caution Date of manufacture the first pair of LOT numbers presents month of manufacture the second pa...

Страница 14: ...medicine and is never nebulized 5 Take a medicine cup with the medicine in it as shown in Fig 3 6 Put the sealed ring on the machine around the mouth of the tank before placing the medicine cup in 7...

Страница 15: ...erosol therapy Fig 2 Fig 5 Fig 6 Fig 7 Fig 1 Fig 4 Warning Air outlet is strictly prohibited from entering water Indicate line for water level in water tank Fig 8 Fig 9 Fig 3 10ml Level for Medicine l...

Страница 16: ...ank for the next treatment Caution normally at the end of the treatment a small amount of medicine remains in the Medicine holder this amount called the residual volume cannot be nebulized Once the tr...

Страница 17: ...y other materials Do not wash or clean the filter Only use filters supplied by your distributor And do not operate without a filter 2 Change the filter every 30 days or when it turns grey 3 Changing p...

Страница 18: ...10 to 95 RH The above technical features may be subject to change at the discretion of the producer Figure 1 the distribution of atomized particles Albuterol sulfate Troubleshooting If any abnormalit...

Страница 19: ...ions CISPR 11 Group 1 The device only uses RF energy for its internal function Therefore its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment RF...

Страница 20: ...0 5 1 0 KV Signal input output 2 0 KV The mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations in power supply inp...

Страница 21: ...es m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicin...

Страница 22: ...aration distance according to the frequency of the transmitter m 150 KHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 7GHz d 2 3 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...

Страница 23: ...the product can not be repaired or replaced the customer will get the money refund The guarantee is not valid in case of the force majeure accidents or unexpected events such as lightning water fire e...

Страница 24: ...Slovenia info mediblink com www mediblink com Exclusive representative for Slovenia Prolat d o o Prapro e 9 8210 Trebnje SLO Tel 386 0 7 30 44 555 info prolat si Service and claims servis prolat si ww...

Страница 25: ...pa razpr i naravnost v respiratorni trakt dihalno pot Mediblink Ultrazvo ni inhalator M480 omogo a da razpr eni delci oz aerosoli zaradi svoje majhnosti prodrejo v zgornje in spodnje dihalne poti Opoz...

Страница 26: ...aterial Koli ina 1 Maska za odrasle PNEMAD 180 S08MZ7 PVC PP 1 2 Pediatri na maska PNEMIN 180 S09MZ8 PVC PP 1 3 Posodica za zdravilo PNEBCAM3 XC S02YB PVC 10 4 Tesnilni obro PNEBUANL 180 G02DQ Silikon...

Страница 27: ...istem Mediblink M480 za terapijo z razpr ilom Slika 2 Sestavni deli inhalatorja 1 Razpr ilna oba 2 Posodica za zdravilo 3 Tesnilni obro 4 Senzor ravni vode 5 Telo naprave z vsebnikom za vodo 6 Stikalo...

Страница 28: ...zdravljenje na domu Zdravstvena stanja ki jih zdravi Pripomo ek namenjen za zdravljenje astme KOPB in drugih bolezni dihal pri katerih je med zdravljenjem potrebna terapija z zdravili ali s sterilno...

Страница 29: ...di uporabnik 10 Enote ne uporabljajte e ima po kodovane dele vklju no z napajalnim kablom e vam je padla na tla ali e je bila potopljena v vodo Takoj jo po ljite tehnikom da jo preizkusijo in popravij...

Страница 30: ...e zdravila zbranega na vsaki stopnji impaktorja Marple Slika A Prikaz kumulativne porazdelitve velikosti rezultatov v preglednici 2 2 Rezultati preizkusa NaF najmanj a hitrost Preglednica 1 Povzetek r...

Страница 31: ...zkusa NaF srednja hitrost Preglednica 3 Povzetek rezultatov preizkusa za pripomo ek M480 Preglednica 4 Masni dele zdravila zbranega na vsaki stopnji impaktorja Marple Slika B Prikaz kumulativne porazd...

Страница 32: ...mulativne porazdelitve velikosti rezultatov v preglednici 6 4 Rezultati preizkusa NaF najve ja hitrost Preglednica 5 Povzetek rezultatov preizkusa za pripomo ek M480 Preglednica 6 Masni dele zdravila...

Страница 33: ...vrednost zra nega tlaka shranjevanja Ta stran navzgor Krhko ravnati previdno Pazite da se ne zmo i Omejitev zlaganja na 6 Pozor Datum proizvodnje prvi par LOT tevilke predstavlja mesec proizvodnje dru...

Страница 34: ...a ena v vsebniku za vodo slika 9 voda omogo a prevajanje ultrazvo nih valov v zdravilo in ni namenjena inhaliranju 5 Vzemite posodico za zdravilo z zdravilom kot je prikazano na sliki 3 6 Namestite te...

Страница 35: ...zpr ilom Slika 1 Slika 2 Slika 3 Slika 4 Slika 5 Slika 6 Slika 7 Opozorilo V odvod zraka ne sme pod nobenim pogojem zaiti voda Oznaka za raven vode v vsebniku za vodo 10 ml raven za teko e zdravilo 5...

Страница 36: ...prostor obrisati z mehko isto suho krpo Pred naslednjo terapijo je potrebno ponovno v vsebnik naliti vodo Pozor obi ajno ostane po koncu terapije v notranjosti posodice za zdravilo majhna koli ina zd...

Страница 37: ...ali drugih materialov Ne umivajte ali istite filtra Uporabljajte samo filtre ki jih dobavlja va distributer Ne uporabljajte brez filtra 2 Filter zamenjajte vsakih 30 dni ali ko filter postane siv 3 P...

Страница 38: ...5 RV Zgoraj navedene tehni ne lastnosti se lahko po presoji proizvajalca spremenijo Slika 1 Porazdelitev atomiziranih delcev albuterol sulfat Odpravljanje te av e se med uporabo pojavi kakr na koli ne...

Страница 39: ...en ne emisije CISPR 11 Skupina 1 Pripomo ek uporablja radiofrekven no energijo samo za svoje notranje funkcije Zato so njegove emisije RF zelo nizke in obstaja majhna verjetnost motenj bli nje elektro...

Страница 40: ...0 kV Kakovost elektri nega omre ja mora biti enaka kot v tipi nem komercialnem ali bolni ni nem okolju Padci napetosti kratke prekinitve in napetostna nihanja na napajalnih vodih IEC 61000 4 11 0 5 ci...

Страница 41: ...m Jakosti polj ki jih oddajajo fiksni radiofrekven ni oddajniki dolo ene z raziskavo elektromagnetnega sevanja a morajo biti ni je od stopnje skladnosti v vsakem posami nem frekven nem obmo ju b V bl...

Страница 42: ...izhodna mo oddajnika W Lo ilna razdalja glede na frekvenco oddajnika m 150 KHz do 80 MHz d 1 2 80 MHz do 800 MHz d 1 2 800 MHz do 2 7GHz d 2 3 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...

Страница 43: ...anjkljivosti ki so posledica napak materiala ali proizvodnje s pomo jo popravila ali menjave V primeru da popravilo ali zamenjava izdelka nista mogo a Dajalec garancije kupcu vrne kupnino Garancija ne...

Страница 44: ...528325 P R China Proizvedeno za uvoznik v EU Mediblink d o o Gub eva cesta 19 8210 Trebnje Slovenija info mediblink com www mediblink com Zastopnik za SLO Prolat d o o Prapro e 9 8210 Trebnje SLO Tel...

Страница 45: ...osolne estice idealne veli ine to omogu ava dublju penetraciju lijeka u respiratorni trakt Mediblink Ultrazvu ni raspr iva M480 omogu ava radi male veli ine estica dublje prodiranje aerosola u gornje...

Страница 46: ...la Broj stavke Materijal Koli ina 1 Maska za odrasle PNEMAD 180 S08MZ7 PVC PP 1 2 Maska za djecu PNEMIN 180 S09MZ8 PVC PP 1 3 a ica za lijek PNEBCAM3 XC S02YB PVC 10 4 Brtveni prsten PNEBUANL 180 G02D...

Страница 47: ...tav Mediblink M480 za aerosolnu terapiju Slika 2 Dijelovi ure aja 1 Mlaznica za atomizaciju 2 a ica za lijek 3 Brtveni prsten 4 Senzor razine vode 5 Ku i te ure aja sa spremnikom za vodu 6 Prekida 7 S...

Страница 48: ...tvenog osoblja ili pacijenta uz smjernice kvalificiranih medicinskih stru njaka za lije enje kod ku e Lije enje sljede ih zdravstvenih stanja Ure aj je namijenjen za upotrebu u lije enju astme KOPB a...

Страница 49: ...raspr iva a i ozljede korisnika 10 Nikad nemojte upotrebljavati jedinicu ako su njezini dijelovi o te eni uklju uju i kabel za napajanje ili ako je pao u vodu ili je uronjen u nju Po aljite ga bez odg...

Страница 50: ...aseni udio lijeka prikupljen u svakoj fazi ispitivanja udarnom glavom Marple Slika A Grafikon ukupne raspodjele veli ina iz tablice 2 2 Rezultati ispitivanja najmanja brzina NaF Tablica 1 Sa etak rezu...

Страница 51: ...ispitivanja srednja brzina NaF Tablica 3 Sa etak rezultata ispitivanja predlo enog ure aja M480 Tablica 4 Maseni udio lijeka prikupljen u svakoj fazi ispitivanja udarnom glavom Marple Slika B Grafiko...

Страница 52: ...fikon ukupne raspodjele veli ina iz tablice 6 4 Rezultati ispitivanja najve a brzina NaF Tablica 5 Sa etak rezultata ispitivanja predlo enog ure aja M480 Tablica 6 Maseni udio lijeka prikupljen u svak...

Страница 53: ...kladi tenja Ovom stranom prema gore Lomljivo pa ljivo rukovati Ostaviti na suhom Ograni enje slaganja do 6 ambala a Oprez Datum proizvodnje prvi par brojeva LOT a predstavlja mjesec proizvodnje drugi...

Страница 54: ...a voda omogu uje provo enje ultrazvu nih valova do lijeka i nikad se ne raspr uje 5 Uzmite a icu s lijekom i napunite je lijekom kako je prikazano na slici 4 6 Postavite brtveni prsten na stroj oko ul...

Страница 55: ...Slika 1 Slika 2 Slika 3 Slika 4 Slika 5 Slika 6 Slika 7 Upozorenje strogo je zabranjeno dopustiti ulazak vode u izlaz zraka Nazna ite liniju za razinu vode u spremniku vode 10 ml razina medicinske tek...

Страница 56: ...a koje stvori ure aj 6 Nakon jednokratnog tretmana potrebno je zamijeniti vodu u spremniku za sljede i tretman Oprez Obi no na zavr etku tretmana mala koli ina lijeka ostaje u dr a u lijeka ta koli in...

Страница 57: ...ltra 1 Nemojte upotrebljavati pamuk ili bilo koje druge materijale Nemojte prati ili istiti filtar Upotrebljavajte samo filtre koje vam je dostavio va distributer Nemojte rukovati ure ajem bez filtra...

Страница 58: ...Veli ina estica MMAD NaF 1 19 1 52 m Obujam a ice za lijek Najvi e oko 10 ml Razina buke 32 9 dB Dimenzije 164 x 97 x 140 mm Te ina Pribli no 425 g Radna temperatura i vla nost 10 C do 40 C 50 F do 1...

Страница 59: ...aj trebate poslati u servis koji e provjeriti je li ventilator vrsto i pravilno montiran na osovinu motora Smjernice i izjava proizvo a a elektromagnetsko zra enje Ure aj je namijenjen za upotrebu u...

Страница 60: ...0 KV Opskrbni ulazi za napajanje 2 0 kV Kvaliteta elektri ne energije trebala bi biti tipi na za komercijalno ili bolni ko okru enje Padovi napona kratki prekidi i varijacije napona na ulaznim vodovim...

Страница 61: ...preporu ena udaljenost u metrima m Ja ine polja fiksnih RF oda ilja a kako je to odre eno elektromagnetskim istra ivanjem na lokaciji a trebale bi biti manje od razine sukladnosti u svakom rasponu fr...

Страница 62: ...na izlazna snaga oda ilja a W Udaljenost prema frekvenciji oda ilja a m 150 KHz do 80 MHz d 1 2 80 MHz do 800 MHz d 1 2 800 MHz do 2 7GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10...

Страница 63: ...ke u radu ure aja nastale uslijed nedostatka materijala ili proizvodnje U slu aju da popravak ili zamjena proizvoda nije mogu a jamac vra a kupovnu cijenu kupcu Jamstvo se ne odnosi na tete uzrokovan...

Страница 64: ...ng Province 528325 P R China Proizvedeno za EU importer uvoznik Mediblink d o o Gub eva cesta 19 8210 Trebnje Slovenija info mediblink com www mediblink com Zastupnik za HR Golia d o o XI Vrbik 3 1000...

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