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ENVIRONMENTAL CONDITIONS

The device is weatherproof. 

A weatherproof device can tolerate light fresh water splashing (e. g. rain) 
but does not allow submersion. Dry thoroughly after contact with fresh 
water. 

No salt water or chlorinated water allowed. 

REPORT A SERIOUS INCIDENT
Important notice to users and/or patients established in Europe:

The user and/or patient must report any serious incident that has 
occurred in relation to the device to the manufacturer and the competent 
authority of the Member State in which the user and/or patient is 
established.

DISPOSAL

All components of the product and packaging should be disposed of in 
accordance with respective national environmental regulations.

LIABILITY

Össur does not assume liability for the following:

 

– Device not maintained as instructed by the instructions for use.

 

– Device assembled with components from other manufacturers.

 

– Device used outside of recommended use condition, application, 

or environment.

Summary of Contents for Unity for Pro-Flex Pivot

Page 1: ...Instructions for Use UNITY FOR PRO FLEX PIVOT...

Page 2: ...FIGURES 3 EN Instructions for Use 4 CS N vod k pou it 8 SK N vod na pou itie 12 RO Indica ii pentru utilizare 17 HR Upute za uporabu 22 HU Haszn lati tmutat 26 BG 31 SL Indik cie Pre Pou itie 36...

Page 3: ...3 mm 5 7 8 mm 6 1 8 mm 6 5 16 mm 1 2 3 4 5 6 7 8 9...

Page 4: ...socket with an Iceross Seal In Liner The function of Unity is activated during gait the weight placed on the prosthetic foot expands the vacuum pump reservoir that efficiently draws air out from the s...

Page 5: ...or replacing during the lifetime of the product Duckbill valves Outlet Port Tube NOTE It is recommended to have the product inspected every 6months by a healthcare professional NOTE The duckbill valve...

Page 6: ...he pyramid of the foot Remove the yellow warning label torque according to specifications see the adapter instructions for use The female pyramid is incorrectly connected to the male foot pyramid Read...

Page 7: ...serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and or patient is established DISPOSAL All component...

Page 8: ...s chodidlem Pro Flex Pivot Foot krytem chodidla FST0 a sadou Unity Socket Valve Kit pro p ipojen k usazovac mu l ku pomoc n vleku Iceross Seal In Liner Funkce syst mu Unity je aktivov na b hem ch ze h...

Page 9: ...po kozen Upozorn n Ujist te se e trubka syst mu Unity nen zm knuta Obr 7 ani ohnuta pou it m kosmetick ch obal Obr 9 VAROV N Neupevn n nebo voln vis c trubka m e p edstavovat riziko zakopnut Upevn te...

Page 10: ...r ta podtlaku V n vleku Seal In jsou net snosti Vizu ln zkontrolujte t sn n a nebo n vlek zda nejsou po kozen a v p pad pot eby je vym te Pomoc st ka ky zkontrolujte zda je zachov n podtlak Doch z k n...

Page 11: ...jte siln j rozpou t dla ne izopropylalkohol jinak m e doj t k po kozen materi lu nebo proniknut p es ventil a do l ka PODM NKY PROST ED Prost edek je odoln proti pov trnostn m vliv m Prost edek odoln...

Page 12: ...pomocou vlo ky Iceross Seal In Liner Funkcia pom cky Unity sa aktivuje po as ch dze Hmotnos p sobiaca na protetick chodidlo roz iruje z sobn k v kuov ho erpadla ktor pri ka dom kroku inne odv dza vzdu...

Page 13: ...pom cky Unity nie s stla en Obr 7 alebo zohnut pou it m kozmetick ch obalov Obr 9 VAROVANIE Uvo nen alebo visiaca trubica m e predstavova nebezpe enstvo zakopnutia Trubicu trvalo pripevnite k prot ze...

Page 14: ...tupn port Strata podtlaku N vlek Seal In netesn Vizu lne skontrolujte tesnenie a alebo vlo ku i nie s po koden a v pr pade potreby ich vyme te Pomocou strieka ky skontrolujte i je zachovan podtlak Doc...

Page 15: ...te vlhkou handri kou a jemn m mydlom izopropylalkoholom alebo lubrika n m sprejom Iceross Clean Simple Opl chnite istou vlhkou handri kou a d kladne osu te UPOZORNENIE Nepou vajte rozp adl silnej ie a...

Page 16: ...nepreber zodpovednos za nasleduj ce pr pady Pom cka sa neudr iava pod a pokynov v n vode na pou itie Pom cka je zostaven z komponentov in ch v robcov Pom cka sa pou va mimo podmienok odpor an ho pou i...

Page 17: ...upap cu priz Unity pentru conectarea la o priz cu suspensie cu c ptu eal Iceross Seal In Func ionarea Unity este activat n timpul mersului greutatea plasat pe piciorul protetic extinde rezervorul pomp...

Page 18: ...clema pentru tub pentru a evita deteriorarea n timpul deplas rii Aten ie Asigura i v c tubulatura Unity nu este comprimat Fig 7 sau pliat prin aplicarea finis rii cosmetice Fig 9 AVERTIZARE Un tub lib...

Page 19: ...e Filtrul este murdar Schimba i portul de evacuare Vid pierdut Seal In prezint scurgeri Verifica i vizual garnitura i sau c ptu eala pentru a observa eventuale deterior ri schimba i dac este necesar F...

Page 20: ...9 CUR ARE Cur a i componentele cu o c rp umed i s pun bl nd alcool izopropilic sau spray cu lubrifiant Iceross Clean Simple Cl ti i cu o c rp umed curat i usca i bine ATEN IE Nu utiliza i solven i ma...

Page 21: ...c dispozitivul nu este ntre inut n conformitate cu indica iile din instruc iunile de utilizare Dac dispozitivul este asamblat cu componente de la al i produc tori Dac dispozitivul este utilizat n afar...

Page 22: ...pletom ventil le i ta Unity za spajanje s ovjesnim le i tem s oblogom Iceross Seal In Liner Funkcija Unity aktivira se tijekom hoda te ina stavljena na protetsko stopalo pro iruje spremnik vakuumske p...

Page 23: ...retanja Oprez pazite da cijevi Unity ne budu pritisnute Sl 7 ili presavijene primjenom kozmeti ke zavr ne obrade Sl 9 Upozorenje otpu tena ili vise a cijev mo e stvoriti opasnost od spoticanja Pri vrs...

Page 24: ...Filtar je prljav Promijenite izlazni otvor Nema vakuuma Obloga Seal In propu ta Vizualno provjerite ima li o te enja na brtvi i ili oblozi i po potrebi promijenite Pomo u trcaljke provjerite odr ava...

Page 25: ...ross Clean and Simple Lubricant Isperite istom vla nom krpom i temeljito posu ite Oprez nemojte upotrebljavati otapala ja a od izopropilnog alkohola jer mogu o tetiti materijal ili pro i kroz ventil i...

Page 26: ...metikai bor t ssal s a Unity szelep k szlettel haszn lhat egy Iceross Seal In linerrel ell tott felf ggeszt si tokhoz val csatlakoztat shoz A Unity a j r s sor n aktiv l dik ahogy s ly nehezedik a pro...

Page 27: ...el hogy elker lje annak s r l s t a j r s sor n Vigy zat gyeljen r hogy a kozmetikai befejez s sor n 9 bra a Unity cs ve ne nyom djon ssze 7 bra s ne t rj n meg FIGYELEM A laza vagy kil g cs botl st e...

Page 28: ...szos a sz r Cser lje ki a kimeneti portot El gtelen v kuum Nem z r megfelel en a Seal In membr n Szemrev telez ssel ellen rizze hogy a membr n s vagy a liner s r lt e s sz ks g eset n cser lje ki Fecs...

Page 29: ...helyez s re 9 bra TISZT T S Az alkatr szeket enyhe szappanos oldattal benedves tett t rl kend vel izopropil alkohollal vagy Iceross Clean Simple Lubricant spray vel tiszt tsa bl tse le tiszta nedves t...

Page 30: ...bbiak eset ben Ha nem v gzik el az eszk z n a haszn lati tmutat ban ismertetett karbantart st Ha az eszk zt m s gy rt kt l sz rmaz alkatr szekkel szerelik ssze Ha az eszk zt nem az aj nlott k r lm nye...

Page 31: ...31 Unity Pro Flex Pivot UNITY 2 1 2 3 4 5 6 7 Pro Flex Pivot FST0 Unity Iceross Seal In Unity 15 inHg a...

Page 32: ...32 1 5 2 3 Pro Flex Pivot 6 Pro Flex Pivot 6 3 Loctite 243 5 Nm 4 4 i Unity ii iii Unity 7 9 Unity 6 8 Loctite 243 4 Nm Unity...

Page 33: ...33 Unity Unity Unity Loctite 243 5Nm 5 6 Seal In Unity Unity 8...

Page 34: ...34 Loctite 243 Loctite 243 4Nm 8 Spectra Spectra 9 Iceross Clean Simple...

Page 35: ...35 ssur...

Page 36: ...delom za stopalo FST0in kompletom ventila le i a Unity za priklju itev na le i e s suspenzijo z oblogo Iceross Seal In Delovanje pripomo ka Unity se spro i med hojo z obte itvijo proteti nega stopala...

Page 37: ...objemko da prepre ite po kodbe med hojo Pozor Pazite da pri namestitvi kozmeti nega prekrivnega dela ne stisnete Slika 7 ali zvijete cevi Unity Slika 9 Opozorilo Zrahljana ali vise a cev lahko povzro...

Page 38: ...trezno name ena Prepri ajte se da je cev v celoti vstavljena v vstopno odprtino in ventil le i a Unity Kljunasta ventila sta bila napa no name ena Preverite ali sta kljunasta ventila usmerjena v pravo...

Page 39: ...tiku s sladko vodo ga temeljito posu ite Stik s slano ali klorirano vodo ni dovoljen PORO ANJE O RESNIH DOGODKIH Pomembno obvestilo za uporabnike in ali bolnike v Evropi Uporabnik in ali bolnik mora o...

Page 40: ...ssur APAC Tel 31 499 462840 2F W16 B info europe ossur com No 1801 Hongmei Road 200233 Shanghai China ssur Deutschland GmbH Tel 86 21 6127 1707 Augustinusstrasse 11A asia ossur com 50226 Frechen Deut...

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