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Össur TOTAL KNEE 1900, Instructions For Use Manual

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Summary of Contents for TOTAL KNEE 1900

Page 1: ...Instructions for Use TOTAL KNEE 1900...

Page 2: ...FIGURES 3 EN Instructions for Use 6 CS N vod k pou it 12 SK Indik cie pou itia 18 RO Indica ii de utilizare 25 HR Upute za uporabu 32 HU Haszn lati javallat 38 BG 45...

Page 3: ...3 B D E C A 1 2 3 A 4 5 B D C E A 5 6 A B D C 7...

Page 4: ...4 I A B C E G F H D B A C A B C A 8 9 10 11...

Page 5: ...5 13 1 2 343mm 18 457mm 9 228mm 11 3 4 298mm 16 406mm 11 1 2 343mm 13 3 4 349mm 16 1 2 419mm 20 1 4 514mm 19 1 2 495mm A B 12...

Page 6: ...contraindications The device is for low to moderate impact use e g walking The weight limit for the device is 100kg GENERAL SAFETY INSTRUCTIONS The healthcare professional should inform the patient a...

Page 7: ...ference line B should pass through midpoint of socket at the ischial tuberosity level D pass through pivot axis A fall at the 1 3mark on the inside of the foot cover Note Prioritize knee alignment ove...

Page 8: ...prosthesis without a stance flexion feature may initially prefer a stiffer Bumper After a trial period of two weeks selecting a softer Bumper is recommended Increasing the softness of the Bumper allow...

Page 9: ...ick the device is shipped with the Clear Shim installed Adding Shims changes the release point of the Geometric Lock that allows for knee flexion during the swing phase Adjusting the height of the Bum...

Page 10: ...nstall the selected Shims Bumper and Bumper Cover Follow up check Reassess adjustments after a couple of weeks It may be necessary to change the Shim and Bumper adjustments after the patient has gaine...

Page 11: ...c solutions are available please refer to ssur catalogue for further information Shin Fairing Black 11A Knee Cap Large Beige 11B Knee Cap Small Black 11C Cosmetic Foam Cover Regular 12A and Cosmetic F...

Page 12: ...aindikace Prost edek je ur en pro slab a st edn intenzivn r zy nap pro ch zi Hmotnostn limit prost edku je 100kg V EOBECN BEZPE NOSTN POKYNY Zdravotnick pracovn k mus pacienta informovat o v em co je...

Page 13: ...et st edem l ka v rovni sedac ho hrbolu D proch zet osou ot en A dopadat na zna ku 1 3 na vnit n stran krytu chodidla Pozn mka V p pad neshody up ednostn te zarovn n s kolenem p ed zarovn n m s chodid...

Page 14: ...a usnad uje p echod k pou v n funkce flexe ve stoji Statick se zen Ujist te se e pacient ve stoje p en v hu rovnom rn na ob nohy Zkontrolujte zda m prot za spr vnou d lku Zkontrolujte vnit n i vn j ro...

Page 15: ...jn f zi Ni doraz Zvy uje stabilitu za zen a flexi ve stojn f zi a sou asn zpo uje uvoln n flexe ve vihov f zi Postupn zvy ujte v ku dorazu dokud pacient nepoc t p ed asn uvoln n kolene Sni ujte po et...

Page 16: ...p ej t na tu doraz a nebo zv it tlou ku podlo ky POU V N i t n a dr ba Ot ete prost edek m kkou ut rkou Nepou vejte rozpou t dla Podm nky prost ed Tento prost edek nesm p ij t do styku se sladkou slan...

Page 17: ...CH P HOD Ve ker z va n ne douc p hody ke kter m dojde v souvislosti s t mto prost edkem ohlaste v robci a p slu n m org n m LIKVIDACE Prost edek a balen je t eba likvidovat v souladu s p slu n mi m s...

Page 18: ...kon atiny Nie s zn me iadne kontraindik cie T to pom cka je ur en na pou vanie pri n zkom a strednom r zovom za a en napr na ch dzu Hmotnostn limit tejto pom cky je 100kg V EOBECN BEZPE NOSTN POKYNY...

Page 19: ...n kontakt je medzi l kom a dist lnou jednou tretinou zadn ho tiahla pom cky POKYNY NA ZAROVNANIE Z kladn zarovnanie Obr 3 Cie zarovnania Referen n l nia zarovnania B by mala prech dza stredov m bodom...

Page 20: ...as telesa a zatla en m dvoch apov do otvorov v telese Faktory ovplyv uj ce v ber tlmi a n razov Akt vni pacienti m u vy adova tuh tlmi n razov Pacienti ktor s zvyknut nosi prot zu bez funkcie flexie...

Page 21: ...n razov s m kk mi p tami a pevnej tlmi n razov s pevn mi p tami Nastavenie v ky tlmi a n razov Na pravu v ky tlmi a n razov sa pod neho 7A umiestni tenk plastov doska alebo podlo ka Obr 7B Existuj dva...

Page 22: ...avle te gu ovit koniec k bla cez otvor E v trubicovom konektore a pomocou telef nnych klie t alebo mal m skrutkova om zasu te gu ku do otvoru v spodnom tiahle pom cky I 8 Znovu nasa te vybran podlo ky...

Page 23: ...nosti Obr 11 12 T to pom cka sl i na ochranu prot zy a obnovenie vzh adu ch baj cej kon atiny Odpor a sa preru ovan kozmetick rie enie ktor nezasahuje do funkcie kolena Kontinu lne kozmetick rie enia...

Page 24: ...pri troch mili noch z a ov ch cyklov V z vislosti od aktivity pacienta to m e zodpoveda 3 a 3 rokom pou vania ISO 10328 P5 100 kg Neprekra ujte limit telesnej hmotnosti Konkr tne podmienky a obmedzeni...

Page 25: ...inferioare i sau deficien congenital Nu exist contraindica ii cunoscute Dispozitivul este destinat utiliz rii cu impact redus c tre moderat de exemplu pentru mersul pe jos Limita de greutate pentru d...

Page 26: ...imal de 2 3 a leg turii posterioare a dispozitivului trebuie evitat atunci c nd flecta i complet genunchiul Fig 2 Contactul din aceast zon poate deteriora dispozitivul Contactul acceptabil este ntre c...

Page 27: ...B n pozi ie 3 Selecta i un amortizor de instalat n func ie de dispozitivul Total Knee utilizat i de greutatea pacientului Greutate kg Greutate livre lb Culoare Tip 35 50 80 110 Verde Moale 50 70 110 1...

Page 28: ...selecta il pe cea care se potrive te cel mai bine nevoilor pacientului Selec ia final a amortizorului poate diferi de selec ia ini ial n func ie de greutatea pacientului consulta i sec iunea anterioa...

Page 29: ...a extensie este o caracteristic op ional care faciliteaz extensia complet a genunchiului Utilizarea Asisten ei la extensie este recomandat numai atunci c nd pacientul nu poate extinde genunchiul pentr...

Page 30: ...ea frecvent a dispozitivului ntr o pozi ie u or flectat vor fi vizibile trei seturi de rulmen i cu role Fig 10A A eza i c teva pic turi de ulei de uz general sau ulei pentru ma ina de cusut pe rulmen...

Page 31: ...onente de la al i produc tori Dac dispozitivul este utilizat n afara condi iilor aplica iei sau mediului de utilizare recomandate Conformitatea Acest dispozitiv a fost testat conform standardului ISO...

Page 32: ...njim utjecajem npr za hodanje Ograni enje te ine za proizvod iznosi 100kg OP E UPUTE ZA SIGURNOST Zdravstveni djelatnik trebao bi obavijestiti pacijenta o svemu u ovom dokumentu to je potrebno za sigu...

Page 33: ...ro i kroz sredi nju to ku le i ta na razini ishijalne izbo ine D pro i kroz os osovine A pasti na oznaku 1 3 s unutarnje strane navlake stopala Napomena dajte prednost poravnanju koljena u odnosu na p...

Page 34: ...tezu bez zna ajke savijanja oslanjanja mogu u po etku preferirati kru i amortizer Nakon probnog razdoblja od dva tjedna preporu uje se odabir mek eg amortizera Pove anje meko e amortizera omogu uje pa...

Page 35: ...e visine Postoje dvije vrste podlo ke siva debljine 0 38mm i prozirna debljine 0 76mm ure aj se isporu uje s instaliranom prozirnom podlo kom Dodavanjem podlo ke mijenja se to ka otpu tanja geometrijs...

Page 36: ...njoj sponi ure aja I pomo u iglastih klije ta ili malog odvija a 8 Ponovno umetnite odabrane podlo ke amortizer i poklopac amortizera Kontrolna provjera Preispitajte prilagodbe nakon par tjedana Mo da...

Page 37: ...atne informacije pogledajte katalog tvrtke ssur Obloga za cjevanicu crna 11A Navlaka za koljeno velika be 11B Navlaka za koljeno mala crna 11C Kozmeti ka pjenasta navlaka obi na 12A i Kozmeti ka pjena...

Page 38: ...gy velesz letett v gtaghi ny Nincs ismert ellenjavallat Az eszk z alacsony m rs kelt aktivit si szint haszn latra vagyis norm l s t ra szolg l Az eszk z s lykorl tja 100kg LTAL NOS BIZTONS GI UTAS T S...

Page 39: ...akoz j nak proxim lis 2 3 a k z tti rintkez st 2 bra Az ezen a ter leten t rt n rintkez s k ros thatja az eszk zt Az rintkez s a prot zistok s az eszk z h ts csatlakoz j nak diszt lis 1 3 a k z tt meg...

Page 40: ...Az al t tet hagyja a hely n 7B 3 A Total Knee eszk z t pusa s a p ciens tests lya alapj n v lasszon ki egy tk z t Tests ly kg Tests ly lbs Sz n T pus 35 50 80 110 Z ld Puha 50 70 110 155 Fekete K zep...

Page 41: ...hoz s a flexi s mozg shoz sz ks ges nyomat k puha tk z haszn latakor n s kem ny tk z haszn latakor cs kken Att l f gg en hogy melyik prot zisl bat v lasztotta kombin lja a puh bb tk z t puha sarokkal...

Page 42: ...ny rt D a diszt lis cs csatlakoz belsej ben l v lyukba E 3 Gumikalap ccsal vagy hasonl k ziszersz mmal finoman kopogtassa a hely re a rug t ny rt 4 Helyezze r a gy r t F a k belre G 5 Helyezze a rug...

Page 43: ...st T r lje le az eszk zt egy kev s univerz lis olajjal vagy varr g polajjal megnedves tett puha t rl kend vel Vigy zat Ne haszn ljon s r tett leveg t az eszk z tiszt t s hoz A leveg a szennyez anyago...

Page 44: ...nem az aj nlott k r lm nyek k z tt megfelel k rnyezetben vagy m don haszn lja Megfelel s Az eszk zt az ISO 10328 szabv ny szerint tesztelt k h rommilli terhel si ciklusra A beteg aktivit s t l f gg en...

Page 45: ...45 7A 7D 100...

Page 46: ...46 1 4 1A 1B 4 1C or 1D Total Knee ssur 1 2 1E 1D 4 1A 4 1C 1 45 3 o o 2 3 2 1 3 3 B D A 1 3 1 B 1 3 2...

Page 47: ...47 3 A 4 D E 5 B D 6 5 7 4 1E 5 A 15 Nm 6 7 1 7C 6 2 7A 7B 3 Total Knee 35 50 80 110 50 70 110 155 70 90 155 200 90 100 200 220 4 7C...

Page 48: ...48 8 1 8A 2 8 8C 3 2 Nm 17 in lbs 7B 7A 0 38 0 76...

Page 49: ...49 7D 9 1 A B C 2 D E 3 4 F G 5 H 6...

Page 50: ...50 7 E H 8 15 50 6 10A 11 12...

Page 51: ...51 ssur 11A 11B 11C 12 12B ssur ISO 10328 3 5 ISO 10328 P5 100 kg...

Page 52: ...indikacij Pripomo ek je namenjen nizki do zmerni stopnji sile npr pri hoji Omejitev te e za pripomo ek zna a 100kg SPLO NA VARNOSTNA NAVODILA Zdravstveni delavec mora bolnika obvestiti o vsem kar v te...

Page 53: ...kozi sredi no to ko le i a na ravni sedni ne gr e D potekati skozi vrtljivo os A ustrezati oznaki za 1 3 na notranji strani prekrivnega dela za stopalo Opomba V primeru neskladja prednostno obravnavaj...

Page 54: ...vajeni nositi protezo brez funkcije prilagajanja dr e imajo sprva raje tr i bla ilec Po preskusnem obdobju dveh tednov je priporo ljivo izbrati mehkej i bla ilec Pove anje mehkobe bla ilca omogo a bol...

Page 55: ...odlo k siva debela 0 38mm in prozorna debelina 0 76mm pripomo ek je dobavljen z name eno prozorno podlo ko Dodajanje podlo k spremeni to ko sprostitve geometrijske blokade ki omogo a upogibanje kolena...

Page 56: ...a vstavite kroglico v re o na spodnjem priklju ku pripomo ka I 8 Znova namestite izbrane podlo ke bla ilec in pokrov bla ilca Kontrolni pregled Po nekaj tednih ponovno ocenite prilagoditve Ko bolnik p...

Page 57: ...formacije si oglejte katalog ssur prevleka za golen rna 11A pokrov kolena velik be 11B pokrov kolena majhen rn 11C kozmeti ni penasti pokrov navaden 12A in kozmeti ni penasti pokrov velik 12B PORO ANJ...

Page 58: ...orders italy ossur com The Netherlands Tel 800 3539 3668 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...

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