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background image

Unacceptable environmental conditions
Chemicals/liquids:

fresh water, salt water, perspiration, urine,

acids, soapsuds, chlorine water

Solids:

dust, sand, highly hygroscopic particles (e. g. talcum)

2.4 Lifetime

This product was tested by the manufacturer with 3 million load
cycles. Depending on the user’s activity level, this corresponds to a
maximum lifetime of 5 years.

3 Safety

3.1 Explanation of warning symbols

CAUTION

Warning regarding possible risks of accident or
injury.

3.2 General safety instructions

CAUTION!

Risk of injury and risk of product damage

►

Note the combination possibilities/combination exclusions in the
instructions for use of the products.

►

Comply with the product's field of application and do not expose
it to excessive strain (see page 7).

►

Do not expose the product to prohibited environmental condi
tions.

►

Check the product for damage if it has been exposed to prohib
ited environmental conditions.

►

Do not use the product if it is damaged or in a questionable con
dition. Take suitable measures (e.g. cleaning, repair, replace
ment, inspection by the manufacturer or a specialist workshop).

►

To avoid the risk of injury and product damage, do not use the
product beyond the tested lifetime.

8

►

To avoid the risk of injury and product damage, only use the
product for a single patient.

►

To prevent mechanical damage, use caution when working with
the product.

►

If you suspect the product is damaged, check it for proper func
tion and readiness for use.

►

Do not use the product if its functionality is restricted. Take suit
able measures (e.g. cleaning, repair, replacement, inspection by
the manufacturer or a specialist workshop).

Signs of changes in or loss of functionality during use

Among other factors, changes in functionality can be indicated by an
altered gait pattern, a change in the positioning of the prosthetic com
ponents relative to each other and by the development of noises.

4 Scope of delivery

Quantity

Designation

Reference number

1

Instructions for use

–

Double adapter, sliding

–

1

Pre-assembled:

8

Set screw

506G3=M8x16

1

Set screw

506G3=M5x8

2

Cap screw

501Z16

5 Preparing the product for use

CAUTION

Incorrect alignment or assembly

Risk of injury due to damaged prosthetic components

►

Observe the alignment and assembly instructions.

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Содержание 4R104-60

Страница 1: ...al de utiliza o 20 Gebruiksaanwijzing 23 Bruksanvisning 27 Brugsanvisning 30 Bruksanvisning 33 K ytt ohje 36 Instrukcja u ytkowania 40 Haszn lati utas t s 43 N vod k pou it 46 Instruc iuni de utilizar...

Страница 2: ...15 Nm 1 2...

Страница 3: ...Loctite 241 15 Nm 2 5 Nm 3 3...

Страница 4: ...atibel mit dem Ottobock Modu larsystem Die Funktionalit t mit Komponenten anderer Hersteller die ber kompatible modulare Verbindungselemente verf gen wurde nicht getestet 2 Bestimmungsgem e Verwendung...

Страница 5: ...n z B Reini gung Reparatur Ersatz Kontrolle durch den Hersteller oder eine Fachwerkstatt Anzeichen von Funktionsver nderungen oder verlust beim Ge brauch Funktionsver nderungen k nnen sich z B durch e...

Страница 6: ...nebeneinanderliegenden Gewindestifte her ausschrauben 6 5 2 Adapter justieren Ben tigte Werkzeuge Drehmomentschl ssel 710D20 Voraussetzung Die Prothese wird nicht getragen und nicht be lastet 1 Die Zy...

Страница 7: ...you have questions about the product or in case of problems Report each serious incident related to the product to the manu facturer and to the relevant authority in your country This is par ticularl...

Страница 8: ...repair replace ment inspection by the manufacturer or a specialist workshop To avoid the risk of injury and product damage do not use the product beyond the tested lifetime 8 To avoid the risk of inj...

Страница 9: ...e set screws with Loctite Screw in the set screws Pre tighten the set screws with the torque wrench 10 Nm and then tighten them 15 Nm 9 3 Replace any set screws that are protruding or are recessed too...

Страница 10: ...d conditions can be obtained from the competent manufacturer distribution company 10 Technical data Reference number 4R104 60 4R104 75 Weight g 215 225 System height mm 97 112 Build height mm 60 75 10...

Страница 11: ...les notices d utilisation des produits Respecter le domaine d application du produit et ne pas l exposer une sollicitation excessive consulter la page 11 Ne pas exposer le produit des conditions ambia...

Страница 12: ...cl dynamom trique 710D20 PRUDENCE Utilisez l adaptateur uniquement avec une tige filet e viss e dans la glissi re en queue d aronde Assurez vous que la tige filet e voir ill 3 est bien viss e dans la...

Страница 13: ...les Toutes les conditions l gales sont soumises la l gislation nationale du pays d utilisation concern et peuvent donc pr senter des varia tions en cons quence 13 9 1 Responsabilit Le fabricant est re...

Страница 14: ...che dispongono di elementi di collegamento modulari com patibili 2 Uso conforme 2 1 Uso previsto Il prodotto deve essere utilizzato esclusivamente per protesi esosche letriche di arto inferiore 2 2 Ca...

Страница 15: ...it Denominazione Codice 1 Libretto di istruzioni per l uso Attacco doppio scorrevo le 1 Premontato 8 Perno filettato 506G3 M8x16 1 Perno filettato 506G3 M5x8 15 Quantit Denominazione Codice 2 Vite a t...

Страница 16: ...idit rimanente all aria 7 Manutenzione Dopo i primi 30 giorni di utilizzo sottoporre i componenti della protesi a un controllo visivo e a un controllo del funzionamento In occasione della normale ispe...

Страница 17: ...e permiten cambiar los ngulos distales y proximales de los com 17 ponentes prot sicos en el plano frontal y en el plano sagital La gu a en cola de milano permite deslizar los componentes prot sicos en...

Страница 18: ...abajar con el producto a fin de evitar da os mec nicos Compruebe que el producto funcione correctamente y que est preparado para el uso si sospechara que est da ado 18 No utilice el producto si su fun...

Страница 19: ...s con ayuda de la llave di namom trica 10 Nm y luego apri telas m s fuerte 15 Nm 3 Sustituya las varillas roscadas que sobresalgan demasiado o es t n insertadas con demasiada profundidad por varillas...

Страница 20: ...mientras perdure el plazo de vigencia de la garant a Para obtener informaci n m s detallada sobre las condiciones de ga rant a consulte a la empresa de distribuci n del fabricante 10 Datos t cnicos R...

Страница 21: ...poss veis nas instru es de utiliza o dos produtos Respeite a rea de aplica o do produto e n o o exponha a esfor os excessivos consulte a p gina 21 N o exponha o produto a condi es ambientais inadmiss...

Страница 22: ...adaptador somente com o pino rosca do aparafusado na guia do tipo rabo de andorinha Certificar se de que o pino roscado veja a fig 3 est aparafusa do corretamente na guia do tipo rabo de andorinha to...

Страница 23: ...respectivo direito em vi gor no pa s em que o produto for utilizado e podem variar correspon dentemente 23 9 1 Responsabilidade O fabricante se responsabiliza se o produto for utilizado de acordo com...

Страница 24: ...r compatibele modulaire verbin dingselementen is niet getest 2 Gebruiksdoel 2 1 Gebruiksdoel Het product mag uitsluitend worden gebruikt als onderdeel van uit wendige prothesen voor de onderste ledema...

Страница 25: ...che werkplaats Tekenen van functieveranderingen of verlies tijdens het gebruik Functieveranderingen kunnen bijvoorbeeld tot uiting komen in een verandering van het gangbeeld een verandering van de pos...

Страница 26: ...t inge schroefde stelbouten die naast elkaar liggen eruit 26 5 2 Adapter afstellen Benodigd gereedschap momentsleutel 710D20 Voorwaarde De prothese wordt niet gedragen en niet belast 1 Draai de cilind...

Страница 27: ...datering 2021 07 05 27 L s noga igenom detta dokument innan du b rjar anv nda pro dukten och beakta s kerhetsanvisningarna Instruera anv ndaren i hur man anv nder produkten p ett s kert s tt Kontakta...

Страница 28: ...pliga tg rder vid behov t ex reng ring reparation byte kontroll hos tillverkaren eller i en fackverkstad 28 Forts tt inte anv nda produkten n r livsl ngden har passerats f r att f rhindra fara f r per...

Страница 29: ...som sticker ut eller har skruvats in f r mycket mot andra passande g ngstift se urvalstabell 29 Urvalstabell f r g ngstift Artikelnummer L ngd mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16 Byte oc...

Страница 30: ...INFORMATION Dato for sidste opdatering 2021 07 05 L s dette dokument opm rksomt igennem f r produktet tages i brug og f lg sikkerhedsanvisningerne Instru r brugeren i hvordan man anvender produktet si...

Страница 31: ...r Kontroller produktet for skader hvis det har v ret udsat for ikke tilladte omgivelsesbetingelser Benyt ikke produktet hvis det er beskadiget eller er i en tvivlsom tilstand S rg efter behov for egne...

Страница 32: ...er holderens ge vindstifter 32 N dvendige materialer momentn gle f eks 710D20 Locti te 241 636K13 1 Pr vning Skru gevindstifterne ind Fastsp nd gevindstifterne med momentn glen 10 Nm 2 Endelig monteri...

Страница 33: ...ikantens hjemmeside 9 3 Garanti Producenten yder garanti p dette produkt fra k bsdato Garantien d kker mangler der p viseligt skyldes materiale fremstillings eller konstruktionsfejl og som g res g lde...

Страница 34: ...alt 5 r 34 3 Sikkerhet 3 1 Varselsymbolenes betydning FORSIKTIG Advarsel mot mulige ulykker og personskader 3 2 Generelle sikkerhetsanvisninger FORSIKTIG Fare for personskader og fare for produktskade...

Страница 35: ...otese Innstilling av anslaget Settskruen i svanehalesporet begrenser forskyvningen av adapteren i n retning For motsatt forskyvning kan adapteren dreies eller settsk ruen flyttes N dvendig verkt y mom...

Страница 36: ...itt land n r det gjelder prosedyrer for retur innsamling og avfallsh ndtering 9 Juridiske merknader Alle juridiske vilk r er underlagt de aktuelle lovene i brukerlandet og kan variere deretter 36 9 1...

Страница 37: ...ettu k ytett v ksi yksinomaan alaraajan eksoprotesoin tiin 2 2 K ytt alue Korkein sallittu ruumiinpaino 100 kg 2 3 Ymp rist olosuhteet Varastointi ja kuljetus L mp tila alue 20 C 60 C suhteellinen ilm...

Страница 38: ...ennettu 8 Kierretappi 506G3 M8x16 1 Kierretappi 506G3 M5x8 2 Lieri kantaruuvi 501Z16 38 5 Saattaminen k ytt kuntoon HUOMIO Virheellinen kokoonpano tai asennus Loukkaantumisvaara proteesin osien vaurio...

Страница 39: ...oteamiseksi 39 Suorita vuosittaiset turvallisuustarkastukset 8 J tehuolto Tuotetta ei saa h vitt kaikkialla lajittelemattomien kotitalousj tteiden mukana Ep asiallisella h vitt misell voi olla haitall...

Страница 40: ...kowej 1 2 Mo liwo ci zestawie Omawanie komponenty protezowe s kompatybilne z systemem modularnym Ottobock Funkcjonalno z komponentami innych pro ducent w kt re wyposa one s w kompatybilne modularne el...

Страница 41: ...ograniczone Nale y podj w a ciwe kroki np wyczyszczenie naprawa wymiana kontrola przez producenta lub wykwalifikowany serwis itp Oznaki zmiany lub utraty funkcji podczas u ytkowania Zmiany funkcjonowa...

Страница 42: ...bela wyboru ko k w gwintowych Symbol D ugo mm 506G3 M8x12 V 12 506G3 M8X14 14 506G3 M8X16 16 42 Wymiana i demonta Podczas wymiany lub demonta u ustawiona pozycja podzespo w protezowych mo e by zachowa...

Страница 43: ...kle r s Magyar INFORM CI Az utols friss t s d tuma 2021 07 05 A term k haszn lata el tt olvassa el figyelmesen ezt a dokumen tumot s tartsa be a biztons gi utas t sokat A term k tad sakor oktassa ki a...

Страница 44: ...t s ne tegye ki a term ket t lzott ig nybev telnek l sd ezt az oldalt 43 A term ket ne tegye ki nem megengedett k rnyezeti hat soknak Ha a term ket nem megengedett k rnyezeti hat sok rt k ellen rizze...

Страница 45: ...zt az br t 3 megfelel en van e becsavarva megh z si nyomat k 5 Nm 45 A piramisadapter s a piramisbefog sszek t se A piramisadaptert a piramisbefog herny csavarjai r gz tik Sz ks ges anyagok nyomat kku...

Страница 46: ...al k l n sen a term k szakszer tlen haszn lat val vagy nem megengedett m dos t s val okozott k rok rt 9 2 CE megfelel s g A term k megfelel az Eur pai Parlament s a Tan cs EU orvostech nikai eszk z kr...

Страница 47: ...ach p sek siln hygroskopick stice nap ta lek 47 2 4 Provozn ivotnost Produkt byl v robcem podroben zkou ce 3 mili ny zat ovac ch cykl To odpov d p edpokl dan provozn ivotnosti max 5 let podle stup n a...

Страница 48: ...ky roub a zaji t n roub 48 5 1 Mont do modul rn prot zy Nastaven dorazu Stav c roub v rybinov veden omezuje posunut adapt ru v jednom sm ru Pro protch dn posunut lze adapt r oto it nebo p esadit sta v...

Страница 49: ...t tu u ivatele a mo hou se odpov daj c m rou li it 9 1 Odpov dnost za v robek V robce nese odpov dnost za v robek pokud je pou v n dle postup a pokyn uveden ch v tomto dokumentu Za kody zp soben nere...

Страница 50: ...100 kg 2 3 Condi ii de mediu Depozitare i transport Interval de temperatur 20 C p n la 60 C umiditate relativ a aerului 20 p n la 90 f r vibra ii sau ocuri mecanice Condi ii de mediu admise Interval...

Страница 51: ...uc iuni de utilizare Adaptor dublu glisant 1 Premontat 8 tift filetat 506G3 M8x16 1 tift filetat 506G3 M5x8 2 urub cap cilindric 501Z16 51 5 Realizarea capacit ii de utilizare ATEN IE Aliniere sau asa...

Страница 52: ...sul s se usuce la aer 7 ntre inere Verifica i componentele protetice dup primul interval de purtare de 30 de zile printr o examinare vizual i o prob func ional n cadrul consulta iei curente verifica i...

Страница 53: ...ezgre za namje tanje omogu uju distalne i proksimalne promjene kuta komponenti proteze 53 na frontalnoj i sagitalnoj razini Ra ljasta vodilica omogu uje pomica nje komponenti proteze na frontalnoj i s...

Страница 54: ...oda Pa ljivo rukujte proizvodom kako biste sprije ili mehani ko o te enje Ako sumnjate da je proizvod o te en provjerite njegovu funkci onalnost i uporabljivost Ne rabite proizvod ako je njegova funkc...

Страница 55: ...dabir zatika s navojem Oznaka Duljina mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16 55 Zamjena i demonta a Namje teni polo aj komponente proteze mo e se zadr ati pri zamjeni ili demonta i Za to od...

Страница 56: ...ka ta dokument natan no preberite in upo te vajte varnostne napotke Uporabnika pou ite o varni uporabi izdelka e imate vpra anja glede izdelka ali se pojavijo te ave se obr nite na proizvajalca Proizv...

Страница 57: ...otovite ustrezne ukrepe npr i enje popravilo zamenjavo preverjanje s strani proizvajalca ali strokovne slu be 57 Izdelka ne uporabljajte dlje od preizku ene ivljenjske dobe da prepre ite nevarnost po...

Страница 58: ...te z Loctite Privijte navojne zati e Navojne zati e predhodno privijte z momentnim klju em 10 Nm in zategnite 15 Nm 58 3 Navojne zati e ki preve izstopajo ali so pregloboko priviti zame njajte z ustre...

Страница 59: ...a mm 97 112 Vgradna vi ina mm 60 75 Material Titan Maks nastavitev mm 11 Najv telesna te a kg 100 59 1 Popis v robku Slova ko INFORM CIA D tum poslednej aktualiz cie 2021 07 05 Pred pou it m v robku s...

Страница 60: ...povolen m podmienkam okolia Ak bol v robok vystaven nepovolen m podmienkam okolia pre kontrolujte i nie je po koden V robok nepou vajte ak je po koden alebo v pochybnom stave Vykonajte vhodn opatrenia...

Страница 61: ...fixuje kol kmi so z vitom uchytenia nastavova cieho jadra 61 Potrebn materi ly momentov k napr 710D20 Locti te 241 636K13 1 Sk anie Zato te kol ky so z vitom Kol ky so z vitom utiahnite momentov m k...

Страница 62: ...robok pou va pod a pokynov v tomto dokumente V robca neru za kody ktor boli sp soben ne dodr an m pokynov tohto dokumentu najm neodborn m pou van m alebo nedovolen mi zmenami v robku 9 2 Zhoda s CE V...

Страница 63: ...1 2 Ottobock 2 2 1 2 2 100 2 3 20 C 60 C 20 90 10 C 45 C 20 90 2 4 3 5 63 3 3 1 3 2 63...

Страница 64: ...4 1 1 8 506G3 M8x16 1 506G3 M5x8 2 501Z16 5 64 5 1 710D20 3 5 710D20 Loctite 241 636K13 1 10 2 Loctite 10 15 3...

Страница 65: ...506G3 M8x12 V 12 506G3 M8x14 14 506G3 M8x16 16 5 2 710D20 1 1 2 3 15 6 1 2 3 7 30 65 8 9 9 1 9 2 2017 745 CE 9 3...

Страница 66: ...rontal ve sagital d zlemde kayd rma yap l r 66 1 2 Kombinasyon olanaklar Bu protez bile eni Ottobock mod ler sistemi ile uyumludur Ba ka reticilerin uyumlu mod ler ba lant elemanlar na sahip par alar...

Страница 67: ...r oldu unu tahmin ediyorsan z r n fonksiyon ve kullan labilirli i a s ndan kontrol edin Fonksiyonu s n rl r n kullanmay n Uygun nlemlerin al nmas n sa lay n rn retici veya yetkili at lye taraf ndan te...

Страница 68: ...mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16 68 De i tirme ve s kme i lemi Protez bile enlerinin ayarl konumu de i tirme veya s kme s ras nda kalabilir Bunun i in en derin ekilde vidalanm yan yan...

Страница 69: ...n indirile bilir 9 3 Garanti retici r n i in sat n alma tarihinden itibaren garanti sunar Eksiklik lerin malzeme retim veya yap m hatalar ndan kaynakland belgele nebilindi inde ve bu eksiklikler retic...

Страница 70: ...2 3 20 C 60 C 20 90 10 C 45 C 20 90 2 4 3 5 3 3 1 3 2 70 69...

Страница 71: ...4 1 1 8 506G3 M8x16 1 506G3 M5x8 2 501Z16 5 5 1 71 710D20 3 5 Nm 710D20 Loctite 241 636K13 1 10 Nm 2 Loctite 10 Nm 15 Nm 3 mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16...

Страница 72: ...5 2 710D20 1 1 2 3 15 Nm 6 1 2 3 7 30 8 72 9 9 1 9 2 CE 2017 745 9 3 10 4R104 60 4R104 75 g 215 225 mm 97 112 mm 60 75 mm 11 kg 100...

Страница 73: ...1 2021 07 05 1 1 4R104 60 4R104 75 2 1 2 Ottobock 2 2 1 73 2 2 100 2 3 20 C 60 C 20 90 10 C 45 C 20 90 2 4 3 5 3 3 1...

Страница 74: ...3 2 73 74 4 1 1 8 506G3 M8x16 1 506G3 M5x8 2 501Z16 5...

Страница 75: ...5 1 710D20 3 5 710D20 Loctite 241 636K13 1 10 2 Loctite 10 15 75 3 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16 5 2 710D20 1 1 2 3 15 6 1 2 3...

Страница 76: ...7 30 8 9 9 1 9 2 2017 745 CE 9 3 76 10 4R104 60 4R104 75 215 225 97 112 60 75 11 100 1 2021 07 05 1 1 4R104 60 4R104 75 2...

Страница 77: ...1 2 2 2 1 2 2 100 kg 2 3 20 C 60 C 20 90 10 C 45 C 20 90 2 4 300 5 77 3 3 1 3 2 77 1...

Страница 78: ...4 1 1 8 506G3 M8x16 1 506G3 M5x8 2 501Z16 5 78 5 1 710D20 3 5 Nm 710D20 636K13 Loctite 241 1 10 Nm 2 Loctite 10 Nm 15 Nm 3 mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16...

Страница 79: ...2 5 2 710D20 1 1 2 3 15 Nm 6 1 2 3 7 30 8 9 79 9 1 9 2 EU 2017 745 CE 9 3 10 4R104 60 4R104 75 g 215 225 mm 97 112 mm 60 75 mm 11 kg 100 1 2021 07 05...

Страница 80: ...1 1 4R104 60 4R104 75 2 1 2 2 2 1 2 2 100kg 2 3 20 C 60 C 20 90 10 C 45 C 20 90 80 2 4 3 5 3 3 1 3 2 80...

Страница 81: ...4 1 1 8 506G3 M8x16 1 506G3 M5x8 2 501Z16 5 81 5 1 710D20 3 5 Nm 710D20 Loctite 241 636K13 1 10 Nm 2 Loctite 10 Nm 15 Nm 3 mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16...

Страница 82: ...5 2 710D20 1 1 2 3 15 Nm 6 1 2 3 7 30 8 9 9 1 82 9 2 CE 2017 745 CE 9 3 10 4R104 60 4R104 75 g 215 225 mm 97 112 mm 60 75 mm 11 kg 100 1 2021 07 05...

Страница 83: ...1 1 4R104 60 4R104 75 2 1 2 2 2 1 2 2 100 kg 2 3 20 C 60 C 20 90 10 C 45 C 20 90 2 4 3 5 83 3 3 1 3 2 83...

Страница 84: ...4 1 1 8 506G3 M8x16 1 506G3 M5x8 2 501Z16 5 84 5 1 710D20 3 5 Nm 710D20 Loctite 214 636K13 1 10 Nm 2 Loctite 10 Nm 15 Nm 3 mm 506G3 M8X12 V 12 506G3 M8X14 14 506G3 M8X16 16...

Страница 85: ...5 2 710D20 1 1 2 3 15 Nm 6 1 2 3 7 30 8 9 85 9 1 9 2 CE EU 2017 745 CE 9 3 10 4R104 60 4R104 75 g 215 225 mm 97 112 mm 60 75 mm 11 kg 100...

Страница 86: ...86...

Страница 87: ...87...

Страница 88: ...l_INT 22 2107 Template Version 2016 05 25 FM478 SB_148x105_IFU_ONLY_StructurePar Ottobock SE Co KGaA Max N der Stra e 15 37115 Duderstadt Germany T 49 5527 848 0 F 49 5527 848 3360 healthcare ottobock...

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