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Permissible cleaning agents and disinfectants
Requirements:

Free of solvents, chlorine and phosphates

INFORMATION

►

Clean the product if it gets dirty.

►

Observe the instructions for cleaning and drying in the section “Environmental conditions”
(see page 30).

►

Only use cleaning agents and disinfectants that do not affect the materials of the product.
Test the chosen agent for material compatibility in an inconspicuous location.

►

Do not spray the product directly with a pump spray or propellant spray cleaner and disin
fectant.

►

Only apply cleaners and disinfectants using a soft, lint-free cloth.

►

Dry with a soft, lint-free cloth. Allow to air dry in order to remove residual moisture.

►

Observe the cleaning instructions for all prosthetic components.

9 Maintenance

CAUTION

Failure to follow the maintenance instructions

Risk of injuries due to changes in or loss of functionality and damage to the product

►

Observe the following maintenance instructions.

►

NOTICE! Do not lubricate and grease the prosthetic joint

.

►

NOTICE! Repair work must be performed exclusively by manufacturer service.

►

Arrange regular maintenance intervals with the patient depending on the level of use.

►

Following an individual period for the patient to get accustomed to the prosthesis, check the
settings of the prosthetic joint and adapt them to the patient's requirements again as needed.

►

The prosthetic components should be inspected after the first 30 days of use.

►

Inspect the entire prosthesis for wear during normal consultations.

►

Conduct annual safety inspections.

►

As part of the safety inspections, inspect the prosthetic joint for wear and proper functionality.
Special attention should be paid to movement resistance, bearings and abnormal noises. Full
flexion and extension must be ensured at all times. Readjust as required.

10 Disposal

In some jurisdictions it is not permissible to dispose of the product with unsorted household
waste. Improper disposal can be harmful to health and the environment. Observe the information
provided by the responsible authorities in your country regarding return, collection and disposal
procedures.

11 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.

11.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descrip
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.

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Содержание 3R80

Страница 1: ...struzioni per l uso 48 Instrucciones de uso 59 Manual de utiliza o 69 Gebruiksaanwijzing 80 Bruksanvisning 90 Instrukcja u ytkowania 100 Haszn lati utas t s 110 N vod k pou it 120 Instruc iuni de util...

Страница 2: ...1 3 3 1 Empfohlene Kombinationen Unzul ssige Kombinationen 3 3 1 Recommended combinations Unallowable combinations 7E10 3R80 3R80 ST 7E7 7E9 3R80 ST 7E7 7E9 3R80 2 2...

Страница 3: ...3 6 Technische Daten 6 Technical data max 150 kg max 330 lbs kg m 1260 g 1255 g 3R80 3R80 ST 4 3...

Страница 4: ...6 Technische Daten 6 Technical data 34 mm 150 235 mm 28 mm 135 mm 163 mm 179 mm 44 mm 235 mm 5 4...

Страница 5: ...u der Prothese 7 2 Bench alignment of the prosthesis a 5 mm 50 a 0 mm 20 mm 0 mm 30 mm 30 mm 50 50 50 50 50 6 7 2 Grundaufbau der Prothese 7 2 Bench alignment of the prosthesis 0 mm 50 50 m l p a 5 m...

Страница 6: ...Prothese 7 2 Bench alignment of the prosthesis 3R80 3R106 HD KD ST 743Y580 0 mm 8 7 2 Grundaufbau der Prothese 7 2 Bench alignment of the prosthesis 0 mm 0 mm 10 Nm 4 mm 0 mm 0 mm 719R4 1 2 1 1 1 3 70...

Страница 7: ...liaca anterior superior 20 mm 20 mm 50 50 10 mm 10 mm 40 60 mm 40 60 mm 10 7 3 Optimierung des Statischen Aufbaus 7 3 Optimising the static alignment 743L500 3D L A S A R posture 743L100 L A S A R pos...

Страница 8: ...esistance 12 7 4 2 bersicht der Einstellm glichkeiten 7 4 2 Overview of setting options Schaltschwelle Switching threshold Einstellbereich Setting range Schaltschwelle verringern Geringeres Gewicht zu...

Страница 9: ...nce Schwungphasenflexionswiderstand erh hen Increasing swing phase flexion resistance 360 14 7 4 2 bersicht der Einstellm glichkeiten 7 4 2 Overview of setting options Schwungphasenextensionswiderstan...

Страница 10: ...e lock 16 7 4 3 Einstellungen berpr fen und auf Werkseinstellungen zur cksetzen 7 4 3 Checking the settings and resetting to factory settings Threshold for initiation of the stance phase Standphasenfl...

Страница 11: ...ry settings Swing phase extension resistance Schwungphasenflexionswiderstand Swing phase extension resistance Schwungphasenextensionswiderstand 18 7 4 3 Einstellungen berpr fen und auf Werkseinstellun...

Страница 12: ...dphasenflexionswiderstand deaktiviert Standphasenflexionswiderstand aktiviert bei Fersenentlastung Stance phase flexion resistance deactivated at heel relief bei Fersenauftritt Stance phase flexion re...

Страница 13: ...7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Hinsetzen Sitting down 22 7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Gehen Walking 23 13...

Страница 14: ...5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments 2 Nm 5 mm 513D59 1 3X8 8X86 24 7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Abw rtsgehen auf Rampen Walking down ramps 25...

Страница 15: ...7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Abw rtsgehen auf Treppen Walking down stairs 26 7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Gehen Walking 27 15...

Страница 16: ...7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Verwenden der Sperre Using the lock 28 7 4 5 bungen und Einsteuuungen 7 4 5 Exercises and adjustments Fahrradfahren Cycling 29 16...

Страница 17: ...Verkleideng anbringen 7 5 Attaching the cosmetic cover 3S107 30 7 6 Prothese fertigstellen 7 6 Finishing the prosthesis 241 636K13 4 mm 15 Nm 10 Nm 4 mm LOCTITE 506G3 M8X10 506G3 M8X12 V 506G3 M8X14 5...

Страница 18: ...YYYYWWNNN Serialnummer des Produkts YYYY Baujahr WW Kalenderwoche NNN Nummer 647G403 all_INT VV YYMM Normzeile des Dokuments 647G403 all_INT Kennzeichen des Dokuments VV Versionsnummer YYMM Ausgabedat...

Страница 19: ...Kombination von Prothe senkomponenten Pr fen Sie anhand der Gebrauchsanweisungen aller zu verwendenden Prothesenkompo nenten ob sie miteinander kombiniert werden d rfen und f r das Einsatzgebiet des...

Страница 20: ...vermeiden siehe Seite 27 Unzul ssige Umgebungsbedingungen Feststoffe Stark hygroskopische Partikel z B Talkum Staub in erh hter Konzentration z B Baustelle intensiver Kontakt mit Sand Chemikalien Fl s...

Страница 21: ...nten nachbestellbar sind 6 Technische Daten Die Technischen Daten sind auf folgenden Abbildungen dargestellt 4 Seite 3 5 Seite 4 Systemh he Proximale Systemh he Distale Systemh he 7 Gebrauchsf higkeit...

Страница 22: ...rs und der Rohraufnahme mit einem entfettenden Reiniger reini gen Positionieren Sie das Rohr in die Rohraufnahme so dass die minimal zul ssige Einschubtie fe nicht unterschritten wird VORSICHT Den Roh...

Страница 23: ...sich in der Mitte 50 50 Justierkerne des Prothesenkniege lenks und des Prothesenfu es Schuhe Die Verl ngerungslinie der Hilfslinie zeigt auf den Bezugspunkt Spina iliaca anterior su perior Die Hilfsli...

Страница 24: ...d der Dynamischen Anprobe mit dem Patienten die Einstellungen berpr fen und auf Werkseinstellungen zur cksetzen 17 Seite 10 Standphasenflexionswiderstand Schaltschwelle zum Einleiten der Stand phase P...

Страница 25: ...h bei unterschiedlichen Schrittgeschwindigkei ten und Schrittl ngen aktiviert werden kann Den Schwungphasenflexionswiderstand so justieren dass der Prothesenunterschenkel nicht zu weit nach dorsal dur...

Страница 26: ...Schraubensicherung be achten 8 Gebrauch 8 1 Hinweise zum Gebrauch VORSICHT berhitzung der Hydraulik durch berbeanspruchung Verbrennungen Sturzverletzungen durch Funktionsver nderungen und Sch den an...

Страница 27: ...fusselfreien Tuch abtrocknen Restfeuchtigkeit an der Luft trocknen lassen Beachten Sie die Reinigungshinweise aller Prothesenkomponenten 9 Wartung VORSICHT Nichtbeachtung der Wartungshinweise Verletzu...

Страница 28: ...f last update 2021 09 09 Please read this document carefully before using the product and observe the safety notices Instruct the user in the safe use of the product Please contact the manufacturer if...

Страница 29: ...extension assist function the extension assist function can be enhanced by installing an additional spring 3 Intended use 3 1 Indications for use The product is intended exclusively for lower limb exo...

Страница 30: ...e and transport Temperature range 20 C to 60 C 4 F to 140 F relative humidity 20 to 90 no mechanical vibrations or impacts Allowable environmental conditions Temperature range 10 C to 45 C 14 F to 113...

Страница 31: ...stance phase incomplete extension stiffness and the development of noise 5 Scope of delivery The scope of delivery is shown in the following figures 3 page 3 Only product components with reference num...

Страница 32: ...y due to breakage or loosening of the screw connections Clean the threads before every installation Apply the specified torque values Follow the instructions for thread lock CAUTION Incorrect processi...

Страница 33: ...g points are observed 3D mode is deactivated 3D symbol colour dark grey Sequence for optimisation in reference to the planes 2 1 Sagittal plane 2 2 Frontal plane The prosthetic knee joint is in extens...

Страница 34: ...vate lock 7 4 3 Checking settings and restoring factory settings Prior to optimisation during the dynamic fitting check the settings with the patient and restore the factory settings 17 Page 10 Stance...

Страница 35: ...o the lower leg of the prosthesis does not swing through too far in the dorsal direction but reaches full extension in time for the next heel strike Adjust the swing phase extension resistance so the...

Страница 36: ...thetic components Reduce all activities if there are changes in functionality in order to allow the overheated prosthetic components to cool down If overheating or changes in functionality occur have...

Страница 37: ...for the patient to get accustomed to the prosthesis check the settings of the prosthetic joint and adapt them to the patient s requirements again as needed The prosthetic components should be inspecte...

Страница 38: ...roth tique des membres inf rieurs 1 1 Caract ristiques produit document Les caract ristiques suivantes sont importantes pour l identification 1 page 2 3R80 3R80 ST r f rence du produit YYYYWWNNN num r...

Страница 39: ...e de vie quotidienne 3 3 Combinaisons possibles PRUDENCE Combinaison non autoris e des composants proth tiques Blessures dysfonctionnements ou d t riorations du produit dus une combinaison non autori...

Страница 40: ...47 Conditions d environnement non autoris es Particules solides particules fortement hygroscopiques talc p ex poussi res de hautes concentra tions chantier p ex contact intense avec du sable Produits...

Страница 41: ...ans l en t te d un cadre de l illustration vous signale qu il s agit d un kit Les composants du produit illustr s dans le cadre peuvent tre nouveau command s au moyen de cette r f rence 6 Caract risti...

Страница 42: ...provoqu e par un endommagement du tube Ne serrez pas le tube dans un tau Raccourcissez le tube uniquement l aide d un coupe tube ou d un dispositif de mise lon gueur PRUDENCE Montage incorrect du tub...

Страница 43: ...r les plans 2 1 plan sagittal 2 2 plan frontal l articulation de genou proth tique est tendue Si disponible le verrou est activ la ligne de rep re se trouve sur le point de r f rence sagittal de l art...

Страница 44: ...omme indiqu dans l illustration Pour mar cher d sactivez le verrou Lors de l activation et de la d sactivation mettez en charge l articulation de genou proth tique et poussez la contre la but e d exte...

Страница 45: ...abord une vitesse de pas normale puis pas courts et rapides et pour finir pas longs et rapides PRUDENCE Laisser le patient marcher uniquement s il prend appui Avec le r glage par d faut l articulation...

Страница 46: ...9L5 directement sur les surfaces de frottement du rev te ment esth tique pour optimiser les capacit s de glissage et liminer les bruits 7 6 Assemblage de la proth se PRUDENCE 31 page 17 Pour viter tou...

Страница 47: ...ser uniquement des nettoyants et des d sinfectants qui ne sont pas agressifs pour les mat riaux du produit Sur une zone peu visible v rifier que le nettoyant choisi est compa tible avec le mat riau Ne...

Страница 48: ...ble si le produit est utilis conform ment aux descriptions et instructions de ce document Le fabricant d cline toute responsabilit pour les dommages d coulant d un non respect de ce document notamment...

Страница 49: ...blocco della fase statica Resistenza alla flessione in fase statica regolabile ammortizzazione idraulica Soglia d intervento regolabile per commutare dalla resistenza all estensione in fase dina mica...

Страница 50: ...nto della figura relativa alle combinazioni consigliate e alle combinazioni non con sentite 2 Pagina 2 3 4 Condizioni ambientali CAUTELA Utilizzo in condizioni ambientali non consentite Caduta dovuta...

Страница 51: ...il lavoro In caso di prodotto danneggiato controllarne il funzionamento e le possibilit di utilizzo Non utilizzare pi il prodotto in caso di cambiamento o perdita di funzionalit vedere Segni di cambia...

Страница 52: ...one protesica pu essere protetta da eventuali graffi derivanti dall allineamento in officina o dalle prove nell apposita zona di prova me diante la pellicola del 2Z11 KIT Utilizzare la pellicola prote...

Страница 53: ...e che il paziente possa stare in piedi in modo ri lassato e i valori indicati nella figura possano essere rispettati per i punti di riferimento ed an che osservando i seguenti punti La modalit 3D atti...

Страница 54: ...maggiore necessario per avviare la fase statica Resistenza alla flessione in fase dinamica 14 Pagina 9 Campo di regolazione ridurre la resistenza alla flessione in fase dinamica aumentare la resisten...

Страница 55: ...one resistenza alla flessione in fase statica disattivata scaricando il peso dal tallone Quando si appoggia il tallone all avvio della fase statica si attiva la resistenza alla flessione in fase stati...

Страница 56: ...non sia eccessiva Deambulazione ripetizione per regolazione 27 Pagina 15 Controllare di nuovo la resistenza alla flessione in fase dinamica ed eventualmente regolarla con sensibilit in modo tale che...

Страница 57: ...causati dalla fuoriuscita di olio idraulico Verificare l eventuale fuoriuscita di olio idraulico prima di ogni utilizzo del prodotto Non continuare a utilizzare il prodotto in caso di perdite e farlo...

Страница 58: ...nuali di sicurezza Nell ambito dei controlli annuali verificare lo stato di usura e la funzionalit dell articolazione protesica Prestare particolare attenzione alla resistenza al movimento alle sedi d...

Страница 59: ...a o de fabricaci n WW semana NNN n mero 647G403 all_INT VV YYMM l nea est ndar del documento 647G403 all_INT referencia del documento VV n mero de versi n YYMM fecha de edici n YY a o MM mes 1 2 Sign...

Страница 60: ...os a una combinaci n no permitida de componentes prot sicos Consulte las instrucciones de uso de todos los componentes prot sicos que se van a usar para verificar si estos se pueden combinar entre s y...

Страница 61: ...ar deterioros y un aumento del desgaste v ase la p gina 68 Condiciones ambientales no permitidas Sustancias s lidas part culas altamente higrosc picas p ej polvos de talco polvo en concentraciones alt...

Страница 62: ...pedir posteriormente por separado El n mero de referencia en negrita que aparece en la imagen en el encabezado de un recuadro indica un kit con el que pueden pedirse los componentes del producto repre...

Страница 63: ...bo Ca das debidas a da os en el tubo No sujete el tubo en un tornillo de banco Recorte el tubo nicamente con un cortatubos o una herramienta de corte PRECAUCI N Montaje incorrecto del tubo Riesgo de l...

Страница 64: ...que se observen los siguientes puntos El modo 3D est desactivado s mbolo 3D color gris oscuro Secuencia para la optimizaci n con relaci n a los planos 2 1 Plano sagital 2 2 Plano frontal La articulac...

Страница 65: ...exclusivamente pies prot sicos con suela antideslizante Active el bloqueo seg n se muestra en la ilustraci n para el uso en una zona h meda p ej la ducha o la piscina as como para estar de pie de form...

Страница 66: ...ajustes con delicadeza Despu s de cada modificaci n compruebe el efecto en el patr n de marcha Realice los ajustes primero a una velocidad de paso normal seguidamente dando pasos cor tos y r pidos y...

Страница 67: ...j polvos talco Riesgo de lesiones da os en el producto debidos a la falta de lubricante Evite que el producto entre en contacto con part culas altamente higrosc picas Para optimizar las propiedades de...

Страница 68: ...os productos de desinfecci n permitidos Respete las indicaciones de limpieza y cuidado Productos de limpieza y de desinfecci n permitidos Requisitos Sin disolventes sin cloro sin fosfato INFORMACI N L...

Страница 69: ...clasificar Una eli minaci n indebida puede tener consecuencias nocivas para el medioambiente y para la salud Observe las indicaciones de las autoridades competentes de su pa s relativas a la devoluci...

Страница 70: ...inida 1 Numera o das partes de uma figura J Correto Incorreto Observe a indica o de seguran a no cap tulo Risco de queda Substituir 2 Descri o do produto O produto 3R80 distingue se pelas seguintes ca...

Страница 71: ...o sistema modular Ottobock A funcionalidade com componentes de outros fabricantes que disp em de elementos de conex o modulares compat veis n o foi testada Nossos componentes funcionam perfeitamente...

Страница 72: ...da til m xima que est especificada neste cap tulo Este componente prot tico foi testado pelo fabricante quanto resist ncia carga conforme a norma ISO 10328 A vida til m xima de 5 anos 4 Indica es gera...

Страница 73: ...las corrim o e andador na primeira vez que ele andar e ficar em p com a pr tese 7 2 Estabelecer o alinhamento b sico CUIDADO A fim de possibilitar uma bipedesta o segura ao paciente alinhar a pr tese...

Страница 74: ...tu re 743L500 Est o dispon veis os seguintes m todos de otimiza o Otimiza o com o modo 3D ativado Otimiza o com o modo 3D desativado O m todo de otimiza o pode ser utilizado como uma segunda etapa opc...

Страница 75: ...O Adapta o dos ajustes Queda devido a ajustes incorretos ou n o habituais S adapte lentamente os ajustes ao paciente Explique os efeitos das adapta es sobre o uso da pr tese ao paciente 7 4 2 Vis o ge...

Страница 76: ...a flex o na fase de apoio ati vada a cargas baixas Resist ncia flex o na fase de balan o V lvula de ajuste F Batente Resist ncia m nima Resist ncia extens o na fase de balan o V lvula de ajuste E Bate...

Страница 77: ...que a articula o de joelho prot tica fique em extens o completa para o pr ximo apoio do calcanhar Descida de rampas 25 p gina 14 Ajustar a resist ncia flex o na fase de apoio de maneira a proporciona...

Страница 78: ...verificar o componente de pr tese pelo pessoal t cnico autorizado no caso de supe raquecimento ou altera es de fun es INDICA O Sobrecarga mec nica Restri es funcionais devido a danos mec nicos Examin...

Страница 79: ...ificar os ajustes da articula o prot tica e se necess rio reajust la s necessidades do paciente Ap s os primeiros 30 dias de uso submeter os componentes prot ticos a uma inspe o Verificar a pr tese co...

Страница 80: ...door een vakspecialist die over vakinhoudelijke kennis beschikt over prothesen voor de onderste ledematen 1 1 Kenmerkende gegevens product document De volgende kenmerkende gegevens zijn voor de identi...

Страница 81: ...aad 3 4 Toegestaan lichaamsgewicht 150 kg Prothese voor dagelijks gebruik 3 3 Combinatiemogelijkheden VOORZICHTIG Niet toegestane combinatie van prothesecomponenten Verwondingen storingen in de werkin...

Страница 82: ...oorwater Vocht onderdompelen maximaal 1 u op 2 m diepte relatieve luchtvochtigheid geen beperkingen Vaste stoffen stof sporadisch contact met zand Reinig het product nadat dit in contact is geweest me...

Страница 83: ...jv tot uitdrukking komen in een veranderd gangbeeld zwaaifase standfase onvolledige extensie moeilijk bewegen en geluidsontwikkeling 5 Inhoud van de levering De inhoud van de levering is weergegeven o...

Страница 84: ...sen de ronde haakjes bevinden zich niet op de bevestigingsbits Buisadapter monteren VOORZICHTIG Verkeerde montage van de schroefverbindingen Gevaar voor verwonding door breuk of losraken van de schroe...

Страница 85: ...iepunt van het prothesekniescharnier afstelkern 11 Pagina 7 Optimaliseren bij gedeactiveerde 3D modus Optimaliseer de statische opbouw zo dat de in de afbeelding weergegeven waarden voor de referentie...

Страница 86: ...wembad en om ontspannen te staan Deactiveer de vergrendeling voor het lopen Belast tijdens het activeren en deactiveren het prothesekniescharnier en druk tegen de extensieaanslag vergrendeling activer...

Страница 87: ...te laat kan omschakelen naar de zwaaifase flexieweerstand Indien aan het begin van de standfase de standfaseweerstand niet geactiveerd kan worden moet de schakeldrempel behoedzaam zodanig verkleind wo...

Страница 88: ...fdraadpennen worden vervangen en moeten alle schroefverbindingen worden aangedraaid Neem hierbij de in de gebruiksaanwij zingen van alle prothesecomponenten vermelde montage aanhaalmomenten en aanwijz...

Страница 89: ...t met een zachte pluisvrije doek af Laat het achtergebleven vocht aan de lucht opdrogen Volg de reinigingsinstructies voor alle prothesecomponenten op 9 Onderhoud VOORZICHTIG Niet naleven van de onder...

Страница 90: ...tsverklaring kan op de website van de fabrikant gedownload worden 1 Information om dokumentet Svenska INFORMATION Datum f r senaste uppdatering 2021 09 09 L s noga igenom detta dokument innan du b rja...

Страница 91: ...motst nd hydraulisk d mpning Hydraulikenhet med framkastarfunktion framkastarfunktionen kan f rst rkas genom att en extra fj der installeras 3 ndam lsenlig anv ndning 3 1 Avsedd anv ndning Produkten r...

Страница 92: ...sf rh llanden i detta avsnitt Vidta vid behov l mpliga tg rder t ex reng ring reparation byte kontroll hos tillverkaren eller i en fackverkstad om produkten har utsatts f r otill tna omgivningsf rh ll...

Страница 93: ...erkarens kund tj nst och s vidare Tecken p f r ndrad eller f rlorad funktion vid anv ndning Funktionsf r ndringar kan yttra sig som t ex en f r ndrad g ngbild svingfas st fas ofullst n dig extension s...

Страница 94: ...BSERVERA Felaktig montering av skruvf rband Skaderisk om skruvf rbanden lossnar eller g r s nder Reng r g ngan f re varje montering F lj de f reskrivna tdragningsmomenten F lj anvisningarna om skruvs...

Страница 95: ...eden r i extension Om en sp rr finns s r den aktiverad Hj lplinjen ligger p proteskn ledens sagittala referenspunkt vridaxeln Referenspunkterna ligger i mitten 50 50 mellan proteskn ledens pyramidkopp...

Страница 96: ...1 sp rr inaktiverad Funktion Inst llningss tt Fabriksinst llning F rklaring St fasflexionsmot st nd Inst llningsring S Anslag Maximalt motst nd Kopplingsgr ns f r in ledning av st fas Inst llningsring...

Страница 97: ...proteskn leden r helt str ckt vid n sta h lis ttning G nedf r p ramper 25 sida 14 Justera st fasflexionsmotst ndet s att brukaren f r tillr cklig s kerhet och motst ndet inte blir alltf r stort G nedf...

Страница 98: ...ionsbegr nsningar till f ljd av mekaniska skador Kontrollera alltid att produkten inte r skadad innan den anv nds Anv nd inte produkten om dess funktion r begr nsad Vidta vid behov l mpliga tg rder t...

Страница 99: ...ch eventuellt korrigeras p nytt efter brukarens behov Proteskomponenterna b r inspekteras efter de f rst 30 dagarna Under den normala konsultationen ska den kompletta protesen kontrolleras med avseend...

Страница 100: ...produkcji TK tydzie kalendarzowy NNN numer 647G403 all_INT WW RRMM znormalizowany wiersz dokumentu 647G403 all_INT oznaczenie dokumentu WW numer wersji RRMM data wydania RR rok MM miesi c 1 2 Oznaczen...

Страница 101: ...onent w protezowych W oparciu o instrukcje u ywania wszystkich stosowanych komponent w protezowych nale y sprawdzi czy mo na je zestawia ze sob i czy s dopuszczone do obszaru zastosowania pacjenta INF...

Страница 102: ...onym st eniu np plac budowy intensywny kontakt z piaskiem Chemikalia ciecze woda s ona pot mocz kwasy sta e zastosowanie w mediach p ynnych 3 5 Ponowne zastosowanie i trwa o PRZESTROGA Ponowne zastoso...

Страница 103: ...a w obr bie dalszym 7 Uzyskanie zdolno ci u ytkowej 7 1 Wskaz wki odno nie wykonania protezy PRZESTROGA B dne osiowanie monta lub ustawienie Urazy wskutek b dnego monta u lub ustawienia jak i uszkodzo...

Страница 104: ...ejscowi w uchwycie w ten spos b aby minimalnie dopuszczalna g boko wsuni cia nie zosta a przekroczona UWAGA Adapter rurowy nale y ustawia wy cznie w dopuszczalnym zakresie wsuni cia kt ry jest pokazan...

Страница 105: ...y na strza kowym punkcie odniesienia protezowego przegubu kolano wego o obrotu Punkty odniesienia znajduj si po rodku 50 50 adaptery piramidowe protezowego przegubu kolanowego oraz stopy protezowej o...

Страница 106: ...dy 7 4 3 Sprawdzenie ustawie i przywr cenie ustawie fabrycznych Przed optymalizacj podczas dynamicznej przymiarki z pacjentem nale y sprawdzi ustawienia i przywr ci ustawienia fabryczne 17 strona 10 o...

Страница 107: ...ywowa oporu tej fazy nale y z wyczu ciem obni y pr g prze czania do chwili a b dzie go mo na aktywowa tak e przy r nych pr dko ciach chodu oraz d ugo ciach kroku Op r przy zginaniu w fazie wymachu wyr...

Страница 108: ...unik ryzyka potkni cia si nale y wyko czy protez poprzez wymian za kr tkich lub za d ugich ko k w gwintowa nych oraz mocne dokr cenie wszystkich z czy rubowych Nale y przy tym przestrzega instrukcji...

Страница 109: ...kt rych produkt zosta wykonany W niewidocznym miejscu sprawdzi tolerancj materia u na dany rodek Na produkt nie wolno rozpyla bezpo rednio rodka czyszcz cego ani dezynfekuj cego za pomoc pompki lub w...

Страница 110: ...producent nie odpowiada 11 2 Zgodno z CE Produkt jest zgodny z wymogami rozporz dzenia UE 2017 745 w sprawie wyrob w medyczny ch Deklaracj zgodno ci CE mo na pobra ze strony internetowej producenta 1...

Страница 111: ...lend t f zis vez rl s hez Lend leti f zis ll that hajl t si ellen ll sa hidraulikus csillap t s Lend leti f zis ll that ny jt si ellen ll sa hidraulikus csillap t s Hidraulikus egys g el relend t fun...

Страница 112: ...ed seket pl tiszt t s jav t s p tl s gy rt i vagy szakm helyi ellen rz s T rol s s sz ll t s H m rs klet tartom ny 20 C s 60 C k z tt relat v p ratartalom 20 s 90 k z tt nem jelentkeznek mechanikus re...

Страница 113: ...ppel lend t f zis ll sf zis nem teljes kiny jt ssal neh z j r ssal s zajk pz d ssel v lnak felismerhet v 5 Sz ll t si terjedelem A sz ll t si terjedelmet a 3 oldalon tal lhat 3 bra mutatja be Csak az...

Страница 114: ...iszt tsa meg Tartsa be az el rt megh z si nyomat kokat gyeljen a csavarok biztos t s ra vonatkoz utas t sokra VIGY ZAT A cs hib s megmunk l sa A cs megrong l d sa okozta es s A cs vet ne fogja be satu...

Страница 115: ...lum sz n s t tsz rke Az optimaliz l s sorrendje a szintekhez viszony tva 2 1 szagitt lis tests k 2 2 koron lis s k Prot zis t rd z let kiny jt sban van Amennyiben rendelkez sre ll akkor a retesz aktiv...

Страница 116: ...3 A be ll t sok ellen rz se s a gy ri be ll t sok vissza ll t sa A dinamikus felpr b l s sor n v gzett optimaliz l s el tt ellen rizze a beteggel a be ll t so kat s ll tsa vissza a gy ri be ll t sokat...

Страница 117: ...a prot zis l bsz ra ne lend lj n t ls gosan h tra de a k vetkez sarok t shez a megfelel id ben teljes kiny jt sban legyen A lend leti f zis ny jt si ellen ll s t gy szab lyozza be hogy a prot zis t r...

Страница 118: ...ot zis t lmelegedett komponenseihez A m k d s megv ltoz s nak szlel sekor cs kkentsen minden tev kenys get hogy a t lme legedett prot ziskomponensek leh lhessenek T lmeleged s vagy a m k d s megv ltoz...

Страница 119: ...YZ S Jav t sokat csak a gy rt szervize v gezhet A haszn lat szerint besz lje meg a beteggel a rendszeres karbantart sok id pontj t Miut n a beteg egy nileg hozz szokott a prot zishez a t rd z let be l...

Страница 120: ...na v robce Ka dou z va nou ne douc p hodu v souvislosti s produktem zejm na zhor en zdravotn ho stavu ohlaste v robci a p slu n mu org nu ve va zemi Tento dokument uschovejte Tento dokument a produkt...

Страница 121: ...ty 3 4 P pustn t lesn hmotnost 150 kg Prot za pro ka dodenn aktivity 3 3 Mo nosti kombinace komponent POZOR Nep pustn kombinace komponent prot zy Nebezpe poran n chybn funkce nebo po kozen produktu v...

Страница 122: ...viz t strana 128 Nep pustn okoln podm nky Pevn l tky siln hygroskopick stice nap talek prach o zv en koncentraci nap staveni t in tenzivn kontakt s p skem Chemik lie kapaliny slan voda pot mo kyseliny...

Страница 123: ...oduktu zn zorn n v r me ku 6 Technick daje Technick daje jsou zn zorn ny na n sleduj c ch vyobrazen ch 4 strana 3 5 strana 4 Syst mov v ka Proxim ln syst mov v ka Dist ln syst mov v ka 7 P prava k pou...

Страница 124: ...olohujte trubkov adapt r v hradn v p pustn m rozsahu zasunut zn zorn n m na vyobrazen 9 strana 6 P pustn rozsah zasunut 0 mm Nep pustn rozsah zasunut 0 mm 7 3 Optimaliziace statick stavby INFORMACE Da...

Страница 125: ...linie ukazuje na referen n bod spina iliaca anterior superior Pomocn linie le na front ln m referen n m bodu prot zov ho kolenn ho kloubu ad justa n pyramida Prodlu ovac linie pomocn linie ukazuje na...

Страница 126: ...c krou ek S Doraz Maxim ln odpor Pr h sepnut pro zah jen stojn f ze Se izovac krou ek Tlumi bezv lov p e depnut N zk pr h sepnut flek n odpor ve stoj n f zi se aktivuje p i mal m zat en Flek n odpor v...

Страница 127: ...strana 15 Se i te flek n odpor ve stojn f zi tak aby poskytoval pacientovi dostate nou bezpe nost a z rove nevyv jel p li velk odpor Ch ze opakov n pro dose zen 27 strana 15 Znovu zkontrolujte flek n...

Страница 128: ...d nebo podr d n k e v d sledku vyt kaj c ho oleje P ed ka d m pou it m produktu zkontrolujte zda nevyt k hydraulick olej V p pad net snost produkt p esta te pou vat a nechte jej ihned opravit 8 2 i t...

Страница 129: ...opot eben a funkce P itom je zejm na nutn v novat zvl tn pozornost odporu pohybu lo isk m a nezvykl m zvu k m Mus b t v dy zaru ena pln flexe a extenze kloubu V p pad pot eby prove te znovu se zen 10...

Страница 130: ...ertisment asupra unor posibile pericole de accidente sau r nire INDICA IE Avertisment asupra unor posibile defec iuni tehnice 1 3 Semnifica ia pictogramei n imagini 1 Numerotarea imaginilor Trimitere...

Страница 131: ...i am puta iei greutatea corporal gradul de activitate condi iile de mediu i domeniul de utilizare Aceast component de protez este compatibil cu sistemul modular Ottobock Nu a fost testat func ionalita...

Страница 132: ...nc ional C dere cauzat de modificarea sau pierderea func ionalit ii precum i deteriorarea produsului Asigura i v c nu este dep it durata maxim de via func ional care este definit n acest capitol Aceas...

Страница 133: ...a utilizare a protezei de c tre pacient C dere din cauza lipsei de experien a pacientului sau din cauza alinierii ori regl rii gre ite a protezei Pentru siguran a pacien ilor utiliza i la primul stat...

Страница 134: ...rea structurii statice INFORMA IE Instruc iunile de utilizare ale aparatului de m surare utilizat posterul de structur TF i seminarele Ottobock ofer cuno tin e de specialitate suplimentare Pentru a op...

Страница 135: ...re indic punctul de referin miez de ajustare 7 4 Optimizare n timpul prob rii dinamice 7 4 1 Indica ii referitoare la probarea dinamic ATEN IE Ajustarea reglajelor C dere din cauza reglajelor gre ite...

Страница 136: ...Blocare dezactivat Func ie Mijloc de reglare Reglare din fabric Semnifica ie Rezisten a la flexiune a fazei de sprijin Inel de reglare S Opritor Rezisten maxim Prag de comutare pentru ini ierea fazei...

Страница 137: ...ul extensiei dar s fie la timp n extensie complet pentru urm torul atac cu talonul Dac este necesar monta i arcul livrat conform figurii 24 la pagina 14 pentru a amplifica func ia de extensor pentru c...

Страница 138: ...rior rii compo nentelor protezei Nu atinge i componentele supra nc lzite ale protezei La modific ri func ionale diminua i toate activit ile pentru a da posibilitatea unei r ciri a componentelor supra...

Страница 139: ...cta i urm toarele indica ii de ntre inere INDICA IE Nu unge i articula ia protetic cu ulei sau vaselin INDICA IE Dispune i executarea repara iilor numai de c tre service ul produc toru lui Stabili i t...

Страница 140: ...zvo a u u slu aju pitanja o proizvodu ili pojave problema Svaki ozbiljan tetni doga aj povezan s proizvodom posebice pogor anje zdravstvenog sta nja prijavite proizvo a u i nadle nom tijelu u svojoj z...

Страница 141: ...njegovim odobrenim podru jem primjene Dopu teno podru je primjene 3R80 3R80 ST Preporu eni stupanj mobilnosti 3 4 Dopu tena tjelesna te ina 150 kg Svakodnevna proteza 3 3 Mogu nosti kombiniranja OPRE...

Страница 142: ...proizvod nakon kontakta s vlagom kemikalijama krutim tvarima kako biste izbjegli pove ano tro enje i o te enja vidi stranicu 148 Nedopu teni uvjeti okoline Krute tvari jako higroskopske estice npr ta...

Страница 143: ...slikama 4 stranica 3 5 stranica 4 visina sustava proksimalna visina sustava distalna visina sustava 7 Uspostavljanje uporabljivosti 7 1 Upute za izradu proteze OPREZ Neispravno poravnanje monta a ili...

Страница 144: ...agodnik pozicionirajte isklju ivo u dopu teno podru je umetanja prikaza no na slici 9 stranica 6 dopu teno podru je umetanja 0 mm nedopu teno podru je umetanja 0 mm 7 3 Optimizacija stati kog poravnan...

Страница 145: ...pomo ne linije usmjeren je prema referentnoj to ki Spina iliaca anterior supe rior Pomo na linija nalazi se na frontalnoj referentnoj to ki protetskog zgloba koljena jezgra za uga anje Produ etak pomo...

Страница 146: ...nziji u fazi zamaha 19 stranica 11 blokada deaktivirana Funkcija Sredstvo za namje tanje Tvorni ka postavka Zna enje Otpor pri fleksiji u fazi oslonca Prsten za namje tanje S Grani nik Maksimalni otpo...

Страница 147: ...te prema prikazu na slici 24 na strani ci 14 radi oja anja funkcije mehanizma za ekstenziju kako bi protetski zglob koljena bio u pu noj ekstenziji do sljede eg oslanjanja na petu Sila enje po rampama...

Страница 148: ...vjeri ovla teno stru no osoblje NAPOMENA Mehani ko preoptere enje Ograni enja funkcije uslijed mehani kog o te enja Prije svake primjene provjerite je li proizvod o te en Proizvodom se nemojte koristi...

Страница 149: ...ijentovim zahtjevima Komponente proteze podvrgnite inspekciji nakon prvih 30 dana uporabe Za vrijeme uobi ajenih konzultacija cijelu protezu provjerite na istro enost Provodite godi nje sigurnosne kon...

Страница 150: ...r 647G403 all_INT Dok man n tan m etiketi VV Versiyon numaras YYMM Bask tarihi YY Y l MM Ay 1 2 Uyar sembollerinin anlam D KKAT Olas kaza ve yaralanma tehlikelerine kar uyar DUYURU Olas teknik hasarla...

Страница 151: ...ar alar hastan n amp tasyon derecesine v cut a rl na aktivite derecesine ortam ko ullar na ve kullan m alan na ba l taleplerini yerine getirmelidir Bu protez bile eni Ottobock mod ler sistemi ile uyum...

Страница 152: ...kullan m mr n n a lmamas na dikkat edin Bu protez bile eni ISO 10328 uyar nca retici taraf ndan y kleme bak m ndan kontrol edilmi tir Maksimum kullan m mr 5 y ld r 4 Genel g venlik uyar lar D KKAT Ekl...

Страница 153: ...el tutamaklar ve y r m destekleri 7 2 Temel kurulumun olu turulmas D KKAT Hastan n emniyetli ekilde ayakta durmas i in protez kurulum resimleri yard m yla ve kullan lan t m protez par alar n n kullan...

Страница 154: ...ntemi de erleri vas tas ile optimizas yon yap labilir 10 Sayfa 7 Aktifle tirilmi 3D modunun optimizasyonu Statik kurulumu hastan n rahat durmas ve ekilde g sterilen referans noktalar n n de erleri ye...

Страница 155: ...leksiyon direnci 14 Sayfa 9 Ayar alan Sal n m faz fleksiyon direncinin azalt lmas Sal n m faz fleksiyon direncinin artt r lmas Sal n m faz ekstansiyon direnci 15 Sayfa 9 Ayar alan Sal n m faz ekstansi...

Страница 156: ...rine tamamen uyarlanam yorsa ayarlamalar ncelikli olarak hastan n g venli i g z n nde bulundurularak yap lmal d r Her ad mda ve her h zda ekstansiyon konu muna ula lmal d r Protez diz ekleminin ayarla...

Страница 157: ...n egzersizler yap n rn kondisyon bisikleti Bu spor t rlerinde kilidin devre d olmas gerekir 7 5 Kozmetik kaplaman n tak lmas Resim nerilen k p k kozmeti i g stermektedir 30 sayfa 17 Kozmeti in tak lma...

Страница 158: ...lar ve hasarlar r n sadece izin verilen temizleme malzemeleri ile temizleyiniz r n sadece izin verilen dezenfeksiyon maddesi ile dezenfekte ediniz Temizleme ve bak m notlar n dikkate al n z zin verile...

Страница 159: ...lmelidir Fleksiyon ve ekstansiyonun tam olarak olu mas daima sa lanm olmal d r Gerekli durumda ilave ayarlar yap lmal d r 10 mha etme Bu r n her yerde ayr t r lmam evsel plerle birlikte imha edilemez...

Страница 160: ...160 1 1 1 2 3R80 3R80 ST YYYYWWNNN YYYY WW NNN 647G403 all_INT VV YYMM 647G403 all_INT VV YYMM YY MM 1 2 1 3 1 1 1 J 2 3R80 3 3 1...

Страница 161: ...161 3 2 3R80 3R80 ST 3 4 150 kg 3 3 Ottobock MOBIS 3 3 1 2 2 3 4 20 C 60 C 20 90...

Страница 162: ...162 10 C 45 C 1 2 169 3 5 ISO 10328 5 4...

Страница 163: ...163 5 3 3 6 4 3 5 4 7 7 1 7 2 6 5 7 5 2Z11 KIT 2Z11 KIT 2Z11 KIT...

Страница 164: ...164 8 6 9 6 0 0 7 3 TF Ottobock 3D L A S A R Posture 743L500 3D 3D L A S A R Posture 743L100 10 7 3D...

Страница 165: ...165 3D 3D 1 1 1 2 50 50 11 7 3D 3D 3D 2 1 2 2 50 50 7 4 7 4 1 7 4 2 12 8 13 8...

Страница 166: ...166 14 9 15 9 16 10 7 4 3 17 10 18 11 19 11 S F...

Страница 167: ...167 E 7 4 4 20 12 7 4 5 21 12 22 13 23 13 24 14...

Страница 168: ...168 25 14 26 15 27 15 28 16 29 16 7 5 30 17 519L5 7 6 31 17 8 8 1...

Страница 169: ...169 8 2 161...

Страница 170: ...170 9 30 10 11 11 1 11 2 2017 745 CE...

Страница 171: ...171 1 2021 09 09 1 1 1 2 3R80 3R80 ST YYYYWWNNN YYYY WW NNN 647G403 all_INT VV YYMM 647G403 all_INT VV YYMM YY MM 1 2 1 3 1 1 1 J 2 3R80...

Страница 172: ...172 3 3 1 3 2 3R80 3R80 ST 3 4 150 kg 3 3 MOBIS 3 3 1 2 2 3 4 20 C 60 C 20 90...

Страница 173: ...173 10 C 45 C 2 m 1 178 3 5 1 ISO 10328 5 4 5 3 3...

Страница 174: ...174 1 6 4 3 5 4 7 7 1 7 2 6 5 7 5 2Z11 KIT 2Z11 KIT 2Z11 KIT 8 6 mm...

Страница 175: ...175 9 6 0 mm 0 mm 7 3 Ottobock 743L500 3D L A S A R 3D 3D 2 743L100 L A S A R 10 7 3D 3D 3D 1 1 1 2 50 50 11 7 3D 3D 3D 2 1 2 2 50 50...

Страница 176: ...176 7 4 7 4 1 7 4 2 12 8 13 8 14 9 15 9 16 10 7 4 3 17 10 18 11 19 11 S...

Страница 177: ...177 F E 7 4 4 20 12 7 4 5 21 12 22 13 23 13 14 24 25 14 26 15 27 15 28 16 29 16...

Страница 178: ...178 7 5 30 17 519L5 7 6 31 17 8 8 1 8 2...

Страница 179: ...179 172 9 30 10 11 11 1...

Страница 180: ...180 11 2 EU 2017 745 CE 1 2021 09 09 1 1 1 2 3R80 3R80 ST YYYYWWNNN YYYY WW NNN 647G403 all_INT VV YYMM 647G403 all_INT VV YYMM YY MM 1 2 1 3 1 1 1 J 2 3R80...

Страница 181: ...181 3 3 1 3 2 3R80 3R80 ST 3 4 150 kg 3 3 MOBIS 3 3 1 2 2 3 4 20 C 60 C 20 90 10 C 45 C...

Страница 182: ...182 1 2 m 187 3 5 ISO 10328 5 4 5 3 3 6 4 3 5 4...

Страница 183: ...183 7 7 1 7 2 6 5 7 5 2Z11 KIT 2Z11 KIT 2Z11 KIT 8 6 mm 9 6 0 mm...

Страница 184: ...184 0 mm 7 3 TF Ottobock 3D L A S A R Posture 743L500 3D 3D L A S A R Posture 743L100 10 7 3D 3D 3D 1 1 1 2 50 50 11 7 3D 3D 3D 2 1 2 2 50 50 7 4 7 4 1 7 4 2 12 8 13 8 14 9 15 9...

Страница 185: ...185 16 10 7 4 3 17 10 18 11 19 11 S F E 7 4 4 20 12 7 4 5 21 12 22 13 23 13...

Страница 186: ...186 14 24 25 14 26 15 27 15 28 16 29 16 7 5 30 17 519L5 7 6 31 17 8 8 1...

Страница 187: ...187 8 2 181 9 30...

Страница 188: ...188 10 11 11 1 11 2 CE 2017 745 CE...

Страница 189: ...189...

Страница 190: ...190...

Страница 191: ...191...

Страница 192: ...647G403 all_INT 13 2110 Template Version 2016 11 23 FM480 SB_148x210 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 de www ott...

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