PROTEOR 1P130 Скачать руководство пользователя страница 9 | Manualshive

Страница: 9 / 64

PROTEOR 1P130 Скачать руководство пользователя страница 9

INSTRUCTIONS FOR USE

Page

3

of

3

If your weight increases significantly, arrange for your prosthetist/orthotist to readjust the knee’s safety settings.

The warranty does not cover damage or degradation caused by misuse, unsuitable alignment, use without suitable protection in

a very dusty environment or any other inappropriate use.

The knee should not be exposed to environments which might induce corrosion of the metal components (fresh water, sea water,

chlorinated water, acids, etc.).

Showering or taking a bath while wearing the prosthesis is prohibited;

this might impair its properties and its correct operation.

Intensive use of the knee brake (e.g. due to a prolonged period of walking down a slope or stairs) may cause the hydraulic system

to overheat and the braking effect to diminish. Do not touch the knee and reduce the activity level to give the components time to
cool down.

Never leave this device near a source of heat since it might burn or release toxic fumes.

If used in very cold (<10°C) or very hot (>40°C) conditions the behaviour of the knee may change significantly. In this case, take

precautions when walking and going down slopes or stairs.

The use of solvents is prohibited.

C.

Side effects

There are no side effects directly associated with the device.

Any serious incident that occurs which relates to the device must be reported to the manufacturer and to the competent authority of
the member state in which the incident occurred.

8.

MAINTENANCE, STORAGE, DISPOSAL AND SERVICE LIFE

A.

Maintenance/cleaning

You can clean the knee using a damp sponge

Do not immerse the knee or hold it under running water

Dry you knee if it is exposed to bad weather (rain) or accidental splashing.

B.

Storage

Service and storage temperature: -10°C to +40°C
Relative humidity of the air: no restrictions

C.

Disposal

The various components of this device are considered as special waste: elastomer, plastic, aluminium, titanium, steel, brass and oil.
They must be treated in accordance with current, applicable legislation.

D.

Service life

It is advisable to arrange for a prosthetist/orthotist to check the product once a year.

9.

DESCRIPTION OF THE SYMBOLS

Manufacturer

Identified risk

CE marking and year of first declaration of

conformity

10.

REGULATORY INFORMATION

This product is a CE-marked medical device that is certified as conforming with regulation (EU) 2017/745

11.

NAME AND ADDRESS OF MANUFACTURER

PROTEOR SAS
6 rue de la Redoute – 21850 Saint-Apollinaire – France
Tel.: +33 3 80 78 42 42 – Fax: +33 3 80 78 42 15
[email protected] – www.proteor.com

«
...
7
8
9
10
11
...
»

Содержание 1P130

Страница 1: ...auchsanweisung IT Istruzioni per l uso ES Instrucciones de uso PT Instru es de utiliza o NL Gebruikershandleiding DA Brugervejledning NO Brukerveiledning SV Bruksanvisning FI K ytt ohjeet PL Instrukcj...

Страница 2: ...phase d appui seuil de passage de la phase pendulaire et r sistance la flexion et de la phase pendulaire impact en fin d extension et amortissement de la flexion L angle de flexion du genou est limit...

Страница 3: ...un choc important consultez votre orthoproth siste 7 MISES EN GARDE CONTRE INDICATIONS EFFETS SECONDAIRES A Mises en garde Attention le m canisme de freinage entre un genou lectronique et un genou fr...

Страница 4: ...mais laisser ce dispositif pr s d une source de chaleur risque de br lure et de d gagement toxique En cas d utilisation dans des conditions de temp rature tr s basse 10 C ou tr s lev e 40 C le comport...

Страница 5: ...NOTICE D UTILISATION Page 4 sur 5 11 NOM ET ADRESSE DU FABRICANT PROTEOR SAS 6 rue de la Redoute 21850 Saint Apollinaire France Tel 33 3 80 78 42 42 Fax 33 3 80 78 42 15 cs proteor com www proteor com...

Страница 6: ...NOTICE D UTILISATION Page 5 sur 5 HISTORIQUE DES MODIFICATIONS Version Date R dacteur Modifications 1 1 30 04 2021 V Barbour Mise au format MDR...

Страница 7: ...ation provide safe management of the stance phase transition after the swing phase and resistance to flexion and the swing phase impact at the end of extension and dampening of flexion The angle of fl...

Страница 8: ...a knee with an electronic braking mechanism does not behave like a braked knee the patient may need some time to get used to a new knee when switching between the two To reduce the risk of falling wh...

Страница 9: ...of solvents is prohibited C Side effects There are no side effects directly associated with the device Any serious incident that occurs which relates to the device must be reported to the manufacturer...

Страница 10: ...cht C Wirkungsmechanismus Dieses Prothesenkniegelenk basiert auf einem Hydraulikzylinder der l enth lt Hydraulikeinheit und Sicherheitsvorrichtung sorgen f r die n tige Sicherheit w hrend der Standpha...

Страница 11: ...inders wieder zu strecken 5 FUNKTIONSWEISE GEBRAUCHSANWEISUNGEN A Verwendung der Verriegelung Das Prothesenkniegelenk verf gt ber eine hydraulische Verriegelung die in der stehenden oder sitzenden Pos...

Страница 12: ...usgesetzt werden die zur Korrosion der Metallteile f hren k nnten S wasser Salzwasser Chlorwasser S uren usw Das Duschen sowie Baden mit der Prothese ist untersagt um diese nicht zu besch digen und de...

Страница 13: ...g 10 ALLGEMEINE ANGABEN Bei diesem Produkt handelt es sich um ein Medizinprodukt mit CE Kennzeichnung das den Anspr chen der Verordnung EU 2017 745 gerecht wird 11 NAME UND ANSCHRIFT DES HERSTELLERS P...

Страница 14: ...oglia di passaggio dalla fase di swing e resistenza alla flessione e dalla fase di swing impatto alla fine dell estensione e ammortizzamento della flessione L angolo di flessione del ginocchio limitat...

Страница 15: ...l ortoprotesista 7 AVVERTENZE CONTROINDICAZIONI EFFETTI SECONDARI A Avvertenze Attenzione il meccanismo di frenata tra un ginocchio elettronico e un ginocchio a freno diverso Una fase di formazione pu...

Страница 16: ...o pu cambiare in modo significativo In tal caso prendere le dovute precauzioni durante la marcia e la discesa di pendii o di scale L uso di solventi vietato C Effetti secondari Non vi sono effetti sec...

Страница 17: ...eguridad de la fase de apoyo umbral de paso de la fase pendular y resistencia a la flexi n y de la fase pendular impacto de extensi n completa y amortiguaci n de la flexi n El ngulo de flexi n de la r...

Страница 18: ...cto importante consulte con su ortoprot sico 7 ADVERTENCIAS CONTRAINDICACIONES Y EFECTOS SECUNDARIOS A Advertencias Atenci n El mecanismo de frenado es diferente para una rodilla electr nica y una rod...

Страница 19: ...uso en condiciones de temperatura muy baja 10 C o muy alta 40 C el comportamiento de la rodilla podr a alterarse significativamente Si eso sucediera tenga cuidado a la hora de caminar y al bajar pend...

Страница 20: ...t o da seguran a durante a fase de apoio limiar da passagem da fase pendular e resist ncia flex o e durante a fase pendular impacto em fim de extens o e amortecimento da flex o O ngulo de flex o do jo...

Страница 21: ...D RIOS A Advert ncias Aten o o mecanismo de travagem entre um joelho eletr nico e um joelho com trav o diferente Pode ser necess ria uma fase de aprendizagem para passar de um joelho ao outro Para evi...

Страница 22: ...to elevadas 40 C o comportamento do joelho pode mudar de forma significativa Neste caso tomar precau es durante a marcha e durante as descidas de inclina es ou escadas proibida a utiliza o de solvente...

Страница 23: ...id tijdens de steunfase drempel slingerfase en flexieweerstand en de slingerfase impact op einde van de extensiefase en dempen van de flexie beheerd worden De flexiehoek van de knie is mechanisch begr...

Страница 24: ...nlangs een grote schok heeft opgevangen 7 WAARSCHUWINGEN CONTRA INDICATIES BIJWERKINGEN A Waarschuwingen Let op de remmechanismen van een elektronische knie en van een remknie zijn verschillend Er kan...

Страница 25: ...C of erg hoge temperaturen 40 C kan het gedrag van de knie aanzienlijk veranderen Neem in dat geval voorzorgsmaatregelen tijdens het stappen en het afdalen van hellingen of trappen Het gebruik van opl...

Страница 26: ...r det muligt at styre st ttefasen t rskelv rdi for pendulfaseskift og b jningsmodstand og pendulfasen slutvirkning p str kning og b jningsd mpning Kn ets b jningsvinkel er mekanisk begr nset til 120 D...

Страница 27: ...fra det ene kn til det andet For at undg risikoen for at falde ned ad trapper anbefales det at st tte sig til gel nderet Efter en pause p flere timer kan kn et afgive en klikkende lyd ved f rste ber r...

Страница 28: ...kninger Der er ingen bivirkninger der er direkte relateret til enheden Enhver alvorlig h ndelse der indtr ffer i forbindelse med enheden skal anmeldes til producenten og medlemsstatens kompetente mynd...

Страница 29: ...g aktiveringssystemet muliggj r styring av sikkerheten i tr kkfasen begrensning av overgang i den pendul re fasen og motstand mot fleksjon og i den pendul re fasen nedslag etter endt utstrekning og fj...

Страница 30: ...ONER BIVIRKNINGER A Advarsler V r oppmerksom p at bremsemekanismen p et elektronisk kne og et kne med bremse er forskjellig en oppl ringsfase kan v re n dvendig ved bytting fra ett kne til et annet Fo...

Страница 31: ...hold ved gange og nedstigning av bakker eller trapper Bruk av l semidler er forbudt C Bivirkninger Det er ingen bivirkninger direkte knyttet til denne enheten Alle alvorlige hendelser som oppst r i fo...

Страница 32: ...ngen kan man hantera st dfasens s kerhet tr skelv rde f r verg ng fr n pendelfasen och flexionsmotst ndet och pendelfasen effekt vid slutextension och d mpning av flexionen Kn ets b jningsvinkel r mek...

Страница 33: ...IKATIONER SEKUND RA EFFEKTER A Varningar T nk p att bromsmekanismen p ett eldrivet kn och ett kn med broms skiljer sig t en inl rningsfas kan beh vas i samband med byte fr n ett kn till ett annat F r...

Страница 34: ...backar eller i trappor F rbjudet att anv nda l sningsmedel C Sekund ra effekter Det finns inga sekund ra effekter som r direkt knutna till enheten Alla allvarliga incidenter som intr ffar och r f rkni...

Страница 35: ...rist Hydrauli ja aktivointij rjestelm mahdollistaa tukivaiheen turvallisen hallinnan siirtym heilahdusvaiheesta ja vastuksesta taipumiseen ja heilahdusvaiheen aikana ojennuksen loppuisku ja taipumisen...

Страница 36: ...STA AIHEET SIVUVAIKUTUKSET A Varoitukset Huomio elektronisen polven ja jarrullisen polven jarrutusmekanismit ovat erilaiset Opetteluvaihe voi olla tarpeen polvea vaihdettaessa Suosittelemme pit m n po...

Страница 37: ...ortaita laskeutuessa on noudatettava varovaisuutta Liuottimien k ytt on kielletty C Sivuvaikutukset T h n laitteeseen ei liity suoria sivuvaikutuksia Kaikista vakavista laitteeseen liittyvist poikkeus...

Страница 38: ...w fazie zamachu uderzenie na ko cowym etapie wyprostu i amortyzacja ugi cia K t zgi cia kolana jest ograniczony mechanicznie do 120 Taka amplituda ruchu umo liwia kl kanie czy jazd na rowerze Przegub...

Страница 39: ...resie w a ciwo ci wyrobu albo w przypadku gdy zosta on uderzony z du si nale y skonsultowa si z protetykiem ortopedycznym 7 OSTRZE ENIA PRZECIWWSKAZANIA EFEKTY UBOCZNE A Ostrze enia Uwaga istnieje r n...

Страница 40: ...ci Nie zostawia wyrobu w pobli u r d a ciep a mo e to spowodowa ryzyko poparzenia i wydzielanie si toksycznych substancji W przypadku u ytkowania w niskiej 10 C lub bardzo wysokiej temperaturze 40 C...

Страница 41: ...INSTRUKCJA U YTKOWANIA Strona 4 z 4 11 NAZWA I ADRES PRODUCENTA PROTEOR SAS 6 rue de la Redoute 21850 Saint Apollinaire Francja Tel 33 3 80 78 42 42 Fax 33 3 80 78 42 15 cs proteor com www proteor com...

Страница 42: ...st obsahuj c olej Hydraulick a aktiva n syst m umo uj zen bezpe nosti ve stojn f zi pr h p echodu do vihov f ze a odpor ve flexi a ve vihov f zi r z na konci extenze a tlumen flexe hel flexe kolene j...

Страница 43: ...d ln P i p echodu z jednoho kolene na druh m e b t nutn ur it obdob u en Pro zabr n n rizika p du p i sestupov n ze schod doporu ujeme p idr ovat se z bradl Po n kolikahodinov p est vce m e koleno p i...

Страница 44: ...nebo ze schod Pou v n rozpou t del je zak z no C Vedlej inky P mo s pom ckou nejsou spojeny dn vedlej inky Jak koliv v n nehoda souvisej c s touto zdravotnickou pom ckou mus b t ozn mena v robci a odp...

Страница 45: ...eho olej Hydraulick a aktiva n syst m umo uje riadenie bezpe nosti f zy opory prah prechodu z kyvadlovej f zy a odolnosti pri flexii a z kyvadlovej f zy n raz na konci extenzie a tlmenie flexie Uhol f...

Страница 46: ...om na ortoprot zy 7 VAROVANIA KONTRAINDIK CIE SEKUND RNE INKY A Varovania Pozor mechanizmus brzdy medzi elektronick m kolenom a kolenom s brzdou je odli n m e by nevyhnutn f za u enia pre prechod z je...

Страница 47: ...ch tepl t 40 C sa m e spr vanie kolena v razne zmeni V tomto pr pade dodr ujte opatrenia po as ch dze dolu svahom a po schodoch Je zak zan pou va rozp adl C Sekund rne inky Neexistuj iadne sekund rne...

Страница 48: ...aktivacijski sustav omogu uju upravljanje sigurno u faze pritiska prag prolaska u fazu nagiba i otpor fleksiji i faze nagiba udar na kraju ekstenzije i ubla avanje fleksije Kut fleksije koljena mehani...

Страница 49: ...NJA KONTRAINDIKACIJE NUSPOJAVE A Upozorenja Imajte na umu da se razlikuju mehanizmi ko enja elektroni kog koljena i ko ionog koljena mo da e biti potrebna faza u enja za prebacivanje s jednog koljena...

Страница 50: ...a prilikom hodanja i spu tanja niz padinu ili stube Uporaba otapala je zabranjena C Nuspojave Ne postoje nuspojave koje su izravno povezane s proizvodom O svakom ozbiljnom doga aju povezanom s proizvo...

Страница 51: ...026 1P13029 B N 1P13028 B N 1P13027 B N 1G16 2 A 1P130 1P131 1P130 KD 1P131 KD M36 1 5 4 34 B 1P130 1P131 1P130 KD 1P131 KD 1265 1285 120 150 NF EN ISO 10328 P7 150 3 4 5 C 120 4 150 75 3 HYTREK 1P130...

Страница 52: ...2 4 L3 L4 150 120 4 5 A 6 7 A PROTEOR 10 C B...

Страница 53: ...3 4 150 10 C 40 C C 8 A B 10 40 C C D 9 CE 1 10 CE 2017 745...

Страница 54: ...4 4 11 PROTEOR SAS 6 21850 33 3 80 78 42 42 33 3 80 78 42 15 cs proteor com www proteor com...

Страница 55: ...F026 1P13029 B N 1P13028 B N 1P13027 B N 1G16 2 A 1P130 1P131 1P130 KD 1P131 KD M36 1 5 4 34 B 1P130 1P131 1P130 KD 1P131 KD 1265 1285 120 150 NF EN ISO 10328 P7 150 3 4 5 C 120 4 150 75 HYTREK 1P130...

Страница 56: ...2 4 3 L3 L4 150 120 4 5 A 6 7 A PROTEOR 10 C...

Страница 57: ...3 4 B 150 10 C 40 C C 8 A B 10 C 40 C C D 9 CE...

Страница 58: ...4 4 10 CE 2017 745 11 PROTEOR SAS 6 rue de la Redoute 21850 33 3 80 78 42 42 33 3 80 78 42 15 cs proteor com www proteor com...

Страница 59: ...3029 B N 1P13028 B N 1P13027 B N 1G16 2 A 4 1P130 1P131 1P130 KD 1P131 KD M36 1 5 4 34mm B 1P130 1P131 1P130 KD 1P131 KD 1265 g 1285 g 120 150 g NF EN ISO 10328 4 5 300 P7 150Kg C 120 4 75 150Nm 3 HYT...

Страница 60: ...2 3 L3 L4 150 g 120 4 5 A 6 7 A PROTEOR 10 C B 150kg...

Страница 61: ...3 3 10 C 40 C C 8 A B 10 C 40 C C D 9 CE 10 CE EU 2017 745 11 SAS 6 rue de la Redoute 21850 Saint Apollinaire France Tel 03 80 78 42 42 fax 33 3 80 78 42 15 cs proteor com www proteor com...

Страница 62: ...P13028 B N 1P13027 B N 1G16 2 A 1P130 1P131 1P130 KD 1P131 KD M36 1 5 4 34mm B 1P130 1P131 1P130 KD 1P131 KD 1265 g 1285 g 120 150 kg NF EN ISO 10328 P7 150kg 300 4 5 C 120 4 1 1 150Nm 75 3 L3 L4 150...

Страница 63: ...2 3 4 5 A 6 7 A PROTEOR 10 C B 150kg...

Страница 64: ...3 3 10 C 40 C C 8 A B 10 C 40 C C D 9 CE 10 CE 2017 745 11 PROTEOR SAS 6 rue de la Redoute 21850 Saint Apollinaire France 33 3 80 78 42 42 33 3 80 78 42 15 cs proteor com www proteor com...

Отзывы:

Нет отзывов