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7

6

 

– Consider dorsiflexion

 

– Check heel of the shoe and shoe performance

Symptoms 

 

– Rapid heel to toe movement

 

– Poor control over prosthesis at initial contact 

 

– Minimal energy return feeling 

 

– Too little push off from the toe

 

– Knee becomes unstable 

Action

 

– Check Wedge instructions (if applicable) 

 

– Shift socket posterior (or device anterior)

 

– Consider plantarflexion

 

– Check heel of the shoe and shoe performance

USAGE

Cleaning and care

Clean with a damp cloth and a mild soap. Dry with a cloth after cleaning.

Environmental Conditions

The device is Weatherproof.
A Weatherproof device can be used in a wet or humid environment and 
can tolerate being splashed by fresh water (e.g., rain), no submersion is 
allowed. 
No contact with salt water or chlorinated water is allowed.
Dry with a cloth after contact with fresh water or humidity.
Clean with fresh water in case of accidental exposure to other liquids, 
chemicals, sand, dust, or dirt and dry with a cloth.

MAINTENANCE

The device and the overall prosthesis should be examined by a healthcare 
professional. Interval should be determined based on patient activity.

Noise from Foot

Noise may occur if sand or debris is present in device. In that case, the 
healthcare professional should doff the foot, clean it with the help of 
compressed air and replace the Spectra sock if it is damaged.

REPORT OF SERIOUS INCIDENT

Any serious incident in relation to the device must be reported to the 
manufacturer and relevant authorities.

DISPOSAL

The device and packaging must be disposed of in accordance with 
respective local or 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.

Содержание PRO-FLEX PIVOT

Страница 1: ...Instructions for Use PRO FLEX PIVOT...

Страница 2: ...FIGURES 3 EN Instructions for Use 4 CS N vod k pou it 9 SK Indik cie pou itia 14 RO Indica ii de utilizare 19 HR Upute za uporabu 24 HU Haszn lati javallat 29 BG 34 SL Indik cie pre pou itie 39...

Страница 3: ...3 A D B C E F J H G I L K B D E C 1 2 3...

Страница 4: ...ce for the prosthesis and the patient must be evaluated by a healthcare professional The device must be fitted and adjusted by a healthcare professional INDICATIONS FOR USE AND TARGET PATIENT POPULATI...

Страница 5: ...the foot into the Foot Cover 5 Put the foot cover attachment back onto the Foot Cover 6 After alignment is complete fix the Spectra Sock to the prosthesis to seal against dust and dirt Note The Spectr...

Страница 6: ...ial tuberosity level D Make a second mark at the midpoint of the socket distally E Draw a line through both marks 5 Position the socket so the alignment reference line B goes through the alignment ref...

Страница 7: ...with fresh water in case of accidental exposure to other liquids chemicals sand dust or dirt and dry with a cloth MAINTENANCE The device and the overall prosthesis should be examined by a healthcare...

Страница 8: ...SO 10328 Label Category Weight Kg Moderate Impact Label Text 1 52 ISO 10328 P3 52kg 2 59 ISO 10328 P3 59kg 3 68 ISO 10328 P3 68kg 4 77 ISO 10328 P3 77kg 5 88 ISO 10328 P4 88kg 6 100 ISO 10328 P5 100kg...

Страница 9: ...hoto prost edku pro danou prot zu a dan ho pacienta mus posoudit zdravotnick pracovn k Nasazen a se zen tohoto prost edku mus prov st zdravotnick odborn k INDIKACE K POU IT A C LOV POPULACE PACIENT Am...

Страница 10: ...hybem l ce vzh ru chodidlo zasu te do krytu chodidla 5 Nasa te n stavec krytu chodidla zp t na kryt chodidla 6 Po zarovn n p ipevn te n vlek Spectra k prot ze aby byla ut sn na proti prachu a ne istot...

Страница 11: ...te dist ln ve st edu l ka E Spojte ob zna ky arou 5 Um st te l ko tak aby referen n linie pro zarovn n B proch zela referen n m bodem pro zarovn n D 6 Nastavte odpov daj c hel l ka pro flexi extenzi...

Страница 12: ...n ho vystaven jin m kapalin m chemik li m p sku prachu nebo ne istot m prost edek o ist te istou vodou a osu te ut rkou DR BA Prost edek i prot zu jako celek by m l prohl dnout zdravotnick pracovn k I...

Страница 13: ...t edn rove r z Text na t tku 1 52 ISO 10328 P3 52kg 2 59 ISO 10328 P3 59kg 3 68 ISO 10328 P3 68kg 4 77 ISO 10328 P3 77kg 5 88 ISO 10328 P4 88kg 6 100 ISO 10328 P5 100kg 7 116 ISO 10328 P6 116kg Skute...

Страница 14: ...odidla a lenku ch baj cej dolnej kon atiny Vhodnos tejto pom cky pre dan prot zu a dan ho pacienta mus vyhodnoti lek r Nasadenie a nastavenie tejto pom cky mus vykona lek r INDIK CIE POU ITIA A CIE OV...

Страница 15: ...atla te do krytu chodidla 5 Nasa te nadstavec krytu chodidla nasp na kryt chodidla 6 Po zarovnan pripevnite n vlek Spectra k prot ze aby bola utesnen proti prachu a ne istot m Pozn mka N vlek Spectra...

Страница 16: ...st lne v stredovom bode l ka E Spojte obe zna ky iarou 5 Umiestnite l ko tak aby referen n l nia zarovnania B prech dzala referen n m bodom zarovnania D 6 Nastavte spr vne uhly l ka pre flexiu extenzi...

Страница 17: ...u alebo vlhkos ou osu te handri kou V pr pade n hodn ho vystavenia in m tekutin m chemik li m piesku prachu a pine pom cku o istite sladkou vodou a osu te handri kou DR BA Pom cku aj prot zu ako celok...

Страница 18: ...kg Stredn odolnos Text t tku 1 52 ISO 10328 P3 52 kg 2 59 ISO 10328 P3 59 kg 3 68 ISO 10328 P3 68 kg 4 77 ISO 10328 P3 77 kg 5 88 ISO 10328 P4 88 kg 6 100 ISO 10328 P5 100 kg 7 116 ISO 10328 P6 116 k...

Страница 19: ...cient trebuie evaluat de c tre un profesionist din domeniul medical Dispozitivul trebuie montat i reglat de c tre personalul medical INDICA II DE UTILIZARE I POPULA IA INT DE PACIEN I Amputarea membre...

Страница 20: ...entru picior 5 Pune i ata amentul husei pentru picior napoi pe husa pentru picior 6 Dup finalizarea alinierii fixa i oseta Spectra pe protez pentru a o etan a la praf i murd rie Not oseta Spectra treb...

Страница 21: ...elul tendonului rotulian fie la nivelul tuberozit ii ischiatice D Face i un al doilea marcaj n centrul distal al mufei E Trasa i o linie prin ambele marcaje 5 Pozi iona i mufa astfel nc t linia de ref...

Страница 22: ...nu permite scufundarea Nu este permis niciun contact cu apa s rat sau clorurat Usca i cu o c rp dup contactul cu ap dulce sau umiditate Cur a i cu ap dulce n caz de expunere accidental la alte lichide...

Страница 23: ...are ISO 10328 Etichet Categorie Greutate Kg Impact moderat Text etichet 1 52 ISO 10328 P3 52 kg 2 59 ISO 10328 P3 59 kg 3 68 ISO 10328 P3 68 kg 4 77 ISO 10328 P3 77 kg 5 88 ISO 10328 P4 88 kg 6 100 IS...

Страница 24: ...taje Prikladnost proizvoda za protezu i pacijenta mora procijeniti zdravstveni djelatnik Proizvod mora postaviti i podesiti zdravstveni djelatnik INDIKACIJE ZA UPOTREBU I CILJNA POPULACIJA PACIJENATA...

Страница 25: ...ma gore kako biste potpuno gurnuli stopalo u navlaku 5 Vratite spojnicu navlake stopala natrag na navlaku za stopalo 6 Nakon zavr etka poravnanja u vrstite arapu Spectra na protezu kako biste sprije i...

Страница 26: ...ine D Ozna ite drugu oznaku na sredini le i ta distalno E Provucite crtu kroz obje oznake 5 Postavite le i te tako da referentna linija poravnanja B prolazi kroz referentnu to ku poravnanja D 6 Postav...

Страница 27: ...on kontakta sa slatkom vodom ili vlagom O istite obi nom vodom u slu aju slu ajnog izlaganja drugim teku inama kemikalijama pijesku pra ini ili ne isto i i osu ite krpom ODR AVANJE Proizvod i cjelokup...

Страница 28: ...Umjereni utjecaj Tekst oznake 1 52 ISO 10328 P3 52 kg 2 59 ISO 10328 P3 59 kg 3 68 ISO 10328 P3 68 kg 4 77 ISO 10328 P3 77 kg 5 88 ISO 10328 P4 88 kg 6 100 ISO 10328 P5 100 kg 7 116 ISO 10328 P6 116...

Страница 29: ...i szakembernek kell rt kelnie Az eszk zt eg szs g gyi szakembernek kell felszerelnie s be ll tania FELHASZN L SI JAVALLATOK S C LCSOPORT Az als v gtag amput ci ja s vagy velesz letett v gtaghi ny Ninc...

Страница 30: ...jesen beker lj n a l bbor t sba 5 Helyezze vissza a l bbor t s csatlakoz elem t a l bbor t sra 6 A be ll t s v gezt vel a por s koszmentes szigetel s rdek ben r gz tse a Spectra zoknit a prot zishez M...

Страница 31: ...hialis tuberosity vonal ban D Tegyen egy m sodik jel l st a prot zistok diszt lis k z ppontj ba E Egy vonallal k sse ssze a k t jel l st 5 gy pozicion lja a prot zistokot hogy a be ll t si referenciav...

Страница 32: ...lhat s elviseli az desv z pl es r fr ccsen s t de v zbe mer teni tilos S s vagy kl rozott v zzel nem rintkezhet desv zzel vagy nedvess ggel val rintkez s ut n egy t rl kend vel t r lje sz razra desv z...

Страница 33: ...l si ciklusra A beteg aktivit s t l f gg en ez 2 3 vnyi haszn latnak felelhet meg ISO 10328 C mke Kateg ria Testt meg kg K zepes aktivit s C mke sz vege 1 52 ISO 10328 P3 52 kg 2 59 ISO 10328 P3 59 kg...

Страница 34: ...34 1 A B C D E F G H I J K L Spectra...

Страница 35: ...171 194 195 220 221 256 257 275 22 1 1 2 3 4 23 24 1 1 2 3 4 5 25 26 2 2 2 3 4 5 6 7 27 28 3 3 3 3 4 5 6 7 29 30 4 4 4 4 4 5 6 7 22 1 2 3 4 23 24 1 2 3 4 5 25 26 2 2 3 4 5 6 7 27 28 3 3 3 4 5 6 7 29...

Страница 36: ...36 3 B D 1 3 1 B 1 3 2 3 4 D E 5 B D 6 7...

Страница 37: ...37 Spectra...

Страница 38: ...38 ssur ISO 10328 2 3 ISO 10328 1 52 ISO 10328 P3 52 2 59 ISO 10328 P3 59 3 68 ISO 10328 P3 68 4 77 ISO 10328 P3 77 5 88 ISO 10328 P4 88 6 100 ISO 10328 P5 100 7 116 ISO 10328 P6 116 ISO 10328 P m kg...

Страница 39: ...sistema ki zamenjuje funkcijo stopala in gle nja manjkajo ega spodnjega uda Primernost pripomo ka za protezo in bolnika mora oceniti zdravstveni delavec Pripomo ek mora namestiti in prilagoditi zdrav...

Страница 40: ...dvigujte lico za obuvanje da stopalo do konca vstavite v prekrivni del za stopalo 5 Nastavek za prekrivni del stopala znova nataknite na prekrivni del za stopalo 6 Po kon ani poravnavi pritrdite navle...

Страница 41: ...o kolena 4 Na lateralni strani le i a naredite prvo oznako referen na to ka za poravnavo v sredi ni to ki le i a na ravni poga i ne kite ali na ravni sedni ne gr e D Distalno v sredi ni to ki le i a n...

Страница 42: ...nskim vplivom lahko uporabljate v mokrem ali vla nem okolju lahko se tudi nekoliko zmo i s sladko vodo npr de ne smete pa ga potopiti v vodo Stik s slano ali klorirano vodo ni dovoljen Po stiku s slad...

Страница 43: ...enitvenih ciklov Glede na bolnikovo aktivnost lahko tovrstna potreba nastane po 2 3 letih uporabe ISO 10328 oznaka Kategorija Te a kg Zmerna stopnja sile Besedilo oznake 1 52 ISO 10328 P3 52 kg 2 59 I...

Страница 44: ...68 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 Melli Beese Str 11 asia ossur com 50829 K ln Deutschl...

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