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Össur VARI-FLEX JUNIOR Скачать руководство пользователя страница 5

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ENGLISH

VARI-FLEX

®

JUNIOR FOOT SYSTEM (Figure 1)

•  Minimal Clearance 120mm-124mm (4 3⁄4" - 4 7⁄8")
•  Maximum weight 55 kg (121 lbs)
•  Available in sizes 16-24 cm

SAFETY PRECAUTIONS

Warning:

Statement that alerts the user to the possibility of serious injury, or serious adverse

reactions associated with the use or misuse of the device.

Caution:

Statement that alerts the user to the possibility of a problem with the device associated

with its use or misuse.

Precaution:

Please follow the safety precautions as failure to do so can lead to malfunction of

the device and risk injury to the user. Prosthetists should make sure their clients are aware of, and
understand, the safety precautions.

Warning:

Make sure that the user knows if he/she feels or notices any

change of function or alignment of the device, he should contact his
healthcare practitioner. This noticeable function loss may be the result of
reduced stiffness or loss of support.

Caution:

Make sure that the user knows that he needs to replace socks

that have holes in it because otherwise it may damage the foot cover.

Precaution:

The foot is designed to be used with spectra socks and foot

cover to prevent noise and for proper shoe fit.

Precaution:

The device is weather-proof but not resistant to corrosion.

Therefore, the device should not come into contact with salt water or
chlorinated water. The device is not designed to be used under extreme
conditions like diving or jumping into water. If for some reason the foot
components get wet parts should be dried with a lint free cloth. Should
the device come into contact with salt water, chlorinated water, dust or
dirt it must be rinsed with fresh water immediately.

INDICATIONS FOR USE

The foot is a non-invasive, single patient, reusable prosthetic device. The
foot is intended for unilateral and bilateral lower extremity amputees.

CONTRAINDICATIONS FOR USE

N/A

CATEGORY SELECTION CHART

Please refer to the selection charts below to determine the appropriate
stiffness required according to Össur recommendations.

WEIGHT KG

15-24

25-34

35-45

46-55

WEIGHT LBS

33-53

54-75

76-99

100-123

16

1

N/A

N/A

N/A

17

1

N/A

N/A

N/A

18

1

2

N/A

N/A

19

1

2

N/A

N/A

20

N/A

2

3

N/A

21

N/A

2

3

N/A

22

N/A

2

3

4

23

N/A

2

3

4

24

N/A

N/A

N/A

4

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4
5
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Содержание VARI-FLEX JUNIOR

Страница 1: ...Instructions for Use VARI FLEX JUNIOR...

Страница 2: ...S Instrucciones para el uso 17 IT Istruzioni per l uso 21 NO Bruksanvisning 25 DA Brugsanvisning 29 SV Bruksanvisning 33 EL 37 NL Gebruiksaanwijzing 42 PT Instru es de Utiliza o 46 PL Instrukcja u ytk...

Страница 3: ...3 Size Build height 18 120 mm 4 3 4 21 123 mm 4 13 16 24 124 mm 4 7 8 1 2 3...

Страница 4: ...4 4 5 Insertion Removal 6 7...

Страница 5: ...s in it because otherwise it may damage the foot cover Precaution The foot is designed to be used with spectra socks and foot cover to prevent noise and for proper shoe fit Precaution The device is we...

Страница 6: ...ll come to flat position too early amputee feels he she is sinking into a hole Extra energy is required to climb up over the toe Toe will feel too stiff Knee may hyperextend Actions Add polyurethane h...

Страница 7: ...ead of the sock should rest on top of foot module and not underneath the toe split The sock should be loose from the heel area and secured proximally with the cable tie provided SHOE HORN Figure 6 7 W...

Страница 8: ...afety checks ISO 10328 P m kg Body mass limit not to be exceeded For specific conditions and limitations of use see manufacturer s written instructions on intended use In the standard mentioned test l...

Страница 9: ...ungsverlustes sein Warnhinweis Stellen Sie sicher dass sich der Anwender dar ber im Klaren ist dass er Socken mit L chern ersetzen muss da das Fu cover sonst besch digt werden k nnte Vorsichtsmassnahm...

Страница 10: ...de des Abrollvorgangs erm glicht Die Abrollphase kann durch die folgenden Faktoren beeinflusst werden A P Positionierung des Fu es Dorsal Plantarflexion Absatzsteifheit ABSATZSH RTE Der Absatz ist zu...

Страница 11: ...bildung 5 Um den Fersenkeil aus Urethan zu sichern wird Sekundenkleber ben tigt Der Kleber ist in 15 20 Sekunden ausgeh rtet ABSATZAUFBAU Wenn Absatz oder Absatzbauteile ausgetauscht werden m ssen ver...

Страница 12: ...keit 0 100 relative Luftfeuchtigkeit Transport und Lagertemperatur von 15 C 5 F bis 50 C 122 F Lagerfeuchtigkeit 0 100 Relative Feuchtigkeit nicht kondensierend NORMKONFORMIT T Diese Komponente wurde...

Страница 13: ...soutien Mise en garde Informer l utilisateur qu il doit remplacer les chaussettes si elles pr sentent des trous pour viter d endommager le rev tement esth tique Pr cautions Le pied est con u pour tre...

Страница 14: ...ALON Le talon est trop souple Sympt mes La flexion plantaire est trop rapide les amput s ressentent l impression de s enfoncer dans un trou Un effort est n cessaire pour passer sur l avant pied L avan...

Страница 15: ...e colle sur un c t D MONTAGE DU CAPUCHON DES BOULONS Si le capuchon des boulons doit tre retir localisez la jonction module de pied capuchon des boulons et utilisez un couteau aiguis pour les s parer...

Страница 16: ...la norme ISO 10328 qui s applique deux millions de cycles de charge Cela correspond une dur e d utilisation de deux trois ans selon l activit de l amput Il est conseill d effectuer des contr les de s...

Страница 17: ...n aseg rese de que el usuario sabe lo necesario para cambiar los calcetines que tienen orificios ya que en caso contrario se podr an provocar da os a la funda cosm tica Precauciones el pie est dise a...

Страница 18: ...l dedo puede verse afectada por la posici n A P del pie la flexi n dorsiplantar la rigidez del tal n RIGIDEZ DEL TAL N Tal n demasiado suave S ntomas El pie llega prematuramente a posici n plana el am...

Страница 19: ...n SEPARADOR DE TAL N El separador del tal n debe colocarse en el tercio posterior del segmento de tal n con ranura Para fijarlo en su posici n puede aplicarse una gota de adhesivo instant neo en uno d...

Страница 20: ...F to 50 C 122 F Humedad de almacenamiento del 0 100 De humedad relativa sin condensaci n CUMPLIMIENTO Este componente ha sido probado seg n la normativa ISO 10328 a dos millones de ciclos de carga En...

Страница 21: ...i supporto Attenzione Assicurarsi che l utente sia a conoscenza del fatto di dover sostituire le calze bucate in quanto potrebbero danneggiare la cover piede Precauzioni Il piede progettato per essere...

Страница 22: ...tacco punta pu essere influenzato da Posizionamento antero posteriore A P del piede Dorsiflessione plantarflessione Rigidit del tallone RIGIDIT DEL TALLONE Tallone troppo morbido Sintomi Il piede ragg...

Страница 23: ...L TALLONE Se fosse necessario sostituire il tallone utilizzare Loctite 410 e stringere come segue DIVISORIO DEL TALLONE Il divisorio del tallone deve essere posizionato nell ultimo terzo della parte d...

Страница 24: ...nto dallo 0 al 100 Umidit relativa Temperatura durante il trasporto e lo stoccaggio dallo 15 C 5 F a 50 C 122 F Umidit di stoccaggio dallo 0 al 100 Umidit relativa non condensante CONFORMIT Questo com...

Страница 25: ...ker med hull m erstattes fordi de kan skade fotdekselet Forholdsregler Foten er konstruert for brukes med spektrasokker og fotdeksel for hindre st y og s rge for at skoen passer riktig Forholdsregler...

Страница 26: ...osisjon for tidlig den amputerte f ler at han hun synker ned i et hull Det kreves ekstra energi for komme over t en T en f les for stiv Kneet kan strekkes for mye Handlinger Bruk h lkile av polyuretan...

Страница 27: ...ten Sokken b r v re l s i h lomr det og sikret proksimalt med den medf lgende kabelstrips SKOHORN FIGUR 6 7 Bruk et skohorn ved fjerning og installering av fotkosmetikken for unng skade p foten eller...

Страница 28: ...jekk ISO 10328 P m kg Kropsmassegrensen m ikke overstiges For spesifikke vilk r og begrensninger for bruk se produsentens skriftlige instruksjoner om tiltenkt bruk I standarden som nevnes er testniv e...

Страница 29: ...kning Forholdsregler Foden er designet til at blive brugt med spektre sokker og mund d kke for at forhindre st j og for korrekt sko fit Note Foden er designet til at blive brugt med spektre sokker og...

Страница 30: ...an vil for hurtigt komme til at st p flad fod den amputerede vil f le det som om han eller hun synker i et hul Der kr ves ekstra energi for at komme frem over t en t en vil f les for stiv Kn et kan ov...

Страница 31: ...FOOT SOK T enden af sokken er delt af en tr d og passer ind i t delingen F r sokken tages p hold i det verste af t tr den og tr k sokken ind i t delingen Sokkens tr d skal v re p det verste af fodmod...

Страница 32: ...til en brugsvarighed p to til tre r Det anbefales at udf re regelm ssige rlige sikkerhedstjek ISO 10328 P m kg Kropsv gtgr nse m ikke overstiges Se fabrikantens skriftlige instruktioner om p t nkt an...

Страница 33: ...st d Obs Informera brukaren att han hon m ste byta ut Spectra sockan om det g r h l p den f r att undvika skada p fotkosmetiken F rsiktighets tg rder Fotmodulen skall f rses med en Spectra socka inna...

Страница 34: ...fr n h l till t h lens styvhet H LENS STYVHET H len f r mjuk Symtom Foten plantarflekterar f r tidigt brukaren f r en k nsla av att g i uppf rsbacke Extra energi kr vs f r att avveckla steget Framfote...

Страница 35: ...FLEX FOOTSTRUMPA Strumpans t del delas av en tr d som skall inpassas i springan mellan t delarna Ta i tr den och f r in den i splitt n l gg tr den p ovansidan av fotmodulen Strumpan skall sitta l st r...

Страница 36: ...Vi rekommenderar regelbundna rliga s kerhetskontroller av produkten ISO 10328 P m kg Maximal kroppsmassa f r inte verskridas F r s rskilda villkor och begr nsningar f r anv ndnin gen se tillverkarens...

Страница 37: ...37 VARI FLEX 1 120mm 124mm 55 kg 16 24 cm N A ssur...

Страница 38: ...38 2 3 2 KG 15 24 25 34 35 45 46 55 16 1 N A N A N A 17 1 N A N A N A 18 1 2 N A N A 19 1 2 N A N A 20 N A 2 3 N A 21 N A 2 3 N A 22 N A 2 3 4 23 N A 2 3 4 24 N A N A N A 4...

Страница 39: ...39 3 4 1 5 15 20 Loctite 410 FLEX FOOT 1 4 14Nm 10ft lbs...

Страница 40: ...40 6 7 15 C 5 F to 50 C 122 F 0 100 15 C 5 F to 50 C 122 F 0 100 ISO 10328 ISO 10328 P m kg m kg ISO10328 Kg 1 24 ISO 10328 P3 24 kg 2 34 ISO 10328 P3 34 kg 3 45 ISO 10328 P3 45 kg...

Страница 41: ...41 ISO10328 Kg 4 55 ISO 10328 P3 55 kg...

Страница 42: ...verminderde stijfheid of verlies van ondersteuning Let op Zorg ervoor dat de gebruiker weet dat hij zij stompsokken die gaten hebben moet vervangen anders kan de voetovertrek beschadigd raken Voorzor...

Страница 43: ...vrijlating bij de eindstand De afwikkeling van hiel tot teen kan be nvloed worden door A P positie van de voet Dorsaal Plantairflexie Hielstijfheid HIELSTIJFHEID Hiel te zacht Symptomen De voet komt t...

Страница 44: ...IELMONTAGE Als het nodig is om het hieldeel te vervangen gebruikt u Loctite 410 en draait u de bouten als hierna volgt aan HIELVERDELER De hielverdeler moet in het achterste derde deel van het gesplet...

Страница 45: ...reik 0 100 Relatieve luchtvochtigheid Verzendings en opslagtemperatuur 15 C 5 F tot 50 C 122 F Luchtvochtigheid opslag 0 100 Relatieve vochtigheid niet condenserend COMPLIANCE Deze component is getest...

Страница 46: ...a de apoio Aten o Certifique se de que o usu rio tem a capacidade para perceber se precisa de substituir meias que tenham buracos caso contr rio pode danificar a cobertura do p Precau o O p foi desenv...

Страница 47: ...alcanhar para os dedos pode ser influenciada por Posicionamento antero posterior do p Flex o dorsiplantar Rigidez do calcanhar RIGIDEZ DO CALCANHAR Calcanhar demasiado flex vel Sintomas O p atinge o a...

Страница 48: ...NTAGEM DO CALCANHAR Caso necessite substituir o componente do calcanhar use Loctite 410 e aparafuse de acordo com as seguintes especifica es DIVISOR DE CALCANHAR O divisor do calcanhar deve ser montad...

Страница 49: ...relativa Temperatura de armazenamento e envio 15 C 5 F a 50 C 122 F Humidade de armazenamento 0 100 De humidade relativa sem condensa o NORMAS REGULAMENTADORAS Este componente foi testado de acordo c...

Страница 50: ...y upewni si e u ytkownik ma wiadomo konieczno ci wymiany po czoch w przypadku ich rozdarcia nieprzestrzeganie tego zalecenia mo e skutkowa uszkodzeniem pokrycia kosmetycznego stopy rodki ostro no ci...

Страница 51: ...cia leja wzgl dem stopy w pozycji strza kowej ustawienie grzbietowo podeszwowe stopy twardo pi ty TWARDO PI TY Pi ta zbyt mi kka Objawy Stopa za szybko przyjmuje sylwetk sp aszczonej osoby po amputacj...

Страница 52: ...tu pi ty u yj rodka Loctite 410 i klucza dynamometrycznego zgodnie z poni sz specyfikacj SEPARATOR PI TY Separator pi ty nale y umie ci w ostatniej jednej trzeciej cz ci podzielonej pi ty W celu umoco...

Страница 53: ...eratura transportu i przechowywania od 15 C 5 F do 50 C 122 F Wilgotno przechowywania 0 100 Wilgotno ci wzgl dnej bez kondensacji ZGODNO Ten komponent przetestowano zgodnie z norm ISO 10328 w zakresie...

Страница 54: ...jinak by mohlo doj t k po kozen obalu chodidla Bezpe nostn opat en Chodidlo je ur eno pro pou it s obalem chodidla a pono kami Spectra kter zamezuj hluku a zaji uj spr vn usazen obuvi Bezpe nostn opat...

Страница 55: ...v do pln ho kontaktu u ivatel m pocit propadnut se Pro odval p es p edn st chodidla je pot eba v c energie U ivatel poci uje p li tuhou p edn st chodidla M e doj t k hyperextenzi kolena e en P idejte...

Страница 56: ...n o ky uchopte horn st rky a zasu te pun o ku do mezery v p edn sti chodidlov ho modulu rka pun o ky by m la z stat na horn sti chodidlov ho modulu a neb t zespod mezery v p edn sti chodidla Pun o ka...

Страница 57: ...pravideln ro n bezpe nostn kontroly ISO 10328 P m kg Limit wagi cia a kt rego nie mo na przekroczy W przypadku okre lonych warunk w i ogranicze dotycz cych u ytkowania zapoznaj si z instrukcj produce...

Страница 58: ...si gerekti ini aksi halde ayak k l f n n zarar g rebilece ini bildi inden emin olun nlem Ayak sesi nlemek ve uygun ayakkab uyumu i in spectra oraplar ve ayak k l f ile kullan lacak ekilde tasarlanm t...

Страница 59: ...Ayak d z konuma ok erken gelecektir amp te bir bo lu a bat yormu gibi hisseder Ayak parma ucunda durmak i in ekstra enerji gerekir Ayak parma ok sert bir hisse sahiptir Diz a r hiperekstansiyona zorl...

Страница 60: ...armak izgisine yerle ir orab yerle tirdikten sonra ayak parma ipinin tepesini tutun ve orab ayak parma izgisine kayd r n orab n ipi ayak parma izgisinin alt taraf nda de il ayak mod l n n tepesinde ba...

Страница 61: ...nli olarak g venlik denetimlerinin y r t lmesini neririz ISO 10328 P m kg V cut kitle s n r a lmamaml d r Belirli ko ullar ve kullan m s n rlamalar i in tasarlanan kullan m hakk nda reticinin yaz l ta...

Страница 62: ...62 VARI FLEX 1 120 124 55 16 24 spectra socks N A ssur...

Страница 63: ...63 2 3 2 1 3 15 24 25 34 35 45 46 55 16 1 N A N A N A 17 1 N A N A N A 18 1 2 N A N A 19 1 2 N A N A 20 N A 2 3 N A 21 N A 2 3 N A 22 N A 2 3 4 23 N A 2 3 4 24 N A N A N A 4...

Страница 64: ...64 3 4 1 5 15 20 Loctite 410 FLEX FOOT SOCK 1 4 1 4 14Nm 10ft lbs...

Страница 65: ...65 6 7 15 C 5 F 50 C 122 F 0 100 O 15 C 5 F 50 C 122 F 0 100 O ISO 10328 2 3 ISO 10328 P m kg ISO P...

Страница 66: ...66 ISO10328 1 24 ISO 10328 P3 24 kg 2 34 ISO 10328 P3 34 kg 3 45 ISO 10328 P3 45 kg 4 55 ISO 10328 P3 55 kg...

Страница 67: ...LEX Junior 1 120mm 124mm 55Kg 16 24cm N A ssur 2 15 24 25 34 35 45 46 55 16 1 N A N A N A 17 1 N A N A N A 18 1 2 N A N A 19 1 2 N A N A 20 N A 2 3 N A 21 N A 2 3 N A 22 N A 2 3 4 23 N A 2 3 4 24 N A...

Страница 68: ...68 3 1 3 1 3 B 1 3 A P 3 4...

Страница 69: ...69 5 15 20 Loctite410 1 3 1 FLEX FOOT 6 7 15 C 5 F 50 C 122 F 0 100 1 4 1 4 14Nm 10ft lbs...

Страница 70: ...70 15 C 5 F 50 C 122 F 0 100 ISO10328 200 2 3 P m in kg ISO10328 kg 1 24 ISO 10328 P3 24 kg 2 34 ISO 10328 P3 34 kg 3 45 ISO 10328 P3 45 kg 4 55 ISO 10328 P3 55 kg...

Страница 71: ...i Flex 1 120 124 55 16 24 Spectra N A Ossur 2 15 24 25 34 35 45 46 55 16 1 N A N A N A 17 1 N A N A N A 18 1 2 N A N A 19 1 2 N A N A 20 N A 2 3 N A 21 N A 2 3 N A 22 N A 2 3 4 23 N A 2 3 4 24 N A N A...

Страница 72: ...72 3 2 3 4 1 5 15 20...

Страница 73: ...73 Loctite 410 6 7 15 C 5 F 50 C 122 F 0 100 15 C 5 F 50 C 122 F 0 100 1 4 1 4 14Nm 10ft lbs...

Страница 74: ...74 ISO 10328 200 ISO 10328 P m kg P ISO10328 Kg 1 24 ISO 10328 P3 24 kg 2 34 ISO 10328 P3 34 kg 3 45 ISO 10328 P3 45 kg 4 55 ISO 10328 P3 55 kg...

Страница 75: ...75 1 120mm 124mm 55 kg 16 24 cm N A ssur...

Страница 76: ...76 2 3 2 3 1 3 A P heel wedge KG 15 24 25 34 35 45 46 55 16 1 N A N A N A 17 1 N A N A N A 18 1 2 N A N A 19 1 2 N A N A 20 N A 2 3 N A 21 N A 2 3 N A 22 N A 2 3 4 23 N A 2 3 4 24 N A N A N A 4...

Страница 77: ...77 3 4 1 5 15 20 Loctite 410 6 7 1 4 1 4 14Nm 10ft lbs...

Страница 78: ...6 15 C 5 F 50 C 122 F 0 100 15 C 5 F 50 C 122 F 0 100 ISO 10328 200 2 3 ISO 10328 P m kg P kg m ISO10328 Kg 1 24 ISO 10328 P3 24 kg 2 34 ISO 10328 P3 34 kg 3 45 ISO 10328 P3 45 kg 4 55 ISO 10328 P3 55...

Страница 79: ...tes Si se produce alg n problema derivado del uso este producto p ngase en contacto inmediatamente con su especialista cl nico IT Avvertenze I prodotti ed i componenti Ossur sono stati progettati e co...

Страница 80: ...rodukowanymi lub zalecanymi przez Ossur W przypadku zauwa enia jakiegokolwiek niepo danego zu ycia lub ruchu elementu konstrukcyjnego produktu pacjent powinien zosta pouczony aby natychmiast zaprzesta...

Страница 81: ...9 462840 2F W16 B info europe ossur com No 1801 Hongmei Road 200233 Shanghai China ssur Deutschland GmbH Tel 86 21 6127 1707 Augustinusstrasse 11A asia ossur com 50226 Frechen Deutschland Tel 49 0 223...

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