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5

PB

ENGLISH

UNITY

®

SYSTEM COMPONENTS (Figure 2)

1. Membrane Housing

2. Pump Blade
3. Membrane

4. Inlet Port

5. Outlet Port
6. Duckbill

7. Mounting Screw

8. Tube

Flex-Foot Assure / Balance Foot J
See IFU for Flex-Foot Assure / Balance Foot J

SAFETY PRECAUTIONS

Please follow the safety precautions as failure to do so can lead to
malfunction of the Unity System and risk injury to the user.

• This product is to be used exclusively for unilateral or bilateral major

lower-limb amputations.

• Use a Unity Socket Valve Kit to connect the system to the socket.
• Make sure that the socket is a close fit to prevent blistering and/or

wounds.

• Make sure the tube is not folded, bent, or closed off in any way

(Figure 3)

.

• Make sure the tube is secured firmly away from any sharp objects or

components.

• Clinical specialists should make sure their clients are aware of and

understand the following:

– The tube must be well secured at all times.

– Never operate this product if a change in its operation is

observed. In such cases the user should consult the clinical
specialist.

caution

: U.S. federal law requires this device to be sold by a prosthetist

and by the order of a physician. The clinical specialist must provide each
user with training for appropriate use and proper application of the Unity
System.

UNITY SYSTEM OVERVIEW

The Unity System is designed to provide elevated vacuum for socket
suspension. Expected attainable vacuum achieved by the Unity System
during normal operation ranges from 15-18 inHg or higher.
With the Unity System, assisted suspension is obtained through the act
of a pump which draws air out from the socket in each step creating an
elevated vacuum inside the socket interface.
The Unity System is designed to function in any temperature and
humidity that the user encounters during normal use.

Unity for Flex-Foot Assure / Balance Foot J is single patient device.

The users of Unity for Flex-Foot Assure / Balance Foot J are clinical
specialists and end user. This device should only be used with a
prescription from a physician that includes the necessary treatment
information.

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Содержание UNITY

Страница 1: ...Instructions for Use UNITY FOR ASSURE BALANCE FOOT J...

Страница 2: ...R Notice d utilisation 13 ES Instrucciones para el uso 17 IT Istruzioni per l uso 21 DA Brugsanvisning 25 SV Bruksanvisning 29 EL 33 FI K ytt ohjeet 37 NL Gebruiksaanwijzing 41 PT Instru es de Utiliza...

Страница 3: ...ild Height 19 24 130 mm 4 1 8 25 27 125 mm 4 11 16 28 30 130 mm 4 1 8 10 mm 3 8 6mm 1 4 Build Height 19 24 120 mm 5 7 8 25 27 125 mm 4 11 16 28 30 130 mm 4 1 8 10 mm 3 8 6mm 1 4 1 2 1 7 8 6 4 6 5 3 2...

Страница 4: ...4 0 5 1 5 mm 0 5 1 5 mm 0 5 mm A B C 3Nm A B C D A B C 5 C A B 6 7...

Страница 5: ...if a change in its operation is observed In such cases the user should consult the clinical specialist caution U S federal law requires this device to be sold by a prosthetist and by the order of a ph...

Страница 6: ...alve kit 3 Use the supplied tube fixture to secure the tube against the pylon The tube should be located medially rather than laterally to avoid damage during ambulation Once the Unity System has been...

Страница 7: ...angling during gait Located laterally as there is more likelihood of damage IN CASE THE UNITY SYSTEM IS NOT FUNCTIONING PROPERLY Check the following Is there a leakage in the socket Is the tube punctu...

Страница 8: ...lymer Gel liners Usage without liners or other means which can lead to sweat or other fluids than Iceross Lubricant entering the system Exposure to environment with extreme airborne particle contamina...

Страница 9: ...nd verstehen Der Schlauch muss jederzeit gut gesch tzt sein Verwenden Sie dieses Produkt auf keinen Fall wenn Sie nderungen seiner Funktionsweise feststellen Wenden Sie sich in einem solchen Fall an I...

Страница 10: ...der ausschlie lichen Verantwortung des Orthop dietechnikers 1 Legen Sie die Prothese die das System enth lt am Anwender an 2 Schneiden Sie den Schlauch auf die richtige L nge und verbinden Sie ihn am...

Страница 11: ...R SCHLAUCH Der Schlauch ist das empfindlichste Teil des Unity Systems und sollte daher mit besonderer Vorsicht behandelt werden um eventuelle Funktionsst rungen zu vermeiden WARNHINWEIS Achten Sie dar...

Страница 12: ...r das Unity System wird eine 24 monatige eingeschr nkte Garantie mit Ausnahme der Membran gew hrt F r die Membran wird eine 12 monatige eingeschr nkte Garantie gew hrt Die folgenden Aktivit ten f hre...

Страница 13: ...e des pr cautions de s curit suivantes Le tube doit tout moment tre correctement fix Ne jamais utiliser ce produit si vous constatez un changement dans son fonctionnement Si tel est le cas l utilisate...

Страница 14: ...remarque Pour connecter le syst me une embo ture nous conseillons un Kit de valve d embo ture Unity seul le professionnel de sant est responsable de l utilisation d applications diff rentes 1 Posez le...

Страница 15: ...yst me Unity avec le manchon Iceross Seal In attention Assurez vous que la chaussette Flex Foot n interf re pas avec le syst me Unity car cela compromettrait le fonctionnement de la pompe LE TUBE Le t...

Страница 16: ...num ros de pi ces correspondants GARANTIE Le syst me Unity comporte une garantie limit e de 24 mois l exception de la membrane La membrane comporte une garantie limit e de 12 mois Les activit s suivan...

Страница 17: ...se de que sus clientes conocen y entienden lo siguiente El tubo debe estar bien asegurado en todo momento Nunca utilice este producto si se observa un cambio en su funcionamiento En estos casos el usu...

Страница 18: ...ma a un encaje se recomienda hacer uso de un kit de v lvula de encaje UnityTM el empleo de otros componentes es responsabilidad exclusiva del proveedor 1 Coloque al usuario el pie que contiene el sist...

Страница 19: ...ot no interfiera con el sistema Unity en caso contrario podr a comprometer la funci n de la bomba EL TUBO El tubo es la parte m s delicada del Unity y debe prest rsele especial atenci n si surge alg n...

Страница 20: ...tema Unity tiene una garant a limitada de 24 meses con excepci n de la membrana La membrana tiene una garant a limitada de 12 meses Las siguientes actividades anular n la garant a Exposici n al agua d...

Страница 21: ...i clienti siano consapevoli e comprendano quanto segue Il tubo deve essere sempre fissato bene Non utilizzare mai questo prodotto se si osserva un cambiamento nel suo funzionamento In questi casi l ut...

Страница 22: ...ta per collegare il sistema a un invasatura consigliato un kit valvola dell invasatura UnityTM l utilizzo di altre applicazioni responsabilit esclusiva del fornitore 1 Adattare l utente al piede che c...

Страница 23: ...di utilizzare il sistema Unity System con la cuffia Iceross Seal In attenzione Assicurarsi che la calza Flex Foot non interferisca con il sistema Unity poich potrebbe compromettere il funzionamento de...

Страница 24: ...isponibili e i codici appropriati GARANZIA Il sistema Unity presenta una garanzia limitata di 24 mesi fatta esclusione per la membrana La garanzia limitata della membrana di 12 mesi Le seguenti attivi...

Страница 25: ...observeres en ndring i funktionaliteten I s danne tilf lde skal brugeren konsultere den kliniske specialist advarsel U S Forbundsloven kr ver at denne enhed skal k bes hos en ortop disk bandagist p en...

Страница 26: ...passende l ngde og forbind den til Unity System og hylsteret ved brug af Unity Socket Valve Kit 3 Brug det medf lgende beslag til at fastg re slangen sikkert til pylonen Slangen skal anbringes medial...

Страница 27: ...ske finish S rg for at slangen IKKE er Foldet Figur 3 Trykket op mod skarpe genstande Punkteret H nger og dingler under gang Placeret lateralt da risikoen for skader bliver st rre I TILF LDE AF AT UNI...

Страница 28: ...e for havvand eller ekstremt t rende omgivelser Brug sammen med Copolymer Gel liners Brug uden linere eller andre indretninger som kan bevirke at sved og andre v sker end Iceross Lubricant ender i sys...

Страница 29: ...r ndring i dess funktion I s dana fall b r anv ndaren r dfr ga sin kliniska specialist varning Enligt federal lagstiftning i USA r f rs ljning av denna enhet begr nsad till ortopedingenj rer och p upp...

Страница 30: ...ystemet och hylsan med hj lp av Unity hylsventilsats 3 Anv nd den medf ljande slangh llaren f r att f sta slangen mot pylonen Slangen ska hellre placeras medialt n lateralt f r att undvika skada under...

Страница 31: ...ersom det d r st rre sannolikhet f r skada OM UNITY SYSTEMET INTE FUNGERAR SOM AVSETT Kontrollera f ljande L cker hylsan r slangen punkterad r membranet punkterat eller slitet Har membranet dragits ut...

Страница 32: ...ylsa eller p andra s tt som kan leda till att svett eller andra v tskor n Iceross sm rjmedel kommer in i systemet Exponering f r extremt dammig milj Felanv ndning och skada som orsakas av onormal p ve...

Страница 33: ...33 UNITY 1 1 2 3 4 5 6 7 8 Flex Foot Assure Balance Foot J IFU Flex Foot Assure Balance Foot J Unity Unity 3 U S Unity UNITY Unity 15 18 inHg Unity Unity...

Страница 34: ...34 Unity Flex Foot Assure Balance Foot J Flex Foot Assure Balance Foot J Unity Iceross Seal In Unity 104g IFU Flex Foot Assure Balance Foot J UNITY UnityTM 1 2 Unity Unity 3 Unity UNITY Unity Unity 4...

Страница 35: ...35 Unity UNITY 1 Flex foot 2 Unity 3 Flex Foot Assure Balance Foot J 4 5 5 Iceross Clean Simple UNITY 6 4 Unity Unity ssur Unity Iceross Seal In Flex Foot Unity 3 UNITY Unity Unity...

Страница 36: ...36 Unity Unity 6 Iceross Clean Simple ssur online www ossur com Unity 24 12 Copolymer Gel Iceross...

Страница 37: ...aina hyvin kiinnitetty l koskaan k yt t t tuotetta jos havaitset muutoksia sen toiminnassa K ytt j n tulisi t ll in ottaa yhteytt kliiniseen asiantuntijaan huomio U S Yhdysvaltain lain mukaan t t tuot...

Страница 38: ...n sis lt v jalkater 2 Leikkaa letku sopivan pituiseksi ja kytke se Unity j rjestelm n ja holkkiin Unity holkkiventtiilisarjan avulla 3 K yt laitteen mukana toimitettua letkunkiinnitint kiinnitt m n l...

Страница 39: ...ettei kosmeettinen viimeistely aiheuta Unity letkun puristumista tai taittumista Varmista ett letku EI ole taittunut Kuva 3 ole pusertunut ter vi esineit vasten ole puhjennut roiku k velt ess sijaits...

Страница 40: ...un mit t intiin altistuminen merivedelle tai voimakkaasti sy vytt v lle ymp rist lle k ytt kopolymeerigeelituppien kanssa k ytt ilman tuppea tai muulla sellaisella tavalla joka saattaa johtaa hien tai...

Страница 41: ...de hoogte zijn en deze begrijpen De buis moet te allen tijde goed bevestigd zijn Gebruik dit product niet als er een verandering in de werking ervan wordt waargenomen In dergelijke gevallen moet de g...

Страница 42: ...ere toepassingen is volledig op verantwoordelijkheid van de aanbieder 1 Pas de voet met het systeem op de gebruiker aan 2 Snij de slang op de geschikte lengte en sluit deze op het Unity System en de k...

Страница 43: ...pomp kan hinderen DE SLANG De slang is het meest gevoelige deel van de Unity systeem en er moet speciaal aandacht aan worden besteed om potenti le functioneringsproblemen te voorkomen LET OP Zorg ervo...

Страница 44: ...van 24 maanden met uitzondering van het membraan Het membraan heeft een beperkte garantie van 12 maanden De volgende activiteiten zullen ertoe leiden dat de garantie vervalt Blootstelling aan zeewater...

Страница 45: ...o dever assegurar se de que os seus clientes est o cientes e compreendem o seguinte O tubo deve estar sempre bem seguro Nunca utilize este produto se se verificar alguma altera o no seu funcionamento...

Страница 46: ...za o do Flex Foot Assure Balance Foot J AJUSTAR O SISTEMA UNITY nota Para conectar o sistema a um encaixe recomendamos a utiliza o de um Kit de V lvula de Engate para o Sistema Unity a utiliza o de ou...

Страница 47: ...mento Iceross Seal In aten o Assegure se de que a meia Flex Foot n o interfere com o Sistema Unity dado que pode comprometer o funcionamento da bomba O TUBO O tubo a parte mais sens vel do Sistema Uni...

Страница 48: ...em uma garantia limitada de 24 meses excluindo a membrana A membrana tem uma garantia limitada de 12 meses As seguintes actividades invalidar o a garantia Exposi o a gua salgada ou ambientes extremame...

Страница 49: ...kliniczny powinien dopilnowa aby pacjent mia wiadomo nast puj cych kwestii i je rozumia Przew d cz cy musi by zawsze odpowiednio zabezpieczony Nie wolno u ywa wyrobu w przypadku zaobserwowania zmiany...

Страница 50: ...DANIE SYSTEMU UNITY uwaga Do pod czenia systemu do leja protezowego zaleca si zastosowanie zestawu zaworowego UnitySocket Valve Kit inne rozwi zania na wy czn odpowiedzialno dostawcy 1 Za o y u ytkown...

Страница 51: ...s Seal In ostrze enie Nale y upewni si e po czocha Flex Foot nie zak ca dzia ania systemu Unity gdy mog oby to skutkowa niew a ciw prac pompy PRZEW D CZ CY Przew d cz cy jest najbardziej wra liwym ele...

Страница 52: ...esi czn ograniczon gwarancj z wy czeniem membrany Dla membrany okres gwarancji wynosi 12 miesi cy Nast puj ce dzia ania spowoduj uniewa nienie gwarancji Wystawienie wyrobu na dzia anie wody morskiej l...

Страница 53: ...ot J Flex Foot Assure Balance Foot J IFU Unity System Unity Socket Valve Kit 3 U S Unity System UNITY SYSTEM Unity System 15 18inHg Unity System Unity System Unity for Flex Foot Assure Balance Foot J...

Страница 54: ...NITY SYSTEM UnityTM Socket Valve Kit 1 2 Unity System Unity Socket Valve Kit 3 Unity System UNITY SYSTEM Unity System Unity System 4 Unity System Unity 1 Flex Foot 2 Unity 3 Flex Foot Assure Balance F...

Страница 55: ...55 4 Unity Socket Unity ssur Unity System Iceross Seal In Flex Foot Unity System 3 UNITY SYSTEM Unity Socket Unity Unity Socket Unity System 6 Iceross Clean Simple ssur...

Страница 56: ...56 www ossur com Unity System 24 12 Iceross...

Страница 57: ...4 5 6 7 8 Flex Foot Assure Balance Foot J Flex Foot Assure Balance Foot J IFU Unity Unity 3 U S Unity UNITY Unity Unity 15 18 Unity Unity Flex Foot Assure Balance Foot J Flex Foot Assure Balance Foot...

Страница 58: ...58 Unity 104g Flex Foot Assure Balance Foot J UNITY UnityTM 1 2 Unity UnityTM 3 Unity UNITY Unity Unity 4 Unity UNITY 1 Flex foot 2 Unity 3 Flex Foot Assure Balance Foot J 4 5 5 UNITY 6 4...

Страница 59: ...59 Unity Unity ssur Unity Iceross Seal In Flex Foot Unity Unity Unity 3 UNITY Unity Unity Unity Unity 6 ssur www ossur com Unity 24 12...

Страница 60: ...60 Copolymer Gel Iceross...

Страница 61: ...3 4 5 6 7 8 Flex Foot Assure Balance Foot J See IFU for Flex Foot Assure Balance Foot J IFU Unity Unity 3 Unity UNITY Unity Unity 15 18 inHg Unity Unity Flex Foot Assure Balance Foot J Unity Unity Ic...

Страница 62: ...62 Unity 104g Flex Foot Assure Balance Foot J IFU UNITY UnityTM 1 2 Unity Unity 3 Unity UNITY Unity Unity 4 Unity UNITY 1 Flex foot 9 2 Unity 3 Flex Foot Assure Balance Foot J...

Страница 63: ...63 4 5 5 Iceross Clean Simple UNITY 6 4 Unity Unity ssur Unity Iceross Seal In Flex Foot Unity Unity Unity 3 UNITY Unity Unity Unity...

Страница 64: ...64 Unity 6 IcerossClean Simple ssur www ossur com Unity 24 12 Iceross...

Страница 65: ...tturale della protesi mostri segni di usura anche meccanica informare l utente di sospendere immediatamente l uso della protesi e di consultare il proprio tecnico ortopedico Avvertenze Questo prodotto...

Страница 66: ...bie strukturalnej cz ci protezy pacjent powinien zosta pouczony aby natychmiast zaprzesta korzystania z zaopatrzenia i skontaktowa si ze specjalist prowadz cym Ten produkt zosta zaprojektowany i prze...

Страница 67: ...rs italy ossur com The Netherlands Tel 800 3539 3668 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 Aug...

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