Össur MIAMI TLSO 456 Скачать руководство пользователя страница 5 | Manualshive

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Össur MIAMI TLSO 456 Скачать руководство пользователя страница 5

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ENGLISH

Medical Device

PRODUCT DESCRIPTION

Miami TLSO 456 is a modular rigid thoraco-lumbo-sacral spine orthosis
designed to support and provide motion restriction to a patient's spine
during routine daily use.

The device is a non-invasive, adjustable brace for single patient use.
A pulley system is used to tighten the belt and belt panels to the patient.
Product Overview

(Fig. 1)

a.  Chest Buckle
b.  D-Ring
c.  Overlap Closure/Belt End
d.  Shoulder Straps
e.  PTE

f. Belt

g. Strap Anchor

INDICATIONS FOR USE

Indications that require gross thoracic and lumbar spine immobilization
in all three planes, in which the following conditions may be present:

•  Herniated disc
•  Degenerative spinal pathologies
•  Post-surgical stabilization
•  Stable, non-displaced spinal fractures
•  Spinal stenosis
•  Spondylolisthesis
•  Spondylolysis

CONTRAINDICATIONS

Unstable, displaced fractures.

GENERAL SAFETY INSTRUCTIONS / WARNINGS AND PRECAUTIONS
Warning:

In cases of functional change or functional loss, the patient

should stop using the device and contact a healthcare professional.

Warning:

If the device shows signs of damage or wear hindering its

normal functions, the patient should stop using the device and contact
a healthcare professional.

• Do not over tighten the compression system to the point where it

causes discomfort or difficulty breathing. For sitting, the patient may
find it desirable to slightly loosen the compression system. If brace
causes discomfort or irritation, contact your healthcare provider for
further instructions and discontinue.

• These are supportive braces only and are not intended or guaranteed

to prevent spinal injury. They should be applied by a licensed
healthcare practitioner and as directed by a physician or other
qualified medical.

• Do not machine wash or place in a tumble dryer.
• Össur accepts no responsibility for any injury which might occur while

using the orthosis.

• The braces are not designed to be worn while bathing.
• The device is a non-invasive, adjustable brace for single patient use.

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Содержание MIAMI TLSO 456

Страница 1: ...Instructions for Use MIAMI TLSO 456...

Страница 2: ...rucciones para el uso 14 IT Istruzioni per l uso 17 NO Bruksanvisning 20 DA Brugsanvisning 23 SV Bruksanvisning 26 EL 29 FI K ytt ohjeet 32 NL Gebruiksaanwijzing 35 PT Instru es de Utiliza o 38 PL Ins...

Страница 3: ...3 a b d e f g c 1 2 3 4 5 6 7...

Страница 4: ...4 8 9 10 11...

Страница 5: ...ECAUTIONS Warning In cases of functional change or functional loss the patient should stop using the device and contact a healthcare professional Warning If the device shows signs of damage or wear hi...

Страница 6: ...belt can be added to each belt arm to reach a maximum belt circumference of 70 178cm 7 Place belt ends into the Overlap Closures Fig 6 To obtain the lowest profile fit the belt arm ends can be trimme...

Страница 7: ...hly Air dry flat Do not machine wash or place in tumble dryer REPORT A SERIOUS INCIDENT Important notice to users and or patients established in Europe The user and or patient must report any serious...

Страница 8: ...ls ulenfrakturen Spinalkanalstenose Wirbelgleiten Spondylolyse KONTRAINDIKATIONEN Instabile dislozierte Frakturen ALLGEMEINE SICHERHEITSHINWEISE WARNUNGEN UND VORSICHTSMASSNAHMEN Warnung Bei Ver nderu...

Страница 9: ...iesen Schritt berspringen wenn die Orthese im Stehen angepasst wird 5 Den Lumbalgurt um die Taille wickeln und dabei durch das ssur Fitting Tool f hren Abb 3 Die L nge der beiden Gurtarme anpassen um...

Страница 10: ...lettstreifen neben dem Kompressionssystem gel st werden Abb 11 Achten Sie beim Beschneiden im posterioren Bereich darauf dass die Gurtenden erhalten bleiben und gem Abb 6gefaltet werden WARTUNG PRODUK...

Страница 11: ...h sis Spondylolyse CONTRE INDICATIONS Fractures instables et d plac es CONSIGNES DE S CURIT G N RALES AVERTISSEMENTS ET PR CAUTIONS Avertissement en cas de perte ou de changement fonctionnel le patien...

Страница 12: ...ermetures crois es retir es et le syst me de compression desserr Plier uniform ment chaque bras de ceinture pour obtenir le tour de taille souhait et fixer les extr mit s de la ceinture Fig 5 Suivre l...

Страница 13: ...comme indiqu sur la Fig 6 ENTRETIEN ET NETTOYAGE DU PRODUIT Miami TLSO requiert peu d entretien Les rev tements rembourr s peuvent tre retir s des panneaux rigides pour le lavage Laver la main avec u...

Страница 14: ...ebral Espondilolistesis Espondil lisis CONTRAINDICACIONES Fracturas desplazadas e inestables INSTRUCCIONES GENERALES DE SEGURIDAD ADVERTENCIAS Y PRECAUCIONES Advertencia En caso de cambios o deficienc...

Страница 15: ...Fig 4 6 Retire la herramienta de ajuste ssur de la faja NOTA Si no dispone de una herramienta de ajuste ssur coloque la faja plana con los cierres de solapa retirados y el sistema de compresi n afloj...

Страница 16: ...UIDADO Miami TLSO ha sido dise ado para un mantenimiento y cuidados m nimos Las fundas acolchadas se pueden separar de los paneles r gidos para lavarlas L velas a mano con jab n neutro y enju guelas b...

Страница 17: ...oste Stenosi spinale Spondilolistesi Spondilolisi CONTROINDICAZIONI Fratture instabili scomposte ISTRUZIONI GENERALI SULLA SICUREZZA AVVERTENZE E PRECAUZIONI Avvertenza in caso di alterazione o perdit...

Страница 18: ...alla misura desiderata Fig 4 6 Rimuovere l ssur Fit Tool dalla cintura NOTA se l ssur Fit Tool non disponibile stendere la cintura in piano con le chiusure a sovrapposizione rimosse e il sistema di co...

Страница 19: ...ne della cintura Fig 11 Se si rifila posteriormente assicurarsi che le estremit della cintura siano trattenute e piegate come nella Fig 6 MANUTENZIONE CURA DEL PRODOTTO PULIZIA E CURA Miami TLSO stato...

Страница 20: ...e frakturer med forskyvning GENERELLE SIKKERHETSINSTRUKSJONER ADVARSLER OG FORHOLDSREGLER Advarsel I tilfeller der det oppst r funksjonsendring eller funksjonstap m pasienten slutte bruke enheten og k...

Страница 21: ...rbelte f yes til hver belteende for en maksimal belteomkrets p 178cm 70 tommer 7 Plasser belteendene i overlappingslukkingene Figur 6 Endene av beltene kan trimmes for f lavest mulig passform hvis det...

Страница 22: ...luftt rke flatt Ikke vask i maskin ikke bruk t rketrommel RAPPORTERE ALVORLIGE HENDELSER Viktig merknad til brukere og eller pasienter bosatt i Europa Brukeren og eller pasienten m rapportere enhver...

Страница 23: ...se Spondylolyse KONTRAINDIKATIONER Ustabile forskudte frakturer GENERELLE SIKKERHEDSINSTRUKTIONER ADVARSLER OG FORHOLDSREGLER Advarsel I tilf lde af en funktions ndring eller et funktionstab skal brug...

Страница 24: ...r tilpasningsv rkt j til r dighed skal du l gge b ltet fladt ned med de overlappende lukninger fjernet og kompressionsmekanismen l snet Fold hver b ltearm lige meget for at opn det nskede taljem l og...

Страница 25: ...r ver et minimum af vedligeholdelse og pleje De polstrede overtr k kan fjernes fra de stive paneler med henblik p vask Skal vaskes i h nden med mild s be og skylles grundigt Luftt rres liggende fladt...

Страница 26: ...ERHETSINSTRUKTIONER VARNINGAR OCH F RSIKTIGHETS TG RDER Varning I h ndelse av f r ndrad eller utebliven funktion ska patienten sluta anv nda enheten och kontakta sjukv rdspersonal Varning Om produkten...

Страница 27: ...F lj steg 2 4 OBS Om patientens midjem tt r ver 127cm kan du f sta ett f rl ngningsb lte p varje b ltes nde f r att n en maximal b ltesomkrets p 178cm 7 Placera b ltes ndarna i skarvdelarna Bild 6 Obs...

Страница 28: ...ga Lufttorka i plant l ge F r inte tv ttas i maskin eller torkas i torktumlare RAPPORTERA ALLVARLIGA INCIDENTER Viktigt meddelande till anv ndare och eller patienter i Europa Anv ndaren och eller pati...

Страница 29: ...29 Miami TLSO 456 1 a b D c d e PTE f g...

Страница 30: ...30 ssur 1 2 3 2 4 5 ssur 3 4 6 ssur ssur 5 2 4 127cm 50 178cm 70 7 6 8 9 7 8 10 9 11 12 D 10 13...

Страница 31: ...31 14 1 2 3 4 350 F 175 C 11 6 Miami TLSO ssur...

Страница 32: ...RVAOHJEITA VAROITUKSIA JA VAROTOIMIA Varoitus jos laitteessa havaitaan toiminnallisia muutoksia tai toimintah iri it potilaan tulee lopettaa laitteen k ytt ja ottaa yhteytt terveydenhuollon ammattilai...

Страница 33: ...saisesti halutun vy t r n ymp rysmitan mukaan ja kiinnit vy n p t Kuva 5 Tee vaiheet 2 4 HUOMAA Jos potilaan vy t r nymp rys on yli 127cm 50 kumpaankin vy n siivekkeeseen voidaan lis t vy njatke jotta...

Страница 34: ...tetut suojukset voi irrottaa j ykist osista puhdistamista varten Pese k sin miedolla saippualla ja huuhtele perusteellisesti Anna kuivua vaakatasossa l pese koneessa l k rumpukuivaa ILMOITTAMINEN VAKA...

Страница 35: ...se Spondylolysthese Spondylolyse CONTRA INDICATIES Instabiele fracturen met verplaatsing ALGEMENE VEILIGHEIDSINSTRUCTIES WAARSCHUWINGEN EN VOORZORGSMAATREGELEN Waarschuwing bij functieverandering of f...

Страница 36: ...de lengte van de gordelarmen aan om het pashulpmiddel centraal te positioneren Zet de gordeluiteinden vast op de gewenste grootte Afb 4 6 Verwijder het ssur pashulpmiddel van de gordel OPMERKING als e...

Страница 37: ...den moet u ervoor zorgen dat de gordeluiteinden worden vastgehouden en gevouwen zoals weergegeven in afb 6 ONDERHOUD PRODUCTVERZORGING REINIGING EN VERZORGING De Miami TLSO is zodanig ontworpen dat mi...

Страница 38: ...veis INSTRU ES GERAIS DE SEGURAN A AVISOS E PRECAU ES Aviso Em caso de altera o ou perda funcional o paciente deve parar de utilizar o dispositivo e entrar em contacto com um profissional de sa de Av...

Страница 39: ...sobreposi o removidos e o sistema de compress o solto Dobrar cada bra o da correia de forma igual para alcan ar a circunfer ncia da cintura desejada e fixar as extremidades Fig 5 Siga os passos 2 4 NO...

Страница 40: ...LIMPEZA O suporte Miami TLSO foi desenvolvido para manuten o e cuidados m nimos As coberturas almofadadas podem ser separadas dos pain is r gidos para lavagem Lavar m o usando detergente suave e enxag...

Страница 41: ...k kr goszczelina PRZECIWWSKAZANIA Niestabilne z amania kr gos upa z przemieszczeniem OG LNE ZASADY BEZPIECZE STWA OSTRZE ENIA I RODKI OSTRO NO CI Ostrze enie w przypadku zmiany w dzia aniu wyrobu lub...

Страница 42: ...zpieczy ko ce pasa i uzyska wymagany wymiar Rys 4 6 Usun narz dzie ssur Fit Tool z pasa UWAGA je li narz dzie ssur Fit Tool nie jest dost pne umie ci pas p asko z usuni tymi zapi ciami zak adkowymi i...

Страница 43: ...o ci minimalnej konserwacji i piel gnacji Wy cie ane os ony mo na usun ze sztywnych paneli w celu ich umycia Pra r cznie stosuj c agodne myd o i dok adnie p uka Suszy p asko roz o one na powietrzu Nie...

Страница 44: ...N A OPAT EN Upozorn n V p pad zm ny nebo ztr ty funk nosti mus pacient p estat prost edek pou vat a kontaktovat zdravotnick ho pracovn ka Varov n Pokud prost edek vykazuje zn mky po kozen nebo opot e...

Страница 45: ...Pokud obvod pasu pacienta p esahuje 127cm 50 je mo n ke ka d mu ramenu p su p idat voliteln prodlou en p su a dos hnout tak maxim ln ho obvodu p su 178cm 70 7 Um st te konce p su do p ekr vaj c ch se...

Страница 46: ...te na vzduchu v rovn ploch poloze Neperte v pra ce ani nesu te v su i ce HL EN Z VA N CH NE DOUC CH P HOD D le it upozorn n pro u ivatele a nebo pacienty se s dlem v Evrop U ivatel a nebo pacient mus...

Страница 47: ...L MATLARI UYARILAR VE NLEMLER Uyar lev de i ikli i veya kayb durumunda hasta r n kullanmay b rakmal ve bir sa l k uzman ile g r melidir Uyar r nde normal i levlerini engelleyen hasar veya y pranma bel...

Страница 48: ...78cm maksimum kemer evresi uzunlu u elde etmek i in herhangi bir kemer koluna uzatma kemeri eklenebilir 7 Kemer u lar n Kemer ucu Ceplerine ekil 6 yerle tirin Not Daha sonra ayarlama yap lmas gerekli...

Страница 49: ...urulay n A k havada d z bir ekilde kurutun Makinede y kamay n veya d ner bir kurutucuya atmay n C DD B R OLUMSUZ OLAYIN B LD R LMES Avrupa da bulunan kullan c ve veya hastalara y nelik nemli bildirim...

Страница 50: ...50 Miami TLSO 456 1 a b c d e f g...

Страница 51: ...51 ssur 1 2 3 2 4 5 ssur 3 4 6 ssur ssur 5 2 4 127 50 178 70 7 6 8 9 7 8 10 9...

Страница 52: ...52 11 12 10 13 14 1 2 3 4 175 C 350 F 11 6 Miami TLSO ssur...

Страница 53: ...53 Miami TLSO 456 1 1 a b D c d e PTE f g 3 ssur 1...

Страница 54: ...54 1 2 3 2 4 5 ssur 2 3 4 6 ssur ssur 5 2 4 127cm 178cm 7 6 8 9 2 7 8 10 9 11 12 D 10 13 14 1 2 3 4...

Страница 55: ...55 175 C 11 6 Miami TLSO ssur...

Страница 56: ...56 Miami TLSO 456 1 a b D c d e PTE f g ssur...

Страница 57: ...57 1 2 3 2 4 5 ssur 3 4 6 ssur ssur 5 2 4 50 127cm 70 178cm 7 6 8 9 7 8 10 9 11 12 D 10 13 14 1 2 3 4 350 F 175 C 11 6...

Страница 58: ...58 Miami TLSO ssur...

Страница 59: ...59 Miami TLSO 456 1 1 a b D c d e PTE f g 3 ssur...

Страница 60: ...60 1 1 2 3 2 4 5 ssur 3 4 6 ssur ssur 5 2 4 127cm 50 178cm 70 7 6 8 9 7 8 10 9 11 12 D 10 13 14 1 2 3...

Страница 61: ...61 4 350 F 175 C 11 6 Miami LSO ssur...

Страница 62: ...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 Augustinusstrasse 11A asia ossur com 50226 Frechen Deut...

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