Orthofix FORZA PTC Spacer System Скачать руководство пользователя страница 4

4

AW-38-9901 Rev.AE

FO-2001 © Orthofix, Inc.  2/2020

Product Complaints: 

Any Health Care Professional (e.g., customer or user of this system of products) who has any 

complaints or who has experienced any dissatisfaction with the product quality, identity, 

durability, reliability, safety, effectiveness and/or performance, should notify Orthofix Inc., 3451 

Plano Parkway, Lewisville, TX 75056, USA, by telephone at 1-214-937-3199 or 1-888-298-5700 

or by e-mail at [email protected]

Further Information: 

A recommended operative technique for the use of this system is available upon request from 

Orthofix at the phone numbers provided above.

Latex Information:

The implants, instruments and/or packaging material for the FORZA PTC Spacer System are not 

formulated with and do not contain natural rubber. The term “natural rubber” includes natural 

rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural 

rubber in its formulation.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Serial Number

Authorized 

Representative

CAPA Symbols  Chart revised2 - FORZA PTC - EN

See Instructions for Use

 

Lot Number

Manufacturer

Federal (U.S.A.) law restricts this device to sale 

by or on the order of a physician

Single Use Only

Do Not Reuse

 

Catalogue Number

 

Use By Date

Sterilized Using

Irradiation

Do Not Resterilize

 

Provided Non-Sterile

Orthofix.com/IFU

Содержание FORZA PTC Spacer System

Страница 1: ...ctory below for desired language Orthofix Inc 3451 Plano Parkway Lewisville Texas 75056 9453 U S A 1 214 937 3199 1 888 298 5700 www orthofix com Medical Device Safety Service MDSS Schiffgraben 41 301...

Страница 2: ...plant is extremely important The potential for success is increased by the selection of the proper size shape and design of the implant No implant can be expected to withstand the unsupported stresses...

Страница 3: ...200 F f 1 minute purified water rinse 64 66 C 146 150 F g 7 to 30 minute hot air dry 116 C 240 F 6 Inspect the instruments for visible soil 7 If visible soil is noted repeat the above listed steps un...

Страница 4: ...phone numbers provided above Latex Information The implants instruments and or packaging material for the FORZA PTC Spacer System are not formulated with and do not contain natural rubber The term na...

Страница 5: ...tencias y precauciones El cirujano debe ser consciente de lo siguiente al utilizar implantes 1 La selecci n correcta del implante es sumamente importante La probabilidad de xito aumenta con la selecci...

Страница 6: ...de dif cil acceso y de las superficies estrechamente emparejadas 2 Saque los instrumentos de la soluci n de limpieza y enju guelos en agua purificada durante un m nimo de 1 minuto Purgue minuciosa y...

Страница 7: ...bi n protegen los componentes del sistema durante el transporte Tambi n se suministran instrumentos individuales en bolsas de polietileno selladas con etiquetas de producto individuales Quejas sobre e...

Страница 8: ...r Motorfunktion Impotenz andauernde Schmerzen und oder Deformit ten In seltenen F llen k nnen manche Komplikationen t dlich verlaufen Warn und Vorsichtshinweise Bei der Verwendung von Implantaten muss...

Страница 9: ...ehmen und mindestens 3 Minuten lang mit Leitungswasser absp len Lumina L cher und sonstige schwer zug ngliche Bereiche gr ndlich und intensiv durchsp len 3 Die angesetzte Reinigungsl sung in einen Ult...

Страница 10: ...Comprehensive guide to steam sterilization and sterility assurance in health care facilities Ausf hrliche Richtlinien zur Dampfsterilisation und Sterilit tssicherung in Gesundheitseinrichtungen durchg...

Страница 11: ...ne reprise chirurgicale l sions des vaisseaux sanguins de la moelle pini re ou des nerfs p riph riques embolie pulmonaire perte de la fonction sensorielle et ou motrice impuissance douleur permanente...

Страница 12: ...e pendant au moins 3 minutes ou jusqu ce qu il n y ait plus aucune trace de sang ou de souillures sur le dispositif ou dans l eau de rin age Rincer soigneusement et agressivement les lumi res trous e...

Страница 13: ...ar rayonnement gamma Ne pas rest riliser L emballage de chaque composant doit tre intact la r ception En cas d utilisation d un syst me de consignation tous les kits doivent tre soigneusement contr l...

Страница 14: ...alcune complicanze possono essere fatali Avvertenze e precauzioni Nell uso degli impianti il chirurgo deve essere consapevole dei fattori elencati di seguito 1 La scelta corretta dell impianto estrema...

Страница 15: ...ota sporco residuo ripetere le operazioni elencate in precedenza Pulizia automatizzata 1 Immergere completamente gli strumenti in un detergente enzimatico lasciare in ammollo per 10 minuti e sonicare...

Страница 16: ...ll uso per accertarsi che non siano danneggiati Non usare le confezioni o i prodotti danneggiati ma restituirli a Orthofix Gli strumenti del sistema di spaziatori FORZA vengono forniti in cassette mod...

Страница 17: ...fun o sensorial e ou motora impot ncia dor permanente e ou deforma o Em casos raros algumas complica es podem ser fatais Avisos e precau es O cirurgi o deve estar ciente do seguinte ao utilizar implan...

Страница 18: ...cuidadosamente o dispositivo com uma escova de nylon de cerdas macias at toda a sujidade vis vel ser removida Tenha especial aten o a fendas a l menes a superf cies de encaixe a conectores e a outras...

Страница 19: ...espa ador FORZA s o fornecidos em embalagens modulares que foram especificamente concebidas para acomodar e organizar os componentes do sistema Os instrumentos do sistema s o organizados em tabuleiro...

Отзывы: