Table of Contents
Advertisement
Available languages
Available languages
Quick Links
Orthofix Inc.
3451 Plano Parkway
Lewisville, Texas 75056-9453 U.S.A.
1-214-937-3199
1-888-298-5700
www.orthofix.com
AW-38-9901 Rev.AE
FO-2001 © Orthofix, Inc. 2/2020
INSTRUCTIONS FOR USE
Important Information – Please Read Prior to Use
Device System Name:
FORZA
PTC Spacer System
®
Click directory below for desired language
English
EN
Español
ES
Deutsch
DE
Français
FR
Italiano
IT
Português
PT
Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia
1
Medical Device Safety Service
(MDSS)
Schiffgraben 41
30175 Hannover
Germany
+49 511 6262 8630
www.mdss.com
2-4
5-7
8-10
11-13
14-16
17-19
Advertisement
Table of Contents
Related Manuals for Orthofix FORZA PTC Spacer System
Summary of Contents for Orthofix FORZA PTC Spacer System
- Page 1 Sydney, NSW 2000 www.orthofix.com +49 511 6262 8630 Australia www.mdss.com Device System Name: FORZA PTC Spacer System ® Click directory below for desired language English Español Deutsch 8-10 Français 11-13 Italiano 14-16 17-19 Português AW-38-9901 Rev.AE FO-2001 © Orthofix, Inc. 2/2020...
- Page 2 4. DO NOT re-sterilize these implants as this could result in injury or require reoperation due The FORZA PTC Spacer System is not intended to be used as a standalone device. The FORZA PTC to breakage or infection.
- Page 3 System implants and are supplied NON-STERILE. Prior to use, all instruments should be placed Use of recommended temperatures is important for optimal performance of enzymatic in the appropriate Orthofix case which will be wrapped in a FDA cleared sterilization wrap and detergent.
-
Page 4: Product Complaints
Latex Information: Product Complaints: The implants, instruments and/or packaging material for the FORZA PTC Spacer System are not Any Health Care Professional (e.g., customer or user of this system of products) who has any formulated with and do not contain natural rubber. The term “natural rubber” includes natural... -
Page 5: Instrucciones De Uso
INSTRUCCIONES DE USO Información importante: leer antes de usar Australian Sponsor Orthofix Inc. Medical Device Safety Service Emergo Australia 3451 Plano Parkway (MDSS) Level 20, Tower II Lewisville, Texas 75056-9453 U.S.A. Schiffgraben 41 Darling Park 1-214-937-3199 30175 Hannover 201 Sussex Street... - Page 6 No reutilice los instrumentos de un solo uso. Examine visualmente los instrumentos reutilizables deberán colocarse en la posición abierta para permitir que el líquido de limpieza llegue a para determinar si han alcanzado el final de su vida útil. Los instrumentos reutilizables Orthofix las zonas difíciles de limpiar.
-
Page 7: Otra Información
Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Guía notificarlo a Orthofix Inc., 3451 Plano Parkway, Lewisville, TX 75056, EE. UU.; por teléfono: completa para la esterilización por vapor y garantía de esterilidad en instituciones sanitarias). Se +1-214-937-3199 o +1-888-298-5700;... - Page 8 GEBRAUCHSANLEITUNG Wichtige Informationen – Vor Gebrauch bitte lesen Australian Sponsor Orthofix Inc. Medical Device Safety Service Emergo Australia 3451 Plano Parkway (MDSS) Level 20, Tower II Lewisville, Texas 75056-9453 U.S.A. Schiffgraben 41 Darling Park 1-214-937-3199 30175 Hannover 201 Sussex Street...
- Page 9 Sprüngen, Lochfraß oder Schrammen aufweisen oder die auf andere Weise beschädigt c. Weiterhin am Kolben ziehen und im Uhrzeigersinn am Griff drehen, bis er sich vom sind, müssen entsorgt oder an Orthofix zurückgeschickt werden. Keine defekten Instrumente Instrumentenkörper löst. Den universellen Implantateinführinstrument-Griff beiseite verwenden.
-
Page 10: Weitere Informationen
Wirksamkeit und/oder Leistung des Produkts nicht zufrieden sind, sollten sich an die folgende Trocknungsdauer: 30 Minuten Expositionszeit: 4 Minuten Adresse wenden: Orthofix Inc., 3451 Plano Parkway, Lewisville, TX 75056, USA, Telefon: Doppelt eingepackt Trocknungsdauer: 30 Minuten +1-214-937-3199 oder +1-888-298-5700, E-Mail: complaints@orthofix.com. - Page 11 MODE D’EMPLOI Informations importantes – Prière de lire avant l’emploi Australian Sponsor Orthofix Inc. Medical Device Safety Service Emergo Australia 3451 Plano Parkway (MDSS) Level 20, Tower II Lewisville, Texas 75056-9453 U.S.A. Schiffgraben 41 Darling Park 1-214-937-3199 30175 Hannover 201 Sussex Street...
-
Page 12: Nettoyage Automatique
éliminées. en fin de vie conformément à la procédure de l’hôpital ou les renvoyer à Orthofix pour Veiller en particulier aux creux, lumières, surfaces qui s’emboîtent, connecteurs et autres élimination. - Page 13 FORZA PTC et sont fournis NON STÉRILES. Avant l’utilisation, placer tous les rayonnement gamma. Ne pas restériliser. instruments dans le boîtier Orthofix approprié, qui sera emballé dans un champ de stérilisation autorisé par la FDA et placé dans l’autoclave de stérilisation par le personnel hospitalier en L’emballage de chaque composant doit être intact à...
-
Page 14: Istruzioni Per L'uso
ISTRUZIONI PER L’USO Informazioni importanti – Leggere prima dell’uso Australian Sponsor Orthofix Inc. Medical Device Safety Service Emergo Australia 3451 Plano Parkway (MDSS) Level 20, Tower II Lewisville, Texas 75056-9453 U.S.A. Schiffgraben 41 Darling Park 1-214-937-3199 30175 Hannover 201 Sussex Street... - Page 15 Usare uno per determinare se hanno raggiunto il termine della loro durata utile. Gli strumenti Orthofix spazzolino con setole in plastica morbide o uno scovolino per rimuovere lo sporco da tutti riutilizzabili hanno raggiunto il termine della loro durata utile quando si verificano le condizioni i lumi interni.
-
Page 16: Ulteriori Informazioni
Selezionare il contenitore di sterilizzazione rigido appropriato (con base filtrata o base solida) per Reclami relativi al prodotto la cassetta Orthofix (si consiglia un contenitore di dimensioni 59,1 cm x 28,6 cm). In base alle Il personale sanitario (es. un cliente o utilizzatore di questo sistema di prodotti) che intenda dimensioni del contenitore di sterilizzazione rigido, prima di inserire la cassetta per discectomia presentare un reclamo o che non sia soddisfatto della qualità, identità, durabilità, affidabilità,... -
Page 17: Instruções De Utilização
INSTRUÇÕES DE UTILIZAÇÃO Informação importante — Leia antes de utilizar Australian Sponsor Orthofix Inc. Medical Device Safety Service Emergo Australia 3451 Plano Parkway (MDSS) Level 20, Tower II Lewisville, Texas 75056-9453 U.S.A. Schiffgraben 41 Darling Park 1-214-937-3199 30175 Hannover 201 Sussex Street... - Page 18 áreas de vida útil de acordo com o seu procedimento hospitalar ou devolva à Orthofix para a difíceis de limpar. Os lúmenes devem ser limpos com uma escova de cerdas macias longa sua eliminação.
- Page 19 Tempo de secagem: 30 minutos Orthofix Inc., 3451 Plano Parkway, Lewisville, TX 75056, EUA, por telefone através do número +1-214-937-3199 ou +1-888-298-5700 ou via e-mail para complaints@orthofix.com.
Need help?
Do you have a question about the FORZA PTC Spacer System and is the answer not in the manual?
Questions and answers