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BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: N50 648 rev006
Designer: SC
Colour Reference:
THERANOVA
INSTRUCTIONS FOR USE
GEBRAUCHSANWEISUNG
NOTICE D'UTILISATION
ISTRUZIONI PER L'USO
INSTRUCCIONES DE USO
BRUKSANVISNING
BRUKSANVISNING
BRUGSANVISNING
KÄYTTÖOHJEET
INSTRUÇÕES DE UTILIZAÇÃO
GEBRUIKSAANWIJZING
KULLANMA TALİMATLARI
POKYNY K POUŽITÍ
ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ
Gambro Dialysatoren GmbH
Holger-Crafoord-Strasse 26
72379 Hechingen, Germany
N50 648 rev 006
Date of issue: 2020-01-15
Black
400
500
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Date: 18MAR20
Proofread No.: P02
Page: 1 of 24
Material Specification: 1129061
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Resumen de contenidos para baxter THERANOVA 400
- Página 1 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 1 of 24 Black Colour Reference: Material Specification: 1129061 THERANOVA INSTRUCTIONS FOR USE ..........GEBRAUCHSANWEISUNG ..........NOTICE D‘UTILISATION ............ISTRUZIONI PER L‘USO .............
- Página 2 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 2 of 24 Black Colour Reference: Material Specification: 1129061...
- Página 3 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 3 of 24 Black Colour Reference: Material Specification: 1129061 Symbols are referenced from ISO 15223-1 Medical Devices: Symbols to be used Die Symbole stammen aus der Richtlinie ISO 15223-1 Medizinprodukte –...
- Página 4 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 4 of 24 Black Colour Reference: Material Specification: 1129061 Symboler er hentet fra ISO 15223-1 Medisinsk utstyr – Symboler for medisinsk...
- Página 5 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 5 of 24 Black Colour Reference: Material Specification: 1129061 Symboly jsou odkazované z normy ISO 15223-1: 2016 o zdravotnických Τα σύμβολα προέρχονται από το πρότυπο ISO 15223-1 Ιατροτεχνολογικά προϊόντα...
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Página 6: General Information
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 6 of 24 Black Colour Reference: Material Specification: 1129061 General Information Indications for use Adverse events Warranty THERANOVA dialyzers are indicated for treatment of chronic and acute... -
Página 7: Allgemeine Informationen
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 7 of 24 Black Colour Reference: Material Specification: 1129061 Allgemeine Informationen Indikationen für den Gebrauch Unerwünschte Ereignisse Gewährleistung Das Auftreten bestimmter Nebenwirkungen ist im Zusammenhang mit Der Hersteller gewährleistet, dass der Kapillardialysator in Übereinstim-... -
Página 8: Informations Générales
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 8 of 24 Black Colour Reference: Material Specification: 1129061 Informations générales Indications d‘utilisation Effets indésirables Garantie Les facteurs opérationnels associés au traitement peuvent entraîner Les dialyseurs THERANOVA sont indiqués pour le traitement de l'insuffi-... -
Página 9: Informazioni Di Carattere Generale
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 9 of 24 Black Colour Reference: Material Specification: 1129061 Informazioni di carattere generale Indicazioni per l‘uso Eventi avversi Garanzia I dializzatori THERANOVA sono indicati per il trattamento mediante Alcuni tipi di reazioni avverse possono derivare da fattori operativi associati Il fabbricante garantisce che il dializzatore capillare è... -
Página 10: Información General
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 10 of 24 Black Colour Reference: Material Specification: 1129061 Información general Instrucciones de uso Garantía [1] Meyer et al., Hemodialysis-induced release of hemoglobin limits nitric oxide bioavailability and impairs vascular function, J Am Coll Cardiol. -
Página 11: Allmän Information
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 11 of 24 Black Colour Reference: Material Specification: 1129061 Allmän information Användning Garanti hemoglobin i dialysvätskebanan. Detta medför en rödaktig färgning av ultrafiltratet vilket kan utlösa den interna blodläckagedetektorn. -
Página 12: Generell Informasjon
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 12 of 24 Black Colour Reference: Material Specification: 1129061 Generell informasjon Indikasjoner Bivirkninger Garanti THERANOVA-dialysefiltre er indisert for behandling av kronisk og akutt Noen typer bivirkninger kan skyldes behandlingsrelaterte faktorer. -
Página 13: Generelle Oplysninger
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 13 of 24 Black Colour Reference: Material Specification: 1129061 Generelle oplysninger Indikationer for brug Bivirkninger Garanti THERANOVA-dialysatorer er beregnet til behandling af kronisk og akut... -
Página 14: Yleiset Tiedot
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 14 of 24 Black Colour Reference: Material Specification: 1129061 Yleiset tiedot Käyttöaiheet Haittatapahtumat Takuu THERANOVA-dialysaattorit on tarkoitettu kroonisen ja akuutin munuaisten Tietyntyyppisiä, itse dialyysihoitoon liittyviä... -
Página 15: Informações Gerais
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 15 of 24 Black Colour Reference: Material Specification: 1129061 Informações gerais Indicações de utilização Reações adversas Garantia Os dialisadores THERANOVA são indicados para o tratamento da Determinados tipos de reações adversas podem ocorrer devido a fatores... -
Página 16: Algemene Informatie
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 16 of 24 Black Colour Reference: Material Specification: 1129061 Algemene informatie Gebruiksindicaties Garantie [1] Meyer et al., Hemodialysis-induced release of hemoglobin limits nitric oxide bioavailability and impairs vascular function, J Am Coll Cardiol. -
Página 17: Genel Bilgi
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 17 of 24 Black Colour Reference: Material Specification: 1129061 Genel Bilgi Kullanım endikasyonları Advers olaylar Garanti THERANOVA diyalizörler, Hemodiyaliz ile kronik ve akut böbrek Tedaviyle ilişkili operasyonel faktörlerden dolayı... -
Página 18: Všeobecné Informace
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 18 of 24 Black Colour Reference: Material Specification: 1129061 Všeobecné informace Indikace použití Nežádoucí účinky Záruka Dialyzátory THERANOVA jsou určeny k léčbě chronického a akutního Některé... -
Página 19: Γενικές Πληροφορίες
BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 19 of 24 Black Colour Reference: Material Specification: 1129061 Γενικές πληροφορίες Ενδείξεις χρήσης διαπερατότητας για μεγαλύτερες πρωτεΐνες πλάσματος, όπως η ελεύθερη... - Página 20 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 20 of 24 Black Colour Reference: Material Specification: 1129061 Translations Blood Flow rate: Q (ml/min) Blutflussrate: Q (ml/min) Débit sang: Q...
- Página 21 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 21 of 24 Black Colour Reference: Material Specification: 1129061 Translations Veren virtausnopeus: Q (ml/min) Taxa de débito do sangue: Q (ml/min)
- Página 22 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 22 of 24 Black Colour Reference: Material Specification: 1129061 Performances Specifications theranova 400 theranova 500 Blood Flow rate: Q (ml/min) 200 – 600 200 –...
- Página 23 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 23 of 24 Black Colour Reference: Material Specification: 1129061...
- Página 24 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev006 Date: 18MAR20 Proofread No.: P02 Designer: SC Page: 24 of 24 Black Colour Reference: Material Specification: 1129061 Baxter, Gambro and Theranova are trademarks of Baxter International Inc., or its subsidiaries.