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BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: N50 648 rev 007
Designer: DEP
Black
Colour Reference:
THERANOVA
INSTRUCTIONS FOR USE
NOTICE D'UTILISATION
BRUKSANVISNING
GEBRUIKSAANWIJZING
Gambro Dialysatoren GmbH
Holger-Crafoord-Strasse 26
72379 Hechingen, Germany
N50 648 rev 007
Date of issue: 2021-02-19
Date: 22-FEB-2021
Proofread No.: 01
Page: 1 of 24
Material Specification: HEC1129061
400
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Table des Matières
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Sommaire des Matières pour baxter THERANOVA 400

  • Page 1: Table Des Matières

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 1 of 24 Black Colour Reference: Material Specification: HEC1129061 THERANOVA INSTRUCTIONS FOR USE ..........GEBRAUCHSANWEISUNG ..........NOTICE D‘UTILISATION ............ISTRUZIONI PER L‘USO .............
  • Page 2 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 2 of 24 Black Colour Reference: Material Specification: HEC1129061...
  • Page 3: Gebrauchsanweisung

    BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 3 of 24 Black Colour Reference: Material Specifi cation: HEC1129061 Symbols are referenced from ISO 15223-1 Medical Devices: Symbols to be used Die Symbole stammen aus der Richtlinie ISO 15223-1 Medizinprodukte –...
  • Page 4 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 4 of 24 Black Colour Reference: Material Specifi cation: HEC1129061 Symboler er hentet fra ISO 15223-1 Medisinsk utstyr – Symboler for medisinsk...
  • Page 5 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 5 of 24 Black Colour Reference: Material Specifi cation: HEC1129061 Symboly jsou odkazované z normy ISO 15223-1: 2016 o zdravotnických Τα...
  • Page 6: General Information

    Nephrol Dial Transplant 2017; 32(1):165-72. [2] Weiner et al. pH-value of the dialysate, anticoagulation, blood and dialysate flow rates Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 as well as monitoring of the overall treatment parameters are essential to The remedy set out above for manufacturing defects is the sole remedy Dialyzer.
  • Page 7: Allgemeine Informationen

    Nephrol Dial Transplant 2017; 32(1):165-72. [2] Weiner et al. der Blut- und Dialysatflussraten sowie die vollständige Überwachung der Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Behandlungsparameter sind unerlässlich zur Vermeidung von möglichen Die Gewährleistung gilt anstelle und unter Ausschluss jeglicher anderer Dialyzer.
  • Page 8: Informations Générales

    Nephrol Dial Transplant 2017; 32(1):165-72. [2] Weiner et al. généraux afin d‘éviter des effets secondaires susceptibles d‘apparaître au Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 cours de l‘hémodialyse. La solution susmentionnée relative aux défauts de fabrication est l‘unique Dialyzer.
  • Page 9: Informazioni Di Carattere Generale

    La garanzia indicata sopra è da ritenersi in sostituzione e con l’esclusione cacy and Safety of Expanded Hemodialysis with the Theranova 400 bilancio degli elettroliti, della regolazione del pH del dialisato, dell‘uso di di qualsiasi altra garanzia, sia scritta che orale, espressa o implicita, legale Dialyzer.
  • Page 10: Información General

    Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 como la monitorización de los parámetros generales de tratamiento para Dialyzer. A Randomized Controlled Trial. Clin J Am Soc Nephrol 2020;15 La solución arriba mencionada para defectos de fabricación es la única...
  • Page 11: Allmän Information

    Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 flödeshastighet samt övervaka övergripande behandlingsparametrar, för av dialysatorn oavsett om det beror på fel i denna eller har annan orsak.
  • Page 12: Generell Informasjon

    Nephrol Dial Transplant 2017; 32(1):165–72. [2] Weiner et al. kostnader som oppstår direkte eller indirekte på grunn av bruken av Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 ADVARSEL! For å minimere risikoen for kontaminasjon med bakterier og dialysefilteret, uansett om det skyldes en defekt på...
  • Page 13: Generelle Oplysninger

    Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 bivirkninger, der kan være forbundet med hæmodialyse. skader, personskader eller udgifter, der direkte eller indirekte opstår som Dialyzer.
  • Page 14: Yleiset Tiedot

    Nephrol Dial Transplant 2017; 32(1):165-72. [2] Weiner et al. seuranta ovat erittäin tärkeitä, jotta vältetään hemodialyysiin mahdollisesti Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 liittyvät haittavaikutukset. Valmistaja ei ole vastuussa väärinkäytöstä, väärästä käsittelystä, Dialyzer.
  • Page 15: Informações Gerais

    à hemodiálise. A garantia acima exposta substitui e exclui qualquer outra garantia, tanto Dialisador Theranova 400. Um Estudo Randomizado Controlado. Clin J Am escrita como oral, expressa ou implícita, prevista por estatuto ou outra, não Soc Nephrol 2020;15 (9) 1310-1319 ADVERTÊNCIA! Para minimizar a contaminação bacteriana e com...
  • Page 16: Algemene Informatie

    WAARSCHUWING! goede uitvoering instellings- Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 garantie, en er zijn geen garanties van verhandelbaarheid of geschiktheid Dialyzer. A Randomized Controlled Trial. Clin J Am Soc Nephrol 2020;15 primingprocedures, goed...
  • Page 17: Genel Bilgi

    Hemodiyalizle ilişkili diyalizörün kullanılmasının dolaylı veya dolaysız sonucu niteliğindeki veya Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 olabilecek yan etkilerin ortadan kaldırılması için gereklidir. arızi kayıplardan, zararlardan, yaralanmalardan veya masraflardan sorumlu Dialyzer.
  • Page 18: Všeobecné Informace

    ústní, vyjádřené nebo předpokládané, zákonné nebo jiné. Neexistuje Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 klinických požadavcích. žádná záruka obchodovatelnosti nebo vhodnosti pro daný účel, příp. další...
  • Page 19: Γενικές Πληροφορίες

    αντιπηκτική αγωγή, οι ρυθμοί της ροής του αίματος και του διαλύματος Η παραπάνω εγγύηση αντικαθιστά και αποκλείει οποιαδήποτε άλλη εγγύηση, and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer. A αιμοκάθαρσης καθώς και ο έλεγχος των συνολικών παραμέτρων της θεραπείας...
  • Page 20 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 20 of 24 Black Colour Reference: Material Specification: HEC1129061 Translations Blood Flow rate: Q (ml/min) Blutflussrate: Q (ml/min) Débit sang: Q...
  • Page 21 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 21 of 24 Black Colour Reference: Material Specification: HEC1129061 Translations Veren virtausnopeus: Q (ml/min) Taxa de débito do sangue: Q...
  • Page 22 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 22 of 24 Black Colour Reference: Material Specification: HEC1129061 Performances Specifications theranova 400 theranova 500 Blood Flow rate: Q (ml/min) 200 –...
  • Page 23 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 23 of 24 Black Colour Reference: Material Specification: HEC1129061...
  • Page 24 BAXTER CONFIDENTIAL - INTERNAL USE ONLY Part Number: N50 648 rev 007 Date: 22-FEB-2021 Proofread No.: 01 Designer: DEP Page: 24 of 24 Black Colour Reference: Material Specification: HEC1129061 Baxter, Gambro and Theranova are trademarks of Baxter International Inc., or its subsidiaries.

Ce manuel est également adapté pour:

Theranova 500

Table des Matières