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MIETHKE proGAV Instructions For Use Manual

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Table of Contents
  • Medizinische Zweck- Bestimmung
  • Technische Beschreibung
  • Transport und Lagerung
  • Sicherheits- und Warnhinweise
  • Reinigung und Desinfektion
  • Fehlersuche und -Behebung
  • Explanation of the Warnings
  • Display Conventions
  • Technical Description
  • System Components
  • Preparing for Use
  • Cleaning and Disinfecting
  • Troubleshooting
  • Objectif Médical
  • Contre-Indications
  • Description Technique
  • Composants du Système
  • Transport Et Stockage
  • Consignes de Sécurité Et Avertissements
  • Matériel Nécessaire
  • Descripción Técnica
  • Componentes del Sistema
  • Condiciones de Funcionamiento
  • Transporte y Almacenamiento
  • Materiales Requeridos
  • Preparación para el Uso
  • Eliminación de Residuos
  • Localización y Solución de Averías
  • Descrição Técnica
  • Componentes Do Sistema
  • Conformidade Do Produto
  • Transporte E Armazenamento
  • Materiais Necessários
  • Descrizione Tecnica
  • Componenti del Sistema
  • Ricerca E Risoluzione Dei Pro- Blemi
  • Contra-Indicaties
  • Technische Beschrijving
  • Transport en Opslag
  • Veiligheidsvoorschriften en Waarschuwingen

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  • ENGLISH, page 20

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Summary of Contents for MIETHKE proGAV

  • Page 1 ® Tools...
  • Page 3 ® Tools INHALTSVERZEICHNIS proGAV Tools proGAV Tools...
  • Page 4 Bezeichnet eine möglicherweise schädliche Situation. Wenn sie nicht gemieden wird, proGAV Prüfinstrument kann das Produkt oder etwas in dessen proGAV Masterdisk Umgebung beschädigt werden. proGAV Kompass proGAV Verstellinstrument proGAV Verstellscheibe, S/M/L proGAV Instrumenteführung 1.02 DARSTELLUNGSKONVENTIONEN proGAV Verstellkreisel Darstellung Beschreibung Kursiv...

  • Page 5: Medizinische Zweck- Bestimmung

    ® Tools 1.03 WEITERE BEGLEITPAPIERE UND 2.00 BESCHREIBUNG DER proGAV Tools ERGÄNZENDES INFORMATIONS- MATERIAL 2.01 MEDIZINISCHE ZWECK- BESTIMMUNG proGAV Tools proGAV proGAV 2.0 2.02 KLINISCHER NUTZEN Therapieoptionen proGAV proGAV 2.0 1.04 RÜCKMELDUNG ZUR GEBRAUCHS- ANWEISUNG 2.03 INDIKATIONEN proGAV Tools 1.05 COPYRIGHT, DISCLAIMER,...

  • Page 6: Technische Beschreibung

    Masterdisk proGAV Prüfinstrument proGAV Prüfinstrument Prüfinstrument proGAV Masterdisk proGAV Masterdisk proGAV Prüfinstrument Prüfinstruments Abb. 2: proGAV Masterdisk proGAV Kompass proGAV Prüfinstrument proGAV Kompass Ventrikelkatheter HINWEIS Kleine Luftblasen in der Kompasskammer beeinträchtigen die Funktion nicht. Abb. 1: proGAV Prüfinstrument Abb. 3: proGAV Kompass...
  • Page 7 ® Tools proGAV Verstellinstrument proGAV Verstellscheibe proGAV Verstellinstrument proGAV Verstellscheibe proGAV Verstell- scheibe Ventrikelkatheters proGAV Verstellscheibe proGAV proGAV Verstellinstrument Abb. 5: proGAV Verstellscheibe a) Größe S b) Größe M c) Größe L Abb. 4: proGAV Verstellinstrument...
  • Page 8 Prüf Verstellinstru- ment proGAV Tools Instrumenteführung proGAV Verstellinstrument proGAV Prüfinstrument proGAV Masterdisk proGAV Kompass proGAV Verstellscheibe proGAV Instrumenteführung Abb. 6: Schematische Ansicht der proGAV Instrumen- proGAV Tools teführung proGAV Kompass proGAV Verstellkreisel proGAV Artikelnr. Abbildung proGAV Verstell- Prüfinstrument Prüf Verstellinstrumen- 2.09 SYSTEMKOMPONENTEN...
  • Page 9 ® Tools 3.01.04 WIEDERHOLTE ANWENDUNG Artikelnr. Abbildung UND ERNEUTE STERILISATION proGAV Verstellkreisel 3.01.02 LIEFERUMFANG Verpackungsinhalt Anzahl 3.01.05 BETRIEBSBEDINGUNGEN (Artikelnr. FV404T) proGAV Tools proGAV Verstellinstrument proGAV Prüfinstrument proGAV Masterdisk proGAV Kompass 3.01.06 PRODUKTLEBENSDAUER proGAV Instrumentenführung proGAV Tools proGAV Tools Verpackungsinhalt Anzahl (Artikelnr.

  • Page 10: Transport Und Lagerung

    3.04 BENUTZUNG DES PRODUKTS WARNUNG 3.04.01 EINLEITUNG Wegen der Verletzungsgefahr durch Fehl- proGAV Tools bedienung der proGAV Tools muss vor der ersten Verwendung die Gebrauchsan- proGAV Tools leitung sorgfältig gelesen und verstanden werden. proGAV Vor der Verwendung ist es unbedingt erfor- derlich, die Unversehrtheit und Vollständig-...
  • Page 11 ® Tools 3.04.03 BENÖTIGTE MATERIALIEN 2. Prüfvorgang HINWEIS proGAV Das proGAV Prüfinstrument und der proGAV proGAV Prüfinstrument Kompass reagieren empfindlich auf externe proGAV Kompass Magnetfelder. Um unerwünschte Wechsel- wirkungen auszuschließen, sollte das pro- proGAV Verstellinstrument GAV Verstellinstrument bei der Bestimmung proGAV Verstellscheibe des Öffnungsdrucks nicht in unmittelba-...
  • Page 12 ® Tools 2b. Prüfung mit dem proGAV Kompass HINWEIS Ist der Implantationsort ungünstig gewählt proGAV Prüfinstrument oder ist die Haut über dem Ventil zu dick, besteht die Möglichkeit, dass sich die ver- proGAV Kompass stellbare Differenzdruckeinheit nicht mehr proGAV Kompass verstellen lässt.
  • Page 13 3b. Verstellung mit der proGAV Verstellscheibe Verstellscheibe Abb. 12: Platzieren des Verstellinstruments Verstellinstrument Verstellinstruments Abb. 14: Verstellung mit der proGAV Verstellscheibe Verstellscheibe Verstellscheibe proGAV Prüfinstrument Abb. 13: Verstellen der Druckstufe Abb. 15: Aufsetzen und Andrücken der Verstellscheibe auf die verstellbare Differenzdruckeinheit 3c.

  • Page 14: Reinigung Und Desinfektion

    Verfahren zu empfehlen. 3.04.06 REINIGUNGSEMPFEHLUNG FÜR DIE NICHT STERILISIERBAREN proGAV Tools HINWEIS Die proGAV Tools sind aus thermolabilen, wärme- und feuchtigkeitssensiblen sowie chemisch reagierenden Bauteilen gefertigt. proGAV Tools nicht in Reinigungslösungen Manuelle Reinigung/Desinfektion einlegen oder Flüssigkeiten in das Gehäuse gelangen lassen, da eine Beeinträchtigung...
  • Page 15 ® Tools Maschinelle Reinigung/Desinfektion Maschinelle Reinigung/Desinfektion mit manueller Vorreinigung Phase Schritt T (°C/°F) t (min) Konz. (%) Wasser- qualität Chemie T-W: Trinkwasser; RT: Raumtemperatur Maschinelle alkalische Reinigung und thermische Desinfektion Phase Schritt T (°C/°F) t (min) Wasser- qualität Chemie...

  • Page 16: Fehlersuche Und -Behebung

    ® Tools 3.06 FEHLERSUCHE UND -BEHEBUNG Kontrolle, Pflege, Prüfung proGAV Prüfinstrument proGAV 3.05 ENTSORGUNG proGAV Kompass proGAV Verstellinstrument pro- GAV Kompass...
  • Page 17 ® Tools 3.07 TECHNISCHE INFORMATIONEN 3.07.01 TECHNISCHE DATEN Hersteller Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Verstellkreisel proGAV Verstellinstrument proGAV Prüfinstrument proGAV Masterdisk proGAV Kompass proGAV Verstellscheibe proGAV Instrumenteführung proGAV Verstellinstrument proGAV Prüfinstrument proGAV Masterdisk proGAV Kompass...
  • Page 18 ® Tools 3.08 ZUR KENNZEICHNUNG VERWEN- Symbol Erklärung DETE SYMBOLE Symbol Erklärung 4.00 MEDIZINPRODUKTEBERATER Tel. +49 331 62083-0 info@miethke.com...
  • Page 20 ® Tools TABLE OF CONTENTS proGAV Tools proGAV Tools...

  • Page 21: Explanation Of The Warnings

    Tools may be damaged. proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass 1.02 DISPLAY CONVENTIONS proGAV Adjustment Tool Display Description proGAV Adjustment Disc, small/medium/ large Italics proGAV Instrument Guide 1.03 OTHER ACCOMPANYING DOCUMENTS AND ADDITIONAL INFORMATION proGAV Checkmate...
  • Page 22 ® Tools 1.04 FEEDBACK ON THE INSTRUCTIONS 2.00 DESCRIPTION OF THE proGAV Tools FOR USE 2.01 MEDICAL PURPOSE proGAV Tools proGAV proGAV 2.0 2.02 CLINICAL USE Treatment options 1.05 COPYRIGHT, DISCLAIMER, WARRANTY AND OTHER INFORMATION proGAV proGAV 2.0 2.03 INDICATIONS proGAV Tools 2.04 CONTRAINDICATIONS...

  • Page 23: Technical Description

    Tool Fig. 2: proGAV Masterdisc proGAV Verification Compass proGAV Verification Tool proGAV Verification Compass Ventricular Catheter NOTE Small air bubbles in the compass chamber do not impair its function. Fig. 1: proGAV Verification Tool Fig. 3: proGAV Verification Compass...
  • Page 24 Adjustment Tool proGAV Adjustment Disc proGAV Adjustment Tool proGAV Adjustment Disc pro- GAV Adjustment Disc Ventricular Catheter proGAV Adjustment Disc proGAV pro- GAV Adjustment Tool Fig. 5: proGAV Adjustment Disc a) small b) medium c) large Fig. 4: proGAV Adjustment Tool...

  • Page 25: System Components

    Tools Instrument Guide proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc Fig. 6: Schematic view of the proGAV Instrument Guide proGAV Instrument Guide proGAV Verification Compass proGAV Tools proGAV proGAV Checkmate proGAV Adjust- Item no.
  • Page 26 Figure RE-STERILISATION proGAV Checkmate 3.01.02 SCOPE OF DELIVERY 3.01.05 OPERATING CONDITIONS Box content Number (item no. FV404T) proGAV Tools proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc 3.01.06 PRODUCT LIFE proGAV Verification Compass proGAV Instrument Guide proGAV Tools proGAV Tools...
  • Page 27 WARNING CAUTION Due to the risk of injury resulting from incor- rect use of the proGAV Tools, the instruc- The proGAV Adjustment Tool emits a mag- tions for use must be read carefully and netic field. Metallic objects and magnetic...

  • Page 28: Preparing For Use

    3.04.04 PREPARING FOR USE proGAV Verification Tool Verification Tool Checking the sterile packaging proGAV Check- mate Verification Tool Checking the integrity of the proGAV Tools 3.04.05 USING THE INSTRUMENTS proGAV 1. Localisation Fig. 8: Pressure level measurement a) correct b) incorrect Verification Tool 2b.
  • Page 29 ® Tools 3. Adjustment process 3a. Adjustment using the proGAV Adjustment Tool WARNING WARNING When adjusting the adjustable differential pressure unit, care must be taken that the When pressing the release button, make sure opening pressure is changed by a maximum...
  • Page 30 3b. Adjustment with the proGAV Adjustment Disc Checkmate Adjustment Disc Checkmate Ventricular Catheter Checkmate Checkmate Fig. 14: Adjustment with the proGAV Adjustment Disc Adjustment Disc Adjustment Disc proGAV Verification Tool Fig. 16: proGAV Checkmate pressure levels: 0 to 20 cmH...

  • Page 31: Cleaning And Disinfecting

    The proGAV Tools are made from thermola- bile components that are sensitive to heat and moisture as well as chemically reactive. Do not immerse the proGAV Tools in clean- ing solutions or allow liquids to enter the housing, as moisture, corrosion and impuri- ties could impair proper functioning.
  • Page 32 ® Tools Mechanical cleaning/disinfection with manual precleaning Phase Step T (°C/°F) t (min) Conc. (%) Water quality Chemical specifications D-W: Drinking water; RT: Room temperature Mechanical alkaline cleaning and thermal disinfection Phase Step T (°C/°F) t (min) Water quality...

  • Page 33: Troubleshooting

    ® Tools 3.05 DISPOSAL 3.06 TROUBLESHOOTING proGAV Verification Tool Verification Tool Verification Tool proGAV proGAV Verification Compass proGAV Adjustment Tool pro- GAV Verification Compass proGAV Tools...
  • Page 34 ® Tools 3.07 TECHNICAL INFORMATION 3.07.01 TECHNICAL DATA Manufacturer Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Checkmate proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Adjustment Tool...
  • Page 35 ® Tools 3.08 SYMBOLS USED FOR LABELLING Symbol Explanation Symbol Explanation 4.00 MEDICAL DEVICE CONSULTANTS Tel. +49 331 62083-0 info@miethke.com...
  • Page 37 ® Tools TABLE DES MATIÈRES proGAV Tools proGAV Tools...
  • Page 38 Si elle n'est pas évitée, elle peut cau- proGAV Masterdisc ser des dégâts matériels au produit ou à envi- ronnement. proGAV Verification Compass proGAV Adjustment Tool proGAV Adjustment Disc, small/medium/ large proGAV Instrument Guide 1.02 CONVENTIONS DE REPRÉSENTATION proGAV Checkmate Représentation...

  • Page 39: Objectif Médical

    ® Tools 1.03 AUTRES DOCUMENTS D'ACCOMPA- 2.00 DESCRIPTION DE proGAV Tools GNEMENT ET MATÉRIEL D'INFORMATION COMPLÉMENTAIRE 2.01 OBJECTIF MÉDICAL proGAV Tools proGAV proGAV 2.0 2.02 BÉNÉFICE CLINIQUE Options thérapeutiques proGAV proGAV 2.0 1.04 COMMENTAIRE SUR LE MODE D'EMPLOI 2.03 INDICATIONS proGAV Tools 1.05 DROIT D'AUTEUR, CLAUSE DE NON-...

  • Page 40: Description Technique

    Verification Compass proGAV Verification Tool proGAV Verification Com- pass Ventricular Catheter REMARQUE De petites bulles d'air dans la chambre de la boussole n'ont aucun impact sur le fonction- nement. Fig. 1: proGAV Verification Tool Fig. 3: proGAV Verification Compass...
  • Page 41 Adjustment Disc proGAV Adjustment Tool proGAV Adjustment Disc proGAV Adjustment Disc Ventricular Catheter proGAV Adjustment Disc proGAV proGAV Adjustment Tool Fig. 5: proGAV Adjustment Disc a) taille small b) taille medium c) taille large Fig. 4: proGAV Adjustment Tool...

  • Page 42: Composants Du Système

    Instrument Guide proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide Fig. 6: Vue schématique du proGAV Instrument Guide proGAV Tools proGAV Verification Compass proGAV proGAV Checkmate proGAV Adjustment Tool Réf. Figure...
  • Page 43 Checkmate 3.01.02 MATÉRIEL FOURNI Contenu de l'emballage Nombre 3.01.05 CONDITIONS D'EXPLOITATION (réf. FV404T) proGAV Tools proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass 3.01.06 DURÉE DE VIE DU PRODUIT proGAV Instrument Guide proGAV Tools Contenu de l'emballage...

  • Page 44: Transport Et Stockage

    Tools de comprendre le mode d'emploi avant la première utilisation. proGAV Tools Il est absolument nécessaire avant l'utilisa- tion de vérifier que les proGAV Tools sont complets et en bon état. proGAV 3.02.02 COMPLICATIONS, 3.04.02 CONSIGNES DE SÉCURITÉ ET EFFETS INDÉSIRABLES ET...

  • Page 45: Matériel Nécessaire

    Adjustment Tool 2. Opération de contrôle proGAV Adjustment Disc REMARQUE proGAV Masterdisc Le proGAV Verification Tool et la proGAV Verification Tool Verification Compass sont très sensibles aux champs magnétiques externes. Pour exclure proGAV toutes interactions non souhaitées, le pro- GAV Adjustment Tool ne doit pas se trouver à...
  • Page 46 18 cmH O. Le rotor tourne dans le sens des b) incorrect aiguilles d'une montre (fig. 10b). Verification Tool 2b. Contrôle avec la proGAV Verification Compass proGAV Verification Compass Fig. 10: Rotation du rotor pendant l'ajustage proGAV Verification Tool...
  • Page 47 Adjustment Disc Ventricular Catheter Fig. 11: Réglage du niveau de pression souhaité sur l'Adjustment Tool Adjustment Tool Fig. 14: Ajustage à l'aide du proGAV Adjustment Disc Adjustment Disc Adjustment Disc proGAV Verifica- tion Tool Fig. 12: Placement de l'Adjustment Tool...
  • Page 48 3c. Modification du réglage avec le proGAV Checkmate 0297 REMARQUE Checkmate Les proGAV Tools sont fabriqués à partir de composants thermolabiles, sensibles à la chaleur et à l'humidité qui réagissent chimi- quement. Ne pas placer les proGAV Tools dans des solutions de nettoyage ou laisser des liquides pénétrer dans le boîtier, car l'hu-...
  • Page 49 ® Tools 3.04.07 NETTOYAGE ET DÉSINFECTION DU proGAV Checkmate Évitez l'apparition de dommages sur le produit par l'utilisation de produits de nettoyage/ désinfection inadaptés et/ou liés à des températures trop élevées ! Nettoyage/désinfection manuelle Nettoyage/désinfection mécanique Nettoyage/désinfection mécanique avec prélavage manuel Phase Étape...
  • Page 50 ® Tools Nettoyage mécanique alcalin et désinfection thermique Phase Étape T (°C/°F) t (min) Qualité de l'eau chimie EP : Eau potable, ED : Eau déminéralisée Contrôle, entretien, examen...
  • Page 51 ® Tools 3.05 ÉLIMINATION 3.06 RECHERCHE DE PANNE ET DÉPANNAGE proGAV Verification Tool Verification Tool Veri- fication Tool proGAV proGAV Verification Compass proGAV Adjustment Tool proGAV Verification Com- pass proGAV Tools...
  • Page 52 ® Tools 3.07 INFORMATIONS TECHNIQUES 3.07.01 DONNÉES TECHNIQUES Fabricant Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Checkmate proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Adjustment Tool...
  • Page 53 ® Tools 3.08 SYMBOLES UTILISÉS POUR LA Symbole Explication SIGNALÉTIQUE Symbole Explication 4.00 CONSEILLER EN PRODUITS MÉDICAUX Tél. +49 331 62083-0 info@miethke.com...
  • Page 55 ® Tools ÍNDICE proGAV Tools proGAV Tools...
  • Page 56 Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Tool proGAV Adjustment Disc, small/medium/ 1.02 CONVENCIONES DE REPRESENTA- large CIÓN GRÁFICA proGAV Instrument Guide Representación Descripción...
  • Page 57 ® Tools 1.03 OTROS DOCUMENTOS 2.00 DESCRIPCIÓN DE LAS proGAV Tools ADJUNTOS Y MATERIAL INFORMATIVO SUPLEMENTARIO 2.01 USO MÉDICO PREVISTO proGAV Tools proGAV proGAV 2.0 2.02 USO CLÍNICO Opciones terapéuticas pro- GAV proGAV 2.0 1.04 COMENTARIOS SOBRE LAS INS- TRUCCIONES DE USO 2.03 INDICACIONES...

  • Page 58: Descripción Técnica

    Verification Compass pro- GAV Verification Tool proGAV Verification Com- pass Ventricular Catheter NOTA Fig. 1: proGAV Verification Tool Las pequeñas burbujas de aire dentro de la cámara de la brújula no afectan su funciona- miento. Fig. 3: proGAV Verification Compass...
  • Page 59 Adjustment Disc proGAV Adjustment Tool proGAV Adjustment Disc proGAV Adjustment Disc Ventricular Catheter proGAV Adjustment Disc proGAV proGAV Adjustment Tool Fig. 5: proGAV Adjustment Disc a) Tamaño small b) Tamaño medium c) Tamaño large Fig. 4: proGAV Adjustment Tool...

  • Page 60: Componentes Del Sistema

    Instrument Guide proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Tools Fig. 6: Vista esquemática de proGAV Instrument Guide proGAV Checkmate proGAV Verification Compass N.º de artículo Figura proGAV proGAV Adjustment Tool proGAV Verification Tool...

  • Page 61: Condiciones De Funcionamiento

    Checkmate 3.01.02 VOLUMEN DE SUMINISTRO Contenido del paquete Cantidad 3.01.05 CONDICIONES DE (n.º de artículo FV404T) FUNCIONAMIENTO proGAV Adjustment Tool proGAV Tools proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass 3.01.06 VIDA ÚTIL DEL PRODUCTO proGAV Instrument Guide proGAV Tools...

  • Page 62: Transporte Y Almacenamiento

    Tools que supone un mal uso de los dispositivos proGAV Tools. proGAV Tools Antes del uso es requisito indispensa- ble comprobar que las proGAV Tools se encuentren íntegras y completas. proGAV 3.02.02 COMPLICACIONES, 3.04.02 INDICACIONES DE SEGURIDAD Y EFECTOS SECUNDARIOS Y...

  • Page 63: Materiales Requeridos

    Adjustment Tool no debe estar cerca del instrumento de verificación proGAV Veri- proGAV fication Tool o de la brújula proGAV Verifica- tion Compass cuando se vaya a determinar proGAV Checkmate la presión de apertura. Recomendamos una distancia de aprox.
  • Page 64 Al quedar la piel hinchada, puede que el ajuste posoperatorio sea más dificultoso durante unos días. Fig. 9: proGAV Verification Compass Durante el ajuste preoperatorio a través del embalaje estéril, el instrumento de ajuste Adjustment Tool solo se coloca sobre la vál- NOTA vula y no debe apretarse el botón.
  • Page 65 Fig. 11: Ajuste del nivel de presión deseado en el ins- trumento de ajuste Adjustment Tool Adjustment Tool Fig. 14: Ajuste con el disco de ajuste proGAV Adjust- ment Disc Fig. 12: Colocación del instrumento de ajuste Adjust- ment Tool...
  • Page 66 Adjustment Disc Adjustment Disc pro- GAV Verification Tool Fig. 16: proGAV Dispositivo de ajuste Checkmate Niveles de presión: de 0 a 20 cmH 4. Comprobación tras realizar el ajuste Fig. 15: Colocación y accionamiento del Adjustment Disc sobre la unidad de presión diferencial ajustable NOTA 3c.
  • Page 67 ® Tools pro- GAV Tools 3.04.07 LIMPIEZA Y DESINFECCIÓN DEL DISPOSITIVO proGAV Checkmate ¡Evite que el producto se dañe por utilizar detergentes y desinfectantes inapropiados o por temperaturas demasiado elevadas! Limpieza/desinfección manual Limpieza/desinfección mecánica...
  • Page 68 ® Tools Limpieza/desinfección mecánica con limpieza previa manual Fase Paso T (°C/°F) t (min) Conc. (%) Calidad del agua Química A-P: Agua potable, TA: Temperatura ambiente Limpieza mecánica alcalina y desinfección térmica Fase Paso T (°C/°F) t (min) Calidad del agua Química...

  • Page 69: Eliminación De Residuos

    ® Tools Control, cuidado, comprobación proGAV Verification Compass proGAV Adjustment Tool proGAV Verification Compass 3.05 ELIMINACIÓN DE RESIDUOS 3.06 LOCALIZACIÓN Y SOLUCIÓN DE AVERÍAS proGAV Veri- fication Tool Verification Tool Verification Tool proGAV...
  • Page 70 ® Tools 3.07 INFORMACIÓN TÉCNICA 3.07.01 DATOS TÉCNICOS Fabricante Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Checkmate proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Adjustment Tool...
  • Page 71 ® Tools 3.08 SÍMBOLOS DE ETIQUETADO Símbolo Explicación Símbolo Explicación 4.00 ASESORES DE PRODUCTOS SANITA- RIOS Tel. +49 331 62083-0 info@miethke.com...
  • Page 73 ® Tools ÍNDICE proGAV Tools proGAV Tools...
  • Page 74 Se não for evitada, o produto ou algo na sua proximidade poderá sofrer danos. proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Tool 1.02 CONVENÇÕES DE APRESENTAÇÃO proGAV Adjustment Disc, small/medium/ large Apresentação Descrição proGAV Instrument Guide Itálico proGAV Checkmate...
  • Page 75 ® Tools 1.03 OUTROS DOCUMENTOS DE 2.00 DESCRIÇÃO DE proGAV Tools ACOMPANHAMENTO E MATERIAL DE INFORMAÇÃO SUPLEMENTAR 2.01 FINALIDADE MÉDICA proGAV Tools proGAV proGAV 2.0 2.02 UTILIDADE CLÍNICA Opções de terapia proGAV proGAV 2.0 1.04 FEEDBACK SOBRE AS INSTRUÇÕES DE UTILIZAÇÃO...

  • Page 76: Descrição Técnica

    Fig. 2: proGAV Masterdisc proGAV Verification Compass proGAV Verification Tool proGAV Verification Compass Ventricular Catheter OBSERVAÇÃO As pequenas bolhas de ar existentes na Fig. 1: proGAV Verification Tool câmara do Compass não interferem com o seu funcionamento. Fig. 3: proGAV Verification Compass...
  • Page 77 Adjustment Disc proGAV Adjustment Tool proGAV Adjustment Disc proGAV Adjustment Disc Ventricular Catheter proGAV Adjustment Disc proGAV proGAV Adjustment Tool Fig. 5: proGAV Adjustment Disc a) Tamanho small b) Tamanho medium c) Tamanho large Fig. 4: proGAV Adjustment Tool...

  • Page 78: Componentes Do Sistema

    Instrument Guide proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide Fig. 6: Visão esquemática do proGAV Instrument Guide proGAV Tools proGAV Verification Compass proGAV Veri- proGAV Checkmate fication Compass N.º do artigo...

  • Page 79: Conformidade Do Produto

    Checkmate 3.01.02 EQUIPAMENTO FORNECIDO Conteúdo da embalagem Quanti- 3.01.05 CONDIÇÕES OPERACIONAIS (n.º do artigo: FV404T) dade proGAV Tools proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass 3.01.06 DURABILIDADE DO PRODUTO proGAV Instrument Guide proGAV Tools pro- GAV Tools Conteúdo da embalagem...

  • Page 80: Transporte E Armazenamento

    Além disso, não os utilize na proximidade de aparelhos de ressonância magnética, uma vez que estes podem ficar danificados. Por esta razão, não é permi- tida a utilização dos proGAV Tools neste local! Para determinar, alterar e controlar a pres- 3.02.03 DEVER DE COMUNICAÇÃO são de abertura da unidade de pres-...

  • Page 81: Materiais Necessários

    Tools 3.04.03 MATERIAIS NECESSÁRIOS 2. Processo de verificação OBSERVAÇÃO proGAV O proGAV Verification Tool e o proGAV Veri- proGAV Verification Tool fication Compass são sensíveis e reagem a proGAV Verification Compass campos magnéticos externos. Para excluir reações recíprocas indesejadas durante a...
  • Page 82 8 cmH O a cada pro- 3a. Ajuste com o proGAV Adjustment Tool cesso de regulação. Exemplo: A pressão de abertura deve ser ATENÇÃO alterada de 3 para 18 cmH O.
  • Page 83 Ventri- cular Catheter Fig. 11: Ajuste do nível de pressão desejado no Adjust- ment Tool Adjustment Tool Fig. 14: Ajuste com o proGAV Adjustment Disc Adjustment Disc Adjustment Disc proGAV Verification Tool Fig. 12: Posicionamento do Adjustment Tool Adjustment Tool Adjustment Tool Fig.
  • Page 84 3.04.06 RECOMENDAÇÃO DE LIMPEZA PARA OS proGAV Tools NÃO ESTERILIZÁ- VEIS OBSERVAÇÃO Os proGAV Tools são fabricados a partir de componentes termolábeis, sensíveis ao calor e à humidade, bem como quimicamente rea- Limpeza/desinfeção manual gentes. proGAV Tools não introduzir em solu- ções de limpeza ou deixar penetrar líqui-...
  • Page 85 ® Tools Limpeza/desinfeção à máquina Limpeza/desinfeção à máquina com limpeza prévia manual Fase Passo T (°C/°F) t (min.) Conc. (%) Qualidade da água Químico A-P: Água potável, TA: Temperatura ambiente Limpeza alcalina à máquina e desinfeção térmica Fase Passo T (°C/°F)
  • Page 86 ® Tools 3.06 IDENTIFICAÇÃO E RESOLUÇÃO DE Controlo, tratamento, verificação FALHAS proGAV Verification Tool proGAV 3.05 ELIMINAÇÃO proGAV Verification Compass proGAV Adjust- ment Tool proGAV Verification Compass...
  • Page 87 ® Tools 3.07 INFORMAÇÕES TÉCNICAS 3.07.01 DADOS TÉCNICOS Fabricante Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Checkmate proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Adjustment Tool...
  • Page 88 ® Tools 3.08 SÍMBOLOS UTILIZADOS PARA Símbolo Explicação IDENTIFICAÇÃO Símbolo Explicação 4.00 CONSULTOR DE DISPOSITIVOS MÉDICOS Tel. +49 331 62083-0 info@miethke.com...
  • Page 90 ® Tools INDICE proGAV Tools proGAV Tools...
  • Page 91 Indica una possibile situazione dannosa. Se non prevenuti, possono provocare danni al proGAV Verification Tool prodotto o agli oggetti circostanti. proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Tool proGAV Adjustment Disc, small, medium, 1.02 CONVENZIONI GRAFICHE large proGAV Instrument Guide Illustrazione Descrizione Corsivo...
  • Page 92 ® Tools 1.03 ALTRI DOCUMENTI DI ACCOMPA- 2.00 DESCRIZIONE DI proGAV Tools GNAMENTO E MATERIALE INFORMATIVO COMPLEMENTARE 2.01 DESTINAZIONE MEDICA proGAV Tools proGAV proGAV 2.0 2.02 VANTAGGIO CLINICO Opzioni terapeutiche pro- proGAV 2.0 1.04 COMMENTI SULLE ISTRUZIONI PER L'USO 2.03 INDICAZIONI...

  • Page 93: Descrizione Tecnica

    Verification Tool Verification Tool Fig. 2: proGAV Masterdisc proGAV Verification Compass proGAV Verification Tool proGAV Verification Compass NOTA Le piccole bolle nella camera della bussola non compromettono il funzionamento. Fig. 1: proGAV Verification Tool Fig. 3: proGAV Verification Compass...
  • Page 94 Adjustment Disc proGAV Adjustment Tool proGAV Adjustment Disc proGAV Adjustment Disc Ventricular Catheter proGAV Adjustment Disc proGAV proGAV Adjustment Tool Fig. 5: proGAV Adjustment Disc a) Misura small b) Misura medium c) Misura large Fig. 4: proGAV Adjustment Tool...

  • Page 95: Componenti Del Sistema

    Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Tools Fig. 6: Visualizzazione schematica di proGAV Instru- ment Guide proGAV Checkmate proGAV Verification Compass proGAV Cod. art. Figura proGAV Adjustment Tool...
  • Page 96 3.01.05 CONDIZIONI OPERATIVE proGAV Tools 3.01.02 VOLUME DI CONSEGNA Contenuto della confezione Quantità (cod. art. FV404T) 3.01.06 VITA UTILE DEI PRODOTTI proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Tools proGAV Instrument Guide proGAV Tools Contenuto della confezione Quantità...
  • Page 97 Tools proGAV Tools AVVERTENZA A causa del rischio di lesioni dovuto a un proGAV uso improprio di proGAV Tools, prima del 3.04.02 SICUREZZA ED AVVERTENZE primo utilizzo è necessario leggere attenta- mente e comprendere le istruzioni per l’uso. ATTENZIONE Prima dell’utilizzo è assolutamente neces- sario verificare l’integrità...
  • Page 98 è preferibile non collocare proGAV Adjustment Tool nelle immediate vicinanze di proGAV Verification Tool o di proGAV Verification Compass. Si raccomanda una distanza di ca. 30 cm. 2a. Controllo con proGAV Verification Tool...
  • Page 99 Adjustment Tool viene applicato solo sulla valvola. Il pul- sante non deve essere azionato. Una pres- sione eccessiva esercitata con lo Adjust- Fig. 9: proGAV Verification Compass ment Tool può danneggiare l’alloggiamento della valvola e comprometterne il funziona- NOTA mento.
  • Page 100 ® Tools Adjustment Tool Fig. 14: Regolazione con proGAV Adjustment Disc Adjustment Disc Fig. 12: Posizionamento dello Adjustment Tool Adjustment Disc Adjustment Tool proGAV Verification Tool Fig. 15: Applicazione e impostazione del disco di rego- lazione sull’unità a pressione differenziale regolabile 3c.
  • Page 101 3.04.06 RACCOMANDAZIONI PER LA PULIZIA DEI PRODOTTI NON STERILIZZA- BILI proGAV Tools NOTA I prodotti proGAV Tools sono realizzati con componenti termolabili, sensibili al calore Pulizia/disinfezione manuale e all'umidità e chimicamente reattivi. Non immergere i prodotti proGAV Tools in solu- zioni detergenti né...
  • Page 102 ® Tools Pulizia/disinfezione a macchina con pulizia preliminare manuale Fase Passo T (°C/°F) t (min) Conc. (%) Qualità dell’acqua Chimica A-P: acqua potabile, TA: temperatura ambiente Pulizia alcalina a macchina e disinfezione termica Fase Passo T (°C/°F) t (min) Qualità...

  • Page 103: Ricerca E Risoluzione Dei Pro- Blemi

    ® Tools 3.06 RICERCA E RISOLUZIONE DEI PRO- Controllo, cura, verifica BLEMI proGAV Verification Tool proGAV 3.05 SMALTIMENTO proGAV Verification Compass proGAV Adjustment Tool proGAV Verification Compass...
  • Page 104 ® Tools 3.07 INFORMAZIONI TECNICHE 3.07.01 DATI TECNICI Produttore Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Checkmate proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Adjustment Tool...
  • Page 105 ® Tools 3.08 SIMBOLI USATI PER LA DESIGNA- Simbolo Spiegazione ZIONE Simbolo Spiegazione 4.00 CONSULENTI IN PRODOTTI MEDI- CALI Tel. +49 331 62083-0 info@miethke.com...
  • Page 107 ® Tools INHOUDSOPGAVE proGAV Tools proGAV Tools...
  • Page 108 Als deze niet wordt gemeden, kan het pro- proGAV Tools duct of iets in de omgeving hiervan bescha- digd raken. proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Tool 1.02 WEERGAVECONVENTIES proGAV Adjustment Disc, small, medium, large Weergave Beschrijving proGAV Instrument Guide Cursief proGAV Checkmate...

  • Page 109: Contra-Indicaties

    ® Tools 1.03 OVERIGE BEGELEIDENDE 2.00 BESCHRIJVING VAN DE proGAV Tools DOCUMENTEN EN AANVULLEND INFORMATIEMATERIAAL 2.01 MEDISCH GEBRUIKSDOEL proGAV Tools proGAV proGAV 2.0 2.02 KLINISCH VOORDEEL Behandelopties pro- proGAV 2.0 1.04 FEEDBACK OVER DE GEBRUIKSAANWIJZING 2.03 INDICATIES proGAV Tools 1.05 AUTEURSRECHT, VRIJWARINGS-...

  • Page 110: Technische Beschrijving

    Afb. 2: proGAV Masterdisc proGAV Verification Compass proGAV Verification Tool proGAV Verification Compass Ventricular Catheter AANWIJZING Kleine luchtbelletjes in de kamer van het kompas hebben geen invloed op de functio- Afb. 1: proGAV Verification Tool naliteit. Afb. 3: proGAV Verification Compass...
  • Page 111 Adjustment Disc proGAV Adjustment Tool proGAV Adjustment Disc pro- GAV Adjustment Disc Ventricular Catheter proGAV Adjustment Disc proGAV proGAV Adjustment Tool Afb. 5: proGAV Adjustment Disc a) maat small b) maat medium c) maat large Afb. 4: proGAV Adjustment Tool...
  • Page 112 Instrument Guide proGAV Tools proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide Afb. 6: Schematische weergave van de proGAV Instru- proGAV Tools ment Guide proGAV Checkmate proGAV Verification Compass proGAV Artikelnr. Afbeelding...
  • Page 113 Afbeelding HERSTERILISATIE proGAV Checkmate 3.01.02 LEVERINGSOMVANG Inhoud verpakking Aantal 3.01.05 BEDRIJFSVOORWAARDEN (artikelnr. FV404T) proGAV Tools proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass 3.01.06 LEVENSDUUR VAN HET PRODUCT proGAV Instrument Guide proGAV Tools proGAV Tools Inhoud verpakking Aantal (artikelnr.

  • Page 114: Transport En Opslag

    Tools begrijpen voordat u het product voor de eerste keer gebruikt. proGAV Het is voor het gebruik absoluut noodzake- lijk om te controleren of de proGAV Tools intact en volledig zijn. 3.04.02 VEILIGHEIDSVOORSCHRIFTEN EN WAARSCHUWINGEN 3.02.02 COMPLICATIES, BIJWERKINGEN EN RESTERENDE RISICO'S...
  • Page 115 Om ongewenste wisselwerkingen uit te sluiten, mag het proGAV Adjustment Tool tijdens het bepalen van de openingsdruk niet in de buurt van het proGAV Verifica- Controleren van de integriteit van de tion Tool of het proGAV Verification Compass proGAV Tools liggen.
  • Page 116 18 cmH O. De rotor draait met de klok mee a) correct (afb. 10b). b) verkeerd Verification Tool 2b. Controle met het proGAV Verification Compass pro- Afb. 10: Rotatie van rotor tijdens het instellen GAV Verification Tool a) verkeerde richting...
  • Page 117 Adjustment Disc Ventricu- lar Catheter Afb. 11: Het gewenste drukniveau op het Adjustment Tool instellen Adjustment Tool Afb. 14: Instellen met de proGAV Adjustment Disc Adjustment Disc Adjustment Disc proGAV Verifica- tion Tool Afb. 12: Het Adjustment Tool positioneren Adjustment Tool...
  • Page 118 3c. Instellen met de proGAV Checkmate 0297 AANWIJZING Checkmate De proGAV Tools zijn samengesteld uit ther- misch labiele, warmte- en vochtigheidsge- voelige en chemisch reagerende onderde- len. Leg proGAV Tools niet in reinigingsop- lossingen en laat geen vloeistof in de behui- zing dringen;...
  • Page 119 ® Tools 3.04.07 REINIGING EN DESINFECTIE VAN DE proGAV Checkmate Voorkom schade aan het product als gevolg van ongepaste reinigings-/desinfectiemidde- len en/of te hoge temperaturen! Handmatige reiniging/desinfectie Machinale reiniging/desinfectie Machinale reiniging/desinfectie met handmatige voorreiniging Fase Stap T (°C/°F) t (min) Conc.
  • Page 120 ® Tools Machinale alkalische reiniging en thermische desinfectie Fase Stap T (°C/°F) t (min) Water- kwaliteit Chemie DW: Drinkwater: GDMW: gedemineraliseerd water 3.05 VERWIJDERING Controle, onderhoud, testen...
  • Page 121 ® Tools 3.06 FOUTENOPSPORING EN - OPLOSSING proGAV Verification Tool proGAV proGAV Verification Compass proGAV Adjustment Tool proGAV Verification Compass...
  • Page 122 ® Tools 3.07 TECHNISCHE INFORMATIE 3.07.01 TECHNISCHE GEGEVENS Fabrikant Christoph Miethke GmbH & Co. KG proGAV Tools proGAV Checkmate proGAV Adjustment Tool proGAV Verification Tool proGAV Masterdisc proGAV Verification Compass proGAV Adjustment Disc proGAV Instrument Guide proGAV Adjustment Tool...
  • Page 123 ® Tools 3.08 VOOR MARKERING GEBRUIKTE Symbool Uitleg SYMBOLEN Symbool Uitleg 4.00 ADVISEUR MEDISCHE HULPMIDDE- Tel. +49 331 62083-0 info@miethke.com...
  • Page 125 注册人: Christoph Miethke GmbH & Co. KG 克里斯托福弥提柯股份有限公司 住所: Ulanenweg 2, 14469 Potsdam, Germany 联系方式: www.miethke.com, info@miethke.com Distributor: Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 7461 95-0 | Fax +49 7461 95-2600 | www.bbraun.com AESCULAP ®...

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Progav 2.0

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