Page 2
M.blue plus ® Instruments INHALTSVERZEICHNIS M.blue plus Instruments M.blue plus Instruments...
Page 3
M.blue plus ® Instruments 0.00 VORWORT UND 1.00 INFORMATIONEN ZUM UMGANG MIT WICHTIGE HINWEISE DIESER GEBRAUCHSANWEISUNG Vorwort 1.01 ERKLÄRUNG DER WARNHINWEISE M.blue GEFAHR plus Instrumente Bezeichnet eine unmittelbar drohende Gefahr. Wenn sie nicht gemieden wird, sind Tod oder schwerste Verletzungen die Folge. WARNUNG Relevanz der Gebrauchsanweisung Bezeichnet eine möglicherweise drohende...
Page 4
M.blue plus ® Instruments 1.03 WEITERE BEGLEITPAPIERE UND 2.00 BESCHREIBUNG DER ERGÄNZENDES INFORMATIONS- M.blue plus Instruments MATERIAL 2.01 MEDIZINISCHE ZWECK- BESTIMMUNG M.blue plus Instrumente M.blue proGAV 2.02 KLINISCHER NUTZEN Therapieoptionen 1.04 RÜCKMELDUNG ZUR GEBRAUCHS- ANWEISUNG M.blue proGAV 2.0 2.03 INDIKATIONEN 1.05 COPYRIGHT, DISCLAIMER, GARANTIE UND SONSTIGES M.blue plus Instrumente...
M.blue plus ® Instruments 2.06 VORGESEHENE ANWENDER Abb. 3: Das M.blue plus ist eine Kombination aus ver- stellbarer Differenzdruckeinheit (proGAV 2.0) und ver- stellbarer Gravitationseinheit (M.blue) und wird in der dargestellten Reihenfolge ausgeliefert (proGAV 2.0 proximal und M.blue distal). M.blue plus Kompass M.blue proGAV 2.0 2.07 VORGESEHENE...
Page 6
M.blue plus ® Instruments Artikelnr. Abbildung proGAV 2.0 2.09 SYSTEMKOMPONENTEN M.blue plus Instrumente Produktname Abbildung M.blue 3.01.02 LIEFERUMFANG M.blue plus Verpackungsinhalt Anzahl (Artikelnr. FX890T) proGAV 2.0 M.blue plus Kompass M.blue plus Verstellring M.blue plus Instrumente 3.00 EIGENSCHAFTEN DER M.blue plus Instruments Verpackungsinhalt Anzahl (Artikelnr.
Page 7
M.blue plus ® Instruments 3.01.03 STERILITÄT 3.02 WICHTIGE SICHERHEITSINFORMA- TIONEN M.blue Verstellkreisel 3.02.01 SICHERHEITSHINWEISE M.blue plus Instrumente Wichtig! WARNUNG Bei Beschädigung der Verpackung oder Beschädigung der Produkte dürfen die Pro- dukte nicht verwendet werden. WARNUNG 3.01.04 WIEDERHOLTE ANWENDUNG UND ERNEUTE STERILISATION Bei einer Beschädigung der Sterilverpa- ckung des Verstellkreisels darf das Pro- M.blue Verstellkreisel...
M.blue plus ® Instruments 3.02.04 AUFKLÄRUNG DES PATIENTEN VORSICHT Es ist unbedingt erforderlich, für das Ermitteln, Verändern und Kontrollieren des Öffnungsdruckes der Gravitationseinheit des M.blue ausschließlich die M.blue plus Instrumente zu verwenden. Der Öffnungs- druck der Differenzdruckeinheit des pro- GAV 2.0 kann sowohl mit den beschriebe- nen M.blue plus Instrumenten als auch mit den proGAV 2.0 Instrumenten ermittelt, 3.03 TRANSPORT UND LAGERUNG...
Page 9
M.blue plus ® Instruments 3.04.05 VERSTELLEN DES M.blue 2. Prüfvorgang 1. Lokalisierung WARNUNG Der M.blue plus Kompass sollte möglichst zentriert auf das Ventil aufgesetzt werden, sonst kann es zu einer fehlerhaften Bestim- mung des Öffnungsdruckes kommen. proGAV 2.0 M.blue HINWEIS Mögliche Lufteinschlüsse im M.blue plus Kompass haben keinen Einfluss auf des- sen Funktion.
Page 10
M.blue plus ® Instruments Abb. 8: Skalenring des M.blue plus Kompass Außen: Skala der Differenzdruckeinheit des proGAV Abb. 9: Einsetzen des Verstellrings 2.0 von 0 bis 20 cmH Innen: Skala der Gravitationseinheit des M.blue von 0 bis 40 cmH (Öffnungsdruck der Differenzdruckeinheit des pro- GAV 2.0 im Bildbeispiel 17 cmH O, Öffnungsdruck der Gravitationseinheit des M.blue im Bildbeispiel...
Page 11
M.blue plus ® Instruments M.blue Verstellkreisel proGAV 0297 M.blue M.blue Verstellkreisel M.blue Ver- stellkreisel M.blue M.blue Verstellkreisel M.blue M.blue Verstellkreisel M.blue Verstellkreisel M.blue M.blue Verstell- kreisel M.blue Verstellung mit dem Verstellassistenten M.blue plus Verstellassistent M.blue plus Verstellas- sistent Abb. 13: M.blue Verstellkreisel Farbe: blau Druckstufen: 0 bis 40 cmH Abb.
M.blue plus ® Instruments 3.04.06 REINIGUNGSEMPFEHLUNG FÜR DIE NICHT STERILISIERBAREN M.blue plus Instrumente HINWEIS M.blue plus Instrumente sind aus ther- molabilen, wärme- und feuchtigkeitssensi- blen sowie chemisch reagierenden Bautei- len gefertigt. M.blue plus Instrumente nicht in Reinigungslösungen einlegen oder Flüs- sigkeiten in das Gehäuse gelangen lassen, da eine Beeinträchtigung der Funktionsweise durch Feuchtigkeit, Korrosion und Verunrei-...
Page 13
M.blue plus ® Instruments Maschinelle alkalische Reinigung und thermische Desinfektion Phase Schritt T (°C/°F) t (min) Wasser- qualität Chemie T-W: Trinkwasser, VE-W: Vollentsalztes Wasser demineralisiert 3.05 ENTSORGUNG Kontrolle, Pflege, Prüfung M.blue plus Instrumente...
M.blue plus ® Instruments 3.06 FEHLERSUCHE UND -BEHEBUNG M.blue M.blue plus Kompass M.blue plus Kompass M.blue plus Kompass M.blue plus Verstell- ring M.blue plus Kompass M.blue plus Kompass proGAV 2.0 M.blue plus Kompass M.blue M.blue proGAV 2.0 proGAV 2.0...
Page 15
M.blue plus ® Instruments 3.07 TECHNISCHE INFORMATIONEN 3.07.01 TECHNISCHE DATEN Hersteller Christoph Miethke GmbH & Co. KG M.blue plus Instrumente M.blue Verstellkreisel M.blue plus Kompass M.blue plus Verstellring M.blue plus Verstellassistent M.blue plus Kompass M.blue plus Verstellring M.blue plus Verstellassistent M.blue Verstellkreisel...
Page 16
M.blue plus ® Instruments 3.08 ZUR KENNZEICHNUNG VERWEN- Symbol Erklärung DETE SYMBOLE Symbol Erklärung 4.00 MEDIZINPRODUKTEBERATER Tel. +49 331 62083-0 info@miethke.com...
Page 18
M.blue plus ® Instruments TABLE OF CONTENTS M.blue plus Instruments M.blue plus Instruments...
Indicates a possibly harmful situation. If not Scope avoided, the product or items in its vicinity M.blue plus Instruments may be damaged. M.blue plus Compass M.blue plus Adjustment Ring 1.02 DISPLAY CONVENTIONS M.blue plus Adjustment Assistant Display Description M.blue Checkmate...
Page 20
M.blue plus ® Instruments 1.04 FEEDBACK ON THE INSTRUCTIONS 2.00 DESCRIPTION OF THE FOR USE M.blue plus Instruments 2.01 MEDICAL PURPOSE M.blue plus Instruments M.blue M.blue plus proGAV 2.02 CLINICAL USE 1.05 COPYRIGHT, DISCLAIMER, WARRANTY AND OTHER INFORMATION Treatment options M.blue proGAV 2.03 INDICATIONS...
Instruments 2.07 INTENDED USAGE ENVIRONMENT 2.08 TECHNICAL DESCRIPTION M.blue plus Instruments M.blue pro- GAV 2.0 M.blue Fig. 4: M.blue plus Compass a) open b) closed 1. Scale ring 2. Floating compass Fig. 1: M.blue M.blue plus Adjustment Ring proGAV 2.0 M.blue...
M.blue plus Instruments M.blue plus Instruments 3.01 PRODUCT DESCRIPTION 3.01.01 APPROVED COMPONENTS Product name Figure M.blue M.blue plus Instruments M.blue plus Compass M.blue plus M.blue plus Adjustment Ring M.blue plus Instruments proGAV 2.0 M.blue plus Adjustment Assistant M.blue Checkmate Item no.
Page 23
M.blue plus ® Instruments Box content (item no. FX892T) Number M.blue plus Adjustment Ring 3.01.07 PRODUCT CONFORMITY M.blue plus Instruments Box content (item no. FX893T) Number M.blue plus Adjustment Assis- tant M.blue plus Instruments 3.02 IMPORTANT SAFETY INFORMATION Box content (item no. FX894T) Number 3.02.01 SAFETY INSTRUCTIONS M.blue Checkmate Important!
Page 24
Because of the magnets inside M.blue WARNING plus Instruments, M.blue plus Instruments The M.blue plus Compass should be placed must not be used in the vicinity of active as centrally as possible over the valve, as implants, such as cardiac pacemakers.
Page 25
2.0 M.blue Fig. 6: Localising the valve 2. Test procedure Fig. 8: Scale ring of the M.blue plus Compass 1. Inner: Scale of the M.blue gravitational unit from 0 Compass to 40 cmH 2. Outer: Scale of the proGAV 2.0 differential pressure unit from 0 to 20 cmH (The opening pressure of the M.blue gravitational unit...
Page 26
M.blue plus ® Instruments 3. Adjustment process WARNING When adjusting the proGAV 2.0 differential pressure unit, care must be taken that the opening pressure is changed by a maxi- mum of 8 cmH O per adjustment process, otherwise errors can occur. Example: The opening pressure is to be changed from 3 to 18 cmH O.
Page 27
M.blue plus ® Instruments Adjustment with the adjustment assistant M.blue plus Adjustment Assis- tant M.blue plus Adjustment Assistant Adjustment Ring Fig. 13: M.blue Checkmate Colour: blue Pressure levels: 0 to 40 cmH 3.04.06 CLEANING RECOMMENDATION FOR NON-STERILISABLE M.blue plus Instruments NOTE M.blue plus Instruments are made from ther- molabile components that are sensitive to...
M.blue plus ® Instruments 3.04.07 CLEANING AND DISINFECTING Mechanical cleaning/disinfection with THE M.blue Checkmate manual precleaning Avoid damaging the product due to unsuit- able cleaning agents/disinfectants and/or Phase too high temperatures! Step T (°C/°F) t (min) Conc. (%) Water quality Chemical specifica- tions...
Page 29
M.blue plus ® Instruments Mechanical alkaline cleaning and thermal disinfection Phase Step T (°C/°F) t (min) Water quality Chemical specifica- tions D-W: Drinking water, P-W: Purified water demineralised 3.05 DISPOSAL Checking, maintenance, testing M.blue plus Instruments...
M.blue plus ® Instruments 3.06 TROUBLESHOOTING M.blue M.blue plus Compass COMPASS M.blue plus Compass M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Compass M.blue plus Compass proGAV M.blue plus Com- pass M.blue M.blue pro- GAV 2.0 proGAV 2.0...
Page 31
M.blue plus ® Instruments 3.07 TECHNICAL INFORMATION 3.07.01 TECHNICAL DATA Manufacturer Christoph Miethke GmbH & Co. KG M.blue plus Instruments M.blue Checkmate M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant...
Page 32
M.blue plus ® Instruments 3.08 SYMBOLS USED FOR LABELLING Symbol Explanation Symbol Explanation 4.00 MEDICAL DEVICE CONSULTANTS Tel. +49 331 62083-0 info@miethke.com...
Page 34
M.blue plus ® Instruments TABLE DES MATIÈRES M.blue plus Instruments M.blue plus Instruments...
Page 35
Champ d'application Décrit une situation potentiellement dan- M.blue plus Instruments gereuse. Si elle n'est pas évitée, elle peut causer des dégâts matériels au produit ou à M.blue plus Compass l'environnement. M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue Checkmate 1.02 CONVENTIONS DE REPRÉSEN-...
M.blue plus ® Instruments 1.03 AUTRES DOCUMENTS 2.00 DESCRIPTION DES D'ACCOMPAGNEMENT ET MATÉRIEL M.blue plus Instruments D'INFORMATION COMPLÉMENTAIRE 2.01 OBJECTIF MÉDICAL M.blue plus Instruments M.blue proGAV 2.0 2.02 BÉNÉFICE CLINIQUE Options thérapeutiques 1.04 COMMENTAIRE SUR LE MODE D'EM- PLOI M.blue proGAV 2.0 1.05 DROIT D'AUTEUR, CLAUSE DE NON- 2.03 INDICATIONS...
M.blue 3.01 DESCRIPTION DU PRODUIT M.blue plus Adjustment Ring 3.01.01 COMPOSANTS AUTORISÉS proGAV 2.0 M.blue plus Instruments M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Instruments M.blue plus Adjustment Assistant M.blue Checkmate Fig. 5: M.blue plus Adjustment Ring Réf.
Page 39
M.blue plus ® Instruments Contenu de l'emballage Nombre (réf. FX892T) M.blue plus Adjustment Ring M.blue plus Ins- truments Contenu de l'emballage Nombre (réf. FX893T) M.blue plus Adjustment Assis- 3.01.07 CONFORMITÉ DU PRODUIT tant M.blue plus Ins- truments Contenu de l'emballage Nombre (réf.
Instruments, mais aussi avec les proGAV 2.0 Tools décrits. 3.04.03 MATÉRIEL NÉCESSAIRE Conditions de stockage M.blue proGAV 2.0 Plage de températures M.blue plus Compass M.blue plus de stockage Adjustment Ring M.blue plus Adjustment Assistant 3.04 UTILISATION DU PRODUIT 3.04.01 INTRODUCTION M.blue...
Page 41
3.04.05 RÉGLAGE DE M.blue 1. Localisation Fig. 6: Localisation de la valve AVERTISSEMENT Il faut placer la M.blue plus Compass centrée 2. Opération de contrôle le mieux possible sur la valve, sinon la pres- sion d'ouverture risque d'être incorrectement déterminée.
Page 42
O et ensuite de 22 à 36 cmH Compass Fig. 8: Bague graduée de la M.blue plus Compass 1. Intérieur : L'échelle de l'unité gravitationnelle de la M.blue entre 0 et 40 cmH 2. Extérieur : L'échelle de l'unité de pression différen- tielle de la proGAV 2.0 entre 0 et 20 cmH...
Page 43
M.blue plus ® Instruments Fig. 12: M.blue plus Adjustment Assistant Vérification après le réglage Fig. 11: Réglage par la M.blue plus Adjustment Ring proGAV 2.0 M.blue Checkmate 0297 M.blue M.blue Checkmate M.blue Checkmate M.blue M.blue Check- mate M.blue M.blue Checkmate M.blue Checkmate M.blue M.blue Checkmate...
M.blue plus ® Instruments 3.04.06 RECOMMANDATION DE NET- TOYAGE POUR LES M.blue plus Instru- ments NON STÉRILISABLES REMARQUE Les M.blue plus Instruments sont fabriqués à partir de composants thermolabiles, sen- sibles à la chaleur et à l'humidité ainsi que réagissant chimiquement. Ne pas placer les M.blue plus Instruments dans des solutions de nettoyage ou laisser des liquides péné- trer dans le boîtier, car l'humidité, la corro-...
Page 45
M.blue plus ® Instruments Nettoyage/désinfection mécanique avec prélavage manuel Phase Étape T (°C/°F) t (min) Conc. (%) Qualité de l'eau chimie EP : Eau potable ; TA : Température ambiante Nettoyage mécanique alcalin et désinfection thermique Phase Étape T (°C/°F) t (min) Qualité...
Page 46
M.blue plus Compass proGAV 2.0 M.blue pro- GAV 2.0 3.05 ÉLIMINATION M.blue plus Instruments M.blue 3.06 RECHERCHE DE PANNE ET DÉPAN- NAGE M.blue plus Compass M.blue plus Compass M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Compass M.blue plus Compass...
Page 47
® Instruments M.blue proGAV 2.0 3.07 INFORMATIONS TECHNIQUES 3.07.01 DONNÉES TECHNIQUES Fabricant Christoph Miethke GmbH & Co. KG M.blue plus Instruments M.blue Checkmate M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant...
Page 48
M.blue plus ® Instruments 3.08 SYMBOLES UTILISÉS POUR LA Symbole Explication SIGNALÉTIQUE Symbole Explication 4.00 EXPERTS DE NOS DISPOSITIFS MÉDICAUX Tél. +49 331 62083-0 info@miethke.com...
Page 50
M.blue plus ® Instruments ÍNDICE M.blue plus Instruments M.blue plus Instruments...
Page 51
Campo de aplicación M.blue plus Instruments NOTA Se refiere a una posible situación dañina. Si M.blue plus Compass no se evita, se puede dañar el producto o M.blue plus Adjustment Ring algo en el entorno. M.blue plus Adjustment Assistant M.blue Checkmate...
Page 52
M.blue plus ® Instruments 1.03 OTROS DOCUMENTOS ADJUNTOS Y 2.00 DESCRIPCIÓN DE LOS MATERIAL INFORMATIVO SUPLEMENTA- M.blue plus Instruments 2.01 USO MÉDICO PREVISTO M.blue plus Instruments M.blue proGAV 2.0 2.02 USO CLÍNICO Opciones terapéuticas 1.04 COMENTARIOS SOBRE LAS INS- TRUCCIONES DE USO M.blue proGAV 2.0 2.03 INDICACIONES...
M.blue plus Instruments 3.01 DESCRIPCIÓN DEL PRODUCTO 3.01.01 COMPONENTES AUTORIZADOS Nombre del Figura M.blue plus Instruments producto M.blue M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Instruments M.blue plus M.blue plus Adjustment Assistant M.blue Checkmate proGAV 2.0 N.º de artículo Figura 3.01.02 VOLUMEN DE SUMINISTRO...
M.blue plus ® Instruments Contenido del paquete Cantidad (N.º de artículo FX892T) M.blue plus Adjustment Ring M.blue plus Instruments Contenido del paquete Cantidad (N.º de artículo FX893T) 3.01.07 CONFORMIDAD DEL PRODUCTO M.blue plus Adjustment Assis- tant M.blue plus Instruments Contenido del paquete Cantidad (N.º...
Page 56
M.blue plus ® Instruments 3.02.02 COMPLICACIONES, 3.04.02 INDICACIONES DE SEGURIDAD Y EFECTOS SECUNDARIOS Y ADVERTENCIA RIEGOS RESIDUALES ATENCÍON El dispositivo M.blue plus Adjustment Ring M.blue plus Instruments emite un campo magnético. Los objetos metálicos y los dispositivos de almacena- miento magnéticos se deben mantener a una distancia de seguridad suficiente.
NOTA Las posibles burbujas de aire en la brújula M.blue plus Compass no afectan a su fun- proGAV 2.0 cionamiento. M.blue La brújula M.blue plus Compass es sensi- ble a campos magnéticos externos.
Page 58
M.blue plus ® Instruments ADVERTENCIA Al ajustar la unidad gravitacional de la vál- proGAV vula M.blue, debe asegurarse de no cam- biar la presión de apertura más de 16 cmH por cada proceso de ajuste; de lo contrario, podrían producirse errores. M.blue Ejemplo: La presión de apertura debe cam- biarse de 6 a 36 ...
Page 59
M.blue plus ® Instruments Fig. 12: M.blue plus Adjustment Assistant Comprobación tras realizar el ajuste M.blue Checkmate 0297 M.blue Checkmate Fig. 11: Ajuste con el anillo M.blue plus Adjustment M.blue Checkmate Ring proGAV 2.0 M.blue M.blue M.blue Checkmate M.blue M.blue Check- mate M.blue Checkmate M.blue...
Page 60
M.blue plus ® Instruments 3.04.06 RECOMENDACIONES DE LIM- PIEZA PARA LOS DISPOSITIVOS M.blue plus Instruments NO SUSCEPTIBLES DE ESTERILIZACIÓN NOTA Los dispositivos M.blue plus Instruments están fabricados con componentes termolá- biles y sensibles al calor, a la humedad y a reacciones químicas.
M.blue plus ® Instruments Limpieza mecánica alcalina y desinfección térmica Fase Paso T (°C/°F) t (min) Calidad agua Química A-P: Agua potable, A-D: Agua desionizada desmineralizada 3.05 ELIMINACIÓN DE RESIDUOS Control, cuidado, comprobación M.blue plus Instruments...
M.blue plus ® Instruments 3.06 LOCALIZACIÓN Y SOLUCIÓN DE AVERÍAS M.blue M.blue plus Compass M.blue plus Compass M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Compass M.blue plus Compass proGAV 2.0 M.blue plus Compass M.blue M.blue proGAV proGAV 2.0...
Page 63
M.blue plus ® Instruments 3.07 INFORMACIÓN TÉCNICA 3.07.01 DATOS TÉCNICOS Fabricante Christoph Miethke GmbH & Co. KG M.blue plus Instruments M.blue Checkmate M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant...
Page 64
M.blue plus ® Instruments 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 66
M.blue plus ® Instruments ÍNDICE M.blue plus Instruments M.blue plus Instruments...
Page 67
Âmbito de aplicação M.blue plus Instruments Identifica uma situação potencialmente danosa. Se não for evitada, o produto ou algo na sua proximidade poderá sofrer M.blue plus Compass danos. M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue Checkmate 1.02 CONVENÇÕES DE APRESENTAÇÃO Apresentação...
Page 68
M.blue plus ® Instruments 1.03 OUTROS DOCUMENTOS ANEXOS E 2.00 DESCRIÇÃO DOS MATERIAL INFORMATIVO COMPLEMEN- M.blue plus Instruments 2.01 FINALIDADE MÉDICA M.blue plus Instruments M.blue proGAV 2.0 2.02 UTILIDADE CLÍNICA Opções de terapia 1.04 FEEDBACK SOBRE AS INSTRUÇÕES M.blue DE UTILIZAÇÃO proGAV 2.0 2.03 INDICAÇÕES 1.05 COPYRIGHT, EXONERAÇÃO DE RES-...
2.0 2.07 AMBIENTE DE UTILIZAÇÃO PREVISTO 2.08 DESCRIÇÃO TÉCNICA M.blue plus Instruments M.blue proGAV 2.0 M.blue Fig. 4: M.blue plus Compass a) aberto b) fechado 1. Anel graduado 2. Bússola flutuante M.blue plus Adjustment Ring M.blue M.blue plus Adjustment Fig.
M.blue plus Instruments 3.01.02 EQUIPAMENTO FORNECIDO Conteúdo da embalagem Quantidade Nome do Figura (n.º do artigo: FX890T) produto M.blue plus Compass M.blue M.blue plus Adjustment Ring M.blue plus Instruments M.blue plus Conteúdo da embalagem Quantidade (n.º do artigo: FX891T) M.blue plus Compass proGAV 2.0...
M.blue plus ® Instruments 3.01.03 ESTERILIDADE 3.02 INFORMAÇÕES DE SEGURANÇA IMPORTANTES M.blue Checkmate M.blue 3.02.01 INSTRUÇÕES DE SEGURANÇA plus Instruments Importante! ATENÇÃO Caso a embalagem ou o produto apresentem danos, os produtos não poderão ser utiliza- ATENÇÃO dos. 3.01.04 REUTILIZAÇÃO E REESTERILIZA- Se a embalagem esterilizada do Check- ÇÃO mate estiver danificada, o produto não...
é permitida a utilização dos M.blue plus Instruments na proximidade de apa- relhos de ressonância magnética! 1. Localização ATENÇÃO O M.blue plus Compass deve ser colocado, se possível de forma centrada na válvula, caso contrário, pode resultar na determina- ção incorreta da pressão de abertura.
Page 73
2.0 M.blue plus Compass M.blue Fig. 6: Localização da válvula Fig. 8: Anel graduado do M.blue plus Compass 1. Interior: escala da unidade gravitacional da M.blue entre 0 e 40 cmH 2. Processo de verificação 2. Exterior: escala da pressão de abertura da uni- dade de pressão diferencial da proGAV 2.0 entre 0 e...
M.blue plus ® Instruments 3. Processo de regulação ATENÇÃO Durante a regulação da unidade de pres- são diferencial da proGAV 2.0 deve-se ter em atenção que a pressão de abertura só pode ser alterada no máximo 8 cmH por cada processo de regulação, caso contrário, podem ocorrer erros.
Page 75
M.blue plus ® Instruments Regulação com o assistente de regulação M.blue plus Adjustment Assistant M.blue plus Adjustment Assistant Fig. 13: M.blue Checkmate Cor: azul Níveis de pressão: 0 a 40 cmH 3.04.06 RECOMENDAÇÃO DE LIMPEZA PARA OS M.blue plus Instruments NÃO ESTERILIZÁVEIS OBSERVAÇÃO Os M.blue plus Instruments são fabricados...
Page 76
M.blue plus ® Instruments 3.04.07 LIMPEZA E DESINFEÇÃO DO Limpeza/desinfeção à máquina com lim- M.blue Checkmate peza prévia manual Evite danos no produto causados por agentes de limpeza/desinfeção inadequa- Fase dos e/ou temperaturas demasiado eleva- das! Passo T (°C/°F) t (min.) Conc.
Page 77
M.blue plus ® Instruments Limpeza alcalina à máquina e desinfeção térmica Fase Passo T (°C/°F) t (min.) Qualidade da água Químico A-P: Água potável, A-CD: Água completamente dessalinizada e desmineralizada Controlo, tratamento, verificação 3.05 ELIMINAÇÃO M.blue plus Instruments...
M.blue plus ® Instruments 3.06 IDENTIFICAÇÃO E RESOLUÇÃO DE FALHAS M.blue M.blue plus Compass M.blue plus Compass M.blue plus Com- pass M.blue plus Adjustment Ring M.blue plus Com- M.blue plus Compass pass proGAV 2.0 M.blue plus Com- pass M.blue M.blue proGAV 2.0...
Page 79
M.blue plus ® Instruments 3.07 INFORMAÇÕES TÉCNICAS 3.07.01 DADOS TÉCNICOS Fabricante Christoph Miethke GmbH & Co. KG M.blue plus Instruments M.blue Checkmate M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant...
Page 80
M.blue plus ® Instruments 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 82
M.blue plus ® Instruments INDICE M.blue plus Instruments M.blue plus Instruments...
Page 83
Ambito di validità NOTA M.blue plus Instruments Indica una possibile situazione dannosa. Se non prevenuti, possono provocare danni al M.blue plus Compass prodotto o agli oggetti circostanti. M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue Checkmate 1.02 CONVENZIONI GRAFICHE...
Page 84
M.blue plus ® Instruments 1.03 ALTRI DOCUMENTI DI ACCOMPA- 2.00 DESCRIZIONE DEGLI GNAMENTO E MATERIALE INFORMATIVO M.blue plus Instruments INTEGRATIVO 2.01 DESTINAZIONE MEDICA M.blue plus Instruments M.blue proGAV 2.0 2.02 VANTAGGIO CLINICO Opzioni terapeutiche 1.04 COMMENTI SULLE ISTRUZIONI PER L'USO M.blue proGAV 2.0 1.05 COPYRIGHT, ESCLUSIONE DI RES-...
M.blue plus Instruments 3.01 DESCRIZIONE DEL PRODOTTO 3.01.01 COMPONENTI CONSENTITI Nome del Figura M.blue plus Instruments prodotto M.blue M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Instruments M.blue plus M.blue plus Adjustment Assistant M.blue Checkmate proGAV 2.0 Cod. art.
Page 87
M.blue plus ® Instruments Contenuto della confezione Quantità (cod. art. FX892T) M.blue plus Adjustment Ring M.blue plus Instruments Contenuto della confezione Quantità (cod. art. FX893T) 3.01.07 CONFORMITÀ DEL PRODOTTO M.blue plus Adjustment Assi- stant M.blue plus Instruments Contenuto della confezione Quantità...
M.blue plus Instruments descritti sia con gli proGAV 2.0 Tools. 3.04.03 MATERIALI NECESSARI 3.03 TRASPORTO E CONSERVAZIONE M.blue proGAV 2.0 M.blue plus Compass Condizioni di conservazione M.blue plus Adjustment Ring M.blue plus Adjustment Assistant Intervallo di temperatura M.blue per la conservazione M.blue Checkmate...
Instruments 3.04.05 REGOLAZIONE DI M.blue 2. Procedimento di prova 1. Localizzazione AVVERTENZA La M.blue plus Compass deve essere col- locata il più possibile al centro della val- vola altrimenti possono verificarsi errori nella proGAV 2.0 determinazione della pressione di apertura.
M.blue plus ® Instruments Fig. 8: Anello graduato della M.blue plus Compass 1. Interno: scala dell'unità a gravitazione di M.blue da Fig. 9: Inserimento dell'Adjustment Ring 0 a 40 cmH 1. Adjustment Ring 2. Esterno: scala dell'unità a pressione differenziale 2.
Page 91
M.blue plus ® Instruments M.blue Checkmate pro- 0297 GAV 2.0 M.blue M.blue Checkmate M.blue Checkmate M.blue M.blue Checkmate M.blue M.blue Checkmate M.blue Checkmate M.blue M.blue Checkmate M.blue Regolazione con l'Adjustment Assistant M.blue plus Adjustment Assistant M.blue plus Adjustment Assistant Fig. 13: M.blue Checkmate Colore: blu Livelli di pressione: da 0 a 40 cmH 3.04.06 RACCOMANDAZIONI PER LA...
Page 92
M.blue plus ® Instruments Pulizia/disinfezione manuale M.blue plus Instru- ments M.blue Checkmate Pulizia/disinfezione a macchina 3.04.07 PULIZIA E DISINFEZIONE DEL M.blue Checkmate Evitare di danneggiare il prodotto con Pulizia/disinfezione a macchina con pulizia detergenti/disinfettanti inadeguati e/o tem- preliminare manuale perature troppo elevate. Fase Passo T (°C/°F)
Page 93
M.blue plus ® Instruments Pulizia alcalina a macchina e disinfezione termica Fase Passo T (°C/°F) t (min) Qualità dell’acqua Chimica A-P: acqua potabile, A-DD: acqua desalinizzata demineralizzata 3.05 SMALTIMENTO Controllo, cura, verifica M.blue plus Instruments...
M.blue plus ® Instruments 3.06 RICERCA E RISOLUZIONE DEI PRO- BLEMI M.blue M.blue plus Compass M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Compass M.blue plus Compass M.blue plus Com- pass proGAV 2.0 M.blue plus Compass M.blue M.blue proGAV 2.0...
M.blue plus ® Instruments 3.07 INFORMAZIONI TECNICHE 3.07.01 DATI TECNICI Produttore Christoph Miethke GmbH & Co. KG M.blue plus Instruments M.blue Checkmate M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant...
Page 96
M.blue plus ® Instruments 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 98
M.blue plus ® Instruments INHOUDSOPGAVE M.blue plus Instruments M.blue plus Instruments...
Page 99
Duidt op een mogelijk schadelijke situatie. Toepassingsgebied Als deze niet wordt gemeden, kan het pro- duct of iets in de omgeving hiervan bescha- M.blue plus Instruments digd raken. M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant 1.02 WEERGAVECONVENTIES M.blue Checkmate Weergave...
2.0 2.09 SYSTEEMCOMPONENTEN M.blue plus Instruments 3.01.02 LEVERINGSOMVANG Productnaam Afbeelding Inhoud verpakking Aantal (artikelnr. FX890T) M.blue M.blue plus Compass M.blue plus Adjustment Ring M.blue plus M.blue plus Instruments Inhoud verpakking Aantal proGAV 2.0 (artikelnr. FX891T) M.blue plus Compass M.blue plus Instruments 3.00 EIGENSCHAPPEN VAN DE...
Page 103
M.blue plus ® Instruments 3.01.03 STERILITEIT 3.02 BELANGRIJKE VEILIGHEIDSINFOR- MATIE M.blue Checkmate 3.02.01 VEILIGHEIDSVOORSCHRIFTEN M.blue plus Instruments Belangrijk! WAARSCHUWING Bij beschadiging van de verpakking of beschadiging van de producten mogen de WAARSCHUWING producten niet worden gebruikt. 3.01.04 HERHAALDELIJK GEBRUIK EN Als de steriele verpakking van de Check- HERSTERILISATIE mate is beschadigd, mag het product niet...
MRI-apparaat beschadigd kan raken. 1. Lokalisering Daarom is het gebruik van M.blue plus Instruments daar niet toegestaan! WAARSCHUWING Het M.blue plus Compass moet zo gecen- treerd mogelijk op het ventiel worden gezet, om een verkeerde uitlezing van de openings- druk te voorkomen.
Page 105
M.blue plus Compass proGAV 2.0 M.blue Afb. 6: Lokaliseren van het ventiel Afb. 8: Schalenring van het M.blue plus Compass 1. Binnen: Schaal van de gravitatie-eenheid van de M.blue van 0 tot 40 cmH 2. Testprocedure 2. Buiten: Schaal van de differentiaaldrukeenheid van de proGAV 2.0 van 0 tot 20 cmH...
Page 106
M.blue plus ® Instruments 3. Instelprocedure WAARSCHUWING Tijdens het instellen van de differentiaal- drukeenheid van de proGAV 2.0 moet ervoor worden gezorgd dat de openings- druk met maximaal 8 cmH O per instel- procedure wordt gewijzigd, om fouten te voorkomen. Afb.
Page 107
M.blue plus ® Instruments Instellen met de Adjustment Assistant M.blue plus Adjustment Assistant M.blue plus Adjustment Assistant Afb. 13: M.blue Checkmate Kleur: blauw Drukniveau: 0 tot 40 cmH 3.04.06 REINIGINGSAANBEVELING VOOR DE NIET-STERILISEERBARE M.blue plus Instruments AANWIJZING M.blue plus Instruments zijn samengesteld uit thermisch labiele, warmte- en voch- tigheidsgevoelige en chemisch reagerende Afb.
Page 108
M.blue plus ® Instruments 3.04.07 REINIGING EN DESINFECTIE VAN Machinale reiniging/desinfectie met hand- DE M.blue Checkmate matige voorreiniging Voorkom schade aan het product als gevolg van ongepaste reinigings-/desin- Fase fectiemiddelen en/of te hoge temperatu- ren! Stap T (°C/°F) t (min) Conc.
Page 109
M.blue plus ® Instruments Machinale alkalische reiniging en thermische desinfectie Fase Stap T (°C/°F) t (min) Water- kwaliteit Chemie DW: drinkwater: GDMW: gedemineraliseerd water Controle, onderhoud, testen 3.05 VERWIJDERING M.blue plus Instruments...
Page 110
M.blue plus ® Instruments 3.06 FOUTENOPSPORING EN - OPLOSSING M.blue M.blue plus Compass M.blue plus Compass M.blue plus Com- pass M.blue plus Adjustment Ring M.blue plus M.blue plus Compass Compass proGAV 2.0 M.blue plus Compass M.blue M.blue proGAV 2.0 proGAV 2.0...
Page 111
M.blue plus ® Instruments 3.07 TECHNISCHE INFORMATIE 3.07.01 TECHNISCHE GEGEVENS Fabrikant Christoph Miethke GmbH & Co. KG M.blue plus Instruments M.blue Checkmate M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant M.blue plus Compass M.blue plus Adjustment Ring M.blue plus Adjustment Assistant...
Need help?
Do you have a question about the M.blue plus Compass and is the answer not in the manual?
Questions and answers