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Operating Manual
for
MVE Vapor Shippers
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Certificate of Conformance
CHART INC.
2200 Airport Industrial Dr., Ste 500
Ball Ground, GA 30107
U.S.A
www.chartbiomed.com
Chart BioMedical Ltd.
Unit 6 – Ashville Way
Wokingham RG41 2PL
United Kingdom
Page
2-10
11-19
20- 27
28- 35
36-43
44-52
53- 61
63
Chart Australia Pty Ltd.
ABN 21 075 909 410
Sydney Business & Technology Centre
Unit 43 / 2 Railway Parade
Lidcombe, NSW 2141, Australia
Medical Product Services
Borngasse 20
35619 Braunfels, Germany
U
Ref 11562640 Rev
11/18
0029
0459
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Table of Contents
Related Manuals for CHART MVE SC 2/1V
Summary of Contents for CHART MVE SC 2/1V
- Page 1 Français 44-52 Português 53- 61 Certificate of Conformance CHART INC. Chart Australia Pty Ltd. 2200 Airport Industrial Dr., Ste 500 ABN 21 075 909 410 Ball Ground, GA 30107 Sydney Business & Technology Centre U.S.A Unit 43 / 2 Railway Parade www.chartbiomed.com...
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Page 2: General Description
CAUTION: Do not use dewars for longterm storage of human biological contents. Failure to follow Chart’s best operating practices, as set forth in the operating manual, can result in loss of contents. Products bearing the CE marking as shown comply with the requirements of Directive... - Page 3 SHIPPING INSTRUCTIONS UTILIZING THE QWICK CHARGE TECHNOLOGY MVE/Chart recommends the plastic protective shipping containers (PPSC) be used to help keep the Only units bearing QWICK charge label is equipped with QWICK charge technology. To utilize the Vapor Shipper in the upright position and reduce the risk of damage to your valuable asset. DO NOT QWick Charge Technology and charge in under 2 hours, do not allow unit to warm up above -150°C...
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Page 4: General Cleaning
Frost or condensation on the outside of unit would indicate either a weak or no vacuum. Inspect the to questions regarding shipping regulations contact a Chart, AI-Cryobiological Tech Service Representative. cork and cover for signs of damage that may affect NER and Hold Time. Inspect the outside of the tank for signs of shipping damage, such as large dents, especially around the neck tube area. - Page 5 "Repair/Blemished Product" – CHART warrants to the Purchaser that all repaired (D) Defects caused by effects of normal wear and tear; and (E) Acts of God, or other causes not within the control of CHART. equipment and factory blemished equipment (collectively, the "Repair/Blemished Products")
- Page 6 6. The provider of the Warranty is CHART. Relevant contact details are set out below regulations. It is your responsibility to provide correct information, such as warning or caution, on for CHART (to claim the Warranty, please use the contact details provided in shipping package.
- Page 7 MVE Cryopreservation Catalog or contact Customer or Technical Service for assistance. CAUTION: Do not use dewars for longterm storage of human biological contents. Failure to follow Chart’s best operating practices, as set forth in the operating manual, can result in loss of contents.
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Page 8: Shipping Instructions
90% water solution holds as the best method for decontamination. It is recommended that MVE/Chart recommends the plastic protective shipping containers (PPSC) be used to help keep the the unit is filled to its full capacity with the cleaning solution mixture, agitated, and then thoroughly Vapor Shipper in the upright position and reduce the risk of damage to your valuable asset. - Page 9 Weight and divide by 0.8083; then divide by NER. (D) Defects caused by effects of normal wear and tear; and (E) Acts of God, or other causes not within the control of CHART. (Charged Weight – Empty Weight) ÷ 0.8083...
- Page 10 (2) years from the date of shipment, except as provided below. CHART 6. The provider of the Warranty is CHART. Relevant contact details are set out below...
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Page 11: Allgemeine Beschreibung
Bedienungsanleitung für MVE Vapour Shippers Dieser qualitativ hochwertige, vakuumisolierte Behälter ist kompatibel mit unterschiedlichen Extremtemperaturen und einer breiten Palette von Anwendungsgebieten in der Kryobiologie. Die Vertretung (Richtlinie über Medizinprodukte): Haltbarkeit dieses Produkts beträgt fünf (5) Jahre. Medical Product Services, Borngasse 20, 35619 Braunfels, Germany Produkte, die über eine CE-Kennzeichnung verfügen, erfüllen die Anforderungen der MVE Vapor Shipper eignen sich hervorragend für den Transport von kryobiologischen Materialien. - Page 12 Inhaltsstoffen verwendet werden. Bei Nichtbefolgung der in der Handhabungsanleitung von Verwenden Sie die nachstehende Gewichtstabelle als allgemeine Anleitung, wenn Ihr Vapor Chart beschrieben besten Handhabungsmethoden kann es zum Verlust von Inhalten kommen. Shipper vollständig beladen ist. Die Werte dienen lediglich als Referenz. Das Gewicht kann aufgrund des Ladevorgangs variieren.
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Page 13: Allgemeine Reinigung
VERSANDANWEISUNGEN Im Inneren des Gefäßes: MVE / Chart empfiehlt, die Transportbehälter aus Kunststoff zu verwenden(PPSC), um den Vapor Für die Desinfizierung eines MVE Vapor Shippers können jegliche Reinigungsmittel verwendet werden, Shipper in aufrechter Position zu halten und das Risiko von Schäden an Ihrem wertvollen Gut zu die nicht mit Aluminium, Edelstahl bzw. - Page 14 Garantieansprüche, die sich nach einer Untersuchung durch CHART als nicht gerechtfertigt erweisen, da sie aus einem Grund resultieren, der nicht in der Garantie inbegriffen ist. In diesem Fall verrechnet CHART den Nominaltarif für die Reparatur der Einheit. 8. Gießen Sie LN2 gemäß Schritt 4 im Abschnitt HANDHABUNG aus. Setzen Sie den Korken / die Diese eingeschränkte Garantie bezieht sich nicht auf: (A) Normale Routine-Serviceteile;...
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Page 15: Descripción General
Manual de instrucciones para MVE de transporte de vapor Esta unidad aislada al vacío de gran calidad es compatible con las temperaturas extremas divergentes y con una gran variedad de aplicaciones de criobiología. La vida útil de este producto es Representante para las directrices de dispositivos médicos: de cinco (5) años. - Page 16 PRECAUCIÓN: No utilice los dewars para el almacenamiento a largo plazo de contenidos biológicos humanos. Si no se siguen las mejores prácticas operativas de Chart, como se Use la siguiente tabla de pesos como guía general para determinar si el transportador de vapor está...
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Page 17: Instrucciones De Envío
INSTRUCCIONES DE ENVÍO LIMPIEZA GENERAL Se recomienda el contenedor para envíos suministrado (PPSC) por MVE/Chart para ayudar a No use ninguna solución de limpieza basada en el petróleo. mantener el transportador de vapor en posición vertical y reduzca la posibilidad de que su activo Interior del contenedor: valioso se dañe. - Page 18 Producto nuevo, Producto reparado/con imperfecciones o Pieza de repuesto distintos a los aprobados Tiempo de retención = Ecuación 3 por CHART, (D) Defectos causados por efectos de uso y desgaste normales; y (E) Fuerza mayor u otras causas que no están dentro del control de CHART. TEMPERATURA DE MONITORIZACIÓN Si el Comprador cree que un Producto nuevo, Producto reparado/con imperfecciones o Pieza de repuesto no cumple con la garantía limitada...
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Page 19: Descrizione Generale
Istruzioni operative per contenitori di spedizione a vapori MVE Questa unità a vuoto isolata di alta qualità è compatibile con le variazioni di temperatura estreme e le numerose applicazioni della criobiologia. La durata prevista del prodotto è di cinque (5) anni. Rappresentante M.D.D.: Medical Product Services, Borngasse 20, 35619 Braunfels, Germany I prodotti che riportano il marchio CE mostrato in figura sono conformi ai requisiti della I contenitori per il trasporto di vapori MVE sono l’ideale per il trasporto di materiali criobiologici. - Page 20 UTILIZZO UTILIZZO DELLA TECNOLOGIA DI CARICAMENTO QWICK Le unità che sfruttano la tecnologia di caricamento QWICK sono quelle dotate della rispettiva ATTENZIONE: Considerare il valore dell'inventario durante la spedizione e determinare se etichetta. Per utilizzare la tecnologia di caricamento QWick e caricare l’unità in meno di 2 ore, l'inventario debba essere suddiviso tra più...
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Page 21: Pulizia Generale
ISTRUZIONI PER LA SPEDIZIONE PULIZIA GENERALE Si consiglia di servirsi della scatola di spedizione in plastica (PPSC) fornita da MVE/Chart per Non utilizzare soluzioni detergenti a base di petrolio. mantenere il contenitore per il trasporto di vapori in posizione verticale e ridurre la possibilità che il Internamente al contenitore: tuo bene prezioso venga danneggiato. - Page 22 (90) giorni dalla data di consegna, con l’esclusione dei casi sotto descritti. CHART garantisce che il vaso dewar sarà in ogni sua Questo prodotto può essere coperto da uno o più brevetti, validi negli Stati Uniti e all'estero. Visitare il nostro...
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Page 23: Description Générale
Mode d’emploi MVE pour les dewars de transport en vapeur d’azote Les produits portant le marquage CE tel qu’illustré sont conformes aux exigences de la directive 93/42/CEE relative aux dispositifs médicaux dans l’UE. Représentant M.D.D. : Medical Product Services, Borngasse 20, 35619 Braunfels, Germany SÉCURITÉ... - Page 24 MISE EN GARDE : Ne pas utiliser de dewars pour le stockage à long terme de contenu biologique humain. Le non-respect des meilleures pratiques d’exploitation de Chart, telles Se référer au tableau de mesures de poids suivant pour déterminer si le conteneur d’expédition en qu’énoncées dans le manuel d’utilisation, peut entraîner une perte du contenu.
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Page 25: Nettoyage Général
INSTRUCTIONS D’EXPÉDITION NETTOYAGE GÉNÉRAL Il est conseillé d’utiliser le container d’expédition en plastique (PPSC) fourni par MVE/Chart pour Ne pas utiliser de solution de nettoyage à base de pétrole. maintenir le conteneur en phase vapeur en position vertical et réduisez la possibilité que votre À... - Page 26 Au vu de ce qui précède, la consultation auprès de l’organisme Research and Special Programs pour rupture de garantie soit rédigée dans les 60 jours de la découverte d’un défaut prétendu. CHART ne sera pas Administration du Ministère des Transports des États-Unis a déterminé que l’utilisation de « réservoirs responsable d’une rupture présumée de garantie, qui, suite à...
- Page 27 échue de la garantie limitée ou (90) jours à compter de la date d’expédition à Manual Operacional de Botijões de Transporte de Vapor MVE l’acheteur, quelque soit la durée. L’INDEMNITÉ DE CHART VERSÉE À L’ACHETEUR POUR TOUTE RÉCLAMATION Rappresentante M.D.D.: Medical Product Services, Borngasse 20, 35619 Braunfels, Germany NE DOIT PAS DÉPASSER LE PRIX D’ACHAT DE L’ACHETEUR DU NOUVEAU PRODUIT, PRODUIT DE...
- Page 28 ATENÇÃO: Não utilize dewars para o armazenamento de longo prazo de conteúdo biológico transferência de azoto líquido, ou quaisquer objectos que tenham estado em contacto com humano. O descumprimento das boas práticas operacionais da Chart, conforme estabelecidas azoto líquido. no manual de operação, pode resultar em perda de conteúdo.
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Page 29: Instruções De Transporte
Só as unidades com o rótulo QWICK charge estão equipadas com a tecnologia QWICK charge. O recipiente de plástico para transporte (PPSC) fornecido pela MVE/Chart é recomendado para ajudar Para utilizar a Tecnologia QWick Charge e completar o carregamento em menos de 2 horas, não a manter o Vapor Shipper direito, na vertical, e reduza a possibilidade de seu ativo valioso ser permita que a temperatura da unidade ultrapasse os -150°C entre cada transporte. -
Page 30: Manutenção Preventiva
LIMPEZA GERAL 6. Efetue uma segunda pesagem e registe o resultado como Segundo peso, [kg]. 7. Calcule a taxa de evaporação usando a Equação 2. A diferença entre o primeiro peso e o Não use soluções de limpeza à base de petróleo. segundo peso constitui a taxa de evaporação em kg. - Page 31 O Comprador também concorda que qualquer reclamação por violação da GARANTIA OU DECLARAÇÃO, EXPRESSA OU IMPLÍCITA, E, ATRAVÉS DO PRESENTE garantia deve ser feita, por escrito, dentro de 60 dias da descoberta do suposto defeito. A CHART não se REJEITA QUAISQUER OUTRAS GARANTIAS, INCLUINDO, MAS NÃO LIMITADAS ÀS responsabilizará...
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Page 32: Certificate Of Conformance
™ CERTIFICATE OF CONFORMANCE This document certifies that the accompanied dewar upon date of manufacture has successfully passed Chart’s internal factory inspection/testing processes, including: • Mass Spectrometer Vacuum Leak Testing • Vacuum Sealoff Testing • Final Visual Inspection This certificate is not to be interpreted as a warranty,...