11.101

Nom de l'organisation

XVIVO B.V.

SRN

NL-MF-000018307

Statut du fabricant

—

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• CW999

  Use of the device in procedures other than those described in this manual may result in injury.
• CW999

  Start preparation of the recipient when the machine perfusion procedure is completed.
• CW999

  Any serious incident that has occurred in relation to the Liver Assist should be reported to XVIVO and the competent authority of the Member State in which the user and/or patient is established.
• CW999

  Please contact XVIVO directly with any complaint at: qa.xnl@xvivogroup.com
• CW999

  Do not use outside prescribed operation environment, higher temperatures may lead to less efficient cooling.
• CW999

  In the unlikely event that interruption caused by ESD discharge occurs, restart the device and confirm correct functioning. In case of malfunction, e.g. flow measurement, continue preservation using static cold storage.
• CW999

  Maintenance and servicing of the device, including replacement of the batteries, may only be performed by XVIVO-certified personnel. This modification will void the warranty and violates the conformity assessment of the Liver Assist.
• CW999

  • The Liver Assist is not intended to be in contact with the patient and therefore falls outside the definition of applied part. The perfusion set is in contact with the subsequent isolated organ. However, the following parts are treated as type B applied parts since they are in direct contact with the perfusion solution: o Pressure sensor cables o Temperature sensors o Flow sensors o Magnetic pump coupling
• CW999

  Use only manufacturer supplied sensors.
• CW999

  Do not install, use and/or store this unit in; a poorly ventilated room or in locations exposed to direct sunlight or strong artificial light.
• CW999

  Do not replace the IEC power cord or fuses. This modification will void the warranty and violates the conformity assessment of the Liver Assist.
• CW999

  Discard the used device following local regulations.
• CW999

  Safe use of the Liver Assist can only be guaranteed when the operator is a skilled and trained professional and has successfully followed a Liver Assist training course.
• CW999

  The USB cable is not allowed to be connected during perfusion.
• CW999

  • The device does rely on essential performance: o Perfusion temperature between 0°C & 43°C o Pressure below safety limit: P(T) = 2.41∙T + 40.76 (HA) P(T) = 0.207∙T + 21.381 (PV)
• CW999

  • In the unlikely event that, electromagnetic interference does occur, and degradation of the essential performance above is observed, please try one or more of the following measures: o Increase the distance between the Liver Assist and adjacent systems. o Connect the Liver Assist to an outlet on a separate circuit from that to which adjacent systems are connected.
• CW999

  Judgement regarding organ quality is the responsibility of the surgeon.
• CW999

  Use of the Liver Assist adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• CW999

  The POWER button on the Liver Assist will not completely shut off the power from the device. The internal power supply of the Liver Assist Thermo unit will still produce a low noise when the Liver Assist is switched off.
• CW999

  The mains power plug of the power supply is the separator that connects or disconnects the Liver Assist from the mains power. Avoid positioning the equipment such that access to the mains power plug, etc. is limited (so that disconnection becomes difficult).
• CW999

  The use of accessories, sensors and cables other than those specified, except for replacement parts sold by XVIVO, could result in increased electromagnetic emissions or decreased electromagnetic immunity of the ‘Liver Assist’ and result in improper operation.
• CW999

  The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
• CW999

  Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ‘Liver Assist’, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Marché principal en Pays-Bas ; disponible dans 10 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08719925460623

Basic UDI-DI

871992546100M2

Numéro de référence/catalogue

11.101

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://www.xvivogroup.com/resource-type/instructions-for-use/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• C0399CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER