Kidney Assist Transport™

Nom de l'organisation

XVIVO B.V.

SRN

NL-MF-000018307

Statut du fabricant

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22 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

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

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

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

  The accompanying power supply is part of the device. Only use the included ‘Power Supply, Protek PMP30M-12-A’ external power supply.
• CW999

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

  Use only the accompanying battery charger
• CW999

  Judgment of the measurement results regarding organ quality is the responsibility of the surgeon.
• CW999

  In the unlikely event that perfusion is unrecoverable, continue preservation using static cold storage.
• CW999

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

  In case of emergency and failing power button: disconnect pump head to stop perfusion.
• 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

  The USB connection is for servicing activities only and may not be connected during perfusion.
• CW999

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

  Yearly service is required to ensure optimal and safe functioning.
• CW999

  Servicing to any component of this device is to be performed by XVIVO certified personnel only. Unauthorized repair or modifications will void the warranty and may violate the conformity of the Kidney Assist Transport with the requirements of the applicable safety standards and regulations. Maintenance and servicing are not permitted while the device is functioning.
• CW999

  The Kidney Assist Transport does rely on essential performance: Pressure below safety limit: P < 70 mmHg
• CW999

  In the unlikely event that, electromagnetic interference does occur, and degradation of the essential performance is observed, please try to increase the distance between the Kidney Assist Transport and adjacent systems.
• 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 Kidney Assist Transport, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• CW999

  Use of the Kidney Assist Transport adjacent to or stacked with other equipment should be avoided as 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 use of accessories, transducers, and cables other than those specified, with the exception of replacement parts sold by XVIVO, could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Kidney Assist Transport and result in improper operation.
• CW999

  Avoid use of the device near the following strong sources of EM emissions that may be present in the device use environment (e.g., hospital, transport): high frequency (HF) surgical equipment, RFID emitters, and electronic article surveillance (i.e., theft detection) systems. Otherwise, degradation of the performance of this equipment could result.
• CW999

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

Marché principal en Pays-Bas ; disponible dans 13 pays au total.

Dénomination commerciale

Kidney Assist Transport™

Code d'UDI-DI

08719925460517

Basic UDI-DI

871992546100M2

Numéro de référence/catalogue

23.101

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