Pays: Biélorussie
Langue: russe
Source: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Eurosets S.r.l., ИТАЛИЯ
медицинская техника
Eurosets S.r.l.
2023-03-01
5 EN DESCRIPTION The device is a disposable tubing set manufactured to user specifications to be used during an E.C.L.S. procedure for the connection of patient arterial and venous cannulae with the pumping system. The device consists of a set of tubing made of PVC. The tubing’s inner contact surfaces are coated with A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.) system, based on Phosphoriylcoline (PC). The tubing set comprises: • an inflow line, connecting the drainage cannula to the centrifugal pump, and • an outflow line, connecting the outlet of the centrifugal pump to the return cannula. and may optionally include a centrifugal pump and a soft or hard shell reservoir with accessory lines for priming solution. Some configurations may contain a centrifuge pump or other devices by a manufacturer different from Eurosets. In such a case refer to the instructions for use of the relevant device, which accompany the set. The device is single-use, non-pyrogenic, and is supplied STERILE, sterilized by ethylene oxide. TECHNICAL FEATURES Device technical features are given in Table 1. _RECOMMENDED MINIMUM_ _BLOOD FLOW RATE_ 0.2 L/MIN _RECOMMENDED MAXIMUM_ _BLOOD FLOW RATE_ 7.0 L/MIN _MAXIMUM BLOOD_ _CONTACT SURFACE AREA_ 0.3 M 2 _TUBING:_ INTERNAL DIAMETER, MM WALL THICKNESS, MM VOLUME PER 1 M LENGTH 3/8” (9.53 MM) 71 CM 3 1/4” (6.35 MM) 3/32”(2.38 MM) 32 CM 3 3/16” (4.76 MM) 18 CM 3 TABLE 1 The list of materials in contact with blood is available upon request, contact EUROSETS or the authorized local representative. INTENDED USE The E.C.L.S. tubing set is intended for use on patients in extracorporeal circulation during E.C.L.S. procedure, which in current clinical practice, provides assisted extracorporeal circulation of the patient’s blood during conditions consistent with cardiac failure, usually in cases where the patient is unresponsive to pharmacologic management. The device is indicated for use on patients with acute, severe reversibile respiratory and/or cardiac failure, refractory to conve Lire le document complet