Fresenius Medical Care’s heart & lung business unit, Xenios AG, introduces the all-new Xenios 2.0. This system enables healthcare professionals to take the next crucial step in extracorporeal life support (ECLS). It can be used for the full range of ECLS treatments, from neonatal to adult patients, and is approved according to the new Medical Device Regulation (MDR).

森尤斯医疗心肺业务部门 Xenios AG 推出全新 Xenios 2.0。该系统使医疗保健专业人员能够迈出体外生命支持 (ECLS) 的下一个关键步骤。它可用于从新生儿到成人患者的各种 ECLS 治疗，并根据新的医疗器械法规 (MDR) 获得批准。

This system enables healthcare professionals to take the next crucial step in extracorporeal life support (ECLS). It can be used for the full range of ECLS treatments, from neonatal to adult patients, and is approved according to the new Medical Device Regulation (MDR)..

该系统使医疗保健专业人员能够在体外生命支持（ECLS）方面迈出关键的下一步。它可以用于从新生儿到成年患者的全方位ECLS治疗，并根据新的医疗器械法规（MDR）获得批准。。

Xenios 2.0: Safety – simplicity – connectivity

Xenios 2.0：安全–简单–连接

The new device has been designed with innovative safety features, a simplified guided user interface, and advanced connectivity to support physicians and caregivers during ECLS treatment. Various new technical features were implemented during the development, including a redesigned graphical user interface (GUI).

新设备的设计具有创新的安全功能，简化的引导用户界面和先进的连接，可在ECLS治疗期间支持医生和护理人员。在开发过程中实现了各种新的技术功能，包括重新设计的图形用户界面（GUI）。

The new GUI supports all relevant handling steps and functions before and during treatment to make it as safe and trouble-free as possible..

新的GUI支持治疗前和治疗期间的所有相关处理步骤和功能，使其尽可能安全无故障。。

Safety. The system includes features such as power consumption monitoring, which can help with circuit handling. The design of the integrated pressure sensors (IPS) eliminates the risk of air aspiration and measures the pressure directly at the tubing kit. Additionally, the intelligent alarm functions offer recommendations for action in the event of certain physiological and technical alarms, ensuring prompt and appropriate responses..

安全。该系统包括功耗监测等功能，可以帮助处理电路。。此外，智能报警功能在发生某些生理和技术报警时提供行动建议，确保及时和适当的响应。。

Xenios 2.0 is equipped for various backup scenarios to maintain treatment even in the event of a system failure. Two backup battery packs supply the system with power during a power failure or interruption. A second pump drive can be used if the initial pump drive fails. In case of a technical failure of the operator unit itself, the pump drive and a battery pack can be connected directly to each other.

Xenios 2.0适用于各种备份场景，即使在系统出现故障的情况下也能维持治疗。两个备用电池组在电源故障或中断时为系统供电。如果初始泵驱动发生故障，可以使用第二个泵驱动。如果操作单元本身出现技术故障，泵驱动装置和电池组可以直接相互连接。

Simplicity. Comprehensive step-by-step explanations and illustrations during the priming procedure help to avoid user errors, making the system user-friendly. This reduces potential sources of failure that can occur during an ECLS treatment in advance and thus can save time. In addition, Xenios 2.0 supports the learning effort for new personnel so that they are able to prepare a kit for ECLS treatment even in stressful situations..

简单。在启动过程中，全面的逐步解释和插图有助于避免用户错误，使系统用户友好。这可以减少ECLS治疗过程中可能发生的潜在故障源，从而节省时间。此外，Xenios 2.0支持新员工的学习，以便他们即使在压力较大的情况下也能为ECLS治疗准备工具包。。

The trend display allows users to visualize critical parameters and observe how they change over time, providing a clear and continuous overview of the system.

趋势显示允许用户可视化关键参数并观察它们随时间的变化，从而提供系统的清晰而连续的概述。

Connectivity. The system supports the simple implementation of standards-based medical data, allowing for flexible integration of machine data into various patient monitoring systems. Medical data is automatically sent to a Patient Data Management System (PDMS) or Electronic Medical Record (EMR), which can significantly reduce the workload for healthcare providers by streamlining documentation and data management processes..

连通性。该系统支持基于标准的医疗数据的简单实现，允许将机器数据灵活集成到各种患者监测系统中。。。

An MDR-approved system available for the European CE market

MDR认可的系统可用于欧洲CE市场

An approval under the Medical Device Regulation (MDR) is a significantly higher bar than the previous Medical Device Directive (MDD) requirements, with an increased focus on safety, performance, and product lifecycle.

医疗器械法规（MDR）下的批准比之前的医疗器械指令（MDD）要求要高得多，并且更加关注安全性、性能和产品生命周期。

“Based on new regulatory requirements and the need for increased safety standards, the Xenios 2.0 offers enhanced safety features to support physicians and caregivers.”, says Dr. Benjamin Waldmann, CEO of Xenios AG, and adds: “With Xenios 2.0 we are taking the next step towards improved ECLS treatment.”.

“基于新的监管要求和提高安全标准的需要，Xenios 2.0提供了增强的安全功能，以支持医生和护理人员。”Xenios AG首席执行官Benjamin Waldmann博士说，并补充道：“通过Xenios 2.0，我们正在朝着改进ECLS治疗迈出下一步。”。

Fresenius Medical Care received approval from the notified body (CE 0123) at the end of August this year and will soon be able to make the first devices available.

今年 8 月底，费森尤斯医疗用品公司获得了指定机构的批准（CE 0123），很快就能推出首批设备。