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Long-term ventilator for intensive care. For patients requiring tidal volume starting at 50 ml.

Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more. Savina is used in intensive care units, recovery rooms, inter and intra hospital transport and subacute care facilities. LPO means Low-Pressure-Oxygen and allows the supply of oxygen from a low pressure source (such as an oxygen concentrator), independently of high pressure O2 sources. The external low pressure oxygen source is to be provided by the user. The LPO option does not affect the ventilation performance. The only difference between HPO and LPO mode is the supply and monitoring of the O2 concentration. The LPO Option is available for Savina with SW 3.n.

I am sorry but this document does not contain the information requested. This is a 510(k) premarket notification for a ventilator, and it describes the device's intended use and substantial equivalence to previously cleared devices. It does not include information about acceptance criteria or a study that proves the device meets those criteria, as such studies are typically required for more complex or novel devices that pose higher risks.

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