The integrated valve (VIPR) is a medical device designed to supply medical oxygen in “oxygen therapy” and is designed to facilitate the use and the filling operations, it also meets the safety standard requirements. The VIPR is made exclusively to mounting on cylinders and constitutes a unique system with the cylinder.
The pressure regulator is associated with a flow control made with calibrated holes, flow is indicated on a scale on the regulation of the flow itself. The device is made of molded brass (CW617N), integrated with aluminum and plastic parts. It is designed to be used exclusively to supply medical oxygen via a hose connector with calibrated outlet from 0 to 15 lt / m. It consists of a high pressure valve in direct connection, via threaded shank, with the cylinder. When the valve opens feeds a first stage piston reducer, the initial pressure of 200 bar is reduced to a pressure of about 4/5 bars. Through an internal connection this pressure feed, an additional pressure regulator; 2nd stage regulator, which reduces the pressure to about 2 bar, this pressure feed the flow adjustment mechanism which consists of a stainless steel diaphragm with calibrated holes. The manometer show the pressure in the cylinder. A cover is also included to protect the device that integrates with the stem of the cylinder itself.
Directive 93/42 EEC and subsequent amendments, Annex IX, rule 11, (All active devices intended to deliver and / or subtract medicines, body fluids or other substances from the body are into class IIa, unless this is done in a potentially dangerous form, to the nature of the substances in question, the part of the body concerned and the mode of application, in which case they are in Class IIb). Rationale indicating the reason why the manufacturer classifies the medical device in class IIb. “According to the description of the classification rule, according to the directive 93/42 CEE annex IX rule 11, we can say that the device (V.I.P.R. valve) is a valve with integrated pressure reducer”. It is intended, connected to a high pressure cylinder (200 bar), to deliver medicinal gases with nasal cannulas or masks. The flow can be adjusted manually directly by the user. It must also be certified as a transportable pressure device according to the 2010/35 / UE TPED directive. For these characteristics the device is classified in class IIb.
The charging adapter is an accessory used for emptying and filling the cylinder.