MEDIVITAL®

Whole medical range is available on

Pressure regulator integrated with cylinder valve for use with medical gases.

15 YEARS LIFE TIME

15 year life time ensured by extended endurance and cycle testing for future market requirements
Slow opening shut off valve with new Patented design
Latest technology highest shock resistant gauge
Flow selector designed for optimal gas flow and patient safety
Guard design provides maximum protection for the valve

USER FRIENDLY

Suitable for use in Homecare, Emergency and Hospital applications
Easy read Flow Selector and Gauge
Shut off valve with clear open /closed status colour coded marking
Ergonomic guard design allows easy handling of the cylinder package by all users
Compact and lightweight design less than 1150 gr
Easy clean guard material

HIGHEST SAFETY

Testing in accordance with the following standards: EN ISO 10524-3, ASTM G175 Pill test, EN ISO 10297
In accordance with (EU) 2017/745 Medical Device Regulation and TPED 2010/35 EU
Phthalate and Halogenated polymer free components
MRI compatible up to Tesla 3
For use with medical Oxygen, Air, O₂/N₂O, He/O₂ mixed gases up to 300 bar working pressure

735100000767 MediVital leaflet EN

735100000767_Medivital_UNI_MDR

TECHNICAL DATA

Gas:	O₂, Air, O₂/N₂O, He/O₂
Inlet pressure:	Up to 300 bar (4350 psi)
Outlet pressure:	3,6 to 5,5 bar - acc. to EN ISO 10524-3 (or per customer specification)
RPV closing:	> 3 bar
PRV opening and re-closing:	> 5,5 bar
Flow ranges:	0-6, 0-15 and 0-25 lpm
Materials:
Metallic parts (gas wetted):	brass
Elastomers:	EPDM, silicon, PUR
Plastics:	PA66, PEEK
Springs (gas wetted):	CuBe₂, CuSn₆
Dimensions:
Height:	153 mm
Width:	112 mm
Depth:	118 mm
Weight:*	1150 g
Inlet stem:	Tapered or parallel threads (17E, 25E, M18 x 1,5 per customer specification)
Filling port:	ISO 5145 or per customer specification
Regulatory status:	Complies with (EU) 2017/745 Medical Device Regulation Complies with TPED 2010/35/EU Complies with EN ISO 10524-3 Complies with EN ISO 10297 Complies with EN 1789 Complies with ASTM G175 Production in accordance with EN ISO 9001 and EN ISO 13485
Classification:	Class IIb
Manufacturer:	GCE s.r.o, Žižkova 381, 583 01 Chotěboř, Czech Republic

^{* Standard Combivalve (flow control unit 0 - 15 l/min, flow outlet, DIN quick coupling pressure outlet) with the guard. All technical data are given for information only and are subject to modifications by the manufacturer.}

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