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MEDIVITAL®

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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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