Main purpose of these medical device is to regulate the pressure of medical gasses which are coming from gas outlets in order to become useful for other medical devices and patient requirement.
Purpose of Use
Pressure and flow regulators are medical equipment used by healthcare professionals to ensure the delivery of required gases to patients or medical devices at specified flow rates and pressures during treatment. They are typically integrated with gas outlets, probes, and equipment rails.
Usage Environments
Pressure and flow regulators are commonly employed in operating rooms, intensive care units, service rooms, and treatment areas.
Do Not Use the Device in the Following Environments
It is strongly discouraged to use the device in areas where the oxygen concentration exceeds 25% by volume, in locations where flammable or explosive gas mixtures may be present, and in areas where magnetic field applications are being conducted (e.g., magnetic resonance imaging).
Product Conforming to the following Standards
✓ EN ISO 15223-1:2021 ✓ EN ISO 10524-1:2019 ✓ EN 62366-1:2015
✓ EN ISO 10524-2:2019 ✓ EN ISO 11197:2016 ✓ EN ISO 10524-3:2019
✓ EN ISO 14971:2020 ✓ EN ISO 10524-4:2008 ✓ EN ISO 20417:2021
✓ EN ISO 7396-1:2016 ✓ EN ISO 15001:2012 ✓ EN 60601-1:2009
✓ EN ISO 21969:2010 ✓ EN 60601-1-2:2016 ✓ EN ISO 15002:2010
✓ EN 60601-1-8:2008 ✓ EN 62304:2009 ✓ HTM02-01