Flow regulator FR-6

temperatureadultinfant

BQ IV Flow reglator controls IV flow stable and accurate during the infusion procedure. Extension set and rate flow regulator iv set with flow regulator available. – Material: white ABS and clear TPE – Colour: green or blue – Max operating pressure: 0.5 bar in static condition, Gravity Set – Max sterilization temperature: 50°C – Operating Range: 10 to 250 mL/h,5 to 200 mL/h – Tolerance of flow rate: 10%:30~250mL/h is ±20% , 20mL/h is -10% ~ +50% , <20mL/h is not defined – Stablity of Flow Rate: 10% flow rate fluctuation during 24 hours infusion (tested with NaCl 0,9% solution from glass bottles under room temperature 23±2°C) – No leakage under 50kpa – Test height: place the IV solution container at about 100cm above the outlet level – The inlet and outlet are suitable with Φ2.9*Φ4.05±0.1mm tubing – Use Cyclohexanone bond with tubing. Please note if cyclohexanone drops enter into the flow regulator body can cause channel clogging Class: IIa Sterilization Way:Can be EO Sterilized Destination/use:For single use DEHP Free: Yes Latex Free: Yes Biocompatibility: Yes Non-pyrogenic: Yes Shelf life: 3 years Conformity:European Directive 93/42/EEC Standards: The applicable harmonized standards: EN ISO 8536-4:2019 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed EN ISO14971:2012 Medical devices-Application of risk management to medical devices EN ISO13485:2016 Medical devices-Quality management systems-Requirements for regulatory purposes EN ISO 8536-13:2016 Infusion Equipment for medical use- Part 13 Graduated flow regulators for single use with fluid contact