Device Specifications:
| Gas Compatibility | Oxygen and oxygen enriched air |
|---|---|
| Maximum Operating Pressure | 600 kPa*
*Maximum static pressure delivered by the gas supply source |
| Flow Rate | 0.25* - 25 l/min
*The Firesafe Cannula Valve can be safely used at lower flow rates but may not meet the internal leak rate of 10 ml/min when activated in the event of a fire. |
| Resistance to Flow | ≤ 0.16 kPa at 2 l/min ≤ 0.75 kPa at 5 l/min ≤ 2.1 kPa at 10 l/min ≤ 4.2 kPa at 15 l/min ≤ 9.8 kPa at 25 l/min |
| Intended Life | 4 years after date of manufacture (engraved on device) |
| Application | Single patient use |
| Packaging | 100 units per box (5 bags per box, 20 units per bag) |
| Connections | EN 13544-2, 6 mm nominal tubing connection |
| Environmental Limits for Transport and Storage | Temperature: -25 °C (-13 °F) to 70 °C (158 °F) Humidity: 0 - 100 % RH |
| Environmental Limits for Use | Temperature: 0 °C (32 °F) to 50 °C (122 °F) Humidity: 0 - 100 % RH, including internal condensation |
| Applied Standards | EN 13544-2:2002 - Respiratory Therapy Equipment - Part 2: Tubing and connectors. |
| Regulatory | EC: MDD Class IIa Medical Device USA: FDA Class 1 Medical Device; 510(k) exempt Canada: Health Canada licence ref. 78173 Japan: PMDA Class 2 Medical Device Australia: Class IIa, ARTG Indentifiers 177167, 261117 GMDN Code and Term: 60391 - Fire safety valve |
The Firesafe Cannula Valve is a thermal fuse designed to stop the flow of gas in the event that the downstream oxygen tubing is ignited.
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