Firesafe Cannula Valve Instructions for Use

EN - Instructions for Use - Firesafe™ Cannula Valve

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Intended Use The Firesafe™ Cannula Valve is a thermal fuse designed to extinguish an oxygen delivery tube fire and stop the flow of oxygen if the tube is accidentally ignited. It is recommended that at least two Firesafe™ devices are fitted to each oxygen delivery circuit. The first should be positioned close to the source of supply and the second close to the patient as shown in figure 1. The Firesafe™ Cannula Valve provides no protection if a fire burns through the oxygen delivery tubing upstream of the device.

Warnings 1. Read through this instruction before installing a Firesafe™ Cannula Valve. As with all medical equipment, attempting to use or install this device without a thorough understanding of its operation and limitations may result in patient or user injury. 2. This device is intended for use in oxygen delivery tubing that has a low static operating pressure not exceeding that stated in the device specification. It must not be used for other applications. 3. The device must be oriented correctly in the patient circuit as shown in figure 1. Failure to fit the device in the correct orientation will render it ineffective in the event of a fire. 4. This device offers a resistance to flow; consider the impact of this impedance on the system when installing the device. 5. Do not store or install this device near an open flame or near a source of excessive heat that is likely to exceed that stated in the Device Specification.This device must not be used in conjunction with heated oxygen humidifiers. 6. Keep this device free from oil and/or grease. In particular, do not lubricate the hose barb connectors. 7. Never administer oxygen or undertake oxygen therapy while smoking or when near an open flame. 8. Additional risk control measures (e.g. SpO2 monitoring with an alarm) are essential for patients who might suffer injury or death in the event that their oxygen flow is stopped unexpectedly. 9. The device is intended for single patient use and should not be moved between installations due to the risk of cross contamination. 10. This device is designed for use in the delivery of oxygen or oxygen enriched air. Do not use the device with any other gas.

Cleaning Clean the exterior surfaces of the device using an alcohol or disinfectant wipe. Do not immerse the device in any fluid or allow fluid to enter through the hose barb connections.

Maintenance & Disposal The Firesafe™ Cannula Valve is maintenance free and has an intended life of 4 years. Dispose of any Firesafe™ Cannula Valve 4 years after the manufacturing date stated on the device label. Once actuated, the Firesafe™ Cannula Valve cannot be reset and must be discarded.

Device Specification (1)

450 kPa

The Firesafe™ Cannula Valve can be safely used at lower flow rates but may not meet the internal leakage rate specified when activated in the event of a fire

Maximum internal leakage following activation

10 ml/min

(2)

Maximum external leakage following activation

5 ml/min

Flow Rate

≤ 1 kPa @ 2 l/min ≤ 2 kPa @ 5 l/min ≤ 16 kPa @ 15 l/min 0.7 to 20 l/min

Maximum Operating Pressure(2)

Resistance to Flow (1)

Operating Temperature

0 to 50 °C (32 to 122 °F)

Transit & Storage Temperature range

-20 to 60 °C (-4 to 140 °F)

Humidity Range

0 to 100% RH

Gas type

Oxygen/oxygen enriched air

Maximum static pressure delivered by the gas supply source

Installation Instructions Warning! When actuated, the Firesafe™ Cannula Valve will stop the gas flow. The pressure upstream of the device will rise until it reaches the maximum output pressure of the supply system. In order to ensure that the connection between the Firesafe™ Cannula Valve and the supply system can withstand this pressure, it is recommended that a type test be carried out with each style of trumpet connector or cannula tubing used. Note: Due to the differences in the flexibility of the materials used for tubing and trumpet connectors and variations of inner bore diameter, it may not always be possible to fully engage the third barb as shown in figure 1.