SUNSET HEALTHCARE SOLUTIONS RES010 Firesafe Cannula Valve Instructions
- May 15, 2024
- SUNSET HEALTHCARE SOLUTIONS
Table of Contents
Instructions
for Use – Firesafe™ Cannula Valve
RES010 Firesafe Cannula Valve
Intended Use
The FiresafeTM Cannula Valve is a thermal fuse designed to extinguish an
oxygen delivery tube fire by stopping the flow of oxygen if the tube is
accidentally ignited and the fire bums back and reaches the device.
Oxygen fires are relatively common, often caused by patients smoking whilst
receiving oxygen therapy. Such fires are particularly prevalent where oxygen
therapy is provided in the home (domiciliary oxygen), where there is limited
patient supervision, though they may occur in more supervised environments
like healthcare facilities and nursing homes too.
Oxygen is not flammable but oxygen enrichment will dramatically increase the
rate and severity of combustion; materials that will not bum in air may do so
in an oxygen enriched environment. Should a fire start in the oxygen delivery
tube, it will bum back towards the oxygen source, typically an oxygen
cylinder, oxygen concentrator or liquid oxygen supply.
It is recommended that two Firesafe TM 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 FiresafeTM
Cannula Valve provides no protection if a fire bums through the oxygen
delivery tubing upstream of the device.
The FiresafeTM’ Cannula Valve supplied with this instruction is bidirectional
in operation and can be installed either way around in the oxygen delivery
tubing.
The Firesafe TM Cannula Valve is intended to be fitted as a risk control
measure to low flow, low pressure oxygen delivery circuits for patients
requiring supplemental oxygen, whether in the home, healthcare facility or in
the care of the emergency services. It may be used for patients for whom
supplemental oxygen is critical as long as the potential risks of introducing
the device are assessed and additional risk control measures, where necessary,
are applied. Risk controls may include monitoring and increased supervision of
the patient.
The FiresafeTM’ Cannula Valve is contraindicated for use downstream of
aerosolised drug therapy devices. The device is a non-sterile, single patient
use multiple use device.
Warnings!
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Read through this instruction before installing a FiresafetM 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. -
This device is intended for use in oxygen delivery tubing that has a low static operating pressure not exceeding that stated in the device It must not be used for other applications.
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This device offers a resistance to flow; consider the impact of this impedance on the system when installing the device.
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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.
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Keep this device free from oil and/or grease. In particular, do not lubricate the hose barb connectors.
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Never administer oxygen or undertake oxygen therapy while smoking or when near an open flame.
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Additional risk control measures (e.g. Sp02 monitoring with an alarm) are essential for patients who might suffer injury or death in the event that their oxygen flow is stopped unexpectedly.
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The device is intended for single patient multiple use and should not be moved between installations due to the risk of cross-
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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, Maintenance & Disposal
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. The FiresafetM Cannula Valve is maintenance free and has an intended life of 5 years. Dispose of any FiresafetM Cannula Valve when it reaches the expiry date stated on the device label. Once actuated, the Firesafe TM Cannula Valve cannot be reset and must be discarded.
Device Specification
Resistance to Flow| 0.07 kPa at 2 l/min
0.29 kPa at 5 l/min
0.97 kPa at 10 l/min
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Flow Rate (1)| 0.25 – 25 l/min
Maximum Operating Pressure(2)| 600 kPa
Maximum Internal Leakage Following Activation| 10 ml/min
Maximum External Leakage Following Activation| 5 ml/min
Operating Temperature| 0 to 50 °C (32 to 122 °F)
Transit & Storage Temperature range| -25 to 70 °C (-13 to 158 °F)
Humidity Range| 0 to 100% RH
(1) 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.
(2) 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 connector or 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 second barb as shown in figure 2.