Intended Use; Device Specification; Installation Instructions - bpr firesafe Instrucciones De Uso

EN - Instructions for Use - Firesafe™ Cannula Valve

Intended Use

The Firesafe™ 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 burns 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 burn in
air may do so in an oxygen enriched environment. Should a fire start in the oxygen delivery tube, it will burn back towards the oxygen source,
typically an oxygen cylinder, oxygen concentrator or liquid oxygen supply.
It is recommended that 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.
The Firesafe™ Cannula Valve supplied with this instruction is bidirectional in operation and can be installed either way around in the oxygen
delivery tubing. The bidirectional Firesafe™ Cannula Valve is distinguishable from previous models as it has no arrows printed on the side
and the internal valve is orange.
The Firesafe™ 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 Firesafe™ Cannula Valve is contraindicated for use downstream of aerosolised drug therapy devices. The device is a non-sterile, single
patient use 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. This device offers a resistance to flow; consider the impact of this impedance on the system when installing the device.
4. 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.

5. Keep this device free from oil and/or grease. In particular, do not lubricate the hose barb connectors.
6. Never administer oxygen or undertake oxygen therapy while smoking or when near an open flame.
7. 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.
8. The device is intended for single patient use and should not be moved between installations due to the risk of cross-contamination.
9. 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 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
Resistance to Flow
Flow Rate
(1)
Maximum Operating Pressure
Maximum Internal Leakage Following Activation
Maximum External Leakage Following Activation
Operating Temperature
Transit & Storage Temperature range
Humidity Range

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 third barb as shown in figure 2.
0.16 kPa at 2 l/min
0.62 kPa at 5 l/min
4.2 kPa at 15 l/min
0.25 - 25 l/min
600 kPa
(2)
10 ml/min
5 ml/min
0 to 50 °C (32 to 122 °F)
-25 to 70 °C (-13 to 158 °F)
0 to 100% RH
The Firesafe™ Cannula Valve can
(1)
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 static pressure delivered
(2)
by the gas supply source.
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