Intended Use; Device Specifi Cation; Installation Instructions - bpr Firesafe Instrucciones De Uso

EN - Instructions for Use - Firesafe™ Nozzle

Intended Use

The Firesafe Nozzle™ is a thermal fuse designed to extinguish an oxygen delivery tube fi re by stopping the fl ow of oxygen if the tube is
accidentally ignited and the fi re burns back and reaches the Firesafe™ Nozzle.
Oxygen fi res are relatively common, often caused by patients smoking whilst receiving oxygen therapy. Oxygen is not fl ammable but its
presence will drastically increase the rate and severity of combustion. Things that will not burn in air may do so in an oxygen enriched
environment. Should a fi re start in the oxygen delivery tube it will burn back towards the oxygen source, typically an oxygen cylinder, hospital
pipeline with a fl owmeter or an oxygen concentrator or liquid supply.
It is recommended that two Firesafe devices are fi tted to home oxygen delivery circuits. The fi rst should be positioned close to the source of
supply and the second close to the patient as shown in fi gure 1. It is recommended to protect all oxygen supply sources, including hospital
oxygen fl owmeters and oxygen cylinders, with at least one Firesafe device.
The Firesafe™ Nozzle is a risk control measure intended to be permanently fi tted to medical devices that deliver oxygen to 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.
There are a number of Firesafe™ Nozzle models available to cover a wide range of oxygen fl owmeters, gas cylinders, oxygen concentrators
and liquid supplies available in the market. Care should be taken to select the correct Firesafe™ Nozzle for the application.
The Firesafe™ Nozzle is intended for connection to reusable oxygen delivery devices, upstream of single patient use oxygen therapy sets
and similar equipment. It is contraindicated for use downstream of aerosolised drug therapy devices. The device is non-sterile and has an
intended life of 8 years.
Warnings!
1. Read through this instruction before installing a Firesafe™ Nozzle. 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 off ers a resistance to fl ow; consider the impact of this on the system when installing the device.
3. Do not store or install this device near an open fl ame or near a source of excessive heat that is likely to exceed that stated in the Device
Specifi cation.
4. Keep this device free from oil and/or grease. In particular, do not lubricate the hose barb connector.
5. Never administer oxygen or undertake oxygen therapy while smoking or when near an open fl ame.
6. Additional risk control measures (e.g. SpO2 monitoring with an alarm) are essential for patients who might suff er injury or death in the
event that their oxygen fl ow is stopped unexpectedly.
7. 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 fl uid or allow fl uid to enter
the device. The Firesafe™ Nozzle is maintenance free and has an intended life of 8 years. Dispose of any Firesafe™ Nozzle 8 years after the
manufacturing date engraved on the device. Once actuated, the Firesafe™ Nozzle cannot be reset and must be discarded.
Device Specifi cation
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

1. Remove the existing connector from the oxygen supply source and fi t the appropriate Firesafe™ Nozzle.
2. Check that gas fl ows freely through the Firesafe™ Nozzle and that there are no obvious leaks.
Warning! If a Firesafe™ Cannula Valve fi tted downstream of a Firesafe Nozzle™ is activated by fi re, the supply tube downstream of
Firesafe™ Nozzle will rise until it reaches the maximum output pressure of the supply system. In order to ensure that the connection between
the Firesafe™ Nozzle 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: When fi tting to an oxygen concentrator, to meet the requirements of ISO 8359:1996 AMD1 (2012), the DISS version of the Firesafe™
Nozzle (REF 827-0032) should be tightened to a torque of 1.5 to 2.0 Nm (1.1 to 1.5 lbf.ft). This will ensure the Firesafe™ Nozzle can only be
removed by the use of a tool. A specially adapted Firesafe™ Torque Wrench (REF 802-0017) is available for this purpose.
≤ 1 kPa at 2 l/min
≤ 2 kPa at 5 l/min
≤ 16 kPa at 15 l/min
0.7 - 20 l/min
(2) 1000 kPa
10 ml/min
5 ml/min
0 to 50 °C (32 to 122 °F)
-20 to 60 °C (-4 to 140 °F)
0 to 100% RH
(1) The Firesafe™ Nozzle can be safely
used at lower fl ow rates but may
not meet the internal leakage rate
specifi ed when activated in the event
of a fi re.
Maximum static pressure delivered
(2)
by the gas supply source.
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