EN - Instructions for Use - Firesafe™ Nozzle
Intended Use
The Firesafe Nozzle is intended to connect oxygen tubing to a source of supply for use during normobaric oxygen
therapy. A further non-medical purpose is to extinguish a fire in oxygen tubing and stop the flow of oxygen.
Precautions
1.
This device offers a resistance to flow; consider the impact of this on the system when installing the device.
2.
If the flow is blocked downstream, the pressure will rise to the supply system maximum pressure. It is recommended
that a type test is carried out to ensure connections can withstand this pressure.
3.
For oxygen concentrator applications, to meet the requirements of ISO 80601-2-69, the DISS version of the Firesafe
Nozzle (REF 827-0030) should be tightened to a torque of 3 Nm (2.2 lbf.ft). This will ensure the Firesafe Nozzle can
only be removed by the use of a tool.
4.
Do not immerse the device in any fluid or allow fluid to enter the device.
5.
If the packaging is damaged and unsealed or it has been exposed to temperatures outside the transport and storage
temperature range, the devices should not be used.
Warnings
1.
Do not administer oxygen therapy when smoking or when near sources of heat, flame or sparks.
2.
Keep this device free from oil and/or grease. Do not lubricate the hose barb.
3.
Additional risk control measures (e.g. SpO2 monitoring with an alarm) are essential for patients critically dependent
on oxygen therapy.
Installation Instructions
1.
Remove the existing connector (as applicable) from the oxygen supply source and fit the appropriate Firesafe
Nozzle.
2.
Check that gas flows freely through the Firesafe Nozzle and that there are no leaks.
If any serious incident that occurs relating to the device, it should be reported to BPR Medical and the relevant regulatory
authority where the incident occurred.
Cleaning, Maintenance & Disposal
The Firesafe Nozzle is a non-sterile, reusable medical device that does not require reprocessing between uses. Clean
the exterior surfaces of the device with mild detergent solution or disinfectant wipe. The Firesafe Nozzle is maintenance
free. If actuated by a fire, it cannot be reused and should be disposed of. There are no special considerations for disposal.
Device Specification
Resistance to Flow
Flow rate
(1)
Maximum operating pressure
Operating temperature
Transit & storage temperature range
Intended life
(3)
No smoking
0.2 kPa at 2 l/min
0.9 kPa at 5 l/min
6.8 kPa at 15 l/min
1 - 25 l/min
1000 kPa
(2)
0 to 50 °C (32 to 122 °F)
-25 to 70 °C (-13 to 158°F)
8 years
No naked flames
At flows less than 1 l/min, a fire will be
(1)
extinguished but the device may not shut
off the oxygen flow.
Maximum static pressure delivered by
(2)
the gas supply source.
An expiry date
is engraved on the
(3)
device.
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