BPR Medical

Firesafe

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Firesafe™ Cannula Valve 50 °C 0 °C Firesafe Cannula Valve Firesafe Nozzle 827-0001 0120 702-0121... BPR Medical Limited T: +44 (0)1623 628 281 22 Hamilton Way, Mansfield F: +44 (0)1623 628 289 Nottinghamshire cs@bprmedical... m NG18 5BU, United Kingdom www... rmedical... m

Firesafe Cannula Valve End User Instructions for Use

™ Firesafe - making oxygen therapy safer for everyone 4 EN Firesafe™ Cannula Valve - Instructions for Use 5 DE Firesafe™ Rückschlagventil – Bedienungsanleitung 6 FR Vanne de canule Firesafe™ - Mode d'emploi 7 ES Válvula para cánulas Firesafe™ - Instrucciones de uso 8 IT Valvola per cannula Firesafe™ - Istruzioni per l’uso 9 NL Firesafe™ Cannula Valve - Gebruiksaanwijzing 10 PT Válvula de cânula Firesafe™ - Instruções de utilização 11 SV Firesafe™ Slangventil - Användarinstruktioner 12 CZ Kanylový ventil Firesafe™ - Pokyny k použití 13 PL Zawór kaniuli Firesafe™ - Instrukcja obsługi 14 RU Клапан для канюли Firesafe™ - Инструкции по эксплуатации 15 RO Valva pentru canulă Firesafe™ - Instrucțiuni de utilizare 16 FI Firesafe™ kanyyliventtiili - Käyttöohje 17 DA Firesafe™ Cylinderventil - Brugsvejledning 18 SK Kanylový ventil Firesafe™ - Návod na použitie 19 NO Firesafe™ kanyleventil - Bruksanvisning 20 SL Ventil Firesafe™ za kanilo - Navodila za uporabo 21 LT Firesafe™ kaniulės vožtuvas - Naudojimo instrukcija 22 LV Firesafe™ kanulas vārsts - Lietošanas instrukcija 23 HU Használati útmutató Firesafe™ - kanülszelep 24 EL Βαλβίδα Κάννουλας Firesafe™ - Οδηγίες Χρήσης 25 ET Firesafe™ kanüüli klapp - Kasutusjuhend 26 BG Канюла с клапан Firesafe™ - Инструкции за употреба 27 HR Ventil kanile Firesafe™ - Upute za uporabu 50 °C 0 °C 702-0125... EN Figure 1 DE Abbildung 1 FR Figure 1 ES Figura 1 IT Figura 1 NL Afbeelding 1 PT Figura 1 SV Figur 1 CZ Obrázku 1 PL Rysunku 1 RU Рисунке 1 RO Figura 1 FI Kuvan 1 DA Figur 1 SK Obrázku č... NO Figur 1 SL Sliki 1 LT Pav 1 LV Attēlā 1 HU Ábra 1 EL Σχήµα 1 ET Joonisel 1 BG Фигура 1 HR Slici 1 Firesafe Nozzle Firesafe Cannula Valve 827-0001

Firesafe Cannula Valve Instructions for Use

Firesafe™ Flowmeter Instructions for Use 702-0049... May 2014 Contents 1... Symbols ... 2 2... Warnings and Cautions ... 3... 4... 5... 6... 2... Warnings! ... 2 2... Cautions! ... Functional Description ... 4 3... Intended Use ... 3... Technical Description ... 4 Operating Instructions ... 6 4... Connecting to Gas Supply ... 6 4... Adjusting the Flow ... 6 4... Reading the Flowmeter ... 6 4... Connecting to Patient ... 6 4... During Use ... 4... After Use ... Cleaning and Disinfection ... 5... Cleaning ... 7 5... Suspected Contamination ... 7 Maintenance... 7 6... Interim Inspection ... 7 6... Service and Repair ... 7... Specification ... 8 8... Troubleshooting... 9... Parts and Spares... 10 10... istributor Details ... 11

Firesafe Flowmeter Instructions for Use May 2014

Instructions for Use Firesafe™ Nozzle Intended Use The Firesafe™ Nozzle is a thermal fuse designed to stop the flow of oxygen in the event that the downstream PVC tube is ignited... n doing so, the fire in the PVC tube is inclined to extinguish because PVC will not normally burn in air... he Firesafe™ Nozzle is fitted directly to the outlet of each oxygen delivery device, typically an oxygen flowmeter or the outlet of an oxygen concentrator... everal models of Firesafe™ Nozzle are available to suit different types of connection... Style Part Number Bayonet 827-0011 Threaded 827-0021 DISS – 9/16” UNF 827-0031 Device Specification Maximum Flow Typical Resistance to Flow 25 l/min 1 kPa at 2 l/min 2 kPa at 5 l/min 16 kPa at 15 l/min (1) (2) Maximum Static Operating Pressure 1000 kPa (3) 10 ml/min (4) 5 ml/min 0°C to 50°C (32°F to 122°F) -20°C to 60°C (-4°F to 140°F) Maximum Internal Leak Maximum External Leak Operating Temperature Transport and Storage Temperature (1) Typical performance of the DISS version, other figures available on request... 2) Likely upstream system pressure following activation of a Firesafe™ Nozzle (3) Leak through the Firesafe™ Nozzle after full activation... ull activation may not occur at oxygen flow rates of less than 0... l/min; consequently, the internal leak rate may exceed the maximum value under very low flow conditions... 4) Leak from the Firesafe™ Nozzle body after full activation... Warnings! • Read through this entire manual before installing this Firesafe™ Nozzle... s 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... • Oxygen is not flammable but the presence of oxygen will drastically increase the rate and severity of combustion... il and/or grease in the presence of oxygen become highly combustible... o not use oil or grease on this device... n particular, do not lubricate the seals or hose barb connector... • Never administer oxygen or undertake oxygen therapy while smoking or when near an open flame... Cautions! • Do not install this device near an open flame or near a source of excessive heat that is likely to exceed 50°C (122°F)... • The performance of this device cannot be guaranteed when used at flow rates outside of those given in the device specification... • This device offers a resistence to flow; consider the impact of this impendance on the system when installing the device... 702-0047... EN No smoking Consult Instructions for Use Use no oil CE Marked to Medical Device Directive 93/42/EEC modified by directive 2007/47/EC Attention, consult accompanying documents Manufacturer BPR Medical Ltd, 22 Hamilton Way, Mansfield, Nottingham, NG18 5BU, UK February 2013 Fitting Instructions 1... Remove the existing connector from the flowmeter or oxygen concentrator outlet and replace with an equivalent Firesafe™ Nozzle in accordance with the manufacturer’s instructions for use... 2... Once installed, check that gas flows through the Firesafe™ Nozzle and there are no obvious leaks... 3... A DISS Firesafe™ Nozzle can be tightened in one of 2 ways: 1) by hand to allow easy removal or, 2) to ensure it cannot be removed by hand, should be installed and removed using an appropriate tool (Example: 802-0017 Firesafe™ Torque Wrench)... ee note below... Specific Note for DISS Models (when fitting to an Oxygen Concentrator) The DISS model (827-0032) pictured below should be fitted to a DISS outlet (CGA V-5-2005, connection 1240)... hey can be tightened to a torque of between 1... and 2... Nm, to ensure that the nozzle can only be detached by the operator and only with the use of a tool... his being in accordance with ISO 8359 Oxygen concentrators for medical use -- Safety requirements, sub clause 56... , additional requirements for fire mitigation (proposed)... Specific Note for Bayonet Models The bayonet model 827-0011 pictured below has an integrated locking pin that, once fitted, prevents the fitting from being easily removed from the flowmeter... o fit, push the locking pin back towards the barb tip... it the Firesafe™ Nozzle to the flowmeter and then snap the locking pin back into place... Pin Out Pin In Cleaning Clean the exterior surfaces of the device using an alcohol or disinfectant wipe... o not immerse the device in any fluid or allow fluid to enter the device... lways clean the device before moving it between flowmeters... Maintenance and Disposal The Firesafe™ Nozzle is maintenance free and has an intended life of 8 years... ispose of any Firesafe™ Nozzle 8 years after the manufacturing date stated on the device label... nce activated, the FireSafe™ Nozzle cannot be reset and should be discarded... he date of manufacture of a Firesafe™ Nozzle may be derived from the second line of the batch code, which is printed in the format yyyymm... 702-0047... EN BPR Medical Ltd, 22 Hamilton Way, Mansfield, Nottingham, NG18 5BU, UK February 2013

Firesafe Nozzle Instructions for Use Feb 2013