Oxygen Demand Valve - IFU - 702-0051 - EN
Contents
1. ultraflow Oxygen Demand Valve Instructions for Use x wd wr 2 01200 THEQUEEN S AWARDS FOR ENTERPRISE 702 0051 13 June 2014 SA ee ee 2 25 Wamings and Cautions nee eee ee ee ee oe eee eee eee ee 2 2d NAT tithe ae ee one Petes cede ee EEE E 2 22 AMOS euere einen 3 23 APP ee ee BIER ee aye ee eer ye ae ery eee ee ae 3 3 Functional DescriptiON s ssimic ee 4 Jl Intended USE rresten e EE TE E EE near 4 3 2 Technical Description Ra A ernennen Greene 4 4 Operating INSWUCUONS anne eier 5 4 1 Fitting the Exhalation Vale eek ee 5 4 2 Rem ving the LANG nenne la 5 4 3 Refitting the Lanyard na a a a 5 AM Connecting tothe Oxygen SU u 5 ADs Testing Prior TO USS sr ide 5 4 6 Fitting an Exhalation VaWe c c ccc acse ctsecsscocccanesantetdiaastaecenndehsateanneedtanasocoteiaisataneecandeepateacctestociesidess 6 A l OP ria 6 48 After Use euere 6 5 Cleaning and Disinfecton ne une 7 5 1 After Every Use nn ee 7 5 2 SUSpecica CONTAMINA cc E E E E 7 6 Maintenance mimar iS 7 6 1 User Maintenance and Inspection eemnnie ea 7 o o FE E E ee o er eer 8 Troubleshosindg ae era 9 Pals and SO al SS nro 10 105 DiStIDULOED Sta Seize ra cece ate ate tte IAE a eh DUE TA gfe anes 11 E Symbols Warning Indicates a potentially hazardous situation which if not avoided could result in personal injury to the user or others Caution Indicates a potentially hazardous situation which if not avoided could result in d2. for the patient in the following circumstances o If the oxygen regulator or oxygen supply used does not meet the specification 3 o If an extension hose other than those listed in this manual for use with the demand valve is used 3 Functional Description 3 1 Intended Use The Ultraflow Oxygen Demand Valve is intended to be used for the delivery of 100 oxygen in response to the patient s inspiratory effort on the order of a physician This product is designed for use with adult and paediatric patients in hospitals ambulances or other managed clinical environments This product is not intended to be used with infants or neonates 3 2 Technical Description The demand valve comprises of two main components a demand valve handset and a single patient use exhalation valve supplied separately The exhalation valve is single patient use to prevent cross contamination between patients It may be used by a single patient for up to 30 days The demand valve handset is designed to be reused and can be cleaned and disinfected although routine disinfection is not necessary as it is protected from contamination by the single patient use exhalation valve The demand valve handset contains a specially designed tilt valve mechanism that opens when the diaphragm in the back of the demand valve handset moves forward as a result of the patient inhaling When the tilt valve opens the gas which is under pressure behind the tilt valve pas
3. After Use When oxygen therapy is complete disconnect the demand valve from the oxygen supply Where the oxygen is being supplied from a cylinder turn the cylinder off and depressurise the handset before disconnection by pressing the Test Button until the gas is fully exhausted Store the demand valve in a clean dry environment between uses 5 Cleaning and Disinfection Ensure the demand valve handset is disconnected from the gas supply before attempting to clean it Caution The demand valve is not suitable for autoclaving The handset is protected against contamination during normal use by a single patient use exhalation valve 5 1 After Every Use Wipe over the outside of the demand valve handset and the gas supply hose with an alcohol or disinfecting wipe 5 2 Suspected Contamination If you suspect that the demand valve handset is contaminated remove it from use and refer to the Oxygen Demand Valve Service Manual Never immerse the demand valve handset in any fluid or attempt to clean internal parts whilst the demand valve handset is assembled 6 Maintenance 6 1 User Maintenance and Inspection All demand valves should be inspected and tested on an annual basis to ensure correct performance The demand valve handset must be serviced every 4 years to ensure that it continues to perform in accordance with its specification Full details of the recommended servicing requirements can be found in the Service Manual Servicing mu
4. Valve 3m Hose DIN connector 13260 2 831 3003 Oxygen Demand Valve 3m Hose Nordica AGA connector SS 875 24 30 831 4003 Oxygen Demand Valve 3m Hose BS 5682 connector 831 5003 Oxygen Demand Valve 3m Hose DISS connector CGA V 5 1240 Consumables 828 0044 Single Patient Use Exhalation Valve for use with Face Mask 10 EN 1281 1 22mm 828 0045 Single Patient Use Exhalation Valve with Mouthpiece 10 EN 1281 1 22mm 828 0046 Single Patient Use Face Mask Box 40 EN 1281 1 22mm Spare Parts and Servicing 609 0082 Oxygen Demand Valve Cover Grey 212 0067 Demand Valve Lanyard 831 5504 Oxygen Demand Valve 4m DISS extension hose 999 1002 Demand Valve Factory Service 999 1003 Oxygen Demand Valve Service Kit 3m Hose AFNOR 999 2003 Oxygen Demand Valve Service Kit 3m Hose DIN 999 3003 Oxygen Demand Valve Service Kit 3m Hose Nordica AGA 999 4003 Oxygen Demand Valve Service Kit 3m Hose BS 5682 999 5003 Oxygen Demand Valve Service Kit 3m Hose DISS Demand Valve Test Instrument 828 0053 Demand Valve Test Instrument 605 0060 Demand Valve Test Instrument supply hose MA4 CPC BS 5682 605 0072 Demand Valve Test Instrument adaptor hose MA4 O BS 5682 10 Distributor Details Ultra High Flow Limited 11 The Courtyard Essendon Park Essendon Hertfordshire AL9 6GH customer service ultrahighflow com www ultrahighflow com 11 12 13 wall BPR Medical Limi
5. amage to the equipment or property Note Highlights points that might allow more convenient or efficient operation of the equipment Attention consult accompanying documents Use no oil X gt CE Marked to Medical Device Directive 93 42 EEC as amended by directive 2007 47 CE o N o No smoking Single use or Single patient use Service due date 6 SN 1304X12345 M YYMM os Use by 2 Warnings and Cautions 2 1 Warnings Date of manufacture identification gt Read through this entire instruction manual before using or showing others how to use this demand valve As with all medical equipment attempting to use this device without a thorough understanding of its operation may result in patient or user injury gt In the United States of America Federal Law restricts this device to sale by or on the order of a physician gt Oxygen is or should be considered a drug and supplemental oxygen should only be used for medical purposes on the authority of a physician and then strictly in accordance with their instructions gt Oxygen therapy may be a critical treatment Additional risk control measures such as SpO monitoring with an alarm and a backup oxygen supply with delivery device should be provided for patients who might suffer distress or injury if their oxygen supply is not available or is stopped unexpectedly 2 2 2 3 Ensure that the oxygen supply is sufficient for the proposed th
6. erapy and is supplied within the pressure range given in the Device Specification If the supply is an oxygen cylinder check the cylinder contents gauge regularly This demand valve is only for use with medical grade oxygen Check the cylinder or supply is medical grade oxygen before use Use a new exhalation valve for each new patient or after 30 days of use for the same patient The demand valve should not be used as a resuscitator Gas specific connectors are fitted to the demand valve Do not attempt to modify the fittings to suit other gases or fitting systems Oxygen is not flammable however the presence of it will drastically increase the rate and severity of combustion Oil and or grease in the presence of an oxygen enriched atmosphere will become highly combustible Oxygen must never be allowed to come into contact with oil grease or other petroleum based substances Do not use oil or grease on this demand valve Do not use or store analgesic gas near excessive heat gt 50 C 125 F Always refer to the medical gas suppliers recommendations Do not smoke around oxygen equipment Only appropriately trained personnel working in controlled conditions may disassemble or assemble this demand valve Disassemble the device before cleaning Do not submerge an assembled demand valve in any fluid Do not use 100 oxygen as a pressure medium to purge obstructed pipelines or equipment to operate pneumatic tools or to build up any pre
7. hrough the mouthpiece or face mask Repair or service required Audible gas leak Valve or diaphragm has become dislodged Remove the exhalation valve and check that the diaphragm is laying flat and that it moves forwards and backwards when the Test Button is pressed Tilt valve worn bent or broken Repair or service required Constant gas flow Tilt valve damaged or blocked Repair or service required Insufficient gas flow Tilt valve damaged Repair or service required Diaphragm perforated Repair or service required Supply pressure too low and or gas cylinder nearly empty Check gas supply and or replace gas cylinder Exhalation valve will not fit to or be retained on the demand valve body Single patient use exhalation valve has damaged location lugs Check the underside of the single use exhalation valve to see if the locating lugs have been bent over or otherwise damaged It is important to rotate the single use exhalation valve until it locates in the demand valve housing before pressing it down and engaging the locating ears Trying to force the single patient use exhalation valve down before correctly locating it will damage the exhalation valve beyond repair Fit a new single patient use exhalation valve 9 Parts and Spares Part Number Description 831 1003 Oxygen Demand Valve 3m Hose AFNOR connector NF S 90 116 831 2003 Oxygen Demand
8. lling the gas hose before turning on the supply pressure 4 5 Testing Prior to Use Confirm the correct operation of the demand valve before beginning therapy by pressing the Test Button Oxygen should flow freely when the Test Button is pressed and should stop when the Test Button is released If the demand valve does not operate correctly remove it from use and refer to the trouble shooting guide in Section 8 of this booklet 4 6 4 7 4 8 Fitting an Exhalation Valve Use a new exhalation valve for each new patient or after 30 days of use The exhalation valve should be replaced if it becomes soiled or discoloured 1 Place the exhalation 2 Rotate the exhalation 3 Press down the securing valve on the demand valve until it clicks into clip on each side to lock into valve handset as shown place then press down place Do not apply any force at this stage 4 Fit a face mask or mouthpiece 3 Operation The patient should place the mouthpiece into their mouth or the face mask over their nose and mouth and inhale The deeper the patient breathes the greater the volume of oxygen delivered The demand valve is designed for self administration of oxygen and should not be used for periods beyond those prescribed Do not attach the face mask with a head strap or harness Continue to monitor the gas cylinder contents if applicable during use of the demand valve and be aware that the hose may be a trip hazard
9. ng the demand valve when they are not actively using it Should a patient not want the lanyard then it can be removed To remove the lanyard simply pull the lanyard retainer downwards until it is free of the moulded cover and lift the lanyard away Then refit the lanyard retainer 4 3 Refitting the Lanyard 1 To refit the lanyard simply 2 Fitthe lanyard into the 3 Refit the lanyard retainer pull away the lanyard retainer groove in the handset cover taking care to line up the slots in the lanyard retainer with the lanyard 4 4 Connecting to the Oxygen Supply Before use visually check both the hose and demand valve for any damage or contamination Do not connect or use the device if there are any doubts about its condition The demand valve is supplied with a gas specific connector that is designed to connect to a mating gas outlet Gas outlets might be part of a terminal unit in a medical gas pipeline system or part of a pressure regulator outlet on a gas cylinder If you are using a cylinder supply ensure that the cylinder contents are adequate for planned therapy Connect the gas specific inlet connector to the appropriate gas outlet Warning Where the gas specific connector is dependent on a threaded fastener e g DISS CGA V 5 1240 make sure that the connection is tight before turning on the supply pressure For quick connector probes e g BS5682 SIS AFNOR ensure that the connection is correctly made by gently pu
10. ory equipment Compatibility with oxygen Medical devices Symbols to be used with medical device labels labelling and ESTAN Bo information to be supplied General requirements NFS 90 116 Medico surgical equipment Terminal units and related probes for medical fluids Supply systems for medical gases Part 2 Dimensions and allocation of probes DIN 13260 2 and gas specific connection points for terminal units for compressed medical gases and vacuum SS 875 24 30 Medical gas pipeline systems Connectors for medical gases CGA V 5 DISS Diameter Index Safety System SANS 1409 Outlet sockets and probes for medical gas and vacuum service used in hospitals Indicates minium supply pressure at stated value of gas flow Based upon an adult breathing at 30 bpm with a tidal volume of 1 litre and I E ratio of 1 2 8 Troubleshooting Fault No gas flow Possible Cause Demand valve handset is not connected properly Gas cylinder empty Solution Check gas supply Check that the gas specific probe is correctly connected Replace gas cylinder Medical gas terminal unit on a pipeline system is isolated Seek advice from someone authorised to operate the medical gas pipeline system isolation valves Demand valve probe blocked Repair or service required Hole in demand valve diaphragm In this instance the demand valve will work with the Test Button but not when used conventionally by inhaling t
11. ses through the handset and is inhaled by the patient The deeper the patient breathes the greater the volume of gas delivered When the patient exhales the diaphragm moves back the tilt valve closes and no further gas is delivered The demand valve offers a very low resistance to flow during both patient inhalation and exhalation which means less effort for the patient This is achieved by the unique patented exhalation valve design that diverts exhaled gas out through a special valve thus eliminating the need for the patient to exhale through a highly resistant patient filter as is the case with other demand valve systems The demand valve can be driven directly from the terminal unit of a medical gas pipeline system or from a medical gas cylinder via a suitable pressure regulator A gas hose complying with BS EN ISO 5359 carries the gas from the gas supply source to the demand valve The demand valve should be used with either a mouthpiece or a facemask The exhalation valve has a viral filter that allows the flow of inhaled gas to the patient and prevents contamination of the demand valve handset from the patient s expired breath 4 Operating Instructions 4 1 Fitting the Exhalation Valve Use a new exhalation valve for each new patient or after 30 days of use for the same patient The exhalation valve should be replaced if it becomes soiled or discoloured 4 2 Removing the Lanyard The lanyard helps to prevent the patient droppi
12. ssure in tanks Secure cylinders to a wall stand or cart in accordance with local safety regulations If using a cylinder and regulator ensure that the device is connected to the regulator and the cylinder valve is properly opened before beginning therapy Never permit compressed medical gases to enter a pressure regulator suddenly Always open the cylinder valve slowly When therapy is complete disconnect the demand valve from the gas supply When the source of oxygen is from a gas cylinder always close the gas cylinder valve when the demand valve is not in use and disconnect the demand valve from the pressure regulator Arrange the oxygen hose carefully to avoid damage to the hose and the potential for causing a trip hazard Never pull or apply excessive force to the gas hose A leaking hose may result in higher local oxygen concentrations and an increased risk of fire Cautions The performance of the demand valve may be affected if it is stored or transported in temperatures outside of the range 20 C to 60 C 4 F to 140 F The demand valve is not suitable for autoclaving The handset is protected from contamination in normal use by a single patient use exhalation valve The single patient use exhalation valve is not suitable for cleaning If the exhalation valve becomes visually soiled or discoloured it should be replaced Notes Peak flow through the demand valve might be restricted resulting in increased work of breathing
13. st be carried out by a suitably qualified person working in a controlled environment If there is reason to believe that the demand valve handset is contaminated it can be disinfected using a cold disinfection process but will need to be disassembled first Full details of how to disassemble clean and disinfect the device can be found in the Service Manual The Service Manual can be obtained from your local BPR Medical distributor details of which can be found at www bprmedical com 7 Specification Specification Value lt 1 5 kPa 0 22 psi at 200 l min Inspiratory Resistance y lt 0 25 kPa 0 036 psi at 10 l min Maximum 600 kPa 87 psi Supply Pressure UN Minimum 310 kPa 45 psi Supply Flow Capacity gt 120 l min Demand Valve Peak Flow gt 200 l min Transport and Storage Temperature 20 C to 60 C 4 F to 140 F Environmental Operating Temperature 5 C to 40 C 41 F to 104 F Humidity 0 100 RH non condensing Regulatory CE Medical Device Directive 93 42 EEC Active Medical Device Class lla Applied Standards BS 5682 Probes quick connectors for use with medical gas pipeline systems BS EN ISO 5356 1 Anaesthetic and respiratory equipment Conical connectors Cones and sockets BS EN ISO 5359 Low pressure hose assemblies for use with medical gases BS EN ISO 14971 Medical devices Application of risk management to medical devices BS EN ISO 15001 Anaesthetic and respirat
14. ted T 44 0 1623 628 281 wu 22 Hamilton Way Mansfield F 44 0 1623 628 289 b Nottinghamshire cs bprmedical com N FOR ENTERPRISE NG18 5BU United Kingdom www bprmedical com oe MEDICAL GAS CONTROL
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