Analgesic Demand Valve - BOC e-catalogue
Contents
1. Scavenging System 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 gas delivered The demand valve is designed for self administration of analgesic gas 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 After Use When therapy is complete disconnect the demand valve from the gas supply Where the analgesic gas is being supplied from a cylinder turn the cylinder off and depressurise handset before disconnection by pressing the test button until the gas is fully exhausted Store the demand valve in a clean dry environment between use 6 Cleaning amp 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 6 1 After Every Use Wipe over the outside of the demand valve handset and the gas supply hose with an alcohol or disinfecting wipe 6 2 Suspected Contamination If you suspect that the demand valve handset is contaminated remove it from use and refer to Analgesic Demand Valve2. Service Manual Never immerse the demand valve handset in any fluid or attempt to clean internal parts whilst the demand valve handset is assembled 7 Maintenance 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 must 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 Carn t distributor details of which can be found at www carnetmedical com 8 Troubleshooting Fault No gas flow Audible gas leak Constant gas flow Insufficient gas flow Exhalation valve will not fit to or be retained on the demand valve body Possible Cause Demand valve handset is not connected properly Gas cylinder empty Medical gas terminal unit on a pipeline system is isolated Demand valve probe blocked Hole in demand valve diaphragm In this instance the de
3. those listed in this manual for use with the demand valve is used 3 Functional Description 3 1 Intended Use The Carnet Analgesic Demand Valve is intended to be used for self administration of O N 0 50 50 V V hereinafter referred to as analgesic gas in response to the patient s inspiratory effort Analgesic gas is or should be considered a drug and should only be used for medical purposes on the authority of a physician and then strictly in accordance with their instructions The demand valve is designed for use in all type of clinical environment Always refer to the medical gas product labelling 3 2 Technical Description The demand valve comprises two main components a demand valve handset and a single patient use exhalation valve 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 passes through the handset and is inhaled by the patient The dee
4. 20 C to 60 C 4 F to 140 F Operating Temperature 5 C to 40 C 41 F to 104 F Humidity 0 100 RH non condensing CE Medical Device Directive 93 42 EEC Active Medical Device Class lla BS 5682 Probes quick connectors for use with medical gas pipeline systems EN 1281 1 Anaesthetic and respiratory equipment conical connectors Part 1 Cones and sockets BS EN ISO 5359 2008 Low pressure hose assemblies for use with medical gases EN ISO 15001 Anaesthetic and respiratory equipment Compatibility with Oxygen NF S 90 116 Medico surgical equipment Terminal units and related probes for medical fluids DIN 13260 2 Supply systems for medical gases Part 2 Dimensions and allocation of probes 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 BS 4272 2 Anaesthetic and analgesic machines Specification for intermittent demand flow analgesic machines for use with 50 50 V V nitrous oxide and oxygen BS EN 980 2008 Symbols for use in the labelling of medical devices AS 2896 1998 Medical gas systems installation and testing of non flammable medical gas pipeline systems 1 Indicates minimum 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 5
5. Analgesic Demand Valve Instructions for Use the trusted brand carnet ata Aam suction amp oxygen therapy products UK distributor BOC Healthcare Customer Service Centre Priestley Road Worsley Manchester M28 2UT T 44 0 8456 447764 F 44 0 845 0870062 www bochealthcare co uk Regional distributors For regional distributors contact www carnetmedical com 1 Description of Symbols ccssssecessssecessssecesssseeeseseeesssseeeessseeeeseseeeeseseeees 2 2 Warnings Cautions and Notes sccccccssssssscccccessssssscceeeeeesssssnceeeeeseeesees 3 2 1 Warnings cca cei cea os tat 8 dives a E i aise 3 2 2 CAUTIONS loa zis egean a nec aia ca tc at tetera deena 4 2 3 Notes szeged s tea aaa fie iat editata ste ia sa atata cup ate dia 4 3 Functional Description cccssscscsssscccssssecessseeessseeesssseessssceeeseseeeeseseeees 5 3 1 IntendediUse iste ceea a e e a ta at eh a 5 3 2 Techihical Descriptioni i sie pai cetei ea ba a dati acetat Du es 5 4 Device Specification sccseccsecscratcccecacceseraccdesonasavesnscconsnessondnasesoosnscsoonsacs 6 5 Operating Instructions ccsscsssssceeceessssssscceeeeeessesssceeeeeeessessssceeeeesesssees 7 5 1 Fitting the Exhalation Valve acasa ceata cae ceata ata daia ta asc po vada 7 5 2 Removing th lanyard tersin a cete tatea fidea ia dai date d 7 5 3 Refitting the Lanyard lt as iisistavsi e 00 asa daia 9 Dau dp a ia 0 c
6. Never permit compressed medical gases to enter a pressure regulator suddenly Always open the cylinder valve slowly 2 1 17 2 1 18 2 2 2 2 1 2 2 2 2 2 3 2 3 2 3 1 When therapy is complete disconnect the demand valve from the gas supply When the source of analgesic gas 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 gas 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 high local oxygen and nitrous oxide concentrations and an increased risk of fire Cautions The performance of the demand valve may be affected if it is stored or transported in temperature 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 for the patient in the following circumstances e Ifthe analgesic gas regulator or analgesic gas supply used does not meet the specification e Ifan extension hose other than
7. Operating Instructions 5 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 5 2 Removing the Lanyard The lanyard helps to prevent the patient dropping 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 5 3 Refitting the Lanyard 1 To refit the lanyard 2 Fit the lanyard into the 3 Refit the lanyard retainer simply pull away the lanyard groove inthe handset cover taking care to line up the retainer slots in the lanyard retainer with the lanyard 5 4 Connecting to the Analgesic Gas 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
8. d acu ta 7 5 4 Connecting to the Analgesic Gas Supply c men nea nenea emana 7 5 5 Testing Prior to Useri ceace ace ctre oaie iad a a a pita et aa 8 5 6 Fitting an Exhalation Valve se fh atita cata daca aa pa a d til 8 5 7 Fitting an exhalation valve AGSS mean nenea nenea 9 5 8 Operation isinna terta i dai iC a talpa a ata di sep 9 5 9 After Use ai pi picta ia ata e s d ta ia at d data EA aa ada a aaa i Rada 9 6 Cleaning amp Disinfection ssccssscccsssscccsssseecsssseesssseeesssseeesssseeesseseeesees 10 6 1 After Every Users raza eat iata a a zodie al td 10 6 2 Suspected Contamination mee nenea nenea nenea nana ae 10 7 Maintenance ssssscccccccssssssscceeceesssssscceececesssssccceseeesssssscccesesesessssoeses 10 8 Troubleshooting sscccssseccssssecceseseecsseseeesssseeesseseeesasseeessseeeseseeeesesoeees 11 9 Parts and Spares List csssssssscccssssecesssseeesssseeessseeeesssseeessseesessseesesesees 12 1 Description of Symbols Indicates a potentially hazardous situation which if not avoided Warning ie 8 could result in personal injury to the user or others Indicates a potentially hazardous situation which if not avoided ion canon could result in damage to the equipment or property Highlights points that might allow more convenient or efficient operation of the equipment Attention consult accompanying documents o Use No Oil No Smok
9. gas outlet Warning Where the gas specific connector is dependent on a threaded fastener e g DISS CGA V5 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 pulling the gas hose before turning on the supply pressure 5 5 5 6 Testing Prior to Use Confirm the correct operation of the demand valve before beginning therapy by pressing the Test Button Gas 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 towards the back of this booklet 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 valve 2 Rotate the exhalation 3 Press down the securing on the demand valve valve until it clicks into clip on each side to lock into handset as shown Do not place then press down place apply any force at this stage 5 7 5 8 5 9 Fitting an exhalation valve AGSS 1 Place the AGSS adaptor over 2 Press down until it clicks the exhalation valve as shown into place Do not apply any force at this stage 3 Fit face mask or mouthpiece AGSS Anaesthetic Gas
10. ing Single Use or Single Patient Use Service Due date OOXP CE Marked to Medical Device Directive 93 42 EEC modified by directive 2007 47 CE N N 2 Warnings Cautions and Notes 2 1 Warnings 2 1 1 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 2 1 2 O2 N 0 50 50 V V hereinafter referred to as analgesic gas is or should be considered a drug and should only be used for medical purposes as prescribed by a physician or authorised clinician and in accordance with the medicinal product labelling 2 1 3 Continuous exposure to elevated levels of nitrous oxide can be harmful National standards for exposure levels time weighted average TWA if available should be applied Risk controls measures such as adequate room ventilation gas scavenging and or environmental monitoring may be necessary 2 1 4 Ensure that the analgesic gas supply is sufficient for the proposed therapy and is supplied within the pressure range given in the Device Specification If the supply is a gas cylinder check the cylinder contents gauge regularly 2 1 5 This demand valve is only for use with medical grade analgesic gas Check the cylinder or supply is medical grade analgesic gas before use 2 1 6 Use a new exhalation valve for each new patien
11. ion valve 9 Parts and Spares List Part No Description Connection 828 1002 Analgesic Demand Valve 2m Hose AFNOR connector NFS 90 116 828 1003 Analgesic Demand Valve 3m Hose AFNOR connector NF S 90 116 828 1004 Analgesic Demand Valve 4m Hose AFNOR connector NF S 90 116 828 1005 Analgesic Demand Valve 5m Hose AFNOR connector NF S 90 116 828 1006 Analgesic Demand Valve 6m Hose AFNOR connector NF S 90 116 828 7002 Analgesic Demand Valve 2m Hose SIS connector AS 2896 828 7003 Analgesic Demand Valve 3m Hose SIS connector AS 2896 828 7004 Analgesic Demand Valve 4m Hose SIS connector AS 2896 828 7005 Analgesic Demand Valve 5m Hose SIS connector AS 2896 828 7006 Analgesic Demand Valve 6m Hose SIS connector AS 2896 828 3002 Analgesic Demand Valve 2m Hose Nordica connector SS 875 24 30 828 3003 Analgesic Demand Valve 3m Hose Nordica connector SS 875 24 30 828 3004 Analgesic Demand Valve 4m Hose Nordica connector SS 875 24 30 828 3005 Analgesic Demand Valve 5m Hose Nordica connector SS 875 24 30 828 3006 Analgesic Demand Valve 6m Hose Nordica connector SS 875 24 30 828 0013 Analgesic Demand Valve 2m Hose BS5682 connector BS 5682 828 0001 Analgesic Demand Valve 3m Hose BS5682 connector BS 5682 828 0014 Analgesic Demand Valve 4m Hose BS5682 connector BS 5682 828 0015 Analgesic Demand Valve 5m Hose BS5682 connector BS 5682 828 0016 Analgesic Demand Valve 6m Hose BS5682 connector BS 5682 828 6002 Analgesic Demand Valve 2m Hose SANS connector SANS 1409 828 6003 A
12. mand valve will work with the Test Button but not when used conventionally by inhaling through the mouthpiece or face mask Valve or diaphragm has become dislodged Tilt valve worn bent or broken Tilt valve damaged or blocked Tilt valve damaged Diaphragm perforated Supply pressure too low and or gas cylinder nearly empty Single patient use exhalation valve has damaged location lugs Solution Check gas supply Check that the gas specific probe is correctly connected Replace gas cylinder Seek advice from someone authorised to operate the medical gas pipeline system isolation valves Repair or service required Repair or service required 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 Repair or service required Repair or service required Repair or service required Repair or service required Check gas supply and or replace gas cylinder 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 exhalat
13. nalgesic Demand Valve 3m Hose SANS connector SANS 1409 828 6004 Analgesic Demand Valve 4m Hose SANS connector SANS 1409 828 6005 Analgesic Demand Valve 5m Hose SANS connector SANS 1409 828 6006 Analgesic Demand Valve 6m Hose SANS connector SANS 1409 Consumables 828 0045 828 0002 828 0044 828 0042 828 0048 828 0049 828 0050 828 0019 828 0046 609 0034 212 0067 Single Patient Use Exhalation Valve with Mouthpiece 10 EN 1281 1 22mm Single Patient Use Exhalation Valve with Mouthpiece 100 EN 1281 1 22mm Single Patient Use Exhalation Valve for use with Face Mask 10 EN 1281 1 22mm Single Patient Use Exhalation Valve for use with Face Mask 100 EN 1281 1 22mm Single Patient Use Exhalation Valve AGSS for use with Face Mask 10 EN 1281 1 22mm Single Patient Use Exhalation Valve AGSS for use with Face Mask 50 EN 1281 1 22mm Single Patient Use Exhalation Valve AGSS with Mouthpiece 10 EN 1281 1 22mm Single Patient Use Face Mask Box 40 Demand Valve Lanyard Single Patient Use Exhalation Valve AGSS with Mouthpiece 50 EN 1281 1 22mm Analgesic Demand Valve Cover Blue EN 1281 1 22mm Universal Universal the trusted brand ce carnet suction amp oxygen therapy products 702 0038 6 EN www carnetmedical com July 2010
14. per 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 2008 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 Device Specification Inspiratory Resistance Supply Pressure Supply Flow Capacity Demand Valve Peak Flow Environmental Regulatory Applied Standards lt 1 5 kPa 0 22 psi at 200 l min lt 0 25 kPa 0 036 psi at 10 I min Maximum 600 kPa 87psi Minimum 310 kPa 45psi gt 120 l min gt 200 l min Transport and Storage Temperature
15. t or after 30 days of use for the same patient 2 1 7 Gas specific connectors are fitted to the demand valve Do not attempt to modify the fittings to suit other gases or fitting systems 2 1 8 Oxygen and nitrous oxide analgesic gas mixture 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 Analgesic gas must never be allowed to contact oil grease or other petroleum based substances Do not use oil or grease on this demand valve 2 1 9 Do not use or store analgesic gas near excessive heat gt 50 C 125 F or below 10 C 50 F Always refer to the medical gas suppliers recommendations 2 1 10 Do not smoke around analgesic gas equipment 2 1 11 Only appropriately trained personnel working in controlled conditions may disassemble or assemble this demand valve 2 1 12 Disassemble the device before cleaning Do not submerge an assembled demand valve in any fluid 2 1 13 Do not use analgesic gas as a pressure medium to purge obstructed pipelines or equipment to operate pneumatic tools or to build up any pressure in tanks 2 1 14 Secure cylinders to a wall stand or cart in accordance with local safety regulations 2 1 15 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 2 1 16
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