Instructions for Use
12 Pages
Preview
Page 1
Oxygen Demand Valve Instructions for Use
702-0051.21 January 2022
Contents Contents ... 1 1.
Symbols... 2
2.
Warnings and Cautions ... 2
3.
4.
5.
6.
2.1.
Warnings! ... 2
2.2.
Cautions! ... 3
2.3.
Notes ... 3
Functional Description ... 3 3.1.
Intended Use ... 3
3.2.
Technical Description ... 3
Operating Instructions ... 4 4.1.
Fitting the Exhalation Valve ... 4
4.2.
Removing the Lanyard ... 4
4.3.
Refitting the Lanyard ... 4
4.4.
Connecting to the Oxygen Supply ... 5
4.5.
Testing Prior to Use... 5
4.6.
Fitting an Exhalation Valve ... 5
4.7.
Operation... 5
4.8.
After Use ... 6
Cleaning and Disinfection ... 6 5.1.
After Every Use ... 6
5.2.
Suspected Contamination ... 6
Maintenance ... 6 6.1.
Servicing... 6
7.
Specification ... 7
8.
Troubleshooting... 8
9.
Parts and Spares... 9
1.
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 damage to the equipment or property
Note
Highlights points that might allow more convenient or efficient operation of the equipment Use no oil
Service due date
2.
Warnings and Cautions
2.1.
Warnings!
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.
In the United States of America, Federal Law restricts this device to sale by or on the order of a physician.
Risk of asphyxiation - do not secure a face mask to the patient with a headstrap, harness or any other means.
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.
Oxygen therapy may be a critical treatment. Additional risk control measures such as SpO2 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.
Ensure that the oxygen supply is sufficient for the proposed therapy 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.
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.
Gas specific connectors are fitted to the demand valve. Do not attempt to modify the fittings to suit other gases or fitting systems. 2
Many hand creams and moisturisers contain paraffin and petroleum bases which are highly flammable and must never be allowed to contact the Demand Valve. Ensure hands are clean and dry before operating the equipment.
Do not use or store analgesic gas near excessive heat (>50°C/125°F). Always refer to the medical gas supplier’s 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.
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.
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.
2.2.
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.
2.3.
Notes Peak flow through the demand valve might be restricted resulting in increased work of breathing for the patient in the following circumstances: o
If the oxygen regulator or oxygen supply used does not meet the specification.
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. 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).
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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 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 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.
4.3.
Refitting the Lanyard 1. To refit the lanyard, simply pull away the lanyard retainer.
2. Fit the lanyard into the groove in the handset cover.
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3. Refit the lanyard retainer 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 pulling 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.
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 on the demand valve handset as shown. Do not apply any force at this stage.
2. Rotate the exhalation valve until it ‘clicks’ into place then press down.
3. Press down the securing clip on each side to lock into place.
4. Fit a face mask or mouthpiece.
4.7.
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. 5
The demand valve is designed for self-administration of oxygen and should not be used for periods beyond those prescribed. Warning! Risk of asphyxiation - do not secure a face mask to the patient with a headstrap, harness or any other means. 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. If a serious incident should occur in relation to the device, it should be reported to BPR Medical (or via or our distributor) and the relevant national regulatory authority of the country where the device was is use.
4.8.
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 the demand valve handset becomes contaminated internally it cannot be reprocessed effectively and should be disposed of. Never immerse the demand valve handset in any fluid or attempt to clean internal parts. 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.
6.
Maintenance
6.1.
Servicing The demand valve handset has an intended life of 10 years and must be serviced after 5 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 or on SupportWeb. Contact your local distributor for information about SupportWeb online service training. When serviced by BPR Medical Ltd. and where the time to end of life is less than the normal service interval, the Service Due date will be replaced by the End of Life date and preceded by a symbol ( ). In these cases, the date now indicates when the device reaches end of life. As an alternative to servicing the demand valve, a service exchange option is available to replace a used handset with a new one. 6
The Service Manual and access to SupportWeb can be obtained from your local BPR Medical distributor, details of which can be found at www.bprmedical.com.
6.2.
End of Life The materials used to make the demand valve handset can recycled. To assist with recycling, an illustrated list of materials used to manufacture the demand valve handset is available. Please contact BPR Medical at [email protected] or your local distributor.
7.
Specification
Specification Inspiratory Resistance
Supply Pressure1
Value <1.5 kPa (0.22 psi) at 200 l/min <0.25 kPa (0.036 psi) at 10 l/min Maximum 600 kPa (87 psi) Minimum 310 kPa (45 psi)
Supply Flow Capacity1
>120 l/min
Demand Valve Peak Flow
>200 l/min
Intended Life
10 years 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 IIa
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 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
SANS 1409
Outlet sockets and probes for medical (gas and vacuum) service used in hospitals
1 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
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8.
Troubleshooting
Fault
Possible Cause
Solution
No gas flow
Demand valve handset is not connected properly.
Check gas supply. Check that the gas specific probe is correctly connected.
Gas cylinder empty.
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 through the mouthpiece or face mask.
Repair or service required.
Valve or diaphragm has become dislodged.
Remove the exhalation valve and check that the diaphragm is lying 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.
Audible gas leak
Exhalation valve will not fit to or be retained on the demand valve body
Single patient use exhalation valve Check the underside of the single use exhalation valve has damaged location lugs. 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.
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9.
Parts and Spares
Part Number
Description
831-1003
Oxygen Demand Valve - 3m Hose - AFNOR connector (NF S 90 116)
831-2003
Oxygen Demand 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
831-4010
Oxygen Demand Valve - 3m Hose - BS 5682 connector - 5 Exhalation Valves and Facemasks
831-5003
Oxygen Demand Valve - 3m Hose - DISS connector (CGA V-5 1240)
Consumables 828-0039
Single Patient Use Exhalation Valve for use with Face Mask (25) EN 1281-1 (22mm)
828-0040
Single Patient Use Exhalation Valve with Mouthpiece (25) 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
610-0084
Demand Valve Lanyard (10)
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 O2 (BS 5682)
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