Microdial Flowmeter - IFU - 702-0095 - EN
Contents
1. microflow Microdial Flowmeter Instructions for Use CE 0120 702 0095 9 May 2014 1 Symbols Indicates a potentially hazardous situation which if not avoided could Warning aja result in personal injury to the user or others Indicates a potentially hazardous situation which if not avoided could result in damage to the equipment or property A N Attention consult accompanying documents 6 se Use no oil CE Marked to Medical Device Directive 93 42 EEC as amended by 0120 directive 2007 47 CE amp No smoking Pa Service due date SN 1304X1 2345 Date of manufacture identification M YYMM 2 Warnings and Cautions 2 1 Warnings Caution gt Read through this entire instruction manual before using or showing others how to use a Microdial Flowmeter 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 Medical oxygen 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 gt 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 gt Ensure that the medical oxygen supply is sufficient for the proposed therapy and is supplied within the pressure range given in t2. of the orifice through which the gas passes and consequently adjusts the gas flow rate The Microdial Flowmeter includes a pre regulator pressure regulator upstream of the metering orifice plate The pre regulator provides a consistent pressure upstream of the metering orifice plate over a wide range of inlet pressures The Microdial Flowmeter has inlet and outlet connectors The inlet connector is the larger of the two and is a gas specific oxygen probe for connection to the oxygen supply The smaller outlet connector may be either a barbed outlet for direct connection to oxygen delivery tubing or a threaded DISS 9 16 UNF connector for connection to a bubble humidifier 4 Operating Instructions 4 1 Preparation and Connection Turn the flow selection dial fully clockwise and check that the indication in the flowmeter window is zero Connect the medical oxygen probe securely to the oxygen wall outlet or the equivalent outlet of a pressure regulator connected to an oxygen cylinder Warning Where the gas specific connector is dependent on a threaded fastener e g DISS CGA V5 1240 AS 2902 SIS handwheel offer device to outlet and connect a few turns Align device to the final vertical position and fully hand tighten the connection before turning on the supply pressure Do not use the device to tighten or lock the connection For quick connector probes e g BS5682 DIN AFNOR ensure that the connection is correctly made by gent
3. this Microdial Flowmeter gt Never administer oxygen while smoking or when near an open flame gt A gas specific connector is fitted to the Microdial Flowmeter Do not attempt to modify the fittings to suit other gases or fitting systems gt Only appropriately trained personnel working in controlled conditions may disassemble or assemble this Microdial Flowmeter 2 2 Cautions gt The performance of the flowmeter 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 3 Functional Description Flow Indication 9 Flow Selection Dial Window Pre regulator Outlet Connector Gas Specific Probe 3 1 Intended Use The Microdial Flowmeter is intended to control the flow of medical oxygen during oxygen therapy in both homecare and clinical environments The flow selection dial has 12 positions including 11 discrete flow rates and an off position Flow is indicated in litres per minute l min and is visible through a window adjacent to the flow selection dial Medical oxygen 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 Always refer to the medical oxygen product labelling 3 2 Technical Description The Microdial Flowmeter has a flow selection dial that is rotated to select the desired oxygen flow Rotating the dial changes the size
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5. at all flow settings against specification 5 2 Service The Microdial Flowmeter must be serviced every 2 years to ensure that it continues to perform in accordance with its specification Microdial Flowmeters have a Service Due date on their labelling which indicates when the next service is due Warning Servicing must be carried out by a suitably qualified person working in a controlled environment Full details of the recommended servicing requirements 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 Complete the service in accordance with the instructions given in the Service Manual or return the device to a recognised BPR Medical Service Centre on or before the date shown 6 Specification Supply Pressure Nominal Inlet Pressure 345 kPa to 500 kPa 50 psi to 73 psi Maximum 1000 kPa 145 psi Minimum 280 kPa 40 psi Flow Setting l min Range A 0 0 02 0 03 0 05 0 08 0 12 0 2 0 3 0 5 0 75 1 0 3 0 Range E 0 0 01 0 02 0 03 0 04 0 05 0 06 0 07 0 08 0 09 0 1 1 0 Filtration Sintered bronze 40 um nominal first stage 5 um nominal second stage Flow Accuracy 10 of setting at 1 l min and above 20 to 10 of setting below 1 l min Effects on Accuracy Less than 6 of reading fora 100 kPa change in nominal inlet pressure Less than 15 change in rea
6. ding in the range 280 kPa to 580 kPa Varying Inlet Pressure Varying Temperature 7 in the range 20 C 20 C Less than 1 of reading up to Varying Outlet Resistance 5 kPa back pressure Environmental Transport Storage Operation 20 C to 60 C 4 F to 140 F Humidity 0 100 RH non condensing Regulatory CE Medical Device Directive 93 42 EEC Class lla FDA Class 1 Applied Standards BS EN ISO 10524 4 Pressure regulators for use with medical gases Low pressure regulators BS EN ISO 14971 Medical devices Application of risk management to medical devices BS EN ISO 15001 Anaesthetic and respiratory equipment Compatibility with oxygen BS EN ISO 15002 Flow metering devices for connection to terminal units of medical gas pipeline systems BS EN ISO 15223 1 Medical devices Symbols to be used with medical device labels labelling and information to be supplied General requirements BS EN 13544 2 A1 Respiratory therapy equipment Tubing and connectors BS 5682 Specification for probes quick connectors for use with medical gas pipeline systems SS 875 24 30 Medical gas pipeline systems Connectors for medical gases 7 Troubleshooting Fault No gas flow Possible Cause Gas cylinder turned off Solution Check gas supply Flowmeter not connected properly Check gas specific probe is correctly connected Gas cylinder emp
7. he Device Specification If the supply is a gas cylinder check the cylinder contents gauge regularly gt Oxygen therapy may be a critical treatment A regulated flowmeter should be used in strict accordance with the prescription and instructions of a physician The effectiveness of supplemental oxygen therapy can only be determined by continuous monitoring of blood oxygen levels It is essential that PaO2 or SpO2 monitoring is carried out when supplemental oxygen is prescribed gt The Microdial Flowmeter will deliver zero flow between flow settings When selecting a new flow setting ensure that the flow selection dial clicks into place and that a flow is correctly selected gt Do not cover the vent hole in the pre regulator as this will change the device calibration gt Do not submerge a Microdial Flowmeter in any fluid Ensure that no water is allowed to enter ports or vent holes gt The accuracy of the flowmeter will be affected if the input pressure is other than stated in the specifications gt Always disconnect the flowmeter from the gas supply when it is not in use gt Oxygen is not flammable however an oxygen enriched atmosphere 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 hydrocarbon based substances Do not use oil or grease on
8. ly pulling the flowmeter before turning on the supply pressure If the medical oxygen supply is provided from a gas cylinder turn on the oxygen supply at the cylinder Connect a sufficient length of oxygen tubing not supplied to the outlet barb 4 2 Testing Prior to Use Turn the flow seclection dial to its highest setting and check that gas flow can be felt at the patient end of the supply tubing If no medical oxygen flow is sensed refer to Section 7 Troubleshooting of this manual Turn off the oxygen flow by turning the flow selection dial fully clockwise 4 3 Operation Connect the free end of the oxygen tubing to the patient or patient enclosure using the appropriate connector not supplied Determine the approximate oxygen flow rate in l min required for the patient Turn the flow selection dial until the closest rate to this is clearly visible in the flowmeter window Ensure the flow selection dial is in the latched position and the flow rate is visible in the window It will be obvious to the touch when the selection dial clicks into place Warning The Microdial Flowmeter will deliver zero flow between flow settings If the patient requires more or less oxygen flow this is simply achieved in distinct stages by rotating the flow selection dial Check the gas cylinder contents regularly if applicable during use of the Microdial Flowmeter and be aware that the supply tubing may be a trip hazard 4 4 After Use When
9. therapy is complete disconnect the Microdial Flowmeter from the gas supply Where the medical oxygen is being supplied from a cylinder turn the cylinder off Store the Microdial Flowmeter in a clean and dry environment between uses 5 Maintenance 5 1 Interim Inspection Microdial Flowmeters should be cleaned inspected for damage and performance checked regularly The frequency of such checks depends on usage but as a guideline if the flowmeter is used daily this should be performed every six months if used infrequently then an annual check will suffice 5 1 1 Cleaning Wipe over the external surfaces of the Microdial Flowmeter with an alcohol or disinfecting wipe 5 1 2 Internal Leak Test Attach the flowmeter to the medical oxygen supply and turn the flow selection dial to 0 Connect a length of tubing to the outlet barb and immerse the other end of the tube in water Any gas bubbling through indicates an internal leak If any leakage is found the flowmeter should be removed from use and serviced as described in section 5 2 5 1 3 External Leak Test Attach the flowmeter to the medical oxygen supply and turn the flow selection dial to its highest flow rate 1 or 3 I min depending on model Apply an oxygen compatible leak test solution to all joints and check for signs of leakage If any leakage is found the flowmeter should be removed from use and serviced as described in section 5 2 5 1 4 Flow Test Verify flow rates
10. ty 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 Filter blocked Service or repair required Selection dial set to 0 Select a positive flow rate Internal external leak Seal failure Service or repair is required Insufficient gas flow Filter partially occluded Service is required Supply pressure too low and or gas cylinder nearly empty Check gas supply and or replace gas cylinder 8 Parts and Spares List Part Number Description 816 0026 Microdial Flowmeter Range A Hose Barb Outlet AS 2902 816 0027 Microdial Flowmeter Range E Hose Barb Outlet AS 2902 816 0039 Microdial Flowmeter Range A Hose Barb Outlet BS 5682 816 0040 Microdial Flowmeter Range E Hose Barb Outlet BS 5682 Spare Parts and Servicing 604 0034 Microdial Flowmeter Output Barb Assembly 604 0035 Microdial Flowmeter DISS Assembly 610 0040 Microdial Flowmeter Service Kit 5 pack 999 0003 Microdial Flowmeter Service 9 Distributor Details BOC Healthcare Customer Service Centre Priestly Road Worsley Manchester T 44 0 8456 447 764 F 44 0 8450 870 062 www bochealthcare co uk BPR Medical Limited gal 22 Hamilton Way Mansfield Nottinghamshire bpr MEDICAL GAS CONTROL NG18 5BU United Kingdom T 44 0 1
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