Firesafe Flowmeter Instructions for Use Sept 2020

Contents 1.

Symbols ... 2

2.

Warnings and Cautions ... 2

3.

4.

5.

6.

2.1.

Warnings! ... 2

2.2.

Cautions! ... 3

Functional Description ... 4 3.1.

Intended Use ... 4

3.2.

Technical Description ... 4

Operating Instructions ... 6 4.1.

Connecting to Gas Supply ... 6

4.2.

Adjusting the Flow ... 6

4.3.

Reading the Flowmeter ... 6

4.4.

Connecting to Patient ... 6

4.5.

During Use ... 7

4.6.

After Use ... 7

Cleaning and Disinfection ... 7 5.1.

Cleaning ... 7

5.2.

Suspected Contamination ... 7

Maintenance... 7 6.1.

Interim Inspection ... 7

6.2.

Service and Repair ... 7

7.

Specification ... 8

8.

Troubleshooting... 9

9.

Parts and Spares... 10

10. Distributor Details ... 11

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

Attention, consult accompanying documents

Use no oil

0120

CE Marked to Medical Device Directive 93/42/EEC as amended by directive 2007/47/CE

No smoking

Flow should be read level with the top of the float

1304X12345 YYMM

Date of manufacture identification

2.

Warnings and Cautions

2.1.

Warnings!

Read through this entire instruction manual before using or showing others how to use this 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.

Medical gases are, 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 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.

The flowmeter is not MRI compatible.

Ensure that the medical 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.

This flowmeter is only for use with the medical gas indicated on the device label. Check the cylinder or supply is the correct medical grade gas before use. Always check that the flowmeter is connected to the correct gas specific terminal unit. 2

Gas specific connectors are fitted to the flowmeter. 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 flowmeter.

Do not smoke around oxygen equipment.

Only appropriately trained personnel working in controlled conditions may disassemble or assemble this flowmeter.

Do not disassemble the flowmeter whilst under pressure.

Secure cylinders to a wall, stand or cart in accordance with local safety regulations.

Do not stand in front of a flowmeter or regulator outlet when opening a cylinder valve.

Do not allow any fluid to enter this device.

The accuracy of the flowmeter can be affected significantly if the input pressure is other than stated in the technical specification and the device label.

Do not directly connect the flowmeter output to another pressurised gas source as this may lead to corruption of one or other of the gas supplies (e.g. connecting an oxygen flowmeter to an air flowmeter via a Y-piece in an attempt to blend their outputs).

Only use this flowmeter with the flow tube in a vertical position. Failure to do so may result in incorrect flow rates being displayed.

Arrange the oxygen tubing and 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.

Gas flow may be prevented if the supply tubing is kinked or occluded.

Care should be taken to ensure that the flow control valve is free from obstruction and unintended pressure. These scenarios may result in temporary changes in flow.

2.2.

Cautions!

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).

The flowmeter is not suitable for autoclaving.

Where a threaded fastener is used, do not use the device to tighten or lock connection.

The performance of the flowmeter may be affected if the flow control valve is over-tightened when switching off flow. Apply the minimum force required to switch off gas flow.

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3.

Functional Description

Scale

Flow Tube

Precision Rotating Float Gas Specific Inlet Connector

Flow Control Valve Firesafe™ Nozzle

3.1.

Intended Use The Firesafe™ Flowmeter is used to precisely control the flow of medical oxygen or medical air (model dependant) from a low pressure supply. Inlet pressure ranges can be found in the Technical Specification. Medical gases are, or should be considered, drugs and should only be used for medical purposes on the authority of a physician or authorised clinician and then strictly in accordance with their instructions. This product is designed for use in homecare applications, in hospitals, other managed clinical environments and by the emergency services.

3.2.

Technical Description The Firesafe™ enables accurate control of the flow of either medical oxygen or medical air (model dependent) in the range of 0.5 to 15 l/min. A precision rotating float rises inside a transparent graduated flow tube. The flow tube has a scale printed upon it that indicates the rate of gas flow in litres per minute (l/min). The reading should be taken at the top of the float. The flow of gas through the tube is controlled by a valve downstream of the flow tube. BPR Medical Ltd products enhance patient and user safety and as such the Firesafe™ Flowmeter includes many unique features to maximise safety and minimise exposure to risk. These features include: 4

3.2.1.

Firesafe™ Nozzle Every Firesafe™ Flowmeter is fitted with a Firesafe™ Nozzle, minimising the known risks of fire associated with oxygen therapy. The Firesafe™ Nozzle is discernible from a standard tubing connector as it features a bright orange band. The Firesafe™ Nozzle can limit the impact of an oxygen fire by automatically arresting the oxygen flow. Acting like a fuse, it automatically isolates the oxygen supply as a fire tracks back along the tubing towards the oxygen source. Activation of the Firesafe™ Nozzle during a fire requires is highly reliable at oxygen flows above 1 l/min. The Firesafe™ Nozzle is not suitable for use as a fire risk control measure outside this range.

3.2.2.

Flowsafe™ Valve The Flowsafe™ Valve is another feature unique to the Firesafe™ Flowmeter that further lowers the risk of fire associated with oxygen use. In the event of the flow tube being inadvertently sheared from the flowmeter body, it automatically isolates the oxygen flow, preventing a free flow of oxygen into the hospital ward. The pipeline pressure is therefore maintained, negating the need to isolate the ward oxygen supply, upon which other patients may be dependent.

3.2.3.

Precision Rotating Float Unlike conventional ball and glass style flowmeters, the Firesafe™ Flowmeter incorporates a precision float with a fluted rim, which continuously rotates in the gas stream to provide visual confirmation that gas is flowing and the device is providing an accurate reading. Historically, incidents have occurred with conventional designs whereby static charge within the flow tube has caused the ball to stick to the surface and provide a false reading. Unlike conventional ball style flowmeters, where there is often doubt as to where a reading should be taken, the Precision Rotating Float has a red band indicating the position at which the flow reading should be taken.

3.2.4.

Over Pressure Valve The over-pressure (pressure relief) valve further enhances patient and user safety in the event of the source pressure rising to a dangerous level e.g. source equipment malfunction, such as a creeping pressure regulator.

3.2.5.

Static Control (Triboelectric Charge Dissipation) The Firesafe™ Flowmeter incorporates two separate static control measures in order to rapidly dissipate any charge generated during use. These unique measures control the recognised phenomena of static charge, which is known to cause the ball in conventional flowmeters to stick to the flow tube inner surface, leading to either an inaccurate reading or indicating a flow exists when the valve is closed.

3.2.6.

Flush Flow Mode The flowmeter has a Flush Flow Mode. 25-30 l/min to supply a resuscitation bag.

This mode may be used to deliver approximately

3.2.7.

Inlet Filter The flowmeter is fitted with a 25 µm filter to ensure that large particles of debris that might be resident in the gas supply do not contaminate the flowmeter or pass through to the patient.

3.2.8.

Gas Specific Connector The gas specific quick connection probe has characteristics to prevent connections between different gas services.

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4.

Operating Instructions

4.1.

Connecting to Gas Supply Before use, visually check both the flowmeter and hose (if fitted) for any damage or contamination. Do not connect or use the device if there are any doubts about its condition. The flowmeter is supplied with a gas specific connector that is designed to connect to a mating gas specific outlet. Gas specific outlets might be 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 and turn on the supply at the cylinder. Connect the gas specific quick connect to the appropriate gas specific outlet. For indirect connection flowmeters the Medirail bracket should be fastened to a suitable medical rail system (compliant with BS EN ISO 19054 Rail systems for supporting medical equipment) using the thumb screw in the Medirail bracket. Warning! Where the gas specific connector is dependent on a threaded fastener (e.g. DISS CGA – V5 1240, AS 2896/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. BS 5682, DIN, AFNOR), ensure that the connection is correctly made by gently pulling the flowmeter body or hose (as applicable) before turning on the supply pressure. Connect a sufficient length of patient tubing (not supplied) to the outlet barb. Note: Removal of the Firesafe™ Nozzle when fitting a humidifier will temporarily disable the oxygen arresting capability of the flowmeter in the event of a cannula fire. Always remember to refit the Firesafe™ Nozzle (indicated by a distinctive orange band) when the humidifier is no longer needed.

4.2.

Adjusting the Flow Turn the flow control valve anti-clockwise to turn on and increase the flow of gas. If the flowmeter does not operate correctly, remove it from use and refer to the trouble shooting guide in Section 8 of this booklet.

4.3.

Reading the Flowmeter The diagram opposite shows the correct reading level in relation to the float position for both float type and ball type variable area flowmeters.

Reading Level

The right hand illustration indicates the correct reading level for this Firesafe™ Flowmeter i.e. at the top of the float. Float

4.4.

Ball

Connecting to Patient Connect the other end of the oxygen tubing to the patient or patient enclosure using the appropriate connector (not supplied).

6

4.5.

During Use Continue to monitor the level of gas flow during the procedure or therapy and the contents level of the cylinder (if applicable) and be aware that the supply tubing and hose (if applicable) may be a trip hazard.

4.6.

After Use If the supply is from a gas cylinder, close the cylinder valve and disconnect the flowmeter when therapy is no longer required.

5.

Cleaning and Disinfection

Ensure the flowmeter is disconnected from the gas supply before attempting to clean it. Caution! The flowmeter is not suitable for autoclaving.

5.1.

Cleaning Wipe over the outside of the flowmeter and the gas supply hose with an alcohol or disinfecting wipe.

5.2.

Suspected Contamination If you suspect that the flowmeter is contaminated, remove it from use and refer the device to the appropriate department. Never immerse the flowmeter in any fluid or attempt to clean internal parts.

6.

Maintenance

6.1.

Interim Inspection The flowmeter should be regularly cleaned, inspected for damage and checked for performance. The frequency of inspection and performance checks depends upon usage. As a guideline, if the flowmeter is used daily this may need to be performed every six months; if used infrequently an annual check may suffice.

6.1.1.

Leak Test Attach the flowmeter to a low pressure medical gas supply with a nominal supply pressure as specified on the rating label of the device and close the flow control valve. Connect supply tubing to the outlet barb and immerse the other end of the tube in water, the presence of gas bubbles in the water indicates a leak. Remove the tube and apply an oxygen compatible leak test solution to all outlets and fittings and check for leaks. A flowmeter that fails these tests should be removed from use.

6.1.2.

Flow Test Verify flow rates at all flow settings against specification i.e. within ±10% at 1 l/min and above.

6.2.

Service and Repair Direct connection flowmeters do not require routine servicing but can be repaired. The device can be returned to a recognised BPR Medical Service Centre, details of which can be found at www.bprmedical.com. Indirect connection flowmeters should have the hose assembly replaced after four years use or five years from the date of manufacture. The manufacture date can be found on the device label. Device life can be calculated by adding 7 years to the date of manufacture.

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Disassembly, repair or reassembly must be carried out by a suitably qualified person working in a controlled environment.

7.

Specification

Specification

Value

Flow Scale

0 – 15 l/min Model specific between 370 – 550 kPa

Inlet Pressure Range

Supply Pressure Range

Note: The flowmeter is able to operate safely within the pressure range 370 kPa to 550 kPa, but the flowmeter will only deliver accurately when connected to an input pressure as shown on the device. Any input pressure other than shown on the device will result in flow rates different from the flow settings Minimum 370 kPa Maximum 550 kPa Nominal Pressure: ±10 % of indicated reading between 1 – 15 l/min Valve Settling: < 2 % from initial setting within 3 hours

Accuracy

Temperature: 3 % flow increase/decrease per 5 °C temperature increase/decrease Inlet Pressure: 4 % increase/decrease per 10 kPa increase/decrease from nominal pressure Outlet Flow Resistance: Negligible up to 230 kPa gauge back pressure

Over Pressure Valve Set Point

Nominally 700 kPa (550 kPa minimum to 800 kPa maximum)

Gas Compatibility

Medical Oxygen or Medical Air (model dependant)

Maximum Flow (Flush Flow Mode)

25 – 30 l/min

Firesafe™ Nozzle Flow Range

1 – 25 l/min

Inlet Filtration

25 µm 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 FDA: Class I

Applied Standards 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 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 ISO 19054

Rail systems for supporting medical equipment

BS 5682

Probes (quick connectors) for use with medical gas pipeline systems 8

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

AS 2902

Medical gas systems. Low pressure flexible hose assemblies

8.

Troubleshooting

Fault

Possible Cause

Solution

No gas flow

Flowmeter 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.

Inlet filter blocked.

Repair required.

Flowsafe™ Valve has activated.

Flowsafe™ Valve is designed to activate when an exceptionally high flow of gas passes through the device. Disconnect from the gas supply and check the flow meter for damage or rupture.

Firesafe™ Nozzle has activated due to fire or mechanical damage.

Replace Firesafe™ Nozzle.

Seal is worn or damaged.

Repair required.

Audible gas leak

Over Pressure Valve leaking due to Check gas supply pressure is within specification. input pressure being too high.

Constant gas flow

Flow tube cracked or damaged.

Repair required.

Probe nose worn or damaged.

Repair required.

Medical gas hose damaged.

Replacement required.

Valve or valve seat damaged.

Repair required.

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9.

Parts and Spares

Part Number*

Description

Calibration Pressure

829-0101

Firesafe™ Flowmeter - O2 Single Direct 0 – 15 l/min - DIN 13260 connector

500 kPa

829-0301

Firesafe™ Flowmeter - O2 Single Direct 0 – 15 l/min - BS 5682 connector

400 kPa

829-0302

Firesafe™ Flowmeter - O2 Dual Direct 0 – 15 l/min - BS 5682 connector

400 kPa

829-0303

Firesafe™ Flowmeter - O2 Single Indirect (1.5m) 0 – 15 l/min - BS 5682 connector

400 kPa

829-0304

Firesafe™ Flowmeter - O2 Dual Indirect (1.5m) 0 – 15 l/min - BS 5682 connector

400 kPa

829-0351

Firesafe™ Flowmeter - Air Single Direct 0 – 15 l/min - BS 5682 connector

400 kPa

829-0352

Firesafe™ Flowmeter - Air Dual Direct 0 – 15 l/min - BS 5682 connector

400 kPa

829-0353

Firesafe™ Flowmeter - O2 Dual Indirect (3m) 0 – 15 l/min - BS 5682 connector 400 kPa

829-0901

Firesafe™ Flowmeter - O2 Single Direct 0 – 15 l/min - SIS connector (AS 2896)

400 kPa

829-0902

Firesafe™ Flowmeter - O2 Dual Direct 0 – 15 l/min - SIS connector (AS 2896)

400 kPa

829-0951

Firesafe™ Flowmeter - Air Single Direct 0 – 15 l/min - SIS connector (AS 2896)

400 kPa

829-0952

Firesafe™ Flowmeter - Air Dual Direct 0 – 15 l/min - SIS connector (AS 2896)

400 kPa

829-1001

Firesafe™ Flowmeter - O2 Single Direct 0 – 15 l/min - BS 5682 connector (New Zealand)

400 kPa

829-1002

Firesafe™ Flowmeter - O2 Dual Direct 0 – 15 l/min - BS 5682 connector (New Zealand)

400 kPa

829-1051

Firesafe™ Flowmeter - Air Single Direct 0 – 15 l/min - BS 5682 connector (New Zealand)

400 kPa

829-1052

Firesafe™ Flowmeter - Air Dual Direct 0 – 15 l/min - BS 5682 connector (New Zealand)

400 kPa

*All listed part numbers are standard configurations; please contact your BPR Medical distributor for others

Spare Parts 827-0031

Firesafe™ Nozzle (10 pack) 9/16” UNF (DISS) Female

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10.

Distributor Details

United Kingdom BOC Healthcare Customer Service Centre Priestly Road Worsley Manchester M28 2UT T: +44 (0)8456 447 764 F: +44 (0)8450 870 062 www.bochealthcare.co.uk Australia BOC Healthcare Customer Service Centre 10 Julius Avenue North Ryde Sydney NSW, 2113 T: +61 (0)2 8874 4400 F: +61 (0)2 9886 9000 www.boc.com.au New Zealand BOC Healthcare Customer Service Centre 970-992 Great South Road Penrose 1061 Auckland New Zealand T: +64 (0)9 525 5600 www.boc.co.nz

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BPR Medical Limited

T: +44 (0)1623 628 281

22 Hamilton Way, Mansfield

F: +44 (0)1623 628 289

Nottinghamshire

[email protected]

NG18 5BU, United Kingdom

www.bprmedical.com