Carnet Firesafe Flowmeter Instructions for Use April 2010

April 2010

www.carnetmedical.com

702-0049.6

Contents Description of Symbols ... 2

1.

Warnings and Cautions ... 3

2. 2.1

Warnings! ... 3 Functional Description ... 4

3. 3.1

Intended Use ... 4

3.2

Technical Description ... 4

3.2.1

FireSafe™ Nozzle ... 4

3.2.2

FlowSafe™ Valve ... 5

3.2.3

Precision Rotating Float ... 5

3.2.4

Over Pressure Valve ... 5

3.2.5

Static Control (Triboelectric Charge Dissipation) ... 5

3.2.6

Flush Flow Mode ... 5

3.2.7

Inlet Filter... 5

3.2.8

Tamperproof Gas Specific Connector ... 5

3.2.9

FireSafe™ Flowmeter (Oxygen Shown) ... 6

4.

Device Specification ... 7

5.

Operating Instructions... 8 5.1

Connecting to the Gas Supply ... 8

5.2

Adjusting the Flow ... 8

5.3

Reading the Flowmeter ... 8

5.4

Connecting to the Patient ... 9

5.5

During Use ... 9

5.6

After Use ... 9 Cleaning and Disinfection ... 9

6. 6.1

Cleaning ... 9 Maintenance ... 9

7. 7.1

Interim Inspection ... 9

7.1.1 7.1.2

Leak Test ... 9 Flow Test ... 9

7.2

Service and Repair ... 10

7.3

Manufacturing Date ... 10

8.

Troubleshooting ... 11

9.

Parts and Spares List ... 11

10.

Contact ... 11

1.

Description of 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

No Smoking

Flow should be read level with the top of the float

Medical Device: CE Marked to the Medical Device Directive 93/42/EEC

2

2.

Warnings and Cautions

2.1 2.1.1

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.

2.1.2

Medical gases are, or should be considered, drugs and may be used in critical treatments. Medical gases should only be used for medical purposes on the authority of a physician or authorised clinician and then strictly in accordance with their instructions.

2.1.3

When supplemental oxygen therapy is provided, additional risk control measures such as SpO 2 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.

2.1.4

The flowmeter is not MRI compatible.

2.1.5

Ensure that the medical gas supply is sufficient for the proposed procedure or therapy and is supplied within the pressure range given in the technical specification. If the supply is a gas cylinder, check the cylinder contents gauge regularly.

2.1.6

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.

2.1.7

Gas specific connectors are fitted to the flowmeter. Do not attempt to modify the fittings to suit other gases or fitting systems.

2.1.8

Oxygen is not flammable; however, the presence of oxygen will drastically increase the rate and severity of combustion. Oil and/or grease in the presence of oxygen become highly combustible. Oxygen must never be allowed to contact oil, grease or other petroleumbased substances. Do not use oil or grease on this flowmeter.

2.1.9

Do not smoke around oxygen equipment.

2.1.10 Only appropriately trained personnel working in controlled conditions may disassemble, repair or reassemble this flowmeter. 2.1.11 Do not disassemble the flowmeter whilst under pressure. 2.1.12 Secure cylinders to a wall, stand or cart in accordance with local safety regulations. 2.1.13 Arrange the oxygen supply tubing carefully to avoid kinking, occlusion and the potential for causing a trip hazard. Never pull or apply excessive force to the oxygen supply tubing. A leaking system may result in higher local oxygen concentrations and an increased risk of fire. 2.1.14 Do not stand in front of a flowmeter or regulator outlet when opening a cylinder valve. 2.1.15 Do not allow any fluid to enter this device. 2.1.16 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. 2.1.17 Gas flow may be prevented if the supply tubing is kinked or occluded.

3

2.1.18 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). 2.1.19 Only use this flowmeter with the flow tube in a vertical position. 2.1.20 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 an increased risk of fire. Cautions! 2.1.21 The performance of the flowmeter may be affected if it is used, stored or transported in temperature outside of the range -20°C to +60°C (-4°F to +140°F). 2.1.22 The flowmeter is not suitable for autoclaving.

3.

Functional Description

3.1

Intended Use The Carnét FireSafe™ Flowmeter is used to precisely control the flow of medical oxygen or medical air (model dependent) 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 Carnét FireSafe™ Flowmeter 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. Carnét Suction & Oxygen Therapy products enhance patient and user safety and as such the Carnét FireSafe Flowmeter includes many unique features to maximise safety and minimise exposure to risk. These features include: 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 discernable 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. 4

3.2.2

FlowSafe™ Valve The FlowSafe Valve is another feature unique to the Carnét 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. This mode may be used to deliver approximately 25-30 l/min to supply a resuscitation bag.

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

Tamperproof Gas Specific Connector Fitting of the gas specific quick connection probe is tamperproof, preventing it from loosening and overcoming the risk of a probe for a different gas service being used. This minimises the risk of a leak and, unlike union connections, ensures the flow tube is always vertical.

5

3.2.9 FireSafe™ Flowmeter (Oxygen Shown)

Scale

Flow Tube Precision Rotating Float

Gas Specific Inlet Connector (BS 5682 shown)

Flow Control Valve

FireSafe™ Nozzle

6

4.

Device Specification

Specification

Value/Description

Flow Scale

0-15 l/min

Nominal inlet pressure

400 kPa Note: The flowmeter is able to operate safely within the pressure range 370 kPa to 500 kPa, but the flowmeter will only deliver accurately when connected to an input pressure of 400 kPa. Any input pressure other than 400 kPa will result in flow rates different from the flow settings.

Supply Pressure Range

Minimum 370 kPa Maximum 550 kPa

Accuracy at Nominal Pressure

+/-10% of indicated reading between 1 and 15 l/min

Effect of Temperature on Accuracy -5% to +3% in the range 0 to 40°C respectively Effect of Inlet Pressure on Accuracy

+/-1% per 10 kPa increase/decrease from nominal pressure respectively

Effect of Outlet Flow Resistance on Negligible Accuracy Over Pressure Valve Set Point

7 bar +/- 0.5 bar

Gas compatibility

Medical oxygen or medical air (depending on model)

Maximum Flow (Flush Flow Mode)

25 - 30 l/min

FireSafe Nozzle Flow Range

1 - 25 l/min

Inlet filtration

25 μm

Environmental

Transport and Storage Temperature Range: -20°C to +60°C Usage Temperature Range: 0°C to +40°C Humidity: 0-100% RH non-condensing

Regulatory

FDA: Class I CE: Medical Device Directive 93/42/EEC - Active Medical Device – Class lla EN ISO 15001 - Anaesthetic and respiratory equipment - Compatibility with Oxygen EN ISO 15002 - Flow-metering devices for connection to terminal units of medical gas pipeline systems EN ISO 14971 - Medical Devices- Application of risk management BS EN 980:2008 - Graphical symbols for use in the labelling of medical devices

Applied Design Standards

EN 1041:1998 - Information supplied by the manufacturer with medical devices BS EN ISO 19054:2006 Rail systems for supporting medical equipment BS EN 739:1998 Low-pressure hose assemblies for use with medical gases BS EN ISO 19054:2006 Rail systems for supporting medical equipment BS EN 739:1998 Low-pressure hose assemblies for use with medical gases 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

7

5.

Operating Instructions

5.1

Connecting to the 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 19054:2006 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 hand-wheel), make sure that the connection is hand tight before turning on the supply pressure. 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.

5.2

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 troubleshooting guide towards the back of this booklet.

5.3

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 left hand illustration indicates the correct reading level for this Carnét FireSafe Flowmeter i.e. at the top of the float.

Float

8

Ball

5.4

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

5.5

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.

5.6

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

6.

Cleaning and Disinfection

Caution! The flowmeter is not suitable for autoclaving. Caution! Never immerse the flowmeter in any fluid or attempt to clean internal parts. 6.1

Cleaning Wipe over the outside of the flowmeter and the gas supply hose with an alcohol or disinfecting wipe. If you suspect that the flowmeter is contaminated, remove it from use and refer the device to the appropriate department.

7.

Maintenance

7.1

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. 7.1.1

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. 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 service.

7.1.2

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

9

7.2

Service and Repair Direct connection flowmeters do not require routine servicing but can be repaired. The device can be returned to a recognised Carnét Service Centre, details of which can be found at www.carnetmedical.com. Indirect connection flowmeters should have the hose assembly replaced after four years use or five years from the date of manufacture. Disassembly, repair or reassembly must be carried out by a suitably qualified person working in a controlled environment.

7.3

Manufacturing Date The manufacturing date can be found on the device label (month-year, 03-2010 = March 2010). Device life can be calculated by adding 7 years to the date of manufacture.

10

8.

Troubleshooting

Fault

Possible Cause

Solution

No gas flow or insufficient flow

Flowmeter not connected properly.

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 required. 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. Replace FireSafe Nozzle.

Gas cylinder empty. Medical gas terminal unit on a pipeline system isolated. Inlet filter blocked. FlowSafe Valve has activated.

FireSafe Nozzle has activated due to fire or mechanical damage. Seal is worn or damaged. Over Pressure Valve leaking due to input pressure being too high. Flow tube cracked or damaged. Probe nose worn or damaged. Medical gas hose damaged Valve or valve seal damaged.

Audible gas leak

Constant gas flow

9.

Repair required. Check gas supply pressure is within specification. Repair required. Repair required. Replacement required Repair required.

Parts and Spares List

Part Number

Description

Connection

829-0101

FireSafe Flowmeter - O2 – DIN13260 - Single Direct - 0-15 Lpm

DIN13260

829-0301

FireSafe Flowmeter - O2 - BS5682 - Single Direct - 0-15 l/min

BS 5682

829-0302

FireSafe Flowmeter - O2 - BS5682 - Double Direct - 0-15 l/min

BS 5682

829-0303

FireSafe Flowmeter - O2 - BS5682 - Single Indirect - 0-15 l/min

BS 5682

829-0304

FireSafe Flowmeter - O2 - BS5682 - Double Indirect - 0-15 l/min

BS 5682

829-0351

FireSafe Flowmeter - Air - BS5682 - Single Direct - 0-15 l/min

BS 5682

829-0352

FireSafe Flowmeter - Air - BS5682 - Double Direct - 0-15 l/min

BS 5682

Spares 827-0031

10.

FireSafe Nozzle (10 pack) 9/16" UNF (DISS) Female

9/16” UNF (DISS)

Contact

Any questions or concerns in regard to any Carnét product should be addressed to your local authorised Carnét distributor, details of which can be found on our web site - www.carnetmedical.com

11

April 2010

www.carnetmedical.com

702-0049.6