Oxygen Dialflow Meter Instructions for Use May 2014

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 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

Service due date

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 a Dialflow Meter. 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 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.
Never use medical gases from a cylinder without reducing the pressure through a suitable regulator intended for that gas.
Never use oxygen as a pressure medium to purge obstructed pipelines or equipment, to operate pneumatic tools, or to build up any pressure in tanks.
Do not stand in front of a regulator outlet when opening the cylinder valve.
Always disconnect the Dialflow Meter from the gas supply when it is not in use.
The Dialflow Meter 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.
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.
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.
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 this Dialflow Meter.
Ensure that the medical oxygen 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.
Never permit compressed medical gases to enter a regulator suddenly. Always open the cylinder valve slowly.
Do not submerge the Dialflow Meter in any fluid. Ensure that no water is allowed to enter ports or vent holes.
The accuracy of the flowmeter will be affected if the input pressure is other than stated in the specifications.
Never administer oxygen while smoking or when near an open flame.
A gas specific connector is fitted to the Dialflow Meter. Do not attempt to modify the fittings to suit other gases or fitting systems.
Only appropriately trained personnel working in controlled conditions may disassemble or assemble this Dialflow Meter.

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).

3. Functional Description Flow Selection Dial

Gas Specific Probe

Flow Indication Window

Outlet Connector

3.1. Intended Use The Dialflow Meter 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.

3.2. Technical Description The Dialflow Meter has a flow selection dial that is rotated to select the desired oxygen flow. Rotating the dial changes the size of the orifice through which the gas passes and consequently adjusts the gas flow rate. The Dialflow Meter 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. For quick connector probes (e.g. BS5682, DIN), ensure that the connection is correctly made by gently 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 Dialflow Meter 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 Dialflow Meter and be aware that the supply tubing may be a trip hazard.

4.4. After Use When therapy is complete, disconnect the Dialflow Meter from the gas supply. Where the medical oxygen is being supplied from a cylinder, turn the cylinder off. Store the Dialflow Meter in a clean and dry environment between uses.

5. Maintenance 5.1. Interim Inspection Dialflow Meters 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 preformed every six months, if used infrequently then an annual check will suffice. 5.1.1. Cleaning Wipe over the external surfaces of the Dialflow Meter 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. 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 at all flow settings against specification.

5.2. Service The Dialflow Meter must be serviced every 2 years to ensure that it continues to perform in accordance with its specification. Dialflow Meters 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 Specification

Value

Supply Pressure

Nominal Inlet Pressure 400 kPa (58 psi) Range C: 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5

Flow Setting (l/min) Range D: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 15 Filtration

Sintered bronze: 40 µm nominal first stage, 5 µm nominal second stage

Flow Accuracy

±10 % of setting at 1 l/min and above, ±20 % of setting below 1 l/min

Effects on Accuracy

Varying Inlet Pressure:

Less than 8 % of reading for ±40 kPa (i.e. ±10 %) change in input pressure

Varying Temperature:

±5 % in the range 20 °C ±20 °C

Varying Outlet Resistance:

Less than 1% of reading up to 5 kPa back pressure

Transport, Storage and Operation: -20 °C to +60 °C (-4 °F to +140 °F) Environmental Humidity: 0-100 % RH non-condensing CE: Medical Device Directive 93/42/EEC – Class lla Regulatory FDA: Class 1

Applied Standards 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

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. Troubleshooting Fault

Possible Cause

Solution

No gas flow

Gas cylinder turned off

Check gas supply

Flowmeter not connected properly

Check 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

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

817-0001

Dialflow Meter - Range C - Hose Barb Outlet (BS 5682)

817-0002

Dialflow Meter - Range D - Hose Barb Outlet (BS 5682)

817-0004

Dialflow Meter - Range C - Hose Barb Outlet (DIN)

817-0005

Dialflow Meter - Range C - DISS Outlet (BS 5682)

817-0007

Dialflow Meter - Range C - DISS Outlet (DIN)

817-0008

Dialflow Meter - Range D - Hose Barb Outlet (DIN)

817-0009

Dialflow Meter - Range D - DISS Outlet (BS 5682)

817-0011

Dialflow Meter - Range D - DISS Outlet (DIN)

Spare Parts and Servicing 604-0034

Dialflow Meter Output Barb Assembly

604-0035

Dialflow Meter DISS Assembly

610-0040

Dialflow Meter Service Kit (5 pack)

999-0003

Dialflow Meter 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

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