Dialflow Regulator 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 Regulator. 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, 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.

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 or petrochemical based substances. Do not use oil or grease on Dialflow Regulators.

Never administer oxygen while smoking or when near an open flame.

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.

The use of the Dialflow Regulators for gases other than those they are designated is expressly prohibited.

Never permit compressed medical gases to enter a Dialflow Regulator suddenly. Always open the cylinder valve slowly.

Never use medical gases from a cylinder without reducing the pressure through a suitable regulator intended for that gas.

Always close the cylinder valve when the Dialflow Regulator is not in use.

Never use oxygen as a pressure medium to purge obstructed pipelines or equipment, operate pneumatic tools or to build up any pressure in tanks.

Never install a pin index Dialflow Regulator with more than one yoke seal between the valve and the regulator. Before attaching the regulator, verify that the post valve is not already fitted with a yoke seal.

Ensure that you have the correct regulator for the type of cylinder you are intending to use. Never attempt to fit a regulator to an incompatible cylinder.

Ensure that the threaded fittings or indexing pins on the regulator are correctly mated and tightened before opening the cylinder valve.

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

Before removing a regulator from a cylinder, fully close the cylinder valve and release all gas from the regulator.

Secure cylinders to a wall, stand or cart.

Do not use or store oxygen equipment near excessive heat (>50°C or 125°F) or open flame.

Only appropriately trained personnel working in controlled conditions must carry out disassembly, assembly and testing of regulators and flowmeters.

Do not submerge the device in any fluid. Ensure that no fluid is allowed to enter the inlet valve or the vent holes.

Dialflow Regulators are not MRI compatible.

Flowmeters may be affected if the cylinder pressure is other than stated in the specifications.

The threaded bull nose cylinder connection for medical oxygen and medical air may be the same, ensure that you have the correct cylinder for the application. This regulator is only intended for use with oxygen.

Do not obstruct the vent holes or interfere with the relief valve in any way. These are for venting gas in the event that the relief valve is activated.

This regulator is designed for use with cylinder pressures up to 20,000 kPa (3,000 psi/ 200 bar). Do not attempt to connect BPR Medical Ltd regulators to cylinders having fill pressures in excess of this value.

Ensure that the device is not set between flow settings. If set between flow settings failure to provide therapy may occur. Display of flow value does not indicate flow is occurring.

2.2.

Cautions!

Device performance may be affected if it is stored or transported in temperature outside of the range -20°C to +60°C (-4°F to +140°F).

The Dialflow Regulator is not suitable for autoclaving.

3.

Functional Description Flow Selection Dial

Flow Indication Window

Vent Outlet Barb Cylinder Contents/ Pressure Gauge Cylinder Connection

3.1.

Intended Use The Dialflow Regulator is intended to deliver medical gas at one of eleven pre-set rates directly from a high pressure cylinder. Flow is indicated in litres per minute (l/min) and is visible through a window adjacent to the flow selection dial. Medical gas 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 product labelling.

3.2.

Technical Description The Dialflow Regulator reduces the high pressure of the cylinder to a safe, more manageable pressure for application to patients. There are many types of cylinder connection used and these may be different from one country to another, ensure that this regulator is the correct connector for the cylinder to be used. Once connected to a cylinder, and with the cylinder valve opened, the user may select the flow rate prescribed by rotating the gas flow selection dial until the correct flow rate is seen in the viewing window. The rate at which gas flows from the regulator is controlled by a hole of known size and accuracy. Each flow rate has a different size hole. The output connector allows the user to connect an oxygen facemask, cannula or other application device as appropriate.

4.

Operating Instructions

4.1.

Preparation and Connection Check that the cylinder type and regulator inlet connector are compatible. Check the presence and condition of the input connector seal, which for pin index regulators is a washer type seal (Bodoc) and for bullnose regulators an O-ring. Fit the regulator to the cylinder ensuring that it is properly mated and the connectors are done up hand tight.

Turn the flow selection dial fully clockwise and check that the indication in the flow meter window is zero. Open the cylinder valve slowly with a suitable cylinder key. Check the regulator cylinder contents gauge to verify that there is sufficient gas available. Connect a sufficient length of tubing (not supplied) to the outlet barb.

4.2.

Testing Prior to Use Turn the flow selection dial to its highest setting and check that gas flow can be felt at the patient end of the supply tubing. If no medical gas flow is sensed refer to the troubleshooting guide in section 7 of this manual. Turn off the gas flow by turning the flow selection dial fully clockwise.

4.3.

Operation Connect the free end of the tubing to the patient or patient enclosure using the appropriate connector (not supplied). Determine the appropriate flow rate in litres per minute (l/min) required for the patient. Turn the flow selection dial until the required rate is visible in the flow indication window; the dial ’clicks’ into place and is obvious to the touch. Continue to monitor the patient as advised by the clinician. Check the regulator contents gauge regularly.

4.4.

After Use Upon completion of the therapy, turn the flow selection dial to zero, close the cylinder valve and disconnect the outlet hose from the regulator and the patient. To remove the regulator from the cylinder, first ensure the cylinder valve is closed. Bleed off any residual gas pressure in the regulator by turning the flow selection dial to any flow setting until flow ceases. Remove the regulator from the cylinder.

5.

Maintenance

5.1.

Interim Inspection All Dialflow Regulators should be inspected and tested on an annual basis to ensure correct performance.

5.1.1.

Cleaning Wipe down the outside of the device with an alcohol wipe. Do not allow the ingress of water or other solution into the device. Check the exterior condition of the device. Pay particular attention to the input connector seals, which should be replaced if damaged or missing. Check that the holes in the side of the device, which are designed to vent gas in the event of relief valve activation, are not obstructed or have otherwise been tampered with.

5.1.2.

Internal Leak Test Connect the regulator to a cylinder in accordance with this Instructions for Use. Set the flow selection dial to zero and open the cylinder valve. Connect a hose to the outlet barb and immerse the other end of the hose into water. Check for leak through (internal leak). Remove the hose.

5.1.3.

External Leak Test Attach a fresh, dry hose to the outlet barb and connect the other end of the hose to a calibrated flowmeter in the correct range for the device under test.

5.1.4.

Flow Test Verify flow rates at all flow settings against those given in the device specification.

5.2.

Service It is recommended ranges A and E be serviced every 2 years, ranges C and D every 4 years to ensure the device continues to perform in accordance to its specification. All Dialflow Regulators have a Service Due date on their label, indicating 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

Flow Accuracy

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

Input Pressure Range

1,000 to 20,000 kPa (10 to 200 bar) 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

Flow Settings (l/min)

Range C: 0, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5 Range D: 0, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 15.0 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

Operating, Storage and Transport Temperature Range

-20 °C to 60 °C (-4 °F to +140 °F)

Varying Inlet Pressure:

Typically less than 15 % change across the input pressure range: Minimum: 1,000 kPa Maximum: 20,000 kPa

Varying Outlet Pressure:

Less than 1 % of reading up to 5 kPa (50 cmH2O) back pressure

Varying Temperature:

Typically 0.2 % of reading per degree Celsius

Effects on Accuracy

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 llb

FDA: Class 1 Health Canada: Class 2 - Licence No: 83602

Applied Standards BS EN ISO 10524-1

Pressure regulators for use with medical gases. Pressure regulators and pressure regulators with flow-metering devices

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

7.

Troubleshooting

Fault

Possible Cause

Solution

Gas cylinder turned off

Check gas supply

Dialflow Regulator not connected Check gas specific probe is correctly properly connected No gas flow

Internal/external leak Insufficient gas flow

8.

Gas cylinder empty

Replace gas cylinder

Filter blocked

Service or repair required

Flow selection dial set to ‘0’

Select a positive flow rate

Seal failure

Service or repair is required

Filter partially occluded

Service is required

Supply pressure too low and/or gas cylinder nearly empty

Check gas supply and/or replace gas cylinder

Parts and Spares List

Part Number

Description

818-0001

Dialflow Regulator - O2 Range A - UK Bullnose/Barb

818-0002

Dialflow Regulator - O2 Range A - Pin Index/Barb

818-0005

Dialflow Regulator - O2 Range C - Pin Index/Barb

818-0006

Dialflow Regulator - O2 Range C - UK Bullnose/Barb

818-0009

Dialflow Regulator - O2 Range D - Pin Index/Barb

818-0010

Dialflow Regulator - O2 Range D - UK Bullnose/Barb

818-0017

Dialflow Regulator - O2 Range D - Pin Index/Barb/Aux Schrader

818-0018

Dialflow Regulator - O2 Range D - UK Bullnose/Barb/Aux Schrader

818-0024

Dialflow Regulator - Air Range D - UK Bullnose/Barb

818-0025

Dialflow Regulator - Air Range D - UK Bullnose/Barb

818-0028

Dialflow Regulator - Air Range D - Pin Index/Barb/Aux Schrader

818-0030

Dialflow Regulator - O2 Range E - UK Bullnose/Barb

818-0031

Dialflow Regulator - O2 Range E - Pin Index/Barb

818-0037

Dialflow Regulator - Air Range D - UK Bullnose/Barb/Aux Schrader

Spare Parts and Servicing 303-0030

Cylinder Contents Gauge

303-0060

Cylinder Contents Gauge Boot

212-0012

Pin Index Yoke Seal

212-0048

Benelux Bullnose O-ring

212-0094

UK Bullnose O-ring

610-0056

Dialflow Regulator Service Kits (Pack of 10)

610-0057

Bodok Bonded Seal (Pack of 50)

610-0058

Bullnose O-ring (Pack of 50)

9.

Distributor Details

United Kingdom BOC Healthcare Customer Service Centre Priestley Road Worsley Manchester M28 2UT T: +44 (0)8456 447 764 F: +44 (0)8450 870 062 www.bochealthcare.co.uk

Canada BOMImed Inc. 96 Terracon Place Winnipeg MB R2J 4G7 Canada T: +1 204.633.2664 F: +1 204.632.1064 www.bomimed.com BPR Medical Ltd License No: 86841

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