Medireg Range User Instructions Issue H Jan 2014

Medireg Range User Instructions Issue H; January 2014 Page 2 of 7

Standard Regulator (Medireg) Supplies a fixed outlet pressure of 58psi (4 Bar) (Oxygen or Air) or up to 87psi (6Bar) (“Entonox”) Bullnose or Pin Index fittings available (Entonox – Pin Index Only) 3/8” or Schrader Valve outlet Supplied for use with Oxygen, Medical Air or O2/N2O “Entonox” gas Dial Type Regulator (Dialreg) Supplies a fixed outlet pressure of 58psi (4Bar) however through a calibrated ‘dial type’ flow device Dialled flow device fitted to top of the unit as an integral part. Different ranges of flowrates are available Supplied for use with Oxygen or Medical Air Bullnose or Pin Index fittings available Regulator with integral Flowmeter (Flowreg) Supplies a fixed outlet pressure of 58psi (4Bar) however through a calibrated integral Ball/Tube Flowmeter Different ranges of flowmeter flowrates are available Supplied for use with Oxygen or Medical Air Bullnose or Pin Index fittings available Technical Specification Inlet Pressure Outlet Pressure Safety Valve Blows off Flow Tolerances Accuracy

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Up to 200Bar 58 PSI (O2/Air) ; Up to 87psi (N2O/O2) 7 bar Per BS EN ISO 10524-1:2006 +/- 10% of indicated flow or +/- 0.5LPM whichever is the greater. The accuracy of units with a maximum flow of 1 LPM shall be within +/- 10% of the full scale

WARNING: KEEP ALL OIL AND GREASE, AND NON-RECOMMENDED LUBRICANTS AWAY FROM THIS PRODUCT, AS PRESSURISED OXYGEN AND OIL MAY IGNITE. WARNING: LEAK DETECTOR SPRAYS/SOLUTIONS UNAUTHORISED BY THERAPY EQUIPMENT LTD SHOULD NOT BE USED ON THE PRODUCT. UNAUTHORISED SPRAYS/SOLUTIONS MAY HAVE A DETRIMENTAL EFFECT ON THE PLASTICS USED.

Medireg Range User Instructions Issue H; January 2014 Page 3 of 7

USER INSTRUCTIONS 1. 2. 3.

4.

5.

6. 7. 8.

Make sure that the regulator is clean, in good condition and free from oil of grease. Ensure that the fittings on the cylinder to be used are compatible with requirements and also with the type of Medical Regulator being used. For Bullnose type, ensure O Ring seal is fitted to bottom of the Bullnose stem, and screw Regulator into female thread on top of the cylinder, and ensure that the handwheel is hand tight. Please note that overtightening will damage the Bullnose Seal, and may lead to problems in detaching Regulator from cylinder. For Pin Index types pass the yoke over the top of the square Pin Index Valve on top of the cylinder. Ensure that the Gas Identification Pins in the Pin Index Yoke engage in the location holes in the Pin Index Valve on the Cylinder, to ensure correct gas type is being used. Check that the Bonded Seal (Bodok Seal) is correctly situated on the Yoke Inlet, between the cylinder Valve and yoke. Tighten the yoke on to the cylinder valve using the Screw at the back of the Pin Index Yoke ensuring that the point of the securing screw meets with the indent on the Cylinder Valve. Turn cylinder on slowly with the appropriate Cylinder Key and check for any apparent leakage (audible gas escaping). If leaks are found, then turn the Cylinder off, and return to the Hospital Department responsible for Regulator maintenance or the manufacturer. (Turning the cylinder on quickly increases the danger of fire or explosion arising from oxygen pressure shocks) Ensure that the pressure gauge on the front of the Regulator is registering the cylinder pressure. When the Regulator is not is use, ensure that the Cylinder is turned off, and any residual gas within the regulator vented to atmosphere. When removing the Regulator from the cylinder ensure that the gauge is not registering any pressure. Attempting to remove a pressurised Regulator is dangerous, will cause the unit to be very difficult to remove and apply undue pressure to the Bullnose Stem fitting in the Regulator.

SPECIFIC INSTRUCTIONS FOR USE Medireg 1. 2.

Ensure before turning the cylinder on slowly that the secondary product being used is connected to the 3/8” Outlet When not in use, turn the cylinder off and empty any residual gas in the Regulator by venting the secondary equipment to atmosphere.

Dialreg 1. 2. 3. 4.

Ensure that the Control Knob is set to OFF before turning the cylinder on slowly. Some stiffness in operation will be experienced when moving the Dialreg Control Knob before the cylinder is turned on. Turn the Dialreg Control Knob, on the top of the unit, clockwise until the flow rate required lines up with the Tubing Nipple Outlet, and ensure that there is a gas flow. Push the Patient Tubing over the Tubing Nipple outlet. NO GAS IS DELIVERED BETWEEN SETTINGS. When not in use, turn the cylinder off, and empty any residual gas in the Regulator by turning the dial to a flow and venting to atmosphere.

CARE: The unit may become damaged and provide inaccurate flows, if the end-user attempts to force the Dialreg Control Knob directly from OFF to 15LPM. The flowrates should only be increased by turning the Control Knob in the indicated direction only.

Medireg Range User Instructions Issue H; January 2014 Page 4 of 7

Flowreg 1. 2. 3. 4.

Ensure that the Flowmeter is turned off before turning the cylinder on slowly Turn cylinder on, and select flow rate required by turning Control Knob on front of Flowmeter device in an anti-clockwise direction until the centre of the ball reaches the required level. Ensure that there is a gas flow, and push the Patient Tubing over the Tubing Nipple outlet on the side of the Flowmeter. When not in use, turn the cylinder off, and empty any residual gas in the Regulator by turning the dial to a flow and venting to atmosphere. PLEASE NOTE: THE MEDICAL REGULATOR RANGE IS DESIGNED TO CONTROL HIGH PRESSURE GASES UP TO 200BAR. IT IS THEREFORE EXTREMELY IMPORTANT THAT THE REGULATOR IS CHECKED FOR CONDITION PRIOR TO USE, AND THAT THE UNIT IS FULLY CHECKED OVER IF DROPPED OR DAMAGED IN ANY WAY.

It is the responsibility of the end user to ensure that the correct type of Medireg and flow rate is selected. Therapy Equipment accepts no responsibility for the selection of an incorrect unit or flow rate. CLEANING INSTRUCTIONS The unit should be externally cleaned, by wiping the surface with an alcohol or disinfecting wipe. The used wipes should be safely disposed of after use. If you suspect that the unit is contaminated, remove it from use, and refer the device to the appropriate department. We do not recommend the use of Detergent Based Hard Surface Wipes.

Always allow the unit to dry before use. WARNINGS/CAUTIONS DO NOT use near sources of ignition. Always follow recommended procedures, including the guidance given in HSE document ‘Take Care with Oxygen’ DO NOT use Oils, greases, or any combustible materials on or near this Regulator DO NOT use if dirt or contaminants are present in or around the cylinder, valve or product. DO NOT smoke in an area where Oxygen is being administered ALWAYS secure the cylinder using a Cylinder Ring, Cradle or Trolley ALWAYS keep Cylinder Valve closed and vent pressure from Regulator when not in use. ALWAYS store product in a clean environment when not in use

Medireg Range User Instructions Issue H; January 2014 Page 5 of 7

Maintenance Instructions The Medireg range is supplied with a 4-Year Function Warranty, and requires full workshop reconditioning every 4 Years i.e. all internal seals replacing. The unit should also be function and leak checked every year, and external seals replaced. Annually 1. Ensure the unit is in good condition and damage free. 2. Change the Bullnose ‘O’ Ring (6304) on the Bullnose Nipple, and the Bonded Seal (6159) on the Pin Index version. 3. Connect Regulator to Cylinder and Check that the gauge is functional. Static/Dynamic Pressure Test (for units with 3/8 outlet) 1. 2. 3. 4. 5.

Connect the Regulator to the cylinder, and hand tighten the Plastic Handwheel (Bullnose Type) or the Yoke Screw (Pin Index Type). In the case of units supplied with 3/8” Outlets, connect a Fine Adjustment Valve and a calibrated 100psi Pressure Gauge (NOTE: Ensure that the Fine Adjustment Valve is in the open position before turning the cylinder on) Turn the Cylinder on slowly using either a Bullnose or Pin Index Cylinder Key. Check the Dynamic Pressure (Flowing Pressure) i.e. with Fine Adjustment Valve open on the calibrated 100psi Gauge Check the Static Pressure i.e. with Fine Adjustment Valve closed on the calibrated 100psi Gauge. Once settled, the needle should give a fixed reading – any movement in the needle, either up or down, over a period of time signifies malfunction, requires investigation, and the regulator should be removed from use. The above test should conform to the following: Dynamic Pressure Static Pressure

58psi +/- 5psi @ 138Bar Input Pressure 60psi +/- 5psi @ 138Bar Input Pressure

For units without 3/8” Outlets i.e. Flowregs and Dialregs, a Static and Dynamic Pressure test is not possible without returning the unit to a workshop. We therefore recommend the following: 1. 2.

Connect a flowtube calibrated to atmosphere to the Tubing Nipple outlet on the unit. Check the flowrate at 5/10/15 LPM to ensure that the output readings are within tolerance

Leak Test 1. 2. 3. 4. 5. 6. 7. 8.

For units with 3/8” Outlets fitted, ensure that the outlet is occluded by a Blanking Plug. For units without 3/8” Outlets fitted, ensure the connected flow device is in the OFF position. Turn the Cylinder on slowly using either a Bullnose or Pin Index Cylinder Key. Ensure that the regulator gauge is functional, and is registering the approximate contents of the cylinder. Turn the cylinder off, and leave the pressure retained within the regulator. Leave for 10 minutes, and ensure that there is no movement on the gauge needle. If there is movement remove the unit from use and refer to Hospital Department responsible for maintenance or Manufacturer. Once tested, vent regulator and detach any Blanking Plug from outlet. Record Serial Number of product serviced.

Medireg Range User Instructions Issue H; January 2014 Page 6 of 7

Should either of these procedures reveal a function outside of specification, then the unit should be removed from use, and returned to the workshop for servicing. In case of a unit less than 4 years old, the unit maybe returned to Therapy Equipment Ltd under warranty for free of charge repair/reconditioning. ALL UNITS MUST BE FULLY RECONDITIONED OR REPLACED EVERY FOUR YEARS – ANY UNIT FOUND TO BE EITHER OLDER THAN FOUR YEARS, OR HAVE HAD NO APPARENT RECONDITIONING WITHIN THE LAST FOUR YEARS SHOULD BE REMOVED FROM USE WITH IMMEDIATE EFFECT. Four Year Reconditioning Options 1.

2. 3.

The unit can be returned to Therapy Equipment Ltd for reconditioning. Full reconditioning involves the replacement of all internal working parts of the regulator, including the Main Valve Seating and Diaphragm. Any Regulator reconditioned by Therapy Equipment Ltd will be returned with a new Four-Year warranty. The unit can be reconditioned by trained/competent Hospital equipment technicians - Regulator Servicing Kits are available for each type of Medireg unit. The unit can be renewed using our New for Old Scheme – discounted prices to remove old units for brand new units.

USE OF ANIMAL TISSUES/PHTHALATES The Medireg range has not been manufactured using any Animal Tissue or Phthalates. Risk Analysis RISK Gas Leaking from Product

RISK ANALYSIS A hissing sound will be heard

Gauge Failure

Regulator will continue to function, but cylinder contents will not register on gauge Regulator becomes damaged and ceases to function Or Regulator continues to function

Cylinder falls over with the Regulator attached

ACTION Check all external seals for tightness. If apparently in order, send back to Hospital Department responsible for maintenance or Manufacturer Return to Hospital Department responsible for maintenance or Manufacturer to fit new gauge In all instances of possible accidental damage return to the Hospital Department responsible for maintenance or Manufacturer for inspection.

Troubleshooting Q

Unit will not remove from the cylinder after use

A

Ensure that the Regulator has been fully vented prior to removal. Despite only being handtight, the Handwheel on the Regulator will be almost impossible to move on a pressurised Regulator.

Medireg Range User Instructions Issue H; January 2014 Page 7 of 7

PLEASE NOTE: The Bullnose Nipple has been fitted using a torque pressure of 45-75Nm. If a pressure greater than this is applied during the removal of the Regulator i.e. if the regulator has not been vented, and a force being used to remove the Unit from the Cylinder is great enough, it may be possible to loosen the Bullnose Nipple from the Body and therefore allow full cylinder pressure to vent into the atmosphere. Q

The Pressure Relief Valve on side of unit appears to be venting

A

The Pressure Relief Valve (PRV) is designed to vent pressure from the Regulator should the unit become over-pressurised beyond approximately 105psi (7Bar). The venting of the PRV indicates a fault with the unit, and the unit must be returned to Hospital Department responsible for maintenance or Manufacturer.

PLEASE NOTE: Under no circumstances should the setting of Relief Valve be adjusted. Only competent trained engineers are authorised to remove the Serial Number and expose the internal workings of the unit. Over setting of the Pressure Relief Valve is dangerous and can cause catastrophic failure. Q

The unit appears to be giving an incorrect pressure output.

A

The unit does not contain any external pressure adjustment screw, and is designed to give a set 58psi (4Bar) output pressure. The output of the Regulator will vary slightly depending on the contents of the cylinder, however should the unit supply pressures outside of tolerance, it should be reconditioned or returned to the manufacturer for investigation.

Revision No.

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06/01/99

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28/01/09

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15/01/14

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