Series -0 Regulator Instructions for Use Issue 04 Sept 2005

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TABLE OF CONTENTS

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1.0 INTRODUCTION

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These instructions are intended to provide users with information on the features, use and care of the Series-O medical gas regulator.

1.0

INTRODUCTION

3

2.0

GENERAL DESCRIPTION

3

3.0

SAFETY PRECAUTIONS

4

4.0

PARTS IDENTIFICATION

5

The instructions should be read carefully by every intended user of a SERIES-O regulator in any of its applications before attempting to use it to ensure that they are fully conversant with all the information on the features, use and care of the regulator.

5.0

OPERATIONAL CHECK

6

2.0 GENERAL DESCRIPTION

6.0

EQUIPMENT USE

6

7.0

CLEANING

7

8.0

EQUIPMENT TESTING

7

9.0

SPARES AND ACCESSORIES

8

10.0

SPECIFICATIONS

10

11.0

SERVICE RECOMMENDATIONS

11

12.0

WARRANTY

11

The SERIES-O regulator is intended to be connected to high pressure medical gas cylinders in order to supply medical gases at reduced and regulated pressures similar to those from medical gas pipeline systems. The regulated pressure gas is supplied to medical devices intended for typical applications like Respiratory Therapy, Resuscitation and Suction.

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The SERIES-O regulator is a reliable, compact, preset single stage regulator. Pressure reduction is effected by means of an encapsulated pressure regulating valve, protected by a unique triple filtration system in the high pressure side to protect the regulator and downstream equipment from entry of foreign particles. The SERIES-O regulator does not require user pressure adjustment. It has been factory preset to deliver the outlet pressure specified in AS 2896 or applicable Standard. Since it is always adjusted to deliver outlet pressure, it is essential that it should be connected to the high pressure gas cylinder only when attached downstream devices are fitted with an outlet valve.

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A pressure gauge is fitted in the high pressure side of the regulator in order to allow indication of the gas cylinder contents. The gauge is of the safety back design to allow gas to escape away from the operator ensuring maximum safety in the unlikely event of a failure occurring. A solid metal case also provides protection to the internal mechanism.

When using the SERIES-O regulator the following precautions should be observed:

A pressure relief valve is fitted to the outlet pressure side of the regulator to give protection against most seat failures.

- Ensure that the cylinder valve is not opened when there is no

Gas specific inlet and outlet connections allow the regulator to be connected only to the gas for which it is intended. Colour coded pressure gauges and identification labels help for quick identification of the gas for which the regulator is intended.

- Turn off the cylinder valve when not in use.

Use of the SERIES-O regulators should always be undertaken in accordance with the instructions for use of the medical device which will be connected to its outlet connection to deliver care to a patient. This may require clinical or medical advice.

Only use the SERIES-O regulator with the medical gas for which it is intended and labelled. Ensure it is connected to the correct gas cylinder by reading the cylinder label which is the primary identification of its gas. Consult safe gas cylinder handling procedures and guidelines from the medical gas suppliers to plan location and access to the gas cylinder and the connected regulator.

- No smoking, naked flames or sources of ignition nearby. - Use no oil or greases as a fire or an explosion may result. - Open cylinder valve slowly and fully. equipment connected downstream of the regulator - Keep gas cylinders cool. - Do not dump or drop cylinders.

3.0 SAFETY PRECAUTIONS The SERIES-O regulator should be used only if all its components are in correct operating condition as described in these instructions.

The SERIES-O regulator has been primarily designed for use connected to a static and properly secured medical gas cylinder. Ensure the regulator is well protected at all times against accidental contact with other objects. Impact on the regulator could cause malfunction and unintended gas release. Never use the regulator as a means of lifting, carrying and steadying the cylinder.

Most models of the SERIES-O regulator range are intended to be connected to high pressure gas cylinders containing oxygen or oxidising gases. Materials that react normally in contact with air may react violently and ignite in an oxygen-enriched atmosphere. 4

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When connecting a regulator to a gas cylinder, always open the cylinder valve SLOWLY and FULLY. Rapid opening of the cylinder valve may damage downstream equipment.

4.0 PARTS IDENTIFICATION Contents Gauge

Since SERIES-O Regulators are always preset to deliver outlet pressure, they should be pressurised only when downstream equipment fitted with a control valve are attached to them. Ensure that the cylinder valve is not opened when there is no equipment connected downstream of the regulator. This may cause damage to the regulator.

Inlet Handwheel

Inlet O-ring

Operation of the pressure relief valve indicates malfunction in the pressure regulating mechanism. The cylinder valve should be closed immediately and the regulator should be removed from use and subjected to servicing.

Pressure Relief Valve

When the regulator is moved around whilst connected to a gas cylinder, the cylinder valve should always be closed first.

Contents Gauge

For applications where a mobile supply of medical oxygen is required, e.g. during patient transportation, a safe and suitable arrangement for securing the gas cylinder and pressure regulator is required. Ensure the regulator is adequately guarded and protected against impact and knocks during transport.

Bodok Seal

Inlet Filter & Retainer

Inlet Filter & Holder Yoke Wing Screw

When not in use, cylinder valves should be turned off and the regulator depressurised.

Pressure Relief Valve

All repairs should be undertaken only by personnel trained in the servicing procedures for medical equipment. Do not tamper with the setting of the pressure relief valve.

NOTE: Apart from the Inlet Handwheel or Yoke Wing Screw, there are no user controls on the SERIES-O regulator. The cylinder contents pressure gauge only provides indication of the gas cylinder pressure.

Use only manufacturer approved spare parts when servicing. 5

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5.0 OPERATIONAL CHECK

Connect the regulator to the cylinder valve. If the regulator has a pin index yoke connection align the yoke pins with the matching holes in the cylinder valve. Secure by tightening the yoke wing screw until a leak tight seal is achieved.

Before connecting a SERIES-O regulator to a gas cylinder: - Check to ensure that the Bodok seal (Yoke inlet models) or - inlet o-ring (screw connection models) is in a good condition.

If the regulator has an inlet handwheel simply tighten the inlet connection to the cylinder valve until a leak tight seal is achieved.

- Check the pressure gauge to ensure that the pointer reads - - zero when there is no inlet pressure present. - Check the condition of the inlet and outlet gas specific - - - connectors.

Note: Any difficulty in connecting the regulator indicates a possible fault or mismatch in the connections which should be investigated and repaired before use of the regulator.

- Check for any damage that may have occurred to the - regulator.

CAUTION

6.0 EQUIPMENT USE

- Do not open the cylinder valve until downstream equipment - is connected to the regulator outlet.

6.1 Connecting a Regulator to a Gas Cylinder

- Do not check the gas cylinder contents by opening the - - - cylinder valve until downstream equipment has been - - connected to the regulator outlet.

To connect a regulator to a gas cylinder, first verify that the gas cylinder label indicates the correct medical gas for the regulator and the intended application. Remove any protective capping from the cylinder valve and check that the cylinder valve outlet is in good condition and matches the regulator inlet connection.

6.2 Connecting Downstream Equipment Warning: Use only downstream equipment that is compatible with the intended gas and suitable to operate at the rated outlet pressure of the regulator. The downstream equipment should be fitted with the correct SIS inlet connection matching the regulator outlet connection.

Briefly open and close the cylinder valve to remove any foreign matter. Check that the Bodok seal (Yoke inlet models) or inlet O-ring (screw connection models) are in a good condition and replace them as required. 6

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To connect downstream equipment (e.g. flowmeter, suction unit) to a SERIES-O regulator, first ensure that the downstream equipment is turned off. Connect the inlet of any downstream equipment to the regulator outlet connection and tighten. Only then slowly and fully open the cylinder valve. Check the regulator contents pressure gauge to confirm there is sufficient gas in the cylinder for the intended use. Check all connections for leaks. If necessary, re-tighten connections until a leak tight seal is achieved.

6.5 Storing the regulator when not in use If the regulator is not going to be used immediately following removal from a cylinder, it should be stored in a clean, dry, secure place to prevent accidental knocks and impacts and to prevent the ingress of dust or contamination to its gas passages. 6.6 Replacing the inlet filter To replace the inlet filter, first remove the filter retaining screw using a correct size Allen key (3.2 mm - 1/8" for yoke inlet models, 4.8 mm - 3/16" for screw connection models). The filter should drop out of the inlet connector when the regulator is inverted. After fitting a new inlet filter its retaining screw should only be lightly tightened ("nipped up"). Do not over tighten.

Use the downstream equipment as required and in according with its Instructions for use, and if necessary, under clinical or medical supervision. When the downstream equipment is no longer in use, close the cylinder valve and depressurise the regulator.

7.0 CLEANING

6.3 Removing downstream equipment

A SERIES-O regulator should not require regular cleaning after use. If the exterior of the regulator needs cleaning, a mild soap solution should be used. Care should be taken to ensure that none of the cleaning solution enters the gas passages of the regulator. Do not attempt to clean the inside of the regulator. If internal contamination is apparent, the regulator should be removed from use and inspected by trained personnel.

To remove downstream equipment from the regulator, first close the cylinder valve. Depressurise the downstream equipment and the regulator by operating the downstream equipment until the regulator contents gauge reads zero pressure. Remove the downstream equipment. 6.4 Removing a Regulator from a Cylinder

8.0 EQUIPMENT TESTING

With the downstream equipment now disconnected and the regulator depressurised, remove the regulator from the cylinder valve by unscrewing the yoke wing screw or inlet handwheel.

The regulator should be periodically tested for leaks, outlet set pressure and pressure relief valve setting. The recommended frequency of these tests is detailed in section 11.0 of this manual. 7

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Leak Test

9.0 SPARES AND ACCESSORIES

To test for leaks fit the regulator to a full gas cylinder and block off the regulator outlet. Open the cylinder valve and apply an approved leak detection solution to all regulator body connections (inlet, outlet, pressure gauge, pressure relief valve and bonnet). No bubbles should be generated within 30 seconds.

9.1 SERIES-O Accessories

Approved leak detection solutions are BUBBLES

TM

Listed below are some of the accessories suitable for use with a SERIES-O regulator. It is recommended that if any other accessories are intended to be used with a SERIES-O regulator, your nearest authorised distributor should be contacted to check the compatibility of the accessory.

TM

or SNOOPY .

Description

Part No

Outlet Set Pressure and regulator seat performance

EZI-FLOW 0-15 L/min oxygen flowmeter

515800

The outlet set pressure of the regulator should be periodically checked, and adjusted if required. This requires special test equipment and should only be carried out by trained service personnel. Contact your nearest authorised service agent for further information.

EZI-FLOW 0-2.5 L/min oxygen flowmeter

515824

EZI-FLOW 0-15 L/min air flowmeter

515820

Flowmeter Gauge type 0-14 L/min oxygen

TM17

Pressure Relief Valve Setting The operation of the pressure relief valve should be periodically checked. This requires special test equipment and should only be carried out by trained service personnel. Contact your nearest authorised service agent for further information.

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Humidifier

TM11

Twin-O-Vac

TM117G

Oxygen Demand Valve Resuscitator

552095

Equinox Demand Valve with 2m hose

550011

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9.2 User Replacement Parts

9.3 NOTES

Listed below are the items considered to be user replaceable parts. It is recommended that the owner keep stock of items such as Bodok seals to ensure that the SERIES-O regulator is always ready for use. Description

Part No

Bodok seal, 10 pack

552121

Inlet filter RB38 , 10 pack

551024

Inlet filter/retainer RB38/RB39 , 10 pack

552105

(Screw connections) Inlet filter RB38 yoke retainer, 10 pack

551028

(Yoke inlets) Inlet O-ring 110 Neoprene, 5 pack

301703

(Screw connections)

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10.0 SPECIFICATIONS Part No

Gas

Inlet Connection

Rated Inlet Pressure, P1

Outlet Pressure, P2

Standard Discharge, Q1

518800

Oxygen

AS 2473 Type 10 (G5/8 RH INT - Side)

20 000 kPa @ 15°C

400 kPa

125 l/min

518804

Oxygen

AS 2473.3 (Pin Indexed Yoke)

20 000 kPa @ 15°

400 kPa

125 l/min

518808

Nitrous Oxide

AS 2473.3 (Pin Indexed Yoke)

21 000 kPa

400 kPa

125 l/min

518809

Air

AS 2473.3 (Pin Indexed Yoke)

20 000 kPa @ 15°C

400 kPa

125 l/min

518810

Nitrous oxide/Oxygen 50/50 nom.

AS 2473.3 (Pin Indexed Yoke)

20 000 kPa @ 15°C

400 kPa

125 l/min

518803

Oxygen - (Air Viva)

N/A

20 000 kPa @ 15°C

400 kP

125 l/min

518895

Oxygen

20 000 kPa @ 15°C

400 kPa

125 l/min

AS 2473 Type 10 (G5/8 RH INT - Vert)

Notes: AS 2473.3 (Pin Indexed Yoke) inlet connections for the nominated gas SIS - Sleeve Indexed System outlet connections from AS 2896 for the nominated gas

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Pressure Relief Valve:

11.0 SERVICE RECOMMENDATIONS

The pressure relief valve fitted to SERIES-O regulators releases gas at pressures greater than 800 kPa.

A SERIES-O regulator is a critical link in the supply of medical gas to a patient. To ensure that the regulator is always in a safe, reliable, useable condition it is recommended that the unit be placed on a preventative maintenance program.

Filters: All SERIES-O regulators are fitted with three inlet filters: - a 66 micron sintered filter in the inlet connection, - a fibre strand filter upstream of the seat capsule, - a 34 micron sintered filter fitted to the seat capsule. Flow Capacity:

The preventative maintenance program should include as a minimum fixed yearly and every three years servicing. Depending on usage, an additional more frequent service (e.g. six monthly, quarterly or monthly) is recommended. Frequent Inspection program: - Operational Check (Section 5.0) - Leak test (Section 8.0) - Outlet Set Pressure and regulator seat performance (Section 8.0)

Inlet Pressure 15,000 kPa Inlet Pressure 1100 kPa

Outlet Pressure kPa

Fixed Yearly servicing - Frequent Inspection - Inlet filter, Bodok seal and inlet O-ring replacement (Section 6.0)

Flow, L/min Pressure Rise: Pressure Rise:

Fixed Every Three Years Servicing - Fixed Yearly servicing - Pressure relief valve check - Regulator seat capsule replacement

Outlet Flow 1 L/min Outlet Flow 90 L/min

Outlet Pressure kPa

12.0 WARRANTY CIGWELD Pty. Ltd. warrants the purchaser that this equipment is free from defects in material and workmanship for a period of three years from the date of purchase (conditions apply).

Inlet Pressure, kPa

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COMWELD MEDICAL

CIGWELD Pty. Ltd. A.B.N. 56 007 226 815 71 Gower Street, Preston, Victoria, Australia 3072 Customer Service & Technical Support Line Ph: +61-3-9474 7314, Fax: +61-3-9474 7391 In the interest of continuous improvement, CIGWELD Pty. Ltd. reserves the right to change the specifications or design of any of its products without prior notice.

PART NO.

ISSUE

DATE

522460

04

905