Instructions for Use
MIDOGAS ANALGESIC SYSTEM INSTRUCTIONS FOR USE 1.0 INTRODUCTION This manual is intended to provide users with information on the features, testing, use and care of the Midogas Analgesic System. Any potential user of a Midogas Analgesic System should carefully read the contents of this manual to ensure that they are fully conversant with all the information on the testing, use and care of the apparatus before attempting to use it. 2.0 INTENDED USES The intended purpose of the Midogas Analgesic System is providing analgesia (pain relief) to patients by self-controlled demand inhalation of an adjustable ratio mixture of Nitrous Oxide and Oxygen. The Midogas should be used only in accordance with clinical or medical advice and by persons instructed and familiar with basic medical gas handling. Midogas should only be supplied from pressure regulated medical Oxygen and Nitrous Oxide gas systems. Details of the performance of the Midogas unit is given in Section 10 Specifications. 3.0 GENERAL DESCRIPTION The Midogas Analgesic system is a demand inhalation unit for the self-administration of a variable analgesic gas mixture of Nitrous Oxide and Oxygen. It consists of a wall mounted gas mixing and pressure regulating unit supplying mixed gas in the chosen ratio via a flexible hose to a handpiece incorporating a patient Mask and exhale valve. The Midogas operates on the demand principle (intermittent flow). For self administration, the patient simply holds the mask over the nose and mouth. Inhalation triggers the flow of mixed gas, which automatically cuts off when inspiration ceases. The gas flow remains shut during exhalation. An exhale valve in the handpiece allows the patient to exhale without the need to remove the mask. Gas passages and circuitry allow adequate flow for the most vigorous inhalation, thus breathing remains unobstructed at all times. The Midogas requires connection to sources of regulated pressure medical Oxygen and Nitrous Oxide gases at 400 kPa, i.e. medical gas pipeline systems, or alternatively medical pressure regulators fitted with SIS outlets to AS 2896. To prevent accidental connection to an incorrect gas supply, sleeve indexing to SIS in AS 2896 is used for the inlet hose connections of the Midogas, as well as for the gas hoses supplied with the unit. The gas hoses supplied are also colour coded (white for Oxygen and blue for Nitrous Oxide).
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A lever is used to set the desired mixture of Nitrous Oxide and Oxygen. The Nitrous Oxide concentration is variable between 0% and 75%, with the Oxygen concentration automatically adjusted to between 100 % and 25% ensuring the patient receives gas with an adequate concentration of Oxygen even at the maximum Nitrous Oxide setting. The Nitrous Oxide/Oxygen ratio is indicated by a graduated percentage scale with graphical indication alongside the lever, colour coded for each gas (white for Oxygen, blue for Nitrous Oxide). A whistle alarm is incorporated to indicate loss of pressure in the Oxygen supply to the unit. At the same time a pneumatically operated valve opens to admit fresh air to the patient connection, ensuring gas supply with a minimum 10% Oxygen. An emergency Oxygen push button allows full Oxygen supply to the hose in case of emergencies. 4 PARTS IDENTIFICATION 4.1 Contents of the package Midogas Wall unit Handpiece Mask, Adult Size 5 Antistatic corrugated Tube, 1 metre long Antistatic Tube adaptor Oxygen Hose Assembly, 2 metre long, SIS handwheel connectors Nitrous Oxide Hose Assembly, 2 metre long, SIS handwheel connectors Wall mounting bracket Handpiece Hanging Hook Instructions for Use 4.2 Description of the controls (Refer to Figure 1) All controls are accessible from the front panel layout and are as follows: Inlet hose connections for Oxygen and Nitrous Oxide Master rotating ON-OFF switch: Controls the operation of the unit, by simultaneously switching On or Off both gases, eliminating the possibility of only one gas being supplied. Oxygen/Nitrous Oxide mixture control lever and graduated Oxygen/Nitrous Oxide percentage Scale. The Slide lever adjusts the gas mixture between 25% Oxygen (minimum safety locked percentage)/75% Nitrous Oxide and 100% Oxygen/25% Nitrous Oxide. Emergency Oxygen button: When pressed, this delivers 100% Oxygen at approximately 30 litres/min to the patient outlet circuit. Audible whistle alarm: Indicates that there is no Oxygen supply and that the emergency Fresh Air valve has opened Outlet to patient circuit: Connection for the corrugated hose to the Handpiece and patient Mask.
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Antistatic Tube Adaptor
Outlet to Patient Circuit O2/N2O Mixture Control Lever & Scale
ON/OFF Master Switch Emergency Oxygen Button
Antistatic Corrugated Tube
Handpiece Mounting Hook
N2O Gas Inlet (with attached blue N2O Hose Assembly) Handpiece & Mask O2 Gas Inlet (with attached white O2 Hose Assembly) Exhale Valve (Note: Wall mount bracket not shown)
5 SAFETY PRECAUTIONS AND WARNINGS - Use the Midogas only for the purpose for which it is intended (see above) and in accordance with clinical or medical advice. Failure to do so may result in clinical damage to the patient. CAUTION: The Oxygen/Nitrous Oxide setting used for a given application should be a clinical decision - Use the Midogas only for the gases for which it is marked and colour-coded, always ensuring that the medical gas supply labels on the medical pipeline system, or gas cylinder and pressure regulator if used, match those of the inlet connections in the Midogas (Medical Oxygen is colour coded White, and Nitrous Oxide colour coded Blue). CAUTION: Misconnection of gas service can result in clinical damage including death.
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-If using gas cylinder supply, always ensure there is sufficient gas for the intended application - Never allow oil or grease near Oxygen and Nitrous Oxide equipment or in contact with the Midogas as an explosion and/or fire may result - Never allow any source of ignition or naked flame near the equipment or patient during mixed gas administration and for a reasonable period afterwards. - No repair should ever be undertaken by personnel not trained in the servicing procedures of medical gas equipment. - Use only manufacturer approved spare parts when servicing the Midogas -When connected to a pressure regulator fitted to a gas cylinder, always open the cylinder valve SLOWLY. Rapid opening of the cylinder valve may damage the equipment. CAUTION: Equipment connected to high pressure gas cylinders must be handled with care and in accordance with the recommendations from the gas supplier.
6 EQUIPMENT USE 6.1 Installation After unpacking the Midogas unit, check for any obvious physical damage. A suitable, well ventilated location on a convenient wall should be chosen to affix the wall mounting bracket, well protected from possible shocks and impacts and interference with the supply and delivery hoses. Connect the Oxygen hose (white) to the inlet connector beneath the ON/OFF master switch (left hand side) and the Nitrous Oxide hose (blue) to the connector next to the Oxygen. The hose connections are sleeve indexed to prevent incorrect attachment of the connectors. Connect the mask holding handpiece to the corrugated tubing (this is simply a push fit) and connect the other end to the large gas outlet on the front panel of the Midogas unit. Additional safety may be provided by fitting a gas analyser to monitor the Oxygen content of the supplied gas. When not in use, the handpiece may be hung on the left hand side of the machine on the hook provided. 6.2 Operation of the Midogas Before operation of the Midogas: Ensure the gas hoses are connected to the correct wall outlet or cylinder gas supply and that sufficient gas supply is available. Switch the ON/OFF control to ON. Set the desired Oxygen/Nitrous Oxide mixture using the slide control. Place the mask over the patient’s face and instruct them to breathe normally. Ask the patient to confirm that gas supply is being delivered. The operator should not breath from or into the Mask. Adjust the gas mixture as required. MIDOGAS INSTRUCTIONS FOR USE
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If at any time full Oxygen supply is desired, press the push button activated “Emergency Oxygen” supply. Audible whistle alarm activation indicates that the Oxygen supply has failed and fresh air is admitted to the supply hose. The Nitrous Oxide ratio should be immediately decreased. CAUTION: This is a temporary emergency measure only, and normal Oxygen supply should be restored to continue operation of the Midogas. 6.3 Cleaning after use If the exterior of the Midogas wall unit requires cleaning, use a dry cloth only. For difficult to remove residues and contaminants, wipe over with soapy water containing fully dissolved mild soap, then dry. Care should be taken to ensure that none of the cleaning solution enters the gas passages of the Midogas. Do not attempt to clean the inside of the unit. If internal contamination is apparent, the Midogas should be removed from use and inspected by trained personnel. The patient Mask should be cleaned and disinfected after every use according to the instructions supplied. 6.4 Storage after use The Midogas may be left on its Wall bracket provided the location is clean, dry and secure to prevent accidental knocks and impacts and to prevent the ingress of dust or contamination to its gas passages. 7 CHECKS AND INSPECTION BY THE USER 7.1 Operational check and inspection The following checks should be performed each time the Midogas is connected to the gas supply: The gas specific inlet connector handwheels to the Midogas should be in good, working condition (i.e. no cuts, deformation or dirt). A damaged O-ring may be replaced, when a correct replacement is available, by removing it with a pointed object, taking care not to damage the inlet nipple, and inserting the replacement Oring in place. The inlet connection fittings should be tight and secure, ensuring there are no gas leaks. Only approved leak detecting solutions should be used, such as BUBBLESTM or SNOOPPYTM. When connected to the gas supply, the mixture control lever should be adjusted through its entire range, checking for smooth operation. The corrugated hose should be securely connected to the Wall unit and to the handpiece. The hose should be securely protected against accidental disconnection, knocks and impacts. A clean Mask in good condition should be securely attached to the Handpiece ON-OFF Master switch and Oxygen Failure Alarm check: With the Oxygen and Nitrous Oxide gas supply connected to the Midogas, turn the ON-OFF switch to the ON position and: (a) Press the Emergency Oxygen button. Oxygen should flow out of the Mask; MIDOGAS INSTRUCTIONS FOR USE
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(b) Disconnect the Oxygen supply hose from the wall outlet of the pipeline system or from the supply pressure regulator in the gas cylinder (if used) whilst the Nitrous Oxide supply remains connected to the Midogas. Check that the Oxygen failure alarm whistle begins to operate. If so, re-connect the Oxygen supply to the Midogas and check that the Alarm whistle ceases to operate. If the unit fails any part of this checkout procedure, it must be removed from service and repaired before use on a patient. (Refer to Section 8.0 Service Recommendations). 7.2 Trouble shooting Whistle Alarm activation: Operation of the Whistle Alarm indicates failure of the Oxygen supply, e.g. control valves closed in the gas supply upstream of the unit, loose hose connections, empty gas cylinders. Any other unusual condition requires checking by qualified Service Personnel. The Midogas is not intended for User maintenance.
8 SERVICE RECOMMENDATIONS The Midogas is a critical device for gas supply to a patient for pain relief. To ensure that it is always in a safe, reliable, useable condition it is recommended that the unit be placed on a preventive maintenance program. The preventive maintenance program should include as a minimum fixed yearly servicing. Depending on usage, an additional more frequent service (e.g. six monthly, quarterly or monthly) is recommended. Frequent Inspection Program Operational Check and Inspection (Section 7.1) Fixed Yearly Servicing To be performed by trained service personnel only: Frequent Inspection (Section 7.1) Leak test Inspiratory effort test Output mixed gas composition test Alarm whistle and fresh air valve function test Emergency Oxygen valve performance Primary and secondary regulator performance Exhale valve performance Fixed Every Two Years Servicing To be performed by trained service personnel only: Fixed Yearly servicing Complete overhaul and replacement of regulator seats and elastomeric components For repairs or service to your Midogas, contact your nearest Comweld Medical Products distributor.
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9 ACCESSORIES AND SPARE PARTS 9.1 Midogas Accessories Listed below are some of the accessories suitable for use with a Midogas. If any other accessory is intended to be used with a Midogas, your nearest authorised distributor should be contacted to check the compatibility of the accessory. Description
Series O Medical Regulator, Oxygen (Type 10 inlet) Series O Medical Regulator, Oxygen (Pin indexed Yoke Inlet) Series O Medical Regulator, Nitrous Oxide
518800 518804 518808
9.2 Replacement Parts Listed below are the items considered to be user replaceable parts. It is recommended that the user keep stock of such items to ensure that the Midogas is always ready for use. Description
Mask Adult Size 5 Handpiece assembly Hose Assembly Oxygen 2 metre Hose Assembly Nitrous Oxide 2 metre O-ring for Hose Assembly Handwheels (20 pack) Bracket wall mounting
515743 512101 552084 552085 552018 DM524
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10 SPECIFICATIONS Part number MA139 – Midogas Analgesic System (Wall mounted) Supply pressure: Gas mixture:
Demand flow rate: Demand flow trigger pressure: Exhalation resistance: Emergency Oxygen supply Emergency Fresh Air supply on Oxygen supply failure Inlet connection, Oxygen and Nitrous Oxide Alarm on Oxygen supply failure Patient connection Operating temperature Storage Temperature
400 kPa nominal (ref AS 2896) Adjustable between 25% and 100% Oxygen (safety locked at 25% minimum Oxygen), balance Nitrous Oxide 140 l/min -2 cm H2O +2 cm H2O Push button operated from Wall unit, 30 l/min 10% minimum Oxygen supplied gas SIS Handwheel (AS 2896) Audible whistle 22/15 mm male female taper (AS 2496) 10 to 40C 0 to 50C
11 WARRANTY CIGWELD Pty. Ltd. warrants to the purchaser that this equipment is free from defects in material and workmanship for a period of twelve months from the date of purchase (conditions apply – see Terms of Warranty).
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 526516
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