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1、Medical gases Health Technical Memorandum 02-01: Medical gas pipeline systems Part B: Operational management Medical gases Health Technical Memorandum 02-01 Medical gas pipeline systems Part B: Operational management 9 780113 227433 ISBN 0-11-322743-4 www.tso.co.uk Medical gases Health Technical Mem
2、orandum 02 01 Medical gas pipeline systems Part B: Operational management DH INFORMATION READER BOX PolicyEstates HR / WorkforcePerformance ManagementIM medical oxygen, nitrous oxide, nitrous oxide / oxygen mixture (50% v/v), medical air for respiratory applications (at 400 kPa) and surgical air too
3、ls (at 700kPa), medical vacuum, helium / oxygen (oxygen 21%). Waste anaesthetic gases scavenging systems (AGSS) are also covered. 0 n/a 0 n/a Medical gases Health Technical Memorandum 02-01 Medical gas pipeline systems Part B: Operational management London: The Stationery Office Medical gases HTM 02
4、-01 Medical gas pipeline systems Part B: Operational management ii Published by TSO (The Stationery Office) and available from: Online www.tsoshop.co.uk Mail, Telephone, Fax encapsulates the latest standards and best practice in healthcare engineering; provides a structured reference for healthcare
5、engineering. Structure of the Health Technical Memorandum suite The new series of engineering-specific guidance contains a suite of nine core subjects: Health Technical Memorandum 00 Policies and principles (applicable to all Health Technical Memoranda in this series) Health Technical Memorandum 01
6、Disinfection and sterilization Health Technical Memorandum 02 Medical gases DESIGN b. nitrous oxide; c. nitrous oxide/oxygen mixture (50% v/v); d. medical air for respiratory applications (at 400 kPa) and surgical air for tools (at 700 kPa); e. medical vacuum; f. helium/oxygen (oxygen 21%). Waste an
7、aesthetic gas scavenging systems (AGSS) are also covered. Notes Pipeline installations for carbon dioxide can be used for surgical purposes (see Chapter 11, Part A). 1.2 Throughout this document, the “medical gas pipeline system(s)” will be described by the term MGPS. 1.3 This guidance applies to al
8、l MGPS installed in healthcare premises. 1.4 An MGPS is intended to be a safe, convenient and cost-effective alternative to the use of “portable” cylinders, portable compressors and portable suction units, providing gas or vacuum for clinical needs without the associated problems of porterage, noise
9、 and space wastage. 1.5 The guidance given in this Part should be followed for all new installations, and for refurbishment or upgrading of existing installations. 1.6 It is not necessary to apply the guidance retrospectively unless patient or staff safety would be compromised. In this case, the gui
10、dance given in Part A should be followed. 1.7 Existing installations should be assessed for compliance with Part A. A plan for upgrading the existing system should be prepared, taking account of the priority for patient safety. Managers will need to liaise with clinical staff and take account of the
11、 latest guidance published by the Department of Health in order to assess the system for technical deficiencies. 1.8 Part A also contains details of the design, equipment and operational parameters of systems that form the basis for Model Engineering Specification C11 Medical gases. This specificati
12、on is intended for the procurement of an MGPS. As technology develops, this Health Technical Memorandum and Model Engineering Specification C11 will be revised from time to time, but not necessarily simultaneously. Whichever document is the most current takes precedence. 1.9 Whenever appropriate, Eu
13、ropean/British Standards specifications should be used. Operational management 1.10 Part B on operational management covers such issues as statutory requirements, functional responsibilities, operational policies, operational procedures, training and communications, cylinder management, general safe
14、ty, maintenance and risk assessment, and control of exposure to anaesthetic agents, giving definitions and working practices throughout. 1.11 It is intended to be used by operational managers, engineers, quality controllers (QCs), technicians, finance officers and other professionals involved in the
15、 day-to-day running of an MGPS. 1.12 The primary objective of this Part is to ensure the provision of safe and reliable MGPS, and their 1 Scope Medical gases HTM 02-01 Medical gas pipeline systems Part B: Operational management efficient operation and use. This objective will only be achieved if the
16、 medical and nursing users and estates staff participate in the introduction of an operational policy designed to minimise the hazards likely to arise from misuse of the system. Other guidance 1.13 Guidance on provision of MGPS is also given in Health Building Notes. 2.1 An MPGS comprises a source o
17、f supply, pipeline distribution system, terminal units (to which the user connects and disconnects medical equipment) and a warning/alarm system. 2.2 Systems are provided for: oxygen (O2); nitrous oxide (N2O); nitrous oxide/oxygen mixture (N2O/O2: 50%/50%); medical air (MA4) at 400 kPa for respirato
18、ry applications, and at 700 kPa (SA7) for surgical tool applications; helium/oxygen mixture (He/O2: He = 79%; O2 = 21%); and medical vacuum at a pressure of 400 mm Hg (53 kPa) below atmospheric pressure. An AGSS is also provided where nitrous oxide is used for anaesthetic purposes (anaesthetic gas s
19、cavenging can be carried out in dentistry where a nasal mask is used for relative analgesia). Notes Pipeline installations for carbon dioxide can be used for surgical purposes (see Chapter 11, Part A). 2.3 Various medical gas systems and pipeline installation elements are shown in Part A. 2.4 Detail
20、s of the quality requirements for medical gases are given in Chapter 15, Part A. These requirements are summarised as follows: a. medical gases supplied from cylinder or liquid sources should comply with the appropriate European Pharmacopoeia (Ph. Eur.) monograph; b. medical air and pressure swing a
21、dsorber (PSA) systems should comply with the appropriate Ph. Eur. monograph and the requirements given in Part A, Chapter 15, Table 29. Sources of supply Oxygen 2.5 For oxygen systems, the source of supply can be bulk liquid oxygen in a vacuum-insulated evaporator (VIE), liquid or gas cylinders, or
22、an oxygen concentrator (PSA) system. When cylinder supply systems are used, the source of supply comprises a manifold that automatically changes from “duty bank” to “stand-by bank” to ensure continuity of supply. 2.6 An oxygen concentrator (PSA) system may be used to supply an oxygen pipeline system
23、, even though the percentage concentration of oxygen is lower than that derived from liquid or gaseous sources, typically 94% or higher. Nitrous oxide and nitrous oxide/oxygen 2.7 Nitrous oxide and nitrous oxide/oxygen mixture supply systems are usually supplied from a medical gas manifold system in
24、 two banks. When full, nitrous oxide cylinders contain liquid and gaseous product with a liquid/gaseous boundary; they must be used upright. Nitrous oxide can also be supplied by bulk liquid sources. Nitrous oxide/oxygen mixture could also be supplied by means of nitrous oxide and oxygen mixing syst
25、ems, similar to those used for the production of synthetic air. Medical air 2.8 For medical air systems used in respiratory applications, the source of supply can be: a medical gas manifold system; a medical compressor system; or an oxygen and nitrogen mixing system (referred to as a synthetic air p
26、lant). When air-powered ventilators are used regularly, the consumption of air is high; cylinder supply systems are not recommended in these cases. 2 Basic description of an MGPS Medical gases HTM 02-01 Medical gas pipeline systems Part B: Operational management 2.9 Emergency reserve manifold system
27、s are provided for all gases. 2.10 Air or nitrogen for surgical tools is required at 700 kPa. The air supply can be provided by: an automatic manifold system; a small, dedicated compressed-air system; or a compressor plant supplying both medical and surgical air. Note Nitrogen for surgical power too
28、ls is likely to be used only on the sites where it is available for the production of synthetic air. Medical vacuum 2.11 Medical vacuum is provided by means of a central vacuum plant. The vacuum system should always be used in conjunction with vacuum control units that include vacuum jars. In the ev
29、ent of inadvertent contamination of the pipeline systems resulting from vacuum jars overflowing, immediate action is required to clean the system before any fluids etc dry out. The procedure for cleaning vacuum systems is given in Appendix D. Distribution systems 2.12 Medical gases and vacuum are di
30、stributed throughout the hospital via the pipeline distribution system to provide gas (and vacuum) at the terminal units. Terminal units may be wall- mounted or installed within medical supply units, for example operating room pendant fittings, bedhead trunking and wall fittings that include other f
31、acilities such as nurse-call systems, connections for patient monitoring, electrical services, audio systems etc. Medical supply units should comply with the relevant sections of BS EN ISO 11197:2004. 2.13 The pipeline distribution system also includes area valve service units (AVSUs). These permit
32、isolation of certain parts of the system for servicing or repair. They are also provided for use by clinical or nursing staff in an emergency. For example, in the event of a fire in a ward requiring patient evacuation or system damage to the extent that serious gas loss is occurring, the valve shoul
33、d be turned off to prevent further gas loss. Line valve assemblies (LVAs) are also included to permit isolation of larger parts of the system for modification and/or repair. Warning and alarm systems 2.14 Warning and alarm systems are provided to give information to the staff who are responsible for
34、 operating the MGPS, changing cylinders, responding to plant faults, and to the medical staff responsible for the administration of medical gases and clinical users. Standards relevant to medical gases BS EN 737-1:1998. Medical gas pipeline systems. Terminal units for compressed medical gases and va
35、cuum 3.1 This standard specifies the design requirements for their safe functioning. The primary elements in a terminal unit are a gas-specific probe and a socket with dimensions that are specific for each medical gas and for vacuum. The standard does not, however, actually specify these dimensions.
36、 Terminal units for oxygen, nitrous oxide, air for breathing and oxygen/nitrous oxide mixture (50%/50% v/v) must operate in a pressure range 320600 kPa and be safe up to 1000 kPa. Terminal units for air or nitrogen for driving surgical tools must operate in a pressure range 6401200 kPa and be safe u
37、p to 2000 kPa. Terminal units for vacuum must operate at a minimum absolute pressure of 10 kPa (76 mm Hg). 3.2 Terminal units have to be fitted with both a check valve and a separate maintenance valve, which may be manual or automatic. The leakage from the check valve must be less than 0.03 kPa L/mi
38、n, which is close to 0.3 mL/min at atmospheric pressure. Limits for leakage from the maintenance valve are not specified. BS EN 737-2:1998. Medical gas pipeline systems. Anaesthetic gas scavenging disposal systems. Basic requirements 3.3 This standard outlines the principles for active AGSS. Such sy
39、stems differ from current UK systems in both flow rate range and terminal unit design (BS EN 737-4:1998). Flow ranges from 25 to 50 L/min with a maximum induced flow from the patient connection of 0.05 L/min; this compares with British Standard (BS) system specifications of 80 to 130 L/min and 0.5 L
40、/min respectively. 3.4 Care must be taken to ensure that receiving systems designed under BS EN 737 are not used on BS systems, as excessive negative patient-applied pressures and noise may be generated. BS EN 737-3:1998. Medical gas pipeline systems. Pipelines for compressed medical gases and vacuu
41、m 3.5 This standard specifies basic requirements for installation, function, performance, documentation, testing and commissioning of medical gas and vacuum pipeline systems to ensure patient safety by continuous delivery of the correct gas from the pipeline systems. 3.6 The list of medical gases co
42、vered is the same as that for EN 737-1. 3.7 Supply systems with mobile or stationary cryogenic vessels, with one or two vessels and a reserve supply, are permitted, and proportioning systems that use cryogenic liquid to generate synthetic air are specified. The standard permits air compressor system
43、s that have three compressor units and no further reserve, provided that each compressor unit is capable of supplying the system design flow. Vacuum systems must have three or more vacuum pumps and be capable of supplying the system design flow with two units out of service. 3.8 Requirements are als
44、o given for area shut-off valves that must be located in boxes with a means to allow physical separation of the service for modification purposes. A gas-specific inlet (either NIST or a terminal unit) is also required downstream of each area shut-off valve. 3.9 Pipeline pressures must be 400500 kPa
45、for compressed medical gases, except air or nitrogen for surgical tools which has to be 7001000 kPa. Vacuum is required to be 6% C2H4O 3.2 Toxic and/or corrosive and oxidising Nitric oxide mixtures Sulphur dioxide Chlorine 3.3 Toxic and/or corrosive only Ethylene oxide/halocarbon mixtures 15% C2H4O
46、(certain conditions only) Ethylene oxide/carbon dioxide mixtures 6% C2H4O 4 Others including inert, but excluding toxic or corrosive (green diamond on label) Carbon dioxide Helium Medical Nitric oxide 1000 vpm (volume parts per million) in nitrogen Compressed air Carbon dioxide Nitrogen Argon Helium
47、 Halocarbon Refrigerants Table 2 Classification of gas cylinders Cylinder colour codes 8.10 Cylinder colours are changing. See Figure 3 for new cylinder colour codes. Cylinder sizing and naming 8.11 New types of cylinders and sizes have been introduced and are shown in Figure 3. Medical gas cylinder
48、 valve types 8.12 There are four basic valve types: bull-nose, hand- wheel, star and pin-index. The latter may be configured as either top/side spindle or knurled- knob (top) operated. 8.13 Bull-nose valves are used on larger cylinders: for example F, G and J. Gas connection is made between the sphe
49、rical end (bull-nose) of the pipeline or regulator and the conical seat of the valve outlet. The seal is either by direct metal-to- metal contact between the bull-nose and cone (uncommon nowadays) or by an O-ring on the bull-nose. 8.14 The hand-wheel valve is used on F, G and J sizes of medical nitrous oxide, VF and LF sizes of carbon dioxide, and many pathology and industrial gas cylinders. A flat sealing washer (a Bodok seal) fits between the cylinder connector and valve. The cyl
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