CAN CSA-Z168 5 6-1996 Expired-air pulmonary resuscitators (First Edition General Instruction No 1 September 1996).pdf

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1、CAN/CSA-Z168.5.6-96A National Standard of Canada(reaffirmed 2011)Expired-air pulmonary resuscitatorsLAssociation canadlenne de normallsation (CSA), sous les auspices de laquelle cette Norme nationale a dte prdparde, a rep ses lettres patentes en 1919 et son accreditation au sein du Systbme de normes

2、 nationales par le Conseil canadien des normes en 1973. Association daffiliation libre, sans but iucratif ni pouvoir de rdgiementation, elle se consacre B Idlaboration de normes et B la certification. Les normes CSA reflbtent le consensus de producteurs et dusagers de partout au pays, au nombre desq

3、uels se trouvent des fabricants, des consomrnateurs, des ddtaillants et des representants de syndicats, de corps professionnels et dagences gouvernementales. Lutilisation des normes CSA est trbs repandue dans Iindustrie et le commerce, et leur adoption h divers ordres de legislation, tant municipal

4、et provincial que fddbral, est chose courante, particulibrement dans les domaines de la santb, de la sdcuritk, du batiment, de la construction et de Ienvironnement. Les Canadiens dun bout A Iautre du pays tbrnoignent de leur appui au travail de normalisation mend par la CSA en participant bdn8voleme

5、nt aux travaux des cornit cet aspect demeure la responsabilitd de Iorganisme rddacteur de normes accrdditb. pbriodiques ; cest pourquoi il est recommand6 aux utilisateurs de se procurer Ildition la plus rdcente de la norme auprhs de Iorganisrne qui Ia prdparbe. Une Norme nationale du Canada est une

6、norme, approuvde par le Conseil canadien des normes, qui reflbte une entente raisonnable parmi les points de vue dun certain Lapprobation dune norme en tant que Norme nationale du Canada indique quelle est conforme aux methodes et crithres dtablis par le Conseil canadien des normes. II est recommand

7、d aux personnes qui ont besoin de normes de se servir des Normes nationales du Canada lorsque la chose est possible. Ces normes font Iobjet dexamens The Standards Councli of Canada is the coordinating body of the National Standards system, a federation of independent, autonomous organizations workin

8、g towards the further development and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promole voluntary standardization as a means of advancing the national economy, benefiting the health, safety, and welfare of the public, as

9、sisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in the field of standards. A National Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement

10、 among the views of a number of capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is c

11、apable of making a significant and timely contribution to the national interest. Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refer to the technical content

12、of the standard; this remains the continuing responsibility of the accredited standards-development organization. Those who have a need to apply standards are encouraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cau

13、tioned to obtain the latest edition from the organization preparing the standard. La responsabilit6 dapprouver les Normes nationales du Canada incornbe au The responsibility for approving National Standards of Canada rests with the Conseil canadien des normes * Standards Council of Canada 45, rue OC

14、onnor, Piece 1200 45 OConnor Street, Suite 1200 Ottawa, Ontario, K1 P 6N7 Canada Les noms nationales du Canada sont publiees en versions franqaise et anglaise National Standards of Canada are published in English and French Bien que le but premier vis6 par cette norme soit 6noncd sous sa rubrique Do

15、maine dapplicafion, il est important de retenir quil incombe A Iutilisateur de juger si la norme convienf t3 ses besoins particuliers Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the user to judge its

16、 suitability for their particular purpose General Instruction No. 1CAN/CSA-Z168.5.6-96September 1996Title: Expired-air pulmonary resuscitatorsPagination: 19 pages, each dated September 1996To register for e-mail notification about any updates to this publication go on-line to shop.csa.caclick on E-m

17、ail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2005896.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at csagroup.org/legal to find out how w

18、e protect your personal information.Blank pageNational Standard of Canada CAN/CSA -Z168 5 6-96 Expired-Air PuZnzonary Resuscitators Prepared by Can a dian S tan da rds Ass ocia tion Approved by Standards Council of Canada lSSN 03 7 7-5669 Published in September 7 996 by Canadian Standards Associatio

19、n 7 78 Rexdak Boulevard, Etobicoke, Ontario, Canada M9 W I R3 Technical Editor: Trucy Murphy Managing Editor: Gary Burford Senior Project Editor: Ann Martin ditor: Maria Adragna Publishing System Coordinators: Ursula Das/Grace DeStefano 0 Canadian Standards Association - 7 996 All rights reserved. N

20、o part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior permission of the publisher. Expired-Air Pulmonary Resuscitators Contents Technical Committee on Anaesthetic Equipment and Respiratory Technology v Working Group on Expired-Air

21、 Pulmonary Resuscitators Preface viii vii Introduction ix 1. Scope 7 2. Definitions 7 3. Reference Publications 2 4. Oropharyngeal Airways 2 5. Materials 2 5.1 Cleaning and Disinfection 2 5.2 Colour 2 6. Design of Components 2 6.1 Oropharyngeal Airways, Bite Block, and Tongue Depressors 2 6.2 Supple

22、mental Oxygen 2 6.3 Bite Block (Mouth Prop) 3 7. Face-Mask Connectors 3 8. Ports 3 9, Operational Requirements 3 9.1 Disassembly 3 4 10. Performance 3 10.1 Leakage 3 10.1.1 Device Leakage 3 10.1.2 Face-Mask Leakage 10.2 Tidal Volume 4 10.3 Airway Resistance 5 10.4 Function After Contamination with V

23、omitus 5 10.5 Function After Immersion in Water 5 10.6 Maximum Device Dead Space 5 10.7 Function After Manual Dismantling and Reassembly of Device 6 10.8 Function After Drop Test 6 10.9 Resistance of Bite Block to Compression 6 10.1 0 Integrity of Bite Block Following Compression 7 10.1 1 10.1 2 Res

24、istance to the Environment 7 10.12.1 Storage 7 10.1 2.2 Operating Conditions 7 10.1 3 Resistance to Repeated Disinfection Mean Delivered Oxygen Concentration with Supplemental Oxygen 8 7 September 1996 CAN/CSA-Z768.5.6-96 8 11. 11.1 Location 8 11.2 Warning on Use of Device by Untrained Persons 8 11.

25、3 Instructions for Use 8 11.4 Single or Multiple Use of the Device 8 11.5 Information on Reuse 8 11.6 Technique for Clearance of Stomach Contents from Device 9 11.7 Back Leak of Fluids, Bacteria, or Viruses 9 11.8 Mean Delivered Oxygen Concentration 9 Information To Be Supplied by the Manufacturer 1

26、2. Packaging 9 12.1 General 9 12.2 Seal of Package 9 13. Marking 9 13.1 Orientation 9 13.2 Single Use 9 13.3 Limitation of Use to Adults or Children 13.4 Devices for Teaching Only 9 9 September 7 996 Expired-Air Pulmonary Resuscitators Technical Committee on Anaesthetic Equipment and Respiratory Tec

27、hnology LA. Sloan D. Reimer R. Benson D. Bevan L. BrautIgam D. Cashen S.L. Dah j. Doyle A. FInley S.C. Chanthan A. Green E. Koshowski W. Lambert M. Lkvesque The Hospital for Sick Children, Toronto, Ontario Health Sciences Centre, Winnipeg, Manitoba Benson Medical Industries Ud., Markham, Ontario Uni

28、versity of British Columbia, Vancouver, British Columbia Puritan Bennett Canada Ltd., Picker i ng , 0 n ta rio Canadian Society for Respiratory Therapists, Dartmouth, Nova Scotia St. josephs Hospital, London, Ontario The Toronto Hospital, Toronto, Ontario Izaak Walton Killam Hospital for Children, H

29、alifax, Nova Scotia Standards Council of Canada, Ottawa, Ontario Penlon Ltd., Abingdon, England Ohmeda Pharmaceutical Products, Mississauga, Ontario Sudbury, Ontario Mallinckrodt Medical, lnc., Poi nte-Cla i re, Qu 6bec Chair Vice- Chair Associate Associate Associate Associate Ass ociu te September

30、1996 V CAN/CSA-Z7 68.5.6-96 V. Mankiewicz P. Marsden L. McDonald C. Mendes AS. Sinclalr M.C. Smith H. Thiemann G .L. Welycz ko T.L. Murphy 0 h m eda Pharmaceutical Prod ucts, M ississauga, Ontario H ea1 th Industry Consu P ta nts, Etobi co ke, 0 n ta rio South med ic I nc., Barrie, Ontario Puritan B

31、ennett Canada Ltd., Pickering, Ontario Health Canada, Ottawa, Ontario Puritan Bennett Corp., Lenexa, Kentucky, USA North American Drager Inc., Telford, Pennsylvania, USA Ohmeda, Madison, Wisconsin, USA Can ad ia n S ta nda rd s Asso ciati on, Etobicoke, Ontario Associate Associate Associate Administ

32、rator Vi September 1996 Expired-Air Pulmonary Resuscitators Working Group on Expired-Air Pulmonary Resuscitators D. Banke K. Bowden L. Brautlgam D. Cashen 3. Flynn M. Kelly P. Marsden A.S. Sinclair K. Thorn P.L. Yates T.L. Murphy Ontario Ministry of Health, To ro n t 0, 0 n ta r i o 0-Two Systems Lt

33、d., M ississa uga, Ontario Puritan Bennett Canada Ltd., Pickering, Ontario Canadian Society for Respiratory Therapists, Dartmouth, Nova Scotia B.L.S. Systems, Oakville, Ontario Drager Canada, M ississaug a, Ontario Health Industry Consultants, Eto bicoke, Ontario Health Canada, Ottawa, Ontario 0-Two

34、 Systems Ltd., Mississauga, Ontario Allied Healthcare Products hc., Fircrest, Washington, USA Canadian Standards Association, Etobicoke, Ontario Chair Administrator September 7 996 vii CAN/CSA-Z 7 68.5.6- 96 Preface This is the first edition of CSA Standard CAN/CSA-Z168.5.6, Expired-Air Pulmonary Re

35、suscitators. It was developed to provide standard testing protocols and criteria that manufacturers can use as a basic reference guide to design and development, and buyers can use for comparison of devices. This Standard was prepared by the Working Group on Expired-Air Pulmonary Resuscitators under

36、 the jurisdiction of the Technical Committee on Anaesthetic Equipment and Respiratory Technology and the Standards Steering Committee on Health Care Technology, and has been formally approved by these Committees. This Standard has been approved as a National Standard of Canada by the Standards Counc

37、il of Canada. September 7 996 Notes: (1) Use of the singular in this Standard does not exclude the plural (and vice versa) when the sense alfows. (2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the u

38、sers of the Standard to judge its suitability for their particular purpose. (3) This publication wus developed by consensus, which is defined by CSA Regulations Governing Standardization as “substantial agreement reached by concerned interests. Consensus includes an attempt to remove all objections

39、and implies much more than the concept of o simple majoritK but not necessarily unanimity ” It is consistent with this definition that a member may be included in the Technical Committee list and yet not be in full agreement with all clauses of the publication. (4) CSA Standords are subject to perio

40、dic review, and suggestions for their improvement will be referred to the appropriate commit tee. (5) All enquiries regarding this Standard, including requests for interpretation, should be addressed to Canadian Standards Association, Standards Development, 7 78 Rexdale Boulevard, Etobicoke, Ontario

41、 M9 W 7 R3. Requests for interpretation should (a) define the problem, making reference to the specific dause, and, where appropriate, include an illustrative sketch; (b) provide an explanation of circumstances surrounding the actual field condition; and (c) be phrased where possible to permit a spe

42、cific ”yes” or %o” unswec Interpretations are published in CSA3 periodical Info Update. For subscription details, write to CSA Sales Promotion, Info Update, at the address grven above. viii September 7 996 Expired-Air Pulmonary Resuscitators Introduction There is evidence that some rescuers would pr

43、efer to provide expired-air pulmonary resuscitation using an ancillary device rather than by direct mouth-to-mouth or mouth-to-nose contact. However, there is currently no evidence that devices containing a one-way valve or a filter reduce the risk of, or prevent, cross infection. On the other hand,

44、 some valves or filters may increase resistance to inflation of the lungs and to exhalation, making expired-air pulmonary resuscitation difficult and increasing the risk of distension of the stomach or trapping air within the lungs. This Standard introduces performance requirements that will help to

45、 address these safety issues during rescue breathing. Ventilation of the lungs should not be delayed because an expired-air pulmonary resuscitator is not available. Such devices are not necessary for effective performance of expired-air pulmonary resuscitation. They do not ensure the maintenance of

46、a clear airway and, on occasion, may make it more difficult to achieve a clear airway. September 7 996 Blank pageExpired-Air Pulmonary Resuscitators CAN/CSA-Zl68.5 e 6-96 Expired -Air Pulmonary Resuscitators 1. Scope 1.1 This Standard includes all devices designed to assist in the provision of expir

47、ed-air pulmonary resuscitation. These devices are designed to aid in the protection of the rescuer from communicable diseases transmitted from the area covered by the device via bodily fluids and/or expired air. This Standard includes but is not limited to one-way valve/filter devices incorporating

48、either a face mask, face shield, or oropharyngeal airway. 1.2 This Standard does not include devices designed for oesophageal intubation because of the severity of the complications which may attend their use. In addition, laryngeal masks and combined pharyngeal- tracheal airways are not included be

49、cause studies that evaluate their efficacy for expired-air resuscitation in emergency settings have not yet been concluded. 2. Definitions 2.1 The following definitions apply in this Standard: Bite block (mouth prop) - a tube intended to lie between the teeth or gums of the victim. Device dead space - that volume of previously exhaled gas from the victim that is redelivered to the victim in the succeeding inflation phase. Expired-air pulmonary resuscitator - a device that enables the administration of expired-air resuscitation to a victim without contact of t