CAN CSA-CEI IEC-1288-2-1998 Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 2 Maintenance (First Edition).pdf

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1、Norme nationale du Canada CANICSA-CEIIIEC 1288-2-98 (CEMEC 1288-2: 1993) National Standard of Canada Rapport technique international CEVIEC 1288-2: 1993 (premi6re kdition, 1993-10) adopt - la Publication 617 de la C E I: Symbles graphiques pour scMmas. Les symboles et signes contenus dans la prdsent

2、e publication ont Ct6 soit repr;S des Publications 27 ou 617 de la C EI, soit spkifiquement approuvb aux fins de cette publication. Publications de la C E I etablies par le meme ComitC dEtudes Lattention du lecteur est attide sur le deuxiime feuillet de la couverture, qui 6numbre les publications de

3、 la C E I prkparkes par le Cornice dEtudes qui a Ctabli la pr6sente publication. Revision of this publication The technical content of I E C publications is kept under con- stant review by the I E C, thus ensuring that the content reflects current technology. Information on the work of revision, the

4、 issue of revised di- tions and amendment sheets may be obtained from IEC National Committees and From the following I E C sources: LE C 3ulletin I E C Yearbook Catalogue of I E C Publications Published yearly Terminology For general terminology, readers are referred to IEC Publi- cation 50: Interna

5、tional Electmtechnical Vocabw 0, which is issued in the form of separate chapters each dealing with a specific field, the General Index being published as a separate booklet. Full details of the IEV will be supplied on request. The terms and definitions contained in the present publication have eith

6、er been taken from the IEV or have been specifically approved for the purpose of this publication. Graphical and letter symbols For graphical symbols, and letter symbols and signs approved by the I E C for general use, readers are referred to: - I E C Publication 27: Letter symbols ta be used in ele

7、ctrical tec hnology ; - I E C Publication 617: Graphical symbols for diagrams. The symbols and signs contained in the present publication have either been taken from IEC Publications 27 or 617, or have been specifically approved for the purpose of this publication. I E C publications prepared by the

8、 same Technical Committee The attention of readers is drawn to the back cover, which lists I E C publications issued by the Technicd Committee which has prepared the present publication. LAssociation canadienne de normalisation (CSA), sous les auspices de laquelle cette Norme nationale a 6th prepare

9、e, a regu ses lettres patentes en 1919 et son accreditation au sein du Systbme de normes nationales par le Conseil canadien des normes en 1973. Association daffiliation libre, sans but lucratif ni pouvoir de rdglementation, elle se consacre B Idlaboration de normes et B la certification. Les normes

10、CSA reflbtent le consensus de producteurs et dusagers de partout au pays, au nombre desquels se trouvent des fabricants, des consommateurs, des detaillants et des reprdsentants de syndicats, de corps professionnels et dagences gouvernernentales. Lutilisation des norrnes CSA est trbs repandue dans Ii

11、ndustrie et le commerce, et leur adoption A divers ordres de legislation, tant municipal et provincial que f6d6ral, est chose courante, particutibrement dans les domaines de la sante, de la sbcurite, du b2timent, de la construction et de Ienvironnement. Les Canadiens dun bout A Iautre du pays tdmoig

12、nent de leur appui au travail de normalisation men6 par la CSA en participant bdnevolement aux travaux des comites de la CSA et en appuyant ses objectifs par leurs cotisations de membres de soutien. Les quelque 7000 volontaires faisant partie des comites et les 2000 membres de soutien constituent Ie

13、nsemble des membres de la CSA parmi lesquels ses administrateurs sont choisis. Les cotisations des mernbres de soutien representent une source importante de revenu pour les services de soutien h la normalisation volontaire. LAssociation off re des services de certification et de mise A Iessai qui ap

14、puient et cornpibtent ses activitds dans le domaine de Idlaboration de normes. De manihre A assurer Iint6grit6 de son processus de certification, IAssociation procede de faqon rhgulibre et continue A Iexamen et B Iinspection des produits portant la marque CSA. Outre son sibge social et ses laboratoi

15、res A Etobicoke, la CSA posshde des bureaux rdgionaux dans des centres vitaux partout au Canada, de m 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

16、practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard. La responsabititb dapprouver les Norrnes nationales du Canada incombe au + The responsibility for approving National Standards of Can

17、ada rests with the Conseil canadien des normes Standards Counci! of Canada 45, rue OConnor, Bureau 1200 45 OConnor Street, Suite 1200 Ottawa, Ontario, KIP 6N7 Canada Les normes nationales du Canada sont publihes en versions franGaise et anglaise. National Standards of Canada are published in English

18、 and French. Eien que le but premier vis4 par cette norme soit BnoncB sous sa rubrique Domaine dappiication, il est important de retenir quil incombe d Iutilisafeur de juger si la norme convient ;i ses besoins particuliers. Although the intended primary application of this Standard is stated in its

19、Scope, it is important to note that it remains the responsibility of the user to judge its suitability for their particular purpose. CANICSA-CEIIIEC I288-2 -98 Dkfibrillateurs cardiaques- Moniteurs-dfibrillateurs cardiaaues - Partie 2: Maintenance CANICSA-CEIIIEC 1288-2-98 Dbfibrillateurs cardiaques

20、 - Moniteurs- dtsfibrillateurs cardiaques - Partie 2: Maintenance Preface CSA Ce document constitue la premiere edition de la norme CANKSA-CEVI EC 1288-2, Defibriillateurs cardiaques - Moniteurs-dfibrillateurs cardiaques - Partie 2.- Maintenance. II sagit de Iadopt ion, sans modifications, de le rap

21、port technique internationale de la Commission Electrotechnique lnternationale CEMEC 1288-2: 1993 (premiere edition, datee 1993-1 0). applications de Ielectricite dans le domaine des soins rnedicaux, sous Iautorite du Comite directeu r strategique de normalisation sur la technologie des soins medica

22、ux et a ete approuvee par le Comite technique. Une liste des membres de ces comites est disponible sur demande. Cette norme a ete approuvee comme Norme nationale du Canada par le Conseil canadien des normes. Cette norme a ete revisee en vue de son adoption pour le Canada par le Comite technique CSA

23、sur les Mars 1998 0 Association canadienne de normalisation - 7998 Tous droits rbservbs. Aucune partie de cette publication ne peut type 2, lorsque le sujet en question est encore en cours de d6veloppernent technique ou lorsque, pour une raison quelconque, la possibilite dun accord pour la publicati

24、on dune Norme internationale peut type 3, lorsquun cornit4 detudes a rhuni des donn6es de nature diffhrente de celles qui sont normalement publikes comme Norrnes internationales, cela pouvant comprendre, par exemple, des informations sur Ietat de la technique. Les rapports techniques de types 1 et 2

25、 font Iobjet dun nouvel examen trois ans au plus tard apres leur publication afin de decider fhentuellement de leur transformation en Normes inter- nationales. Les rapports techniques de type 3 ne doivent pas nkessairement any IEC National Committee interested in the subject dealt with may participa

26、te in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement bet

27、ween the two organizations. 2) The formal decisions or agreements of the IEC on technical matters, prepared by technical committees on which all the National Committees having a special interest therein are represented, express, as nearly as possible, an international consensus of opinion on the sub

28、jects dealt with. 3) They have the form of recommendations for international use published in the form of standards, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promote international unification, IEC National Committees undertake to appl

29、y IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. The main task of IEC technical committees is to p

30、repare International Standards. in excep- tional circumstances, a technical committee may propose the publication of a technical re- port of one of the following types: type 7, when the required support cannot be obtained for the publication of an Inter- national Standard, despite repeated efforts;

31、type 2, when the subject is stili under technical development or where for any other reason there is the future but not immediate possibility of an agreement on an Inter- national Standard; type 3, when a technical committee has collected data of a different kind from that which is normally publishe

32、d as an International Standard, for example “state of the art“. Technical reports of types I and 2 are subject to review within three years of publication to decide whether they can be transformed into International Standards. Technical reports of type 3 do not necessariiy have to be reviewed until

33、the data they provide are considered to be no longer valid or useful. IEC 1288-2, which is a technical report of type 3, has been prepared by sub-committee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. -

34、6- 1288-2 O CEI: 1993 Le texte de ce rapport technique est issu des documents suivants: 62A(SEC)120 Le rapport de vote indiqu6 dans le tableau ci-dessus donne toute information sur le vote ayant abouti A Iapprobation de ce rapport technique. Le present rapport est destine A setvir de guide au person

35、nel charge de la maintenance des appareils couverts par la CEI 601-2-4 afin de les maintenir en 1288-2 O IEC:1993 - 15 - The operator usually has no time to check the correct functioning of the DEFIBRILLATOR before use. Preventive maintenance is thus important to ensure that the DEFIBRILLATOR always

36、 is functioning correctly. Mains-powered DEFIBRILLATORS with back-up batteries should be checked on battery power as frequently as on mains-power. A minimum maintenance program consists of two levels: a) First level Preventive maintenance performed by the operator consisting of visual inspection and

37、, if applicable, simple tests using the DEFIBRILLATOR itself, (see IEC 1288-1). b) Second level Preventive maintenance performed by clinical engineering personnel consisting of visual inspection and measurements of parameters important for safety and to ensure that the first level maintenance has be

38、en correctly carried out. The procedures for measurements are described in clause 5 below. 4.2 Intervals of maintenance and testing. The intervals for maintenance and testing given in this document are intended nominal values, The hospital may adopt, as far as local regulations allows, a protocol us

39、ing either longer or shorter intervals provided that there is a documented justification based on previous safety testing records for the equipment. 4.3 Maintenance performed by the operator (First level) A written maintenance procedure should be made and kept at the department responsible for the D

40、EFIBRILLATOR. These procedures are described in IEC 1288-1. 4.4 Maintenance performed by the clinical engineering personnel (Second level) The following aspects should be checked at least yearly taking into account the manufacturers information regarding testing procedures and intervals in the accom

41、panying documents. a) Qualitative tests : - condition of cords and plugs; - 16- 1288-2 O CEI 1993 - examen visuel des dispositions de aux dgbordements, renversements, fuites, humidit - contr6le de la protection contre les risques dus - marquages sur lappareil, y compris le rt5sum6 des instructions d

42、utilisation; - prgsence des documents daccompagnement; - date du dernier - pr6cision de PENERGIE DELIWE, (voir 5-41 ; - essai disolement des parties 5 haute tension, (voir 5.5) ; I temps de charge, (voir 5.4 et 5.8,); - taux de perte en Gnergie, (voir 5.6) i - performance de tout SYNCHRONISEUR, (voi

43、r 5.7); - capacite de la batterie, (voir 5.8 ). 4.5 Instruments de mesure On recommande dutiliser les instruments suivants: - - dispositif de mesure du courant de fuite, (voir les annexes A et B); dispositif dessai de continuit - dispositif dessai de lhergie, charge dessai 50 R et erreur dindication

44、 nexc6dant pas 5%; - simulateur ECG avec cadence des pulsations la plus basse, au plus egale I inspection of the protection against hazards caused by overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection; - markings on equipment, including summary of ins

45、tructions for use; - presence of accompanying documents; - date of last exchange of batteries, b) Quantitative tests (measurements according to clause 5) : - resistance of protective earth conductor of Class I equipment, (see 5.2) ; - leakage currents , (see 5.3 1 ; - accuracy of DELIVERED ENERGY, (

46、see 5 -4) ; - insulation test of the high voltage parts, (see 5-51; - charging time, (see 5.4 and 5.8) ; - energy loss rate, (see 5.6) ; - performance of any SYNCHRONIZER, (see 5.7) ; - battery capacity, (see 5.8) 4.5 Measuring instruments The following instruments are recommended to be used: - eart

47、h-continuity test device; - leakage current measuring device, (see annexes A and 8); - energy testing device, test-load SO Q and indicating error not exceeding ,+ 5 %; - ECG-simulator with lowest pulse-rate not more than 60 beats per minute. 4.6 Checking the Class and Type af equipment If the Class

48、or Type of equipment is not marked on the equipment or written in the accompanying documents, the manufacturer or a test house should be consulted. - 18 - 1288-2 O CEI 11 993 5 5.1 Mesurages effectu6.s par le personnel technique biumgdical General i t courant de fuite a la terre, (voir 5.3.2); coura

49、nt de fuite patient, (voir 53-31 (voir - courant de fuite patient, tension secteur sur la PARTIE APPLIQUEE, (voir 5.3.- 4) ; ENERGIE DELIWE, (voir 5.4) . Lorsque des mesurages sont effectugs aprSs utilisation et/ou rgparation de 1 appareil ( llmesurage cons lea eseais eont deetinge aux conettuctcure et aux laboratoircs dessaie, (voir llarticle 2). - 5.2 Contr6le du conducteur de terre de protection Dans les appareils de la Classe I la sgcuritg contre les chocs glectxiques en cas disolation endornmagiSe repose sur le conducteur de terre d