CAN CSA-CEI IEC 1289-2-1998 High frequency surgical equipment - Part 2 Maintenance (First Edition).pdf

1、Norme nationale du Canada CANICSA-CEIIIEC 1289-2-98 (CElllEC 1289-2: 1994) National Standard of Canada Rapport technique international CEUIEC 1289-2: 1994 (premiere kdition, 1994-08) adopt - ia CEI 417: Syniboles graphiqires irrilisables sur IC mott6riel. Index. relesi el conrpifarion des ferrilies

2、ind ividuel Zes; - la CEI 617: Syniboles grnptriqrres yorrr schfinios; - IEC 417: tiierii. jririe.-, slriers: Grophicol symbols for use on equip- survey and conipilarion of rhe single - lEC617: Graphical symbols for diagrams; et pour les appareils klectromidicaux. and for rnrdical electrical equipme

3、nt, - glecrriques en prariqrte nrddicale. la CEI 878: Syniboles grophiqiies pour eqiiipenwnrs - eqrtipnrenr irr niedicoi pracrice. IEC 878: Graphical symbols fur electrontedical Les symboles et signes contenus dans la priscnre putiIi- cation ont 6tL soit tirCs de la CEI 27. de la CEI 417. de la CEI

4、617 et/ou de la CEI 878. soiL spPcifiquetnent approuvis aux fins de cette publication. The symbols and signs contained in the present publi- cation have either been taken from IEC 27, IEC 417, IEC 617 and/or IEC 878. or have been specifically appra- vcd for he purpose of this publication. Publicatio

5、ns de la CEI etablies par le m8me cornitti detudes IEC publications prepared by the same technical commit tee Lattention du lecteur est attirCe sur les listes figurant la fin de cette publication. qui dnumhrent Irs publications de la CEI prkparbes par le comite dktudes qui a cet aspect demeure la re

6、sponsabilitd de Iorganisme redacteur de normes accrddit6. pbriodiques ; cest pourquoi il est recommandb aux utilisateurs de se procurer IBdition la plus r6cente de la norme auprbs de Iorganisme qui Ia prhparde. Lapprobation dune norme en tant que Norrne nationale du Canada indique quelle est conform

7、e aux mdthodes et crithres Btablis par le Conseil canadien des normes. II est recommandd 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 Council of Canada is the coordinating body of the

8、National Standards system, a federation of independent, autonomous organizations working towards the further development and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as a means of advan

9、cing the national economy, benefiting the health, safety, and welfare of the public, assisting 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 ap

10、proved by the Standards Council of Canada and one which reflects a reasonable agreement 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 intere

11、sts, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant and timely contribution to the national interest. Approval does not refer to the technical content of !he standard; this remains the continuing responsibility of the accredited stand

12、ards-development organization. therefore, users are caulioned to obtain the latest edition from the organization preparing the standard. 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 C

13、anada. 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: La responsabilitb dapprouver les Normes nationales du Canada incombe au The responsibility for approving National Standards of Cana

14、da rests with the Conseil canadien des normes Standards Council of Canada 45, rue OConnor, Bureau 1200 0 45 OConnor Street, Suite 1200 Ottawa, Ontario, K1 P 6N7 Canada Les normes nationales du Canada sont publibes en versions francaise et anglaise. National Standards of Canada are published in Engli

15、sh and French. Bien que le but premier vise par cette norme soit type 2, lorsque le sujet en question est encore en cours de developpement technique ou lorsque, pour une raison quelconque, la possibilite dun accord pour la publication dune Norme internationale peut type 3, lorsquun cornite detudes a

16、 reuni des donnees de nature diffkrente de celles qui sont normalement publiees cornme Normes internationales, cela pouvant comprendre, par exemple, des informations sur Ietat de la technique. Les rapports techniques de types I et 2 font Iobjet dun nouvel examen trois ans au plus tard apres leur pub

17、lication afin de decider evenIueHement de leur transformation en Normes internationales. Les rapports techniques de type 3 ne doivent pas necessairernent any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-gove

18、rnmental 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 between the two organizations. 2) The formal decisions or agreeme+ of th

19、e 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 subjects dealt with. 3) They have the form of recommendations for internat

20、ional 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 apply IEC International Standards transparently to the maximum extent possi

21、ble 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. 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment d

22、eclared to be in conformity with one of its standards. The main task of IEC technical committees is to prepare International Standards. In excep- tional circumstances, a technical committee may propose the publication of a technical re- pori of one of the following types: type 1, when the required s

23、upport cannot be obtained for the publication of an Inter- national Standard, despite repeated efforts; type 2, when the subject is still under technical development or where for any other reason there is the future but not immediate possibility of an agreement on an Inter- na t io na I St a nda rd

24、; type 3, when a technical committee has collected data of a different kind from that which is normally published as an lnternationa! Standard, for example “state of the art“. Technical reports of types 1 and 2 are subject to review within three years of publication to decide whether they can be tra

25、nsformed into International Standards. Technical reports of type 3 do not necessarily have to be reviewed until the data they provide are considered to be no longer valid or useful. IEC 1289-2, which is a technical report of type 3, has been prepared by sub-committee 62A: Common aspects of electrica

26、l equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. -6- Projet de cornite 62A(SEC) 122 Le texte de ce rapport technique est issu des documents suivants: Rapport de vote 62A(SEC)135 1289-2 O C El 11 994 Le rapport de vote indiquk dans le tabl

27、eau ci-dessus donne toute information sur le vote ayant abouti a Iapprotation de ce rapport technique. I 1 Le present rapport est destine a servir de guide au personnel charge de la maintenance des appareils couverts par la CEI 601-2-2 afin de les rnaintenir en toutefois les directives contenues dan

28、s le present rapport rendront toujours service pour fa mainte- nance de ces dispositifs. 2 Documents de rbfhrence Les publications qui suivent contiennent des dispositions qui, par les references qui y sont faites dans le present texte, constituent des dispositions du present Rapport international.

29、Au moment de sa publication, les editions indiquees etaient en vigueur. Toute norme est sujette A rtivision, et les parties prenantes aux accords fond however, the guidelines in this report will still be helpful when maintaining these devices. 2 Reference documents The following publications contain

30、 provisions which, through references in this text, constitute provisions of this International Report. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreement based on this International Report are encouraged to investigate the

31、possibility of applying the most recent editions of the standards listed below. Members of IS0 and IEC maintain registers of currently valid International Standards. This report, which contains particular guidelines for the maintenance of HIGH FREQUENCY SURGICAL EQUIPMENT, is a part of application g

32、uidelines prepared by sub-committee 62A. These guidelines comprise the following report in addition to this document: IEC 930: 1988, Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment Particular guidelines for the operator concerning

33、 the safe use of HIGH FREQUENCY SURGICAL EQUIPMENT are found in the following report: IEC 1289-1 : 1994, High frequency surgical equipment - Part I: Operation It is recommended that the clinical engineering personnel are familiar with this particular document. HIGH FREQUENCY SURGICAL EQUIPMENT desig

34、ned and constructed according to the following IEC publications achieves a satisfactory level of safety: IEC 601 -1 : 1988, Medical electrical equipment - Part I: General requirements for safety IEC 601-2-2: 1991, Medical electrical equipment - Par7 2: Particular requirements for the safety of high

35、frequency surgical equipment - 10 - 1289-2 O CEI : 1994 Les prescriptions de securite pour les essais de type et Iagrement des APPAREILS D-ELECTROCHIRURGIE A COURANT HAUTE FREQUENCE ne font pas Iobjet du present rapport mais figurent dans les CEI 601-1 et 601-2-2. A cet egard iI est important de not

36、er ce qui suit: a) Les prescriptions dessai de5 CEI 601 -1 et 601 -2-2 sont destinbes a - examen visuel des dispositions de securite mecanique; - contrgle de la protection contre les risques dus aux debordements, renversements, fuites, humiditk, pknetration de liquides, nettoyage, steritisation et d

37、esinfection; - marquages sur Iappareil; - presence des documents daccompagnernent; - fonctionnement convenable des fonctions de surveillance de ICFECTRODE INDIFFRENTE ; - bonne marche des indicateurs sonores et visuels de declenchement de fa haute f r6qu e nce ; - verification du fonctionnement de l

38、afdes) commande(s) de dkclenchement de la haute frequence. b) Essais quantitatifs (mesurages conformemeni a larticle 5 ci-apres) - rbsistance du conducteur de terre de protection dun appareil de Classe I (voir 5.2); - courants de fuite (voir 5.3); - courants de fuite a haute frequence voir 5.4); - c

39、ontrdle des moyens de prevention de la stimulation neurornusculaire (voir 5.5). 4.5 instruments de mesure On recommande dutiliser les instruments suivants: - dispositif dessai de continuite a la terre; - dispositif de mesure du couranl de fuite (voir les annexes A et 5); - dispositif de mesure du co

40、urant haute frequence (par exemple base sur une sonde de courant, des transformateurs de courant ou un thermocouple); - dispositif dessai disolement, tension nominale en circuit ouvert de 500 V en courant continu. 4.6 Contrele de la classe et du type de Iappareil Lorsque la classe ou le type de Iapp

41、areil nest pas marquee sur Iappareil ou precisee dans les documents daccompagnement, iI convient de consulter le constructeur ou un taboratoire dessais. 1289-2 O IEC:1994 - 15 - 4.3 Maintenance performed by the operator (first level) A written maintenance procedure should be made and kept at the dep

42、artment responsible for the HF SURGICAL EQUIPMENT. These procedures are described in EC 1289-1. 4.4 Maintenance performed by clinical engineering personnel (second level) The following aspects should be checked at least yearly (see also 4.2) taking into account the manufacturers information regardin

43、g testing procedures and intervals in the accompany- ing documents. a) Qualitative fests - condition of supply cords and plugs; - mechanical safety provisions by visual inspection; - inspection of the protection against hazards caused by overflow, spillage, leakage, humidity, ingress of liquids, cle

44、aning, sterilization and disinfection; - markings on equipment; - presence of accompanying documents; - proper operation of NEUTRAL ELECTRODE monitoring functions; - the audible and visual indicators for high frequency output activation; - verification of the function of the high frequency output co

45、ntrol(s). 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); - high frequency leakage currents (see 5.4); - checking means for prevention of neuromuscular stimulation see 5.5). 4.5 Measur

46、ing instrumen?s The following instruments are recommended: - earth-continuity test device; - leakage current measuring device (see annexes A and B); - high frequency current measuring device (e.g. based on current probe, current transformers, or thermocouple); - insulation testing device. nominal op

47、en-circuit voltage of 500 V d.c. 4.6 Checking the type and class of equipment If the class or type of equipment is not marked on the equipment or written in the accompany- ing documents, the manufacturer or a test house should be consulted. - 16 - 1289-2 O CEI:1994 5 Mesurages effectugs par le perso

48、nnel technique biombdical 5. I Gdn&alitds Le but de ces mesurages, a effectuer dans les locaux od Iappareil est utili&, tels que les salles dopkration, est de dhtecter les defauts de Iappareil, et non de decider si Iappareil est conforme ou pas aux normes telles que la CEI 601-1 et la CEI 601-2-2. C

49、ela ne peut &re fait quen effectuant les essais dbcrits dans ces normes. Lorsque IAPPAREIL DLECTROCHIRURGIE HF est livr6 Ihdpital, on effectue les rnesurages suivants et la Sauf a leur point dattache, ies cables des ELECTRODES ACTIVE et lNDlFFERENTE ou tout autre circuit de sortie bipolaire, sont placks 3 200 rnm au moins de Ienveloppe de IAPPARE I L DELECTROCHI R U RGI E H F. d) On met Iappareil en marche en position EN ATTENTE. e) On enregistre la valeur mesuree comme premiere valeur mesuree en condition de premier defaut. E