BS 5724-3 12-1991 Medical electrical equipment - Particular requirements for performance - Method of declaring parameters for lung ventilators《医用电气设备 第3部分 性能专门要求 第12节 肺呼吸器参数规定方法》.pdf

《BS 5724-3 12-1991 Medical electrical equipment - Particular requirements for performance - Method of declaring parameters for lung ventilators《医用电气设备 第3部分 性能专门要求 第12节 肺呼吸器参数规定方法》.pdf》由会员分享，可在线阅读，更多相关《BS 5724-3 12-1991 Medical electrical equipment - Particular requirements for performance - Method of declaring parameters for lung ventilators《医用电气设备 第3部分 性能专门要求 第12节 肺呼吸器参数规定方法》.pdf（90页珍藏版）》请在麦多课文档分享上搜索。

1、BRITISH STANDARD BS5724-3.12: 1991 Medical electrical equipment Part3: Particular requirements for performance Section3.12 Method of declaring parameters for lung ventilatorsBS5724-3.12:1991 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee,

2、 waspublished under the authorityof the Standards Boardand comes into effect on 29November1991 BSI09-1999 The following BSI references relate to the work on this standard: Committee reference HCC/46 Draft for comment89/53567 DC ISBN 0 580 19280 6 Committees responsible for this British Standard The

3、preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/46, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health Care Industries Associatio

4、n of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association British Paediatric Association Department of Health Electro Medical Trade Association Limited Industrial Safety (Protection Equipment) Manufacturers Association Intensiv

5、e Care Society Medical Sterile Products Association Amendments issued since publication Amd. No. Date CommentsBS5724-3.12:1991 BSI 09-1999 i Contents Page Committees responsible Inside front cover Foreword v Section 1. General 1 Scope 1 2 Definitions 1 Section 2. Test and operating conditions 3 Test

6、 conditions 7 3.1 General 7 3.2 Accuracy of measurements 8 3.3 Test apparatus 8 3.4 General test procedures, except for the pre-test running described in5.2 13 3.5 Reporting of test results in the ACCOMPANYING DOCUMENTS 14 Section 3. Declaration and measurement of parameters 4 Performance parameters

7、 15 5 Basic test procedures 15 5.1 General 15 5.2 Pre-test running 15 5.3 Waveform performance test 16 5.4 Expiratory resistance test (under CMV) 16 5.5 Resistance test (under spontaneous ventilation conditions) 19 5.6 Volume performance test 20 5.7 I:E RATIO performance test 23 5.8 INSPIRATORY TIME

8、 performance test 23 5.9 Rebreathing test 23 5.10 Actions-of-controls test 31 5.11 MMV performance test 33 5.12 Synchronization test 33 5.13 Sequence of TRIGGERING sensitivity and delay tests 39 5.14 TRIGGERING-FREQUENCY range test 42 5.15 Over-maximum-FREQUENCY TRIGGERING waveform test 43 5.16 TRIG

9、GERING waveform recording 45 6 LUNG VENTILATORS providing CMV 45 6.1 General 45 6.2 Waveform performance 45 6.3 Expiratory resistance 45 6.4 Volume performance 46 6.5 I:E RATIO performance 46 6.6 Rebreathing 47 6.7 Additional tests for LUNG VENTILATORS with mechanisms for adjusting end-expiratory pr

10、essure 47 6.8 Actions of controls 49 6.9 Additional tests for LUNG VENTILATORS with mechanisms for triggered CMV 49 7 LUNG VENTILATORS allowing spontaneous ventilation which is either unsupplemented or supplemented only by PRESSURE ASSISTANCE 50 7.1 General 50 7.2 Waveform performance 51BS5724-3.12:

11、1991 ii BSI 09-1999 Page 7.3 Resistance 51 7.4 Rebreathing 52 7.5 Additional tests for LUNG VENTILATORS with means for the production of CPAP or CNAP 52 7.6 Additional tests for LUNG VENTILATORS with adjustable mechanisms for assisting or hindering spontaneous ventilation 53 8 LUNG VENTILATORS provi

12、ding IMV 61 8.1 General 61 8.2 Tests with simulated spontaneous breaths only 61 8.3 Tests with mandatory breaths only 61 8.4 Tests with both mandatory and spontaneous breaths 64 9 LUNG VENTILATORS providing MMV 67 9.1 General 67 9.2 Tests with simulated spontaneous breaths only 67 9.3 Tests with man

13、datory breaths only 67 9.4 Tests with both intermittent mandatory and spontaneous breaths or with pressure-assisted mandatory breaths 68 Appendix A Respiratory data on normal children 73 Appendix B Modes of operation 73 Appendix C Bibliography 80 Figure 1 Illustration of the definitions of VBS EXPIR

14、ATORY RESISTANCE and VBS INSPIRATORY RESISTANCE and of the corresponding reference pressures 6 Figure 2 Illustration of two types of COMPLIANCE unit (C) in series with a resistance unit (R) 10 Figure 3 Methods for applying the P muswaveform to the COMPLIANCE units shown in Figure 2 11 Figure 4 P mus

15、waveform 13 Figure 5 Typical presentation of results of waveform performance tests 17 Figure 6 Typical presentation of results of a pair of expiratory resistance tests in CMV 19 Figure 7 Typical presentation of results of a set of resistance tests in unsupplemented spontaneous ventilation 20 Figure

16、8 Typical performance of results of a volume performance test in CMV 21 Figure 9 Typical performance of results of a volume performance test in IMV 22 Figure 10 Typical presentation of results of an I:E RATIO performance test in CMV 24 Figure 11 Typical presentation of results of an INSPIRATORY TIME

17、 test in IMV 25 Figure 12 Rebreathing test apparatus 28 Figure 13 Typical presentation of results of an MMV performance test 34 Figure 14 Typical presentation of results of an interaction test 37 Figure 15 Typical presentation of results of a pair of quality of synchronization tests in IMV 39 Figure

18、 16 Typical presentation of results of a sequence of seven TRIGGERING sensitivity and delay tests 42BS5724-3.12:1991 BSI 09-1999 iii Page Figure 17 Typical presentation of the TRIGGERING waveform recordings obtained at each of the three maximum FREQUENCIES of a TRIGGERING-FREQUENCY range test 44 Fig

19、ure 18 Typical presentation of the results of an over-maximum-FREQUENCY waveform test 44 Figure 19 Typical presentation of a set of waveform performance tests in CMV with PEEP 48 Figure 20 Typical presentation of results of an expiratory resistance test with adjustment of end-expiratory pressure 49

20、Figure 21 Typical presentation of results of a set of waveform performance tests in unsupplemented spontaneous ventilation 53 Figure 22 Typical presentation of results of a set of waveform performance tests in spontaneous ventilation with different levels of CPAP and/or CNAP, or different levels of

21、PRESSURE ASSISTANCE and/or PRESSURE HINDRANCE 54 Figure 23 Typical presentation of results of a set of resistance tests in spontaneous ventilation with different levels of CPAP and/or CNAP 55 Figure 24 Typical presentation of results of a pair of resistance tests in spontaneous ventilation at two FR

22、EQUENCIES with a single level of CPAP and/or CNAP 56 Figure 25 Typical presentation of results of a pair of waveform performance tests in pressure-assisted or pressure-hindered spontaneous ventilation at two spontaneous FREQUENCIES 58 Figure 26 Typical presentation of results of a set of resistance

23、tests in spontaneous ventilation with different levels of PRESSURE ASSISTANCE or PRESSURE HINDRANCE 59 Figure 27 Typical presentation of results of a set of resistance tests in spontaneous ventilation at two different FREQUENCIES with a single degree of PRESSURE ASSISTANCE 60 Figure 28 Typical prese

24、ntation of results of a set of waveform performance tests in IMV (or MMV by IMV) with mandatory breaths only 63 Figure 29 Typical presentation of results of a set of waveform performance tests of the interaction of spontaneous and mandatory breaths in IMV 65 Figure 30 Typical presentation of results

25、 of a waveform performance test for the interaction of spontaneous and machine-induced breaths or any machine assistance in MMV 70 Figure 31 Diagram of opening and closing of window for TRIGGERING showing two ways of closing 77 Figure 32 Diagram of opening and closing of window for TRIGGERING showin

26、g three different criteria for opening 79 Table 1 “High” and “low” flows for resistance tests 5 Table 2 Required accuracies 9 Table 3 Values corresponding to unit distance in displays of waveform performance tests 16 Table 4 Static characteristics of the rebreathing test apparatus 28 Table 5 Setting

27、s of the LUNG VENTILATOR and the active part of the rebreathing test apparatus for the rebreathing tests 30 Table 6 Typical presentation of results of an actions-of-controls test 32 Table 7 Intervals corresponding to a given length of axis in plots of the spontaneous/mandatory interaction test 36BS5

28、724-3.12:1991 iv BSI 09-1999 Page Table 8 Settings of the test apparatus for a sequence of TRIGGERING sensitivity and delay tests 39 Table 9 Conditions for individual TRIGGERING sensitivity and delay tests 39 Table 10 Typical presentation of results of a sequence of TRIGGERING sensitivity and delay

29、tests 41 Table 11 Conditions for the waveform performance test for LUNG VENTILATORS providing CMV 46 Table 12 Conditions for volume performance tests in CMV 46 Table 13 Conditions for I:E RATIO performance tests 47 Table 14 Settings of the LUNG VENTILATOR for a sequence of TRIGGERING sensitivity and

30、 delay tests in triggered CMV and in SIMV 49 Table 15 Settings of the LUNG VENTILATOR for the TRIGGERING-FREQUENCY range test in triggered CMV 50 Table 16 Typical presentation of results of a TRIGGERING-FREQUENCY range test in CMV 50 Table 17 Conditions for the waveform performance test for LUNG VEN

31、TILATORS allowing spontaneous ventilation 52 Table 18 Typical presentation of results of a TRIGGERING-FREQUENCY range test in PRESSURE ASSISTANCE 61 Table 19 Conditions for test1 of waveform performance tests in IMV (DELIVERED VOLUME and INSPIRATORY TIME only) and MMV by IMV using only mandatory bre

32、aths 61 Table 20 Conditions for volume performance tests in IMV 62 Table 21 Conditions for INSPIRATORY TIME tests in IMV 62 Table 22 Conditions for waveform performance tests with interaction of spontaneous and mandatory breaths 64 Table 23 Conditions for synchronization test recordings in SIMV 66 T

33、able 24 Conditions for waveform performance tests with interaction of spontaneous breathing and MMV 69 Table 25 Conditions for MMV performance tests 71 Table 26 Conditions for synchronization test recordings in MMV by SIMV 72 Table 27 Respiratory data on normal children 73 Publication(s) referred to

34、 Inside back coverBS5724-3.12:1991 BSI 09-1999 v Foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee. This standard, together with BS5724-2.12, constitutes a revision of BS3806:1964, which is withdrawn. Attention is drawn to BS5724-2.13,

35、 which specifies requirements for the safety of anaesthetic machines that incorporate lung ventilators and of lung ventilators intended for use with inhalational anaesthetic agents. This standard describes a method of declaring the performance parameters to be declared by the manufacturer of lung ve

36、ntilators to provide purchasing authorities and users with the information necessary to compare lung ventilators made by different manufacturers. Terms defined in this standard and in BS5724-1 are written in capitals. NOTEThroughout this standard the unit of pressure used is the kilopascal (kPa). 1k

37、Pa=10.1972cm H 2 O. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This

38、 document comprises a front cover, an inside front cover, pagesi tovi, pages1to80, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.vi blankBS57

39、24-3.12:1991 BSI 09-1999 1 Section 1. General 1 Scope This standard describes a method of declaring the performance parameters to be stated in documents accompanying a LUNG VENTILATOR, together with test methods to be used to measure the parameters. It does not cover parameters resulting from recent

40、 developments such as jet and very high FREQUENCY ventilation and oscillation. Motive power units for LUNG VENTILATORS together with RESUSCITATORS, RESPIRATORY THERAPY VENTILATORS, EXTERNAL BODY VENTILATORS, ROCKING APPARATUS and ELECTROSTIMULATORS are outside the scope of this standard. The object

41、of this standard is to permit the direct comparison of LUNG VENTILATORS of different manufacture, and to standardize methods for the determination of compliance with the manufacturers declared performance. NOTEThe titles of the publications referred to in this standard are listed on the inside back

42、cover. 2 Definitions NOTEManufacturers should use these terms in their literature. For the purposes of this British Standard, the definitions given in BS5724-1 apply, together with the following. 2.1 alveolar pressure (P A ) the pressure in the alveoli NOTEIn the test apparatus this is represented b

43、y the pressure in the COMPLIANCE unit. For reasons given in note1 to3.3.4, this differs somewhat from true ALVEOLAR PRESSURE and is therefore referred to as “ALVEOLAR” PRESSURE (P “A” ). 2.2 cardiogenic-pulsation-equivalent pressure (P card ) that waveform of pressure which, if it were applied to th

44、e outside of the PATIENTS thoracic cage with the respiratory muscles paralysed, would produce the same waveforms of pressure and flow within the PATIENTS lungs as are actually produced by the beating of the PATIENTS heart NOTEIn performance tests in this standard, the waveform of P cardis fixed in s

45、hape, amplitude and FREQUENCY. It is that waveform which, when applied to a test apparatus with appropriate COMPLIANCE and resistance, produces a sine wave approximation to the waveform of flow at the mouth typically found in some PATIENTS with hyperdynamic hearts. 2.3 compliance volume added per un

46、it pressure increase when gas is added to an enclosed space and the added volume is expressed at the temperature and humidity in that enclosed space and at ambient atmospheric pressure 2.4 continuous mandatory ventilation (CMV) ventilation of the PATIENTS lungs with regular inflations by the LUNG VE

47、NTILATOR and with little or no respiratory effort by the PATIENT 2.5 continuous negative airway pressure (CNAP) negative MOUTH PRESSURE which is applied continuously throughout the spontaneous ventilation cycle 2.6 continuous positive airway pressure (CPAP) positive MOUTH PRESSURE which is applied c

48、ontinuously throughout the spontaneous ventilation cycle 2.7 delivered total ventilation (V DEL ) volume of gas per minute delivered through the PATIENT CONNECTION PORT during the INSPIRATORY PHASES 2.8 delivered volume (V T,DEL ) volume of gas delivered through the PATIENT CONNECTION PORT during an

49、 INSPIRATORY PHASE 2.9 driving gas gas which powers the LUNG VENTILATOR but is not delivered to the PATIENT 2.10 electrostimulator apparatus which induces activity in the respiratory musculature by means of electrical impulses acting upon the corresponding nerves or muscles 2.11 emergency air intake port dedicated GAS INTAKE PORT through which ambient air may be drawn when the supply of FRESH GAS and/or INFLATING GAS is insufficient 2.12 expiratory phas