BS ISO 14835-2-2006 Mechanical vibration and shock - Cold provocation tests for the assessment of peripheral vascular function - Measurement and evaluation of finger systolic blood.pdf

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2、tolic blood pressure ICS 13.160Mechanical vibration and shock Cold provocation tests BRITISH STANDARDBS ISO 14835-2:2005BS ISO 14835-2:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 23 January 2006 BSI 23 January 2006ISBN 0 580 46894 1Cr

3、oss-referencesThe British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Sta

4、ndards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover

5、, an inside front cover, the ISO title page, pages ii to v, a blank page, pages 1 to 14, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsA list of organizati

6、ons represented on this subcommittee can be obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and prom

7、ulgate them in the UK.National forewordThis British Standard reproduces verbatim ISO 14835-2:2005 and implements it as the UK national standard.The UK participation in its preparation was entrusted by Technical Committee GME/21, Mechanical vibration and shock, to Subcommittee GME/21/6, Human exposur

8、e to mechanical vibration and shock, which has the responsibility to: aid enquirers to understand the text;Reference numberISO 14835-2:2005(E)INTERNATIONAL STANDARD ISO14835-2First edition2005-07-01Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular functi

9、on Part 2: Measurement and evaluation of finger systolic blood pressure Vibrations et chocs mcaniques Essais de provocation froid pour lvaluation de la fonction vasculaire priphrique Partie 2: Mesurage et valuation de la tension sanguine systolique des doigts BS ISO 14835-2:2005ii iiiContents Page F

10、oreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Measurement equipment . 1 3.1 General. 1 3.2 Plethysmography 2 4 Measurement procedure 4 4.1 Conditions of examination. 4 4.2 Cold provocation 5 4.3 Conduct of the test . 6 5 Safety aspects. 9 5.1 General. 9 5.2 Electrical safety. 9

11、5.3 Contraindications . 9 5.4 Informed consent 9 5.5 Examiner and medical supervision. 9 6 Data reporting . 9 6.1 General. 9 6.2 Examination conditions . 10 6.3 Subject characteristics. 10 6.4 Symptoms and signs during examination . 10 6.5 Results . 10 7 Assessment of normative values and limits 11

12、Bibliography . 12 BS ISO 14835-2:2005iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member bo

13、dy interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrot

14、echnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted b

15、y the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent ri

16、ghts. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14835-2 was prepared by Technical Committee ISO/TC 108, Mechanical vibration and shock, Subcommittee SC 4, Human exposure to mechanical vibration and shock. ISO 14835 consists of the following parts, under the

17、 general title Mechanical vibration and shock Cold provocation tests for the assessment of peripheral vascular function: Part 1: Measurement and evaluation of finger skin temperature Part 2: Measurement and evaluation of finger systolic blood pressure BS ISO 14835-2:2005vIntroduction Assessing finge

18、r systolic blood pressure (FSBP) before and after local cooling can help to identify the presence and extent of vasoconstriction of the digital arteries in response to cold provocation produced by appropriate finger cooling. A low finger systolic blood pressure following local cooling compared to th

19、at measured before cooling can indicate digital arterial vasoconstriction caused by an exaggerated response to cold. The amount of any change in FSBP following local cooling can reflect the degree of arterial vasoconstriction. BS ISO 14835-2:2005blank1Mechanical vibration and shock Cold provocation

20、tests for the assessment of peripheral vascular function Part 2: Measurement and evaluation of finger systolic blood pressure 1 Scope This part of ISO 14835 specifies a) the methods for measuring finger systolic blood pressures (FSBP) with local cold provocation, b) the procedures for conducting the

21、 measurements, and c) how to report the measurement results. The methods in this part of ISO 14835 are designed to assist in the collection of data for a quantitative evaluation of the vascular response to cold provocation, and to enable specification of normative data. The measurement of FSBP with

22、local cold provocation can be used for the assessment of peripheral vascular function. This part of ISO 14835 is applicable to the assessment of vascular function in persons exposed to hand-transmitted vibration. 2 Normative references The following referenced documents are indispensable for the app

23、lication of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety 3 Measurement equipment 3.1 Gen

24、eral FSBP may be measured using plethysmography. A typical measurement consists of applying an occluding pressure to a digit by means of a pressure cuff connected to a plethysmograph. The cuff may be perfused with water at a controlled temperature for application of local cooling. Alternatively, an

25、air-inflated cuff may be used to apply an occluding pressure and a separate non-pressurized, water-perfused cuff may be used for the application of local cooling. After a period of cooling, the pressure in the occluding cuff is continuously released until a transducer situated distally to this cuff

26、detects blood flow. The cuff pressure at which this blood flow is detected is equivalent to the maximum digital arterial pressure (systolic pressure) and the cuff pressure is noted as the FSBP. The equipment consists of a device, or devices, for applying and controlling pressure around a digit whils

27、t applying controlled local cooling to the digit. The equipment is capable of controlling the release of a BS ISO 14835-2:20052 supra-systolic pressure around the digit whilst monitoring the blood flow distal to the occlusion so as to determine at what pressure arterial blood flow recommences. There

28、 are several types of transducer commonly available for the detection of blood flow in the measurement of FSBP. Mercury-in-elastic strain gauges are sometimes used to detect volume changes; an increase in finger volume during release of pressure indicates the return of arterial blood flow. Photocell

29、s utilize a change in the intensity of light transmitted through or backscattered from the digital tissues to determine the return of blood flow. Laser-doppler flowmetry detects the return of blood flow by means of a frequency shift in reflected electromagnetic waves. It is recommended that all equi

30、pment be maintained and calibrated according to the manufacturers specifications. 3.2 Plethysmography 3.2.1 General The device (or collection of devices) used to measure finger systolic blood pressures is commonly referred to as a plethysmograph and the measurement method is commonly referred to as

31、plethysmography. 3.2.2 Cuffs The choice of cuff size should be determined by the finger size of the individual under examination. The cuff length shall be sufficient to entirely surround the finger, while the cuff width should be at least 20 % greater than the diameter of the finger. The cuff surfac

32、e should maintain contiguity with the surface of the digit throughout the measurement. Cuffs made of a material with a high thermal conductivity and/or with a thin wall are suitable for perfusion with water for thermal provocation. Cuffs should not inhibit blood flow when not pressurized. 3.2.3 Sens

33、ors The sensors used to detect the return of blood flow during release of cuff pressure should not, themselves, occlude digital blood flow. They should neither thermally influence the digit nor provide thermal insulation from the environment. A high sensitivity and accuracy is recommended and sensor

34、s able to detect blood flow within 1 s of its occurrence are the most appropriate. Sensors with different response characteristics may not be comparable; care should be taken when comparing measurements made with different sensors. 3.2.4 Temperature of thermal provocation The application of thermal

35、provocation at controlled temperatures of between 35 C and 10 C is required. 3.2.5 Pressure control The device is required to control pressure between a supra-systolic value ( 250 mmHg is recommended) and the minimum measurable FSBP (0 mmHg is recommended). For pressure measurements, a transducer ac

36、curacy of 1 mmHg is acceptable. NOTE The pressure of 1 mmHg is equal to 133,322 Pa. When measuring the pressure in cuffs perfused with water, there are effects of hydrostatic pressure in the system. The hydrostatic pressure effects may be avoided by ensuring the water level in the system is at the s

37、ame height as the cuff. If the sensor used to measure cuff pressure is submersed in the water, placing it at the height of the cuffs eliminates the hydrostatic pressure effect. Alternatively, a correction for the effects of hydrostatic pressure in the system shall be made. If the hydrostatic pressur

38、e is positive and the measured FSBP is zero, the true FSBP can lie anywhere between zero and the hydrostatic pressure, and it is not possible to apply a correction. BS ISO 14835-2:20053The duration of pressure application is defined for measurements of FSBP and should be controlled with an accuracy

39、of 5 s. The rate of release of pressure can affect the measurement. Rates of pressure reduction between 1 mmHg/s and 3 mmHg/s are appropriate if sensors are capable of the rapid detection of the return of blood flow ( 1 s). 3.2.6 Data recording Finger systolic blood pressure (FSBP) is the quantity t

40、o be measured. It is expressed in millimetres of mercury (mmHg). The cuff pressure at which the return of blood flow is detected, which represents the FSBP, shall be recorded. NOTE For strain-gauge plethysmography, the volume-pressure plot is the recording of interest. For photoplethysmography, the

41、light intensity-pressure plot is the recording of interest. For laser-doppler flowmetry, the frequency-pressure plot is the recording of interest. A general example of a signal-pressure plot is shown in Figure 1. 3.2.7 Calibration The calibration of all equipment shall be traceable to a recognized s

42、tandard. Key X Pressure (mmHg) Y Transducer signal aSignal from transducer. bCuff pressure. cSupra-systolic pressure. dFSBP NOTE The transducer signal shown is for a strain gauge; the transducer signal will differ with different transducer types. Figure 1 Example of signal-pressure plot showing how

43、the cuff pressure at which a change in the transducer signal occurs corresponds to the FSBP BS ISO 14835-2:20054 4 Measurement procedure 4.1 Conditions of examination 4.1.1 General To obtain reproducible data, the test conditions and procedures shall be controlled. Environmental conditions influenci

44、ng the measurements shall also be controlled. 4.1.2 Examination room The room temperature should be maintained at (21 1) C over the whole length of the body, for the duration of the test. Warmer room temperatures may result in normal FSBP in persons with mild vibration-induced white finger (VWF). Th

45、e environment shall be controlled to prevent extraneous conditions that might influence examination results. Atmospheric temperature during the test should be strictly controlled. It is necessary to control room temperature at different vertical levels to prevent temperature differences at different

46、 parts of the body. Atmospheric temperature around the entire body should be maintained within the allowable range by mild air circulation. Stronger air circulation can increase skin cooling and alter the effective ambient room temperature. 4.1.3 Time 4.1.3.1 Time of year Because the season can affe

47、ct the measurement, it is desirable to make measurements in the cold season. If periodic examination at two or more times per year is required for follow-up in addition to the examination in the cold season, a test may be conducted in the autumn or summer. 4.1.3.2 Time of day It is not known if dail

48、y variations have a significant effect on the FSBP. However, to avoid potential effects of circadian biorhythm, examination between 9:00 and 18:00 is recommended. 4.1.3.3 Time lag between previous test(s)/examination(s) A delay of 3 h between any cold provocation test and a subsequent FSBP test is r

49、ecommended so as to avoid the effects of prior cold exposure. This includes a cold provocation test that has been aborted after cold provocation has begun. If a test is repeated, this shall be noted. If cold provocation has been applied only to one hand during the 3 h period, the FSBP test may be conducted on the other. When an FSBP test consists of multiple measurements, these should be conducted consecutively without a recovery period. 4.1.4 Subject preparation 4.1.4.1 Recommendations to subject prior to e