BS 7088-1989 Specification for pneumatic tourniquet equipment《充气式止血带装置规范》.pdf

1、BRITISH STANDARD BS 7088:1989 Specification for Pneumatic tourniquet equipment UDC 615.47:615.815.616-089.811:621.8.033:661.91:620.1BS7088:1989 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Board o

2、f BSI andcomes into effect on 30June1989 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference HCC/12 Draft for comment 87/53102 DC ISBN 0 580 17050 0 Committees responsible for this British Standard The preparation of this British Standard was entrusted b

3、y the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/12, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland British Orthopaedic Association British Surgical Trades Association Incorporated Casualty Surgeons Associati

4、on Department of Health Scottish Health Services Amendments issued since publication Amd. No. Date of issue CommentsBS7088:1989 BSI 01-2000 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Cuffs 1 3 Hoses and connectors 1 4 Pressure gauges 1 5 Elapsed time indicator

5、2 6 Pressure source 2 7 Cuff pressure regulation 2 8 Mobile tourniquet equipment 2 9 Marking 2 10 Accompanying documents 3 Appendix A Recommendations on distribution of pressure under the cuff 4 Appendix B Test for construction of cuffs and performance of fastenings 4 Appendix C Test for leaks from

6、hoses and connectors 4 Appendix D Test to simulate exhaustion or interruption of the gas supply 4 Appendix E Test for indication of deflation 4 Appendix F Test for pressure compensation 4 Appendix G Stability of mobile tourniquet equipment 5 Table 1 Internal dimensions of inflatable bag, measured wh

7、en deflated 1 Table 2 Test for distribution of pressure 4 Publications referred to Inside back coverBS7088:1989 ii BSI 01-2000 Foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee at the request of the Scottish Health Service. It is inten

8、ded to encourage the manufacture of safer tourniquet equipment. The main use of pneumatic tourniquet equipment is to maintain a blood-free field during limb surgery. It is also, however, used extensively as part of the Biers Block technique for intravenous analgesia of the limbs where the function o

9、f the tourniquet is to isolate the analgesic from the main circulation. Cuffs currently available have been shown to produce areas of low pressure which, if sited over a vein, facilitate the escape of anaesthetic into the blood circulation despite arterial occlusion. Attention is drawn to Appendix A

10、 of this British Standard, which recommends that manufacturers perform a test to determine the uniformity of pressure distribution on a dummy limb. The technical committee responsible for this British Standard was unable to include this test as a requirement because of lack of test data and lack of

11、agreement on suitable transducers. The technical committee intends, however, to carry out further studies and to convert the recommendations given in Appendix A into requirements, perhaps with modifications. A British Standard does not purport to include all the necessary provisions of a contract. U

12、sers 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 document comprises a front cover, an inside front cover, pages i and ii, pages1 to 6, an inside back cover and

13、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.BS7088:1989 BSI 01-2000 1 1 Scope This British Standard specifies constructional, safety and performance requirements fo

14、r pneumatic tourniquet equipment. It covers manually inflated tourniquets, such as those provided with rubber bulbs or piston pumps. It also covers powered tourniquets, such as those provided with an integral source of compressed or liquefied gas or a connection to an external supply of compressed g

15、as, either from a cylinder or from a piped medical gas supply in a hospital. It includes fully automatic tourniquet equipment which inflates the cuff to a set pressure and thereafter compensates for pressure losses, semi-automatic tourniquet equipment that inflates the cuff to a set pressure but doe

16、s not compensate for subsequent pressure losses, and non-automatic tourniquet equipment. It does not cover tourniquet equipment which includes an integral electrically driven air pump (see BS 5724-1). NOTEThe titles of the publications referred to in this standard are listed on the inside back cover

17、. 2 Cuffs 2.1 Size, designation and dimensions of inflatable bag The size, designation and dimensions shall be as given in Table 1. 2.2 Construction of cuff 2.2.1 Fastenings. When tested in accordance with Appendix B, none of the recorded pressures shall be lower than 97 kPa (730 mmHg) 1) . 2.2.2 St

18、rength. When tested in accordance with Appendix B, the materials of construction shall not tear, the seams shall not be damaged and the fastenings shall remain effective. Table 1 Internal dimensions of inflatable bag, measured when deflated 3 Hoses and connectors 3.1 Source supply hoses Hose assembl

19、ies intended to connect the equipment to a piped medical gas supply shall comply with the appropriate requirements of clause 15 of BS5682:1984 and shall terminate in a medical airprobe, 400 kPa, complying with 11.2 of BS5682:1984. 3.2 Cuff hoses 3.2.1 Hose assemblies intended to connect the cuffs to

20、 the equipment shall be either: a) permanently attached to the cuff; or b) connected to the cuff by locking connectors that are permanently attached to the hoses. The connectors shall not be Luer fittings. NOTEThe exclusion of Luer fittings is intended to prevent the use of sphygmomanometer cuffs wh

21、ich are not intended to be inflated above a pressure of 40 kPa (approximately 300 mmHg). 3.2.2 When tested in accordance with Appendix C, there shall be no escape of bubbles. 4 Pressure gauges 4.1 General Pressure gauges shall comply with BS 1780. Gauges shall have pointer stop pins, which shall be

22、positioned on the ungraduated portion of the dial. Gauges shall be graduated from 0 mmHg to750mmHg at intervals of 10 mmHg. The scale markings at 100 mmHg intervals shall be longer than those at 10 mmHg intervals and shall be numbered. 4.2 Cuff pressure gauges 4.2.1 A pressure gauge shall be provide

23、d to indicate the actual pressure in the cuff. If a facility for preselecting the cuff pressure is provided, it shall be by the use of either: a) a separate pressure gauge to indicate the selected pressure; or b) a spring-return switch on the cuff pressure gauge which permits the display of the sele

24、cted pressure during its period of operation only. NOTEThe provision of a single gauge to indicate both actual and selected pressures on equipment that does not comply with4.2.1 b) has led to accidents due to the cuff being mistakenly thought to be inflated. 4.2.2 With tourniquet equipment that is i

25、ntended for use with more than one inflatable bag, a pressure gauge (see 4.2.1) shall be provided for each bag. 1) 1 mmHg = 133.4 N/m 2= 133.4 Pa. All pressures specified are gauge pressures. Size Designation Minimum length Width For use on limbs of: mm mm 10 1 up to 120 mm circumference 120 80 2 12

26、0 mm to 280 mm circumference 280 120 3 280 mm to 420 mm circumference 420 160 4 exceeding 420 mm circumference 600 200BS7088:1989 2 BSI 01-2000 4.3 Supply pressure gauge Powered tourniquet equipment incorporating a cylinder or cylinders of compressed gas shall be provided with a pressure gauge that

27、indicates the pressure in the gas cylinder. 5 Elapsed time indicator An elapsed time indicator, if fitted, shall have an accuracy of 1 %. 6 Pressure source 6.1 Compressed gases 6.1.1 Oxygen shall not be provided by the manufacturer as a pressure source. 6.1.2 Tourniquet equipment powered by compress

28、ed gas shall be provided with a pressure relief valve set at 110 kPa (835 mmHg) fitted to prevent excess pressure in the cuff. 6.1.3 The compressed gas pressure indicator, if fitted, shall show whether or not the supply pressure exceeds the minimum working pressure stated by the manufacturer see cla

29、use 10 g). 6.2 Liquefied gases Tourniquets powered by a source of liquefied gas shall be provided with a liquid level indicator. NOTESome polymeric materials used in construction are adversely affected by dichlorodifluoromethane. 7 Cuff pressure regulation 7.1 Non-return valve A non-return valve sha

30、ll be fitted to prevent deflation of the cuff if supply pressure fails. When tested in accordance with Appendix D the pressure drop shall not exceed 2.67 kPa (20 mmHg). 7.2 Cuff pressure gauge When tested in accordance with Appendix E the cuff pressure gauge shall indicate a pressure not exceeding 4

31、.0 kPa (30 mmHg). NOTEIt is important that any accidental disconnection of the cuff be shown on the gauge immediately. 7.3 Cuff pressure regulator 7.3.1 If a cuff pressure regulator is fitted, it shall a) comply with BS 5741 and with 7.3.2 to 7.3.4; and b) if it is intended to be used as an inflate/

32、deflate control, withstand repeated adjustments from zero to 80 kPa (approximately 600 mmHg). 7.3.2 The cuff pressure regulator shall allow control of pressure up to 80 kPa (600 mmHg), in increments of not more than 1.3 kPa (10 mmHg). 7.3.3 Adjustment of the cuff pressure regulator shall be followed

33、 within 5 s by stabilization of the cuff pressure gauge reading. 7.3.4 If means of leak compensation is provided the greatest fall in pressure shall not exceed 2.6 kPa (20mmHg), when tested in accordance with Appendix F. 7.3.5 The time to inflate to 75 kPa (540 mmHg) from atmospheric pressure shall

34、not exceed 5 s. The time to deflate from 80 kPa (600 mmHg) to 1.3 kPa (10mmHg) shall not exceed 5 s. 8 Mobile tourniquet equipment When tested in accordance with Appendix G, the apparatus shall either: a) not overbalance when in the condition intended for normal use and tilted through an angle of 10

35、 ; or b) not overbalance when in the condition intended for normal use when tilted through an angle of 5 , and when in the condition intended for transport and tilted through an angle of 10 see 9.3 b) and 9.3 c). 9 Marking 9.1 The following shall be clearly and permanently marked on the inflation un

36、it. a) The number of this British Standard, i.e.BS7088:1989 2) . b) Unambiguous labels identifying every control, gauge and alarm. c) If the control unit is intended for operating two cuffs, the separate identification of each set of cuff pressure controls, gauges and outlet tubing. d) Arrows on rot

37、ating controls, either with the words “Increase” or “Decrease” or with tapered arrow shafts, as appropriate. e) Either the instructions for use, or, if there is insufficient space, the warning “Read instructions before use” or words to this effect. f) An instruction to test gauge accuracy at least m

38、onthly. g) The name of the manufacturer or supplier. 2) Marking BS 7088:1989 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is the

39、refore solely the responsibility of the person making the claim. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable.BS7088:1989 BSI 01-2000 3 9.2 The following shall be clearly and permanently marked on each cuff. a) The number of this

40、British Standard, i.e.BS7088:1989 3) . b) The name of the manufacturer or supplier. c) The size designation in full as specified in 2.1. 9.3 The following shall be clearly and permanently marked on mobile equipment. a) Whether or not the apparatus is fitted with antistatic castors complying with BS

41、2099. b) If the apparatus complies with clause 8 b) but not clause 8 a), a warning that transport should be undertaken only with the apparatus in a prescribed condition. c) If 9.3 b) applies, the prescribed condition shall be marked on the apparatus and/or described in the instructions for use. 10 A

42、ccompanying documents The accompanying documents shall include the following. a) Instructions for use, with warnings printed in bold typeface, and including a test procedure for calibrating the cuff pressure gauge(s) at not less than monthly intervals. b) Instructions for maintenance. c) List of the

43、 spare parts which are made available by the manufacturer, with part number purchasing references. d) Instructions for cleaning, disinfection and, if possible, sterilizing. e) Recommendations on transporting the pneumatic tourniquet while in use in a manner that will prevent accidental disconnection

44、. f) If the apparatus is self-compensating for pressure losses, the maximum leakage rate, expressed in L/min, that can be compensated. g) If the equipment is intended for use with a source of compressed gas, the range of working pressures. 3) See footnote to 9.1 a).BS7088:1989 4 BSI 01-2000 Appendix

45、 A Recommendations on distribution of pressure under the cuff A.1 Distribution of pressure When tested by the procedure given in A.2, the recorded pressures should not deviate by more than20 mmHg from gauge pressures. On no occasion should the time to reach 90 % of maximumpressure exceed 5 s. A.2 Te

46、st for distribution of pressure Take pressure transducers with dimensions not exceeding 10 mm in diameter or 3 mm in depth, accurate to 5 mmHg over the range 100 mmHg to600 mmHg. Place them on a dummy limb (seeAppendix B) in two evenly spaced circles, one on either side of the centre line according

47、to Table 2. If the ends of the inflatable bag overlap, site one of the transducers within the area of overlap. Arrange the transducer centres in one circle to be opposite the mid-point between transducer centres in the second circle. Cover the transducers and cuff area of the dummy limb with two lay

48、ers of orthopaedic wadding. Place the cuff symmetrically on the dummy limb so that centre of the cuff lies over the centre line. Inflate the equipment from zero to each of the pressures given in Table 2. Record the maximum pressure reached by each transducer at each test pressure and the time taken

49、for them to reach 90 % of the maximum reading starting from the time the cuff pressure gauge reads test pressure. Table 2 Test for distribution of pressure Appendix B Test for construction of cuffs and performance of fastenings B.1 Dummy limbs Dummy limbs shall be cylinders of non-compressible material of length 300 mm. Circumference shall be according to the size of cuffto be tested, as follows: Size 1: 120 mm Size 2: 280 mm Size 3: 420 mm Size 4: 600 mm A centre line shall be marked circumferentially along the long axis of each dummy limb. B.2 Procedure