BS 7068-1989 Specification for alternating pressure air mattresses《交变压力气垫规范》.pdf

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1、BRITISH STANDARD BS7068:1989 Specification for Alternating pressure air mattresses UDC615.478.262/.264:615.835:615.478(075.6):3.002.2.004.13:620.1BS7068:1989 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authori

2、ty of the Board of BSI and comes into effect on 30 June 1989 BSI07-1999 The following BSI references relate to the work on this standard: Committee reference HCC/32 Draft for comment85/35146 DC ISBN 0 580 17150 7 Committees responsible for this British Standard The preparation of this British Standa

3、rd was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/32, upon which the following bodies were represented: British Surgical Trades Association Incorporated Department of Health and Social Security Department of Trade and Industry (Metrology and Standards

4、Requirement Committee) King Edwards Hospital Fund for London Textile Research Council Amendments issued since publication Amd. No. Date of issue CommentsBS7068:1989 BSI 07-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Definitions 1 3 Classification 2 4 Materi

5、als and construction 2 5 Operation 4 6 Instructions for use 5 7 Marking 5 Appendix A Conversion of interface and ischaemic pressure in mmHg to kPa 6 Appendix B Recommended information for inclusion in the instruction manual 6 Appendix C Determination of interface pressure on alternating pressure air

6、 mattresses 7 Appendix D Test body 11 Appendix E Durability test 11 Figure 1 Typical alternating pressure air mattresses 3 Figure 2 Indenter (seeC.2.3) and block 8 Figure 3 Interface pressure measuring equipment 10 Figure 4 Indenter position on APAM pad 11 Figure 5 Location of the test body 12 Table

7、 1 Performance requirements for air cell and protective covering materials 4 Table 2 Conversion of mmHg to kPa 6 Publications referred to Inside back coverBS7068:1989 ii BSI 07-1999 Foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Committee, fo

8、llowing a request from the King Edwards Hospital Fund for London. It specifies requirements for alternating pressure air mattresses that are intended for the prevention and treatment of pressure sores of patients. Pressure sores, of which bedsores are the commonest example, are localized areas of ti

9、ssue necrosis caused by ischaemia resulting from pressure which has been maintained for an excessive period of time. These sores usually occur over bony prominences, where the pressures are highest, in patients who are unable to feel pain or who cannot move sufficiently to relieve pressure. Sick pat

10、ients are less able to withstand pressure than healthy people and, for a very sick person, less than30min of ischaemia caused by pressure may be sufficient to occasion a sore. Alternating pressure air mattresses have been employed for many years in the National Health Service as an aid to the preven

11、tion and treatment of pressure sores and, whilst clinical trials have demonstrated the major benefits of using them, certain problems with these mattresses have contributed towards their poor reputation with some experts. These problems include the poor reliability of some models which fail within a

12、 few months of service due to breakdown of motors and pumps, rupture of air cells, disconnection of air tubes, etc. and the tendency to set incorrectly the internal air pressure which, in most cases, needs to be adjusted to the size and weight of the patient. However, for the latter, a patients body

13、 mass is not usually known with sufficient accuracy to enable the nursing staff to make the required fine adjustments of the controls. To help overcome these problems, the King Edwards Hospital Fund for London set up a working group which recommended that a British Standard specification for alterna

14、ting pressure air mattresses should be prepared with the aim of improving the reliability and performance of these mattresses. In the preparation of this standard certain factors have been identified as requiring further investigation to develop fully the requirements for alternating pressure air ma

15、ttresses. The principal factor still to be determined is the relationship between the inflation pressure and the interface pressure, with the possibility of realizing the ideal situation, from a control point of view, of a single inflation pressure to provide the correct range of interface pressures

16、 without the need for adjustment by nursing staff. The results of such investigations, when they become available, may form the basis of amendment or revision of this standard. Meanwhile this standard includes a description of a method for measuring the interface pressures between an alternating pre

17、ssure mattress and an indenter which has dimensions and loading that allow it to act as a representation of a test body. This test method is applicable to all current types of alternating pressure air mattresses and requires the measurement of the minimum and maximum values of the interface pressure

18、 that are developed by the mattress under test. It is also suitable for the measurement of interface pressure developed between other types of mattress and the indenter. Another factor considered by the responsible Technical Committee was the need to stipulate that, in a hospital ward environment, t

19、he “A” weighted sound pressure level produced by an alternating pressure air mattress when operating in accordance with the manufacturers instructions should not exceed55dB and, for more than90% of its running time, should not exceed45dB. (These limits are not incompatible with those specified in DH

20、SS Health Notice HN(76)126.) However the committee had insufficient evidence to relate sound pressure levels to the sound power levels which would be measurable by reference to BS4196. Moreover, there was little evidence to enable sound pressure limits to be specified for other environments. When su

21、ch evidence becomes available, it will be considered as the basis for amendment of the standard.BS7068:1989 BSI 07-1999 iii This standard is directed at establishing adequate performance of alternating pressure air mattresses in use but, because of the need to ensure the electrical safety of the use

22、r, it also requires the pump unit to comply with BS5724-1. Experience has shown with many patients that alternating pressure air mattresses which comply with this standard can prevent pressure sores developing. However, these mattresses will not always do so, although the severity of sores will usua

23、lly be reduced. Interface and ischaemic pressures are normally expressed in millimetres of mercury (mmHg). To avoid confusion and the possible mis-setting of the mattress pressure, mmHg is used consistently in this standard but, for convenience, conversion of mmHg to the derived SI unit, the kilopas

24、cal (kPa), for pressure is given in Appendix A. Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity with this British Standard based on testing and continuing surveillance, which may be coupled with assessm

25、ent of a suppliers quality systems against the appropriate Part of BS5750. Enquiries as to the availability of third party certification schemes will be forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does not already exist, users should consider ap

26、proaching an appropriate body from the list of Association members. 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 immuni

27、ty from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages1 to12, 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 ame

28、ndment table on the inside front cover.iv blankBS7068:1989 BSI 07-1999 1 1 Scope This British Standard specifies materials, construction and operation requirements for unheated alternating pressure air mattresses (APAM), manufactured from pre-formed sheet material, for use in health care premises an

29、d in the home. Two grades of APAM, grade A and grade B, are specified, differing only in the breaking strength of the mattress material. The alternating pressure air mattresses specified in this standard are suitable for use with adult patients of mass not exceeding95kg, and are suitable for use wit

30、h mattresses complying with BS5223-1 and BS5223-2 and with bedsteads complying with BS4886. NOTEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Definitions For the purposes of this British Standard the following definitions apply. 2.1 alternating pr

31、essure air mattresses (APAM) a mattress assembly with a pressure pad area, for use on a firm base, consisting of a system of cells in any formation which is intended by means of sequential air inflation and deflation to vary, in a controlled manner, the supporting points of pressure under a patients

32、 body, so that no one point or set of points of contact with the body will produce ischaemic pressure of long enough duration to lead to tissue damage. The cells of the mattress are inter-connected (e.g.by means of side tubes), typically to form an alternating series. A switching arrangement permits

33、 air to be pumped firstly into one set of cells and then into the next, while the pressure in the first set is reduced, so that during a cycle each group of adjacent cells is inflated and then deflated to a pressure below that likely to cause tissue damage the term alternating pressure air mattress,

34、 as used throughout this standard, includes the entire equipment for this purpose: i.e.pressure pad area, protective covering, pump, motor, tubing, connectors, etc. NOTETypical alternating pressure air mattresses are shown in Figure 1. 2.2 grounding the state where the pressure in the mattress is in

35、sufficient to support the test body or test subject, allowing it to rest on the underlying surface 2.3 hammocking the effect created by a load placed on to a flexible supported surface such that topographical distortion of the surface takes place until the equilibrium state is established at which t

36、he load is supported 2.4 indenter a simple model of part of a human body lying on its side, essentially comprising three hemispherical domes connected by two hemicylinders; the domes represent respectively the prominences of the shoulder, hip and knee and the cylinders the torso and the thigh (see F

37、igure 2) 2.5 maximum inflation pressure the maximum pressure applied internally to the air cells of the mattress at their maximum distension 2.6 interface pressure the pressure that exists between the surface of the skin of the patient and a supporting surface 2.7 pressure cycle the change of pressu

38、re in an air cell from the point of maximum inflation pressure to deflation and back 2.8 relief area the area corresponding to those air cells of an alternating pressure air mattress at their lower levels of inflation whilst support is given to the patient principally by cells at a higher level of i

39、nflation 2.9 lateral lying with the front of the body towards the side 2.10 recumbent lying down with the body in the horizontal plane and the head supported by not more than two pillows 2.11 semi-recumbent lying down with the upper part of the body supported at an angle to the horizontal (for examp

40、le, by three or more pillows) but with the rest of the body in the horizontal planeBS7068:1989 2 BSI 07-1999 2.12 supine lying with the front of the body uppermost 3 Classification APAM, for which compliance with this standard is claimed, shall be classified into the following grades: Grade A, const

41、ructed of material having a breaking strength (see Table 1) of not lower than600N/S0mm; Grade B, constructed of material having a breaking strength (see Table 1) of not lower than200N/50mm. 4 Materials and construction 4.1 Dimensions and unsupported area 4.1.1 The pressure pad area of an alternating

42、 pressure air mattress shall be a minimum of1.8m long and a minimum of0.75m wide when inflated for normal use. 4.1.2 During a pressure cycle, the surface of each air cell (see Figure 1) which is at its lowest pressure shall not exceed120mm in its shortest dimension and shall not exceed900mm in its l

43、ongest dimension. These areas shall not be surrounded completely by an area at the highest pressure. 4.2 Air cells and protective coverings 4.2.1 Air cells and any protective covering supplied with the mattress shall be constructed from flexible material as specified in Table 1. The tests referred t

44、o in Table 1 and those described in4.2.2 to4.2.5 below shall each be carried out on separate pieces of the mattress material. 4.2.2 Joins and welded material shall have not less than75% of the values of breaking strength, tear strength and bursting strength given in Table 1 when tested both along an

45、d across the joined section. 4.2.3 After heating the material for168 4h in an aircirculating oven at75 3 C and allowing it to cool to ambient temperature over a period of not less than3h, the material shall have retained not less than75% of its original values for breaking strength, tear strength an

46、d bursting strength. 4.2.4 After totally immersing the material in70% (V/V) aqueous ethanol at20 2 C for303min and then thoroughly rinsing with water and drying at the ambient temperature, the material shall have retained not less than75% of its original values for the properties listed in Table 1,

47、with the exception that the colour fastness shall be not worse than grade3. 4.2.5 After totally immersing the material in an aqueous solution of laboratory reagent grade sodium hypochlorite, containing2g of available chlorine per litre, at20 2 C for101min and then thoroughly rinsing with water and d

48、rying at the ambient temperature, the material shall have retained not less than75% of its original values for the properties listed in Table 1, with the exception that the colour fastness shall be not worse than grade3. 4.3 Tubing 4.3.1 The tubing, which shall be of flexible material, shall show no

49、 kinking when, with minimal tension, it is wrapped for one complete turn, around a mandrel of diameter three times the outside diameter of the tubing. The rate of flow of air through a1m straight length of tubing, at a pressure difference of50mmHg, shall not be reduced by more than50% when the tubing is wrapped for one complete turn around a mandrel of diameter three times the outside diameter of the tubing. NOTEThis requirement is intended to ensure that the tubing will be resistant to any kinking which is likely to occur in use (for example, if