ASTM F2428-2004 Standard Guide for Selection and Use for Pelvic Ring Circumferential Compression Stabilization Devices (PRCCSD)《骨盆环状面压缩稳定设备的选择和使用的标准指南》.pdf

1、Designation: F 2428 04Standard Guide forSelection and Use for Pelvic Ring CircumferentialCompression Stabilization Devices (PRCCSD)1This standard is issued under the fixed designation F 2428; the number immediately following the designation indicates the year oforiginal adoption or, in the case of r

2、evision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide establishes minimum standards for devicesdesignated here as pelvic ring circumferenti

3、al compressionstabilization devices(s) (PRCCSD), commonly known as pel-vic slings, belts, or binders. The PRCCSD is used as the initialpelvic ring stabilization device on patients suspected of havingsustained traumatic disruptions of the pelvic ring. It is usedduring patient transport by emergency p

4、ersonnel and beforedefinitive treatment.1.2 This guide addresses the recognized need to reduce andstabilize pelvic ring disruptions through the use of circumfer-ential compression devices.1.3 Peer-reviewed medical literature does describe specifictesting methods used to determine the range of effect

5、ivecompression force, efficacy in reduction, stability, and safetyfor a particular (PRCCSD). This guide, however, does notidentify specific testing methods as it is recognized suchmethods could vary according to device configuration andstudy design.1.4 This guide does not address individual quantita

6、tiveperformance standards for any particular device, but doesaddress general performance standards and good practicecharacteristics for all devices using circumferential compres-sion to reduce and stabilize disruptions of the pelvic ring.1.5 This standard does not purport to address all of thesafety

7、 concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and to determine theapplicability of regulatory limitations prior to use.2. Terminology2.1 Definitions:2.1.1 circumferential compression force, ninfl

8、uence thatdeforms an object by shortening its circumference.2.1.2 compression force, ninfluence that deforms an ob-ject by making it smaller or shorter.2.1.3 controlled level of force, nforce confined withincertain defined limits.2.1.4 disruption of the pelvic ring, nany traumatic alter-ation of the

9、 normal anatomic relationships of the bony struc-tures forming the pelvic ring. Included in these disruptions arefractures, dislocations, subluxation, and diastasis.2.1.5 effective level of force, nthat range of quantifiedforce required by the particular pelvic ring circumferentialcompression stabil

10、ization device (PRCCSD) to reduce andstabilize disruptions of the pelvic ring in the 95thpercentile ofadult American males.22.1.6 immobilization, nlimitation of motion.2.1.7 pelvic ring, nnormal anatomic ring-shaped structureformed by three bones: two innominate bones (each made up ofthe ilium, isch

11、ium, and pubis) and the sacrum.2.1.8 reduction, nreturning anatomic structures to theirnormal anatomic position.2.1.9 retention system, nan adjunct to or an integral partof the primary platform that allows the patient to be securelyattached to that platform, used in whatever configuration andsize ne

12、cessary to accomplish the goal, while still allowingreasonable and necessary access to the patient.2.1.10 safe level of circumferential compression force,nthat range of quantified force producing a resultant effect inwhich no undue alteration of the normal anatomic relationshipof the pelvic ring occ

13、urs.2.1.11 stabilize, vmaintaining in a firm, constant, or fixedstate.2.1.12 spinal immobilization system, ndevice(s) that im-mobilize the spine and contiguous structures, the pelvis, andthe skull.3. Significance and Use3.1 The intent of this guide is to identify the generalperformance and good prac

14、tice standards that a pelvic ringcircumferential compression stabilization device (PRCCSD)should possess.3.2 Currently, a number of base platforms such as full-bodyspinal immobilization devices (long boards) are used to immo-bilize patients during transport and before definitive treatment.These plat

15、forms limit gross movements of the spine and pelvis1This guide is under the jurisdiction of ASTM Committee F30 on EmergencyMedical Services and is the direct responsibility of Subcommittee F30.01 on EMSEquipment.Current edition approved Oct. 1, 2004. Published October 2004.2The Handbook of Adult Ant

16、hropometric and Strength Measurements Data forDesign Safety, University of Nottingham, University Park, Nottingham NG7 2RDUnited Kingdom.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.but do not specifically reduce and stabilize dis

17、ruptions of thepelvic ring. The PRCCSD applied circumferentially about thepatient exerts a compressive force to reduce and stabilizedisruptions of the pelvic ring.3.3 The PRCCSD may be used alone but, according toclinical situations, will commonly be used in conjunction withdifferent supporting base

18、 platforms during transport and beforedefinitive treatment.3.4 The PRCCSD, when circumferentially applied, shouldbe centered at the level of the greater trochanters and symphsispubis.33.5 A device intended for use with adult patients shallaccommodate the 95thpercentile adult American male.23.6 The d

19、evice should be able to be applied by a singlepractitioner.4. Characteristics4.1 When applied, the PRCCSD shall accommodate the95th percentile adult American male patient.24.2 The PRCCSD should be configured to allow ease ofapplication by a single practitioner.4.3 The PRCCSD should be sufficiently r

20、adiolucent to allowgood quality X-rays.4.4 The PRCCSD, when affixed about a patient, shall becapable of applying a controlled level of circumferentialcompression force.4.5 The PRCCSD, when affixed about a patient, shall becapable of applying an effective level of circumferentialcompression force.4.6

21、 The controlled level of circumferential compressionforce applied by the PRCCSD to the pelvic ring should notexceed a safe level of circumferential compression force.4.7 The design of the PRCCSD should allow access forurinary catheterization.4.8 The design of the PRCCSD should allow access to thefem

22、oral vessels.4.9 The design of the PRCCSD should allow access to thepelvic ring for purposes of external fixation.4.10 The design of the PRCCSD should facilitate and notimpede movement of the patient across the surface of supportplatforms such as spine boards or stretchers.4.11 The design of the PRC

23、CSD should not impede the useof other spinal immobilization systems.4.12 The PRCCSD, when applied, shall not alter the posi-tion of the patients spine.4.13 The PRCCSD should be packaged with instructionsdescribing application and removal protocols.4.14 When the PRCCSD is applied on a patient, the pr

24、essureexerted by the PRCCSD on the patients skin shall not exceed32 mm Hg.44.15 When a PRCCSD is applied for an extended period, aregular skin inspection protocol should be used.4.16 The PRCCSD should support reasonable air and mois-ture transmission.5. Durability5.1 The PRCCSD should be functional

25、over the extremerange of normal ambient temperatures.5.2 The function of the PRCCSD should not be affected bychanges in altitude.6. Maintenance6.1 The PRCCSD shall be disposable or easily cleaned,consistent with Center for Disease Control (CDC) and Occu-pational Safety open book fracture; pelvicfrac

26、ture3Bottlang, M., Krieg, J. C., Mohr, M., Simpson, T. S., and Madey, S. M.,“Emergent Management of Pelvic Ring Fractures with Use of CircumferentialCompression,” Journal of Bone and Joint Surgery, Vol 84-A (Supplement 2), 2002,pp. 43-47.4Landis, E.M., “Micro-Injection Studies of Capillary Blood Pre

27、ssure in HumanSkin,” Heart, Vol 18, 1929, pp. 209-228.F2428042ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such

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30、ir hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F2428043